Proactiveinvestors USA & Canada Hemispherx Biopharma Inc https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Hemispherx Biopharma Inc RSS feed en Wed, 22 May 2019 07:55:55 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Hemispherx Biopharma’s well-funded to take promising cancer drug Ampligen through clinical trials ]]> https://www.proactiveinvestors.com/companies/news/220438/hemispherx-biopharmas-well-funded-to-take-promising-cancer-drug-ampligen-through-clinical-trials-220438.html Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) revealed Thursday that it has boosted its cash pile impressively through May to shoulder a series of trials evaluating the company's promising cancer drug Ampligen at major cancer research hospitals.

The Orlando, Florida-based biotech said stockholders participated in a rights offering to raise $5.3 million. Therefore, as of March 31, Hemispherx had cash and cash equivalents of $4.9 million, compared with $1.8 million as of December 31, 2018.

READ: Hemispherx Biopharma says FDA authorizes study using aspirin and flagship drug ampligen to treat prostate cancer

"When our management team began three years ago, Hemispherx identified four significant steps we needed to take to make our company a success,” said Hemispherx CEO Thomas K Equels. “First, raise the funds necessary to produce our drug candidate, Ampligen, for use in immuno-oncology clinical trials and other programs. Second, produce adequate supplies of Ampligen to conduct such trials. Third, initiate multiple immuno-oncology clinical trials. We have now accomplished each of these steps and are using Ampligen to treat cancers in clinical trials.”

Seeking big pharma partnerships

Equels says “now is the time” for the company to seek out big pharma partners who share the company’s “excitement and enthusiasm” for the potential of Ampligen.

“We believe that success in these trials will create the environment for that goal,” said Equels. “Accomplishing success in R&D is based on such progress."

Hemispherx recently announced significant progress in multiple Ampligen-plus-checkpoint-blockade immuno-oncology programs.

Multiple trials underway

It has been a busy spell for the company with the following trials underway:

Initiated a 45-patient clinical study in ovarian cancer at University of Pittsburgh Medical Center combining Ampligen, cisplatin and pembrolizumab, data expected by 2021. Initiated a 12-patient clinical study in colorectal cancer at Roswell Park Comprehensive Cancer Center combining Ampligen, Intron A, and celecoxib, data expected by 2020. Initiated a six-patient clinical study in triple negative breast cancer at Roswell Park Comprehensive Cancer Center combining with Ampligen, Intron A, celecoxib and pembrolizumab, data expected by 2020. Extended the Early Access Program (EAP) at the Erasmus Medical Center in the Netherlands using Ampligen in the treatment of patients with pancreatic cancer. The EAP is approved by the Dutch Health Inspectorate until March 9, 2020 to treat pancreatic cancer patients diagnosed with any stage of the serious disease. Patients receive Ampligen as a maintenance therapy after completing standard care.  An additional round of comprehensive pre-clinical animal pancreatic cancer studies were initiated at the University of Nebraska to reconfirm the successful results seen in the initial animal studies. Received an interim report on a recurrent Ovarian Cancer Phase 1/2 study of intraperitoneal chemo-immunotherapy at University of Pittsburgh Medical Center. The Phase 2 study of neoadjuvant conditioning of prostate cancer using Ampligen as a component of chemokine modulation at Roswell Park Comprehensive Cancer Center has received authorization to proceed by the FDA.

Research and development manufacturing-related expenses for the first quarter were $0.93 million, an 8% increase compared with $0.86 million for the first quarter of 2018. The increase was due to Ampligen related stability testing and maintenance.

The net loss from continuing operations for the first quarter was $3.36 million, or $0.07 per share, compared with $2.71 million, or $0.07 per share, for the same period a year ago.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

]]>
Thu, 16 May 2019 09:45:00 -0400 https://www.proactiveinvestors.com/companies/news/220438/hemispherx-biopharmas-well-funded-to-take-promising-cancer-drug-ampligen-through-clinical-trials-220438.html
<![CDATA[News - Hemispherx Biopharma says FDA authorizes study using aspirin and flagship drug ampligen to treat prostate cancer ]]> https://www.proactiveinvestors.com/companies/news/220151/hemispherx-biopharma-says-fda-authorizes-study-using-aspirin-and-flagship-drug-ampligen-to-treat-prostate-cancer-220151.html Hemispherx Biopharma Inc. (NYSEAMERICAN:HEB) announced Monday that federal regulators will allow the company to proceed with a Phase 2 study of combining aspirin and its flagship drug ampligen to treat prostate cancer.

The study authorized by the US Food and Drug Administration will be carried out at the Roswell Park Comprehensive Cancer Center in Buffalo, New York, involving up to 60 patients, the company said in a statement.

“This positive progress in commencing a new prostate cancer clinical trial is just one more step in our focused plan for R&D success," said CEO Thomas Equels.

READ: Hemispherx sees potential commercialization of flagship drug ampligen for Chronic Fatigue Syndrome

Hemispherx says the study will investigate the effectiveness and safety of aspirin and ampligen with or without drug interferon-alpha 2b (used to treat hepatitis and cancer) compared to no drug treatments in a randomized, three-arm study of patients with prostate cancer before they undergo radical prostatectomy.

The Orlando, Florida-based biotech said aspirin may help to keep the prostate cancer from recurring, while ampligen may stimulate the immune system and interfere with the ability of tumor cells to proliferate. Interferon-alpha 2b may improve the body’s natural response to infections and may slow tumor growth.

It is not yet known how well ampligen, aspirin, and interferon-alpha 2b will work in treating patients with prostate cancer undergoing surgery, the company added.

Hemispherx is studying ampligen to treat ovarian cancer and whether the drug is effective in treating breast cancer in combination with Merck’s (NYSE:MRK) cancer drug keytruda.

Equels said the amount of clinical trials showing progress with ampligen gives the company confidence that “now is the time for us to seek out big pharma partners who share our excitement and enthusiasm for the potential of ampligen.”

Hemispherx's stocks recently trade up 3% to $0.15 a share.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

]]>
Mon, 13 May 2019 09:36:00 -0400 https://www.proactiveinvestors.com/companies/news/220151/hemispherx-biopharma-says-fda-authorizes-study-using-aspirin-and-flagship-drug-ampligen-to-treat-prostate-cancer-220151.html
<![CDATA[News - Hemispherx sees potential commercialization of flagship drug ampligen for Chronic Fatigue Syndrome ]]> https://www.proactiveinvestors.com/companies/news/219723/hemispherx-sees-potential-commercialization-of-flagship-drug-ampligen-for-chronic-fatigue-syndrome-219723.html Hemispherx Biopharma Inc’s (NYSEAMERICAN:HEB) flagship drug ampligen is approved only in Argentina to battle myalgic ncephalomyelitis, commonly called Chronic Fatigue Syndrome, or ME/CFS. And the company has been seeking ways to expand the drug’s commercialization to treat the disease.

On Monday, the Orlando, Florida-based biotech said it is hopeful about the drug's potential expanded use given a recent Stanford University real-time diagnostic test of patients suffering from ME/CFS. Stanford researchers conducted blood-based test on 20 patients, the company said. 

The news pushed Hemispherx’s stock up more than 8% to $0.18 in midday trade.

READ: Hemispherx Biopharma's stock soars on 'significant progress' in ovarian cancer study of Ampligen

People with the disease experience symptoms such as fatigue, sleep abnormalities and pain. But ME/CFS is notoriously hard to diagnose. The disease is diagnosis of exclusion, which means that all other conditions and illnesses that cause the system are ruled out.

The Stanford study essentially demonstrated “an ability to identify moderate to severe ME/CFS patients from normal controls,” the company said.

CEO Thomas Equels called the Stanford study a potential landmark in that “ME/CFS has been thought of by many as a psychological disorder without a physical basis, leaving ME/CFS sufferers with the pain of the disease and a sense of hopelessness. This diagnostic creates a new paradigm of hope for therapy for those with the disease.”

Hemispherx called getting ampligen approved for ME/CFS in the US a "corporate goal.”

Equels said in the statement that the company looks “ forward to the day when we can incorporate such a diagnostic platform into our own clinical testing for ME/CFS. We have the only late-stage drug candidate in the FDA pipeline and have been asked to do a confirmatory clinical trial.”

In the US, Hemispherx sponsors an Expanded Access Program (EAP), known as AMP-511, in which the US Food and Drug Administration has authorized use of ampligen in ME/CFS patients in an effort to expand compassionate care in the absence of commercially approved therapy, the company said.

Hemispherx is studying ampligen to treat ovarian cancer and whether the drug is effective in treating breast cancer in combination with Merck’s (NYSE:MRK) cancer drug Keytruda.

--UPDATED share price--

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @patrickmgraham

]]>
Mon, 06 May 2019 09:50:00 -0400 https://www.proactiveinvestors.com/companies/news/219723/hemispherx-sees-potential-commercialization-of-flagship-drug-ampligen-for-chronic-fatigue-syndrome-219723.html
<![CDATA[Media files - Hemispherx BioPharma reports positive results on ovarian cancer treatment ]]> https://www.proactiveinvestors.com/companies/stocktube/13171/hemispherx-biopharma-reports-positive-results-on-ovarian-cancer-treatment-13171.html Wed, 01 May 2019 08:40:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13171/hemispherx-biopharma-reports-positive-results-on-ovarian-cancer-treatment-13171.html <![CDATA[News - Hemispherx Biopharma's stock soars on 'significant progress' in ovarian cancer study of Ampligen ]]> https://www.proactiveinvestors.com/companies/news/219389/hemispherx-biopharma-s-stock-soars-on--significant-progress--in-ovarian-cancer-study-of-ampligen-219389.html Shares of Hemispherx Biopharma (NYSEAMERICAN:HEB) soared Tuesday after the company announced “significant progress” in the study of its flagship drug Ampligen in treating ovarian cancer.

Hemispherx’s stock recently traded at $0.24 a share, up 41% on heavy volume.  

READ: Hemispherx Biopharma kicks off Phase 1 trial to treat advanced breast cancer with key drug Ampligen

The study currently is being conducted at the University of Pittsburgh Medical Center (UPMC), the company said in statement.

The Orlando, Florida-based company also noted it is now accruing patients for a second ovarian cancer clinical trial at UMPC to evaluate Ampligen in combination with drug Pembrolizumab.

Hemispherx also is studying separately whether Ampligen is effective in treating breast cancer in combination with Merck’s (NYSE:MRK) cancer drug Keytruda.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @patrickmgraham

]]>
Tue, 30 Apr 2019 09:46:00 -0400 https://www.proactiveinvestors.com/companies/news/219389/hemispherx-biopharma-s-stock-soars-on--significant-progress--in-ovarian-cancer-study-of-ampligen-219389.html
<![CDATA[Media files - Hemispherx Biopharma appoints Ellen Lintal as chief accountant ]]> https://www.proactiveinvestors.com/companies/stocktube/13093/hemispherx-biopharma-appoints-ellen-lintal-as-chief-accountant-13093.html Wed, 24 Apr 2019 12:12:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13093/hemispherx-biopharma-appoints-ellen-lintal-as-chief-accountant-13093.html <![CDATA[News - Hemispherx Biopharma promotes Ellen Lintal to chief accountant post ]]> https://www.proactiveinvestors.com/companies/news/218893/hemispherx-biopharma-promotes-ellen-lintal-to-chief-accountant-post-218893.html Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) has tapped Ellen Lintal as its new chief accounting officer.

Lintal joined the Florida biopharmaceutical group in 2018 as a vice-president of finance and control.

READ: Hemispherx Biopharma kicks off Phase 1 trial to treat advanced breast cancer with key drug Ampligen

Prior to coming on board at Hemispherx, Lintal spent a decade at an undisclosed international non-profit organization, where she served as a chief financial officer and a senior vice-president of finance and control. Her career also includes accounting experience while working for Corning, the Carlisle Companies and AGY.

“Ms. Lintal has done a superb job since arriving at Hemispherx and will make an excellent chief accounting officer,” said CEO Thomas Equels in a statement.

Hemispherx is focusing its research and development efforts on advancing its flagship cancer drug Ampliglen as an immuno-therapy. The drug is currently being evaluated to treat nine different types of tumors.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

 

]]>
Mon, 22 Apr 2019 08:23:00 -0400 https://www.proactiveinvestors.com/companies/news/218893/hemispherx-biopharma-promotes-ellen-lintal-to-chief-accountant-post-218893.html
<![CDATA[Media files - Hemispherx Biopharma doses first patient with Ampligen in Phase 1 advanced breast cancer study ]]> https://www.proactiveinvestors.com/companies/stocktube/12896/hemispherx-biopharma-doses-first-patient-with-ampligen-in-phase-1-advanced-breast-cancer-study-12896.html Fri, 05 Apr 2019 16:09:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12896/hemispherx-biopharma-doses-first-patient-with-ampligen-in-phase-1-advanced-breast-cancer-study-12896.html <![CDATA[News - Hemispherx Biopharma kicks off Phase 1 trial to treat advanced breast cancer with key drug Ampligen ]]> https://www.proactiveinvestors.com/companies/news/217775/hemispherx-biopharma-kicks-off-phase-1-trial-to-treat-advanced-breast-cancer-with-key-drug-ampligen-217775.html Hemispherx (NYSEAMERICAN:HEB) on Tuesday said a Phase 1 clinical trial to test its flagship cancer drug Ampligen in combination with Merck’s blockbuster cancer drug Keytruda for the treatment of advanced breast cancer has kicked off at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

The study’s first participant received initial dosing this week and the trial is looking to enroll at least six patients.

Hemispherx shares traded 1.8% higher before the opening bell on Tuesday to hit $0.17.

READ: Hemispherx Biopharma makes headway in advancing flagship cancer drug Ampligen in 2018

"We are very excited to see the first patient treated as part of this important clinical trial evaluating Ampligen in combination with Keytruda (pembrolizumab) in patients with metastatic triple-negative breast cancer. We could not ask for better partners than the world-class team at Roswell Park Comprehensive Cancer Center, as we seek to evaluate the impact of the combined therapy on this high risk and very sick patient population,” said Hemispherx CEO Thomas Equels in a statement.

The study’s lead investigators Drs. Mateusz Opyrchal and Pawel Kalinski of Roswell Park will evaluate the impact of Ampligen-based chemokine modulation therapy when given prior to the checkpoint blockade therapy Keytruda (pembrolizumab) in the treatment of patients with metastatic triple-negative breast cancer.

The Roswell team is undertaking the study to determine whether this approach can modify the tumor microenvironment to convert previously ‘cold’ tumors not susceptible to checkpoint blockade therapy into ‘hot’ tumors which are primed for checkpoint-blockade therapies.

"Our extensive work with Ampligen has led many top oncologists to conclude, including in peer-reviewed medical journal articles, that Ampligen has the potential to change the tumor microenvironment,” said Equels. “Making tumors easier targets for checkpoint blockade therapies creates an exciting new approach with the potential to significantly improve clinical outcomes for patients in multiple solid tumor cancer types."

Contact Ellen Kelleher at ellen@proactiveinvestors.com

]]>
Tue, 02 Apr 2019 09:14:00 -0400 https://www.proactiveinvestors.com/companies/news/217775/hemispherx-biopharma-kicks-off-phase-1-trial-to-treat-advanced-breast-cancer-with-key-drug-ampligen-217775.html
<![CDATA[News - Hemispherx Biopharma makes headway in advancing flagship cancer drug Ampligen in 2018 ]]> https://www.proactiveinvestors.com/companies/news/217766/hemispherx-biopharma-makes-headway-in-advancing-flagship-cancer-drug-ampligen-in-2018-217766.html Hemispherx Biopharma Inc (NYSE American:HEB) late on Monday revealed it has made considerable headway in advancing the development of its flagship cancer drug candidate Ampligen as it announced its financial results for 2018.

High on its list of achievements in 2018 was the signing of an agreement with Roswell Park Comprehensive Cancer Center in Buffalo, New York to evaluate Ampligen together with checkpoint inhibitors in the fight against bladder cancer, melanoma and renal cell carcinoma.

READ: Hemispherx rises as five trials for cancer drug Ampligen kick off this year

The Ocala, Florida drug maker also expanded its production to provide a supply of Ampligen for clinical and expanded access programs in the US, Canada, Europe and a commercial program in Argentina.

As of the close of 2018, two trials evaluating Ampligen were underway at a pair of major cancer research centers to test in humans whether Ampligen can be used to change the tumor microenvironment and increase the effectiveness of cancer immunotherapy like checkpoint blockade.

The first is a Phase 2A study treating patients with colorectal cancer that has spread to the liver at Roswell Park Comprehensive Cancer Center. The second is a Phase ½ study to test Ampligen as a combination therapy with chemo-immunotherapy for patients with recurrent ovarian cancer at the University of Pittsburgh Medical Center.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

Looking ahead to other clinical trials in the US, Hemispherx is also working with the University of Pittsburgh Medical Center, Roswell Park's Comprehensive Cancer Center and the University of Nebraska Medical Center— to study Ampligen in pre-clinical and clinical studies for the treatment of nine cancer types: renal cell carcinoma, melanoma, non-small cell lung cancer, ovarian, breast, colorectal, urothelial, prostate and pancreatic cancer.

On top of this, the Florida company is also supplying Ampligen to an Expanded Access program in Europe at the Erasmus Medical Center in the Netherlands, which is treating pancreatic cancer patients with Ampligen.

Financial results in focus

The company’s research and development expenses in 2018 came to $4.78 million compared with $4.098 million in 2017.

In other news, its net loss from continuing operations amounted to $9.81 million, or $0.22 per share, against $8.259 million, or $0.29 per share, in 2017. The increase in the loss stemmed partly from manufacturing expenses for the 16,000 vials of Ampligen filled and finished in 2018.

As of December, Hemispherx had cash and cash equivalents of $1.825 million.

Hemispherx’s two key drugs are Ampligen, which fights both cancer and chronic fatigue syndrome, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Hemispherx shares closed up 1.88% to finish at $0.16 on Monday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

 

]]>
Tue, 02 Apr 2019 08:01:00 -0400 https://www.proactiveinvestors.com/companies/news/217766/hemispherx-biopharma-makes-headway-in-advancing-flagship-cancer-drug-ampligen-in-2018-217766.html
<![CDATA[Media files - Hemispherx Biopharma updates on current trials, gears up to begin 5 more ]]> https://www.proactiveinvestors.com/companies/stocktube/12623/hemispherx-biopharma-updates-on-current-trials-gears-up-to-begin-5-more-12623.html Fri, 15 Mar 2019 10:21:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12623/hemispherx-biopharma-updates-on-current-trials-gears-up-to-begin-5-more-12623.html <![CDATA[News - Hemispherx rises as five trials for cancer drug Ampligen kick off this year ]]> https://www.proactiveinvestors.com/companies/news/216405/hemispherx-rises-as-five-trials-for-cancer-drug-ampligen-kick-off-this-year-216405.html Hemispherx Biopharma Inc (NYSE American:HEB) updated investors Wednesday on the progress being made with its cancer drug candidate Ampligen which is being evaluated as part of a series of trials at major cancer research institutions.

The Ocala, Florida-based biopharmaceutical company also said that five Ampligen trials are set to kick off this year, subject to funding.

READ: Hemispherx Biopharma gets green light from Dutch health regulators to extend access program for Ampligen to pancreatic cancer patients

The company is now focusing on the use of Ampligen (rintatolimod) as an immuno-therapy as preclinical and early clinical evidence showcases the drug’s potential in the battle against cancer.

So far, nine trials in the US involving Ampligen in combination with checkpoint blockade therapies are in “various stages of advancement” at important cancer research centers, including the Roswell Park Comprehensive Cancer in Buffalo, New York and the University of Pittsburgh Medical Center.

In Europe, Ampligen is also being assessed as a way to treat advanced pancreatic cancer as part of an early access program at the Erasmus Medical Center in Rotterdam, the Netherlands. 

Investors applauded the update, sending Hemispherx shares up 12.1% to $0.18 in morning trade Wednesday.

“We believe steady progress in these combination therapy clinical trials will be an important driver for Hemispherx’s long-term success,” said CEO Thomas Equels in a statement. Scientists involved in the research note that Ampligen has been particularly effective in working with checkpoint blockade therapies such as Merck’s Keytruda (pembrolizumab).

Checkpoint inhibitors function by releasing a natural brake on the immune system so that immune cells called T cells recognize and attack tumors, according to Memorial Sloan Kettering.

“Preclinical studies in mice combining Ampligen with checkpoint inhibitors in various mouse models have yielded very promising results. Transitioning to human tumor explant work has established that Ampligen modifies the human tumor microenvironment by increasing T effector cells without raising T suppressor cell levels, thus creating a better environment for checkpoint therapy,” said Dr David Strayer, chief scientific officer of Hemispherx.

“The objective of our currently ongoing clinical trials is to determine the optimal integration of Ampligen with standard checkpoint inhibitor therapy in the clinic in a variety of solid tumors with the goal of improving survival,” Strayer added.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

The four Ampligen immuno-oncology trials that have already started in the US include a Phase ½ study of chemo-immunotherapy in recurrent ovarian cancer at the University of Pittsburgh Medical Center, with an interim report expected soon.

Also on the list is an open label study of metastatic triple-negative breast cancer using therapy that includes Ampligen and Merck’s blockbuster cancer checkpoint therapy Keytruda (pembrolizumab) at the Roswell Park Comprehensive Cancer Center in Buffalo.

Another University of Pittsburgh study underway is a Phase 2 trial being conducted in advanced recurrent ovarian cancer that will evaluate Ampligen in combination with Keytruda.

Five new Ampligen trials set for this year​

In other news, five Ampligen trials are set to kick off this year, subject to funding. A Phase 2 study is planned that will evaluate Ampligen in combination with Keytruda in refractory metastatic colorectal cancer at Roswell Park.

A second Phase 2 study at Roswell taking aim at advanced bladder, melanoma and renal cancer, which are resistant to checkpoint blockade therapies, will assess Ampligen in combination with a checkpoint blockade therapy at Roswell.

A University of Nebraska study looking at Ampligen in combination with Keytruda as a weapon against non-small cell lung cancer at the University of Nebraska Medical Center is also under development. A Phase 2 study in advanced pancreatic cancer using checkpoint blockade therapy plus Ampligen is in the works too at the University of Nebraska.

Hemispherx’s flagship products include Ampligen, which fights both cancer and chronic fatigue syndrome, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Contact Ellen Kelleher at ellen@proactiveinvestors.com 

 

]]>
Wed, 13 Mar 2019 10:39:00 -0400 https://www.proactiveinvestors.com/companies/news/216405/hemispherx-rises-as-five-trials-for-cancer-drug-ampligen-kick-off-this-year-216405.html
<![CDATA[News - Hemispherx Biopharma takes cancer war to new stage with drug Ampligen ]]> https://www.proactiveinvestors.com/companies/news/216124/hemispherx-biopharma-takes-cancer-war-to-new-stage-with-drug-ampligen-216124.html At the core of Hemispherx Biopharma Inc's (NYSEAMERICAN:HEB) business is its flagship drug Ampligen (rintatolimod), an experimental ribonucleic acid that is in clinical trials to address both chronic fatigue syndrome and to treat multiple cancers.

Since taking over at the helm of the Ocala, Florida-based company in March 2016, CEO Tom Equels has engineered a turnaround and is now steering a course for the company that involves marketing Ampligen as a treatment for chronic fatigue while also applying the drug against cancer, given the strength it has shown in battling solid tumors.

There are a series of cancer trials in various stages underway at major research hospitals to evaluate whether the combination of Ampligen with checkpoint blockade therapies (powerful immunotherapy drugs that block proteins that restrain the body’s immune system from fighting cancer) will improve clinical tumor responses, time to progression and survival rates.

The company is supporting the evaluation of Ampligen’s use in fighting eight solid tumors (urothelial carcinoma, renal cell carcinoma, melanoma, triple-negative breast, colorectal, ovarian, non-small cell lung and pancreatic carcinomas.)

On the list, for example, is a study of Ampligen together with Merck & Co’s (NYSE:MRK) Keytruda on metastatic triple negative breast cancer that is taking place at Roswell Park Comprehensive Cancer Center in Buffalo, New York. Also in play is a Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at the University of Nebraska Medical Center.

A key advantage is that Ampligen shows considerable promise priming the environment for tumor eradication by converting so-called cold tumors, which are more difficult to treat, into hot tumors, which have a better chance of being treated by both the immune system as well as checkpoint blockade therapies.

The company’s second product is Alferon N Injection, its injectable form of natural alpha interferon, which is already FDA-approved for the treatment of genital warts, a sexually-transmitted disease. But its commercialization is not as advanced as Hemispherx focuses on Ampligen.

How is it doing?

Hemispherx is not only generating considerable attention in the scientific community, it’s attracting supporters on Wall Street.

In a note to investors sent in October of 2018, Edward Woo, an analyst with Ascendiant Capital Markets, kicked off coverage of the stock with a Buy rating and a $0.75 price target.

While Hemispherx operates in a “highly competitive environment” such concerns are outweighed by Ampligen’s growth prospects and valuation.

“Though we acknowledge that Hemispherx’s oncology drugs still have long development roads left (approximately two years), we believe the [approximately] billion dollar market potentials present a high reward for the risks,” Woo wrote.

More than 16,000 vials of Ampligen, which is already approved for use in Argentina, have been produced by Hemispherx for the purpose of clinical trials. And in another milestone, the first shipment of Ampligen has been delivered for sale in Europe under the drug’s early access program.

“The big cancer institutions like Roswell Park in Buffalo, the Buffett Cancer Center in Nebraska, the University of Pittsburgh and Erasmus in the Netherlands all share our excitement about what Ampligen can do in oncology,” points out Equels.

Like many biopharma companies of its size, Hemispherx is looking for a partner with adequate capital and expertise or a buyout. “We don’t intend to try to invent ourselves into a major pharma company,” says Equels. “It’s our intention to deliver a product so that a big pharma company can take the ball and run with it to tremendous financial success.”

Cash position

In its latest capital raising, Hemispherx raised gross proceeds of $5.3 million for clinical trials from a rights offering.

And enough money has been raised to manufacture Ampligen and continue the company’s research and development activities in the coming months.

As of the close of September 2018, Hemispherx was sitting on cash and cash equivalents of more than $4 million, representing an increase of over $2 million from its cash position at the close of December 2017.  

What the boss says

“We are knocking out milestone after milestone,” says Equels. “There is no other NYSE company out there in our range that has this kind of clinical activities going on in oncology.” 

]]>
Fri, 08 Mar 2019 15:39:00 -0500 https://www.proactiveinvestors.com/companies/news/216124/hemispherx-biopharma-takes-cancer-war-to-new-stage-with-drug-ampligen-216124.html
<![CDATA[News - Hemispherx Biopharma expects gross proceeds of $5.3M from rights offering ]]> https://www.proactiveinvestors.com/companies/news/215929/hemispherx-biopharma-expects-gross-proceeds-of-53m-from-rights-offering-215929.html Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) said Wednesday that it expects gross proceeds of $5.3 million from its recently expired rights offering.

Upon closing, the immune-pharma research company said shares and warrants will be distributed to holders of rights who exercised them and paid the subscription price in full.

Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B convertible preferred stock with a stated value of $1,000 and immediately convertible into shares of common stock at a conversion price of $0.20 per share as well as 5,000 warrants to purchase Hemispherx's common stock with an exercise price of $0.20 per share.

READ: Hemispherx Biopharma gets green light from Dutch health regulators to extend access program for Ampligen to pancreatic cancer patient

Shares of Hemispherx slipped $0.01 to $0.17 in Wednesday’s premarket trading.

The closing of the offering is expected on or about Friday, March 8, according to the Ocala, Florida, company. The warrants will be exercisable for five years after the date of issuance.

Hemispherx engaged Maxim Group LLC and Ascendiant Capital Markets LLC as dealer-managers. The rights offering expired Tuesday, and the rights are no longer exercisable, according to Hemispherx.

Last month, the company said that its early-access program at the Erasmus Medical Center in the Netherlands, which uses its flagship drug Ampligen for the treatment of pancreatic cancer, had been extended.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

]]>
Wed, 06 Mar 2019 09:16:00 -0500 https://www.proactiveinvestors.com/companies/news/215929/hemispherx-biopharma-expects-gross-proceeds-of-53m-from-rights-offering-215929.html
<![CDATA[News - Hemispherx Biopharma gets green light from Dutch health regulators to extend access program for Ampligen to pancreatic cancer patients ]]> https://www.proactiveinvestors.com/companies/news/215555/hemispherx-biopharma-gets-green-light-from-dutch-health-regulators-to-extend-access-program-for-ampligen-to-pancreatic-cancer-patients-215555.html Hemispherx Biopharma Inc (NYSE American:HEB) said Thursday that its early access program at the Erasmus Medical Center in the Netherlands, which uses its flagship drug Ampligen for the treatment of pancreatic cancer, has been extended.

The early access program is now approved by Dutch Health authorities until March 9, 2020 to allow for the treatment of pancreatic cancer patients diagnosed with any stage of the disease. The pancreatic cancer patients receive Ampligen as maintenance therapy after completing standard care.

Investors applauded the news, sending Hemispherx shares up 11.6% to $0.19 in afternoon trade Thursday.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

In a recent abstract, clinicians at Erasmus found that Ampligen showed positive results in treating pancreatic cancer. Of 26 pancreatic cancer patients treated with Ampligen as maintenance therapy, five patients showed stable disease and two patients exhibited the regression of cancer metastases during treatment.

Hemispherx is dedicated to evaluating Ampligen for the potential treatment of pancreatic cancer, especially in combination with checkpoint blockade therapies.

“We are grateful for the groundbreaking work done by the clinicians at Erasmus and are committed to the goal of helping patients with this deadly disease,” says Thomas Equels, CEO of Hemispherx.

READ: Hemispherx Biopharma updates terms of $8 million rights offering, says senior management is participating

Recent results from animal studies will be used to help finalize the design of a Phase 2 clinical trial in patients with advanced pancreatic cancer using checkpoint blockade therapies plus Ampligen at the University of Nebraska Medical Center.

Hemispherx is studying the use of Ampligen as a combination therapy for the treatment of multiple cancers at key cancer centers throughout the US.

Headquartered in Ocala, Florida, Hemispherx’s flagship products include Ampligen (rintatolimod), which fights both cancer and chronic fatigue syndrome, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

]]>
Thu, 28 Feb 2019 12:11:00 -0500 https://www.proactiveinvestors.com/companies/news/215555/hemispherx-biopharma-gets-green-light-from-dutch-health-regulators-to-extend-access-program-for-ampligen-to-pancreatic-cancer-patients-215555.html
<![CDATA[News - Hemispherx Biopharma extends $8M rights offering to March 5 ]]> https://www.proactiveinvestors.com/companies/news/215543/hemispherx-biopharma-extends-8m-rights-offering-to-march-5-215543.html Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) said Thursday it has extended the subscription period for its $8 million rights offering until 5 pm ET on March 5, 2019.

Proceeds from the offering will be used to fund the biopharmaceutical company’s trials for its anti-cancer agent Ampligen.

According to the terms of the deal, the pricing remains $1,000 per unit, consisting of one share of Series B convertible preferred stock with a stated value of $1,000 (and immediately convertible into Hemispherx’s common stock) and warrants to purchase Hemispherx’s common stock.

READ: Hemispherx Biopharma's cancer drug Ampligen to be used in new oncology study

The Series B convertible preferred stock conversion price will now be $0.20 and each unit will now consist of 5,000 warrants to purchase Hemispherx’s common stock at an adjusted exercise price of $0.20. The warrants will be exercisable for five years after the date of issuance.

Holders of stock or related options and warrants who wish to participate in the rights offering must deliver a signed subscription rights statement, along with payment, to the subscription agent via mail, hand or overnight courier, before 5 pm ET on March 5.

The subscription agent is American Stock Transfer & Trust Company LLC.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

All of the members of the Ocala, Florida-based company’s senior management and board of directors are planning to participate in the rights offering, the company said.

Hemispherx’s flagship products include the Argentina-approved Ampligen, which treats chronic fatigue syndrome and cancer, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Hemispherx shares added 6.26% to finish at US$0.18 on Wednesday.

]]>
Thu, 28 Feb 2019 09:40:00 -0500 https://www.proactiveinvestors.com/companies/news/215543/hemispherx-biopharma-extends-8m-rights-offering-to-march-5-215543.html
<![CDATA[News - Hemispherx Biopharma updates terms of $8 million rights offering, says senior management is participating ]]> https://www.proactiveinvestors.com/companies/news/215432/hemispherx-biopharma-updates-terms-of-8-million-rights-offering-says-senior-management-is-participating-215432.html Hemispherx Biopharma Inc (NYSE American: HEB) said Wednesday that it has adjusted certain pricing information for its announced $8 million rights offering, which will be used to fund trials for its anti-cancer agent Ampligen.

The pricing remains $1,000 per unit, consisting of one share of Series B convertible preferred stock with a stated value of $1,000 (and immediately convertible into Hemispherx’s common stock) and warrants to purchase Hemispherx’s common stock.

But the Series B convertible preferred stock conversion price will now be $0.20 and each unit will now consist of 5,000 warrants to purchase Hemispherx’s common stock at an adjusted exercise price of $0.20. The warrants will be exercisable for five years after the date of issuance.

READ: Hemispherx Biopharma's cancer drug Ampligen to be used in new oncology study

All of the members of the Ocala, Florida-based company’s senior management and board of directors are planning to participate in the rights offering.

The subscription period for the rights offering expires at 5 pm (ET) on March 1, 2019, unless extended by the company.

Maxim Group and Ascendiant Capital Markets LLC have been hired as dealer-managers in the rights offering.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

Hemispherx’s flagship products include the Argentina-approved Ampligen, which treats chronic fatigue syndrome and cancer, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Hemispherx shares slipped by 2 cents to US$0.18 in morning trade on Wednesday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

]]>
Wed, 27 Feb 2019 09:45:00 -0500 https://www.proactiveinvestors.com/companies/news/215432/hemispherx-biopharma-updates-terms-of-8-million-rights-offering-says-senior-management-is-participating-215432.html
<![CDATA[News - Hemispherx Biopharma posts reminder of deadline for $8M rights issue ]]> https://www.proactiveinvestors.com/companies/news/214489/hemispherx-biopharma-posts-reminder-of-deadline-for-8m-rights-issue-214489.html Hemispherx Biopharma Inc (NYSEAmerican:HEB) on Tuesday issued a reminder to its stockholders that the record date of its proposed $8 million rights offering is Thursday, February 14.

To be a stockholder of record on the record date, ownership of Hemispherx stock must occur before the market closes on February 12 to account for settlement.

READ: Hemispherx Biopharma launches $8M rights issue to fund cancer drug trials

Under the terms of the rights offering, Hemispherx will distribute to holders of its stock as well as holders of certain options and warrants as of February 14 at no charge, one non-transferable subscription right for each share of stock held or deemed held on the record date.

Each right allows the shareholder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred stock with a face value of $1,000 (and immediately convertible into common stock at a conversion price of $0.25) and 4,000 five-year warrants with an exercise price of $0.25.

Subscription rights are non-transferable and may only be exercised during the subscription period of Friday, February 15, 2019, through Friday, March 1, 2019, unless extended by Hemispherx.

Hemispherx’s flagship products include the Argentina-approved Ampligen, which treats chronic fatigue syndrome and cancer, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Hemispherx traded up 1% at US$0.24 in afternoon trade on Tuesday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

 

]]>
Tue, 12 Feb 2019 14:35:00 -0500 https://www.proactiveinvestors.com/companies/news/214489/hemispherx-biopharma-posts-reminder-of-deadline-for-8m-rights-issue-214489.html
<![CDATA[News - Hemispherx announces start of Merck-supported ovarian cancer clinical drug trial ]]> https://www.proactiveinvestors.com/companies/news/214370/hemispherx-announces-start-of-merck-supported-ovarian-cancer-clinical-drug-trial-214370.html Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) announced Monday the start of a clinical trial supported by Merck & Co Inc (NYSE:MRK), combining treatments for a type of ovarian cancer.

The immune-pharma company said in a statement that the study will combine its Ampligen with Merck's Keytruda in targeting recurrent, platinum-sensitive ovarian cancer.

The trial will enrol as many as 45 participants and will be performed in the Pittsburgh at the UPMC Hillman Cancer Center, which is sponsoring the study. It is being conducted by Dr Robert Edwards, the director of the ovarian cancer program at UPMC Magee Womens Hospital.

READ: Hemispherx Biopharma's cancer drug Ampligen to be used in new oncology study

Ocala, Florida-based Hemispherx said that over the past year, it has produced 16,000 vials of Ampligen, including all of the supply needed for the clinical trial.

The study, according to Hemispherx, will look at how well Ampligen-based combination therapy works, when given with the anti-cancer chemotherapy drug Cisplatin and Keytruda in treating participants with recurrent ovarian cancer compared with historical controls. The company added that the trial will test the effectiveness of Ampligen in converting "cold" tumors into "hot" tumors, making the tumors more responsive to Keytruda.

"At Hemispherx we are determined to pursue a comprehensive R&D program focused on improved immune therapies for lethal malignancies such as recurrent ovarian cancer,” Hemispherx CEO Thomas K. Equels said. “We are deeply grateful for the attention and support we are getting from Merck and the world-class ovarian cancer team at UPMC in this important major clinical trial.”

Shares of Hemispherx slipped $0.01 to $0.23 in Friday’s New York trading.

Last month, the company said that the Roswell Park Comprehensive Cancer Center in Buffalo, New York, began testing the use of Ampligen and Keytruda for patients with metastatic, triple-negative breast cancer.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

]]>
Mon, 11 Feb 2019 09:28:00 -0500 https://www.proactiveinvestors.com/companies/news/214370/hemispherx-announces-start-of-merck-supported-ovarian-cancer-clinical-drug-trial-214370.html
<![CDATA[News - Hemispherx Biopharma launches $8M rights issue to fund cancer drug trials ]]> https://www.proactiveinvestors.com/companies/news/214188/hemispherx-biopharma-launches-8m-rights-issue-to-fund-cancer-drug-trials-214188.html Hemispherx Biopharma Inc (NYSE American:HEB) has lodged a prospectus for an $8 million rights offering to purchase up to 8,000 units at $1,000 each as it looks to raise money to fund trials for its anti-cancer agent Ampligen.

Under the proposed rights offering, Hemispherx will distribute to its shareholders and to holders of certain options and warrants as of February 14, one non-transferable subscription right for each share of stock held on the record date.

READ: Hemispherx Biopharma's cancer drug Ampligen to be used in new oncology study

Each right permits the shareholder to purchase one unit at a subscription price of $1,000, consisting of one share of Series B Convertible Preferred stock (with a face value of $1,000) and 4,000 five-year warrants, each with an exercise price of $0.25.

“We are extremely pleased with the progress to date, moving Ampligen into immuno-oncology clinical trials for evaluation as an anti-cancer agent. Our use of a rights offering allows those stockholders who participate in the offering to help fund the Company and benefit from our future work,” said Thomas Equels, CEO of Hemispherx, in a statement.

The rights offering is expected to expire on or about March 1, 2019. Maxim Group and Ascendiant Capital Markets LLC have been hired as dealer-managers in the rights offering.

Hemispherx’s flagship products include the Argentina-approved Ampligen, which treats chronic fatigue syndrome and cancer, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.

Hemispherx shares closed up by 11% to hit $0.26 on Wednesday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

 

]]>
Thu, 07 Feb 2019 08:00:00 -0500 https://www.proactiveinvestors.com/companies/news/214188/hemispherx-biopharma-launches-8m-rights-issue-to-fund-cancer-drug-trials-214188.html
<![CDATA[Media files - Hemispherx Biopharma to begin two clinical trials at two major US cancer centers ]]> https://www.proactiveinvestors.com/companies/stocktube/11808/hemispherx-biopharma-to-begin-two-clinical-trials-at-two-major-us-cancer-centers-11808.html Fri, 11 Jan 2019 11:33:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11808/hemispherx-biopharma-to-begin-two-clinical-trials-at-two-major-us-cancer-centers-11808.html <![CDATA[News - Hemispherx Biopharma's cancer drug Ampligen to be used in new oncology study ]]> https://www.proactiveinvestors.com/companies/news/212180/hemispherx-biopharma-s-cancer-drug-ampligen-to-be-used-in-new-oncology-study-212180.html Hemispherx Biopharma (NYSE American:HEB) reports that Roswell Park Comprehensive Cancer Center will kick off an oncology study to evaluate its experimental drug Ampligen along with the Merck & Co (NYSE:MRK) blockbuster cancer drug Keytruda in patients with metastatic triple-negative breast cancer.

The trial will enroll at least six participants and be conducted by Drs. Mateusz Opyrchal and Pawel Kalinski at Roswell Park, a National Cancer Institute-designated comprehensive cancer center in Buffalo, New York.

The study will assess how well Ampligen-based chemokine modulation therapy works when given prior to Keytruda in treating patients with triple-negative breast cancer that has spread to other places in the body.

“At Team Hemispherx, we are determined to pursue an aggressive R&D program focused on improved immune therapies for lethal malignancies, and we are grateful for the support and attention we are getting from big pharma and these major research institutions,” said Hemispherx CEO Thomas Equels in a statement.

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

Drugs used in this chemokine modulation therapy – celecoxib, recombinant interferon alfa-2b and Ampligen – work by boosting cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules.

The clinical trial aims to determine whether chemokine modulation therapy before Keytruda will work better than Keytruda alone in patients with metastatic triple-negative breast cancer by altering the tumor microenvironment to favor immune rejection.

Investors applauded news of the trial, sending Hemispherx shares up 18.3% to $0.23 in Tuesday’s afternoon trading session.

READ: Biotech companies dominate at Dawson James Securities Small Cap Growth Conference

The study will assess patients with metastatic triple-negative breast cancer who will undergo a pre-treatment biopsy. Participants then receive two cycles of chemokine modulation therapy followed by an additional biopsy. After the biopsy and chemokine modulation therapy, participants will receive Keytruda every three weeks for two cycles.

A second clinical trial combining Ampligen with Keytruda to treat 40 patients with ovarian cancer is set to launch later this month at the University of Pittsburgh. It will be an important and more extensive test of Ampligen as an immune system primer that can change cold tumors into hot tumors and make the formerly cold tumors more responsive to Keytruda, according to the company.

“Relevant preclinical experiments in several types of solid tumors and conducted at different major US cancer research centers support the proposition that Ampligen can change the micro-environment of tumors so as to create a robust and significant positive synergy with check point blockade therapies,” explained Equels.

Hemispherx is making great strides in using its therapy Ampligen as an immuno-oncology agent to fight multiple types of cancer.

The company is currently supporting the evaluation of Ampligen’s use in fighting eight solid tumors (urothelial carcinoma, renal cell carcinoma, melanoma, triple-negative breast, colorectal, ovarian, non-small cell lung and pancreatic carcinomas) as part of a number of separate clinical studies at major research institutions.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

]]>
Tue, 08 Jan 2019 09:19:00 -0500 https://www.proactiveinvestors.com/companies/news/212180/hemispherx-biopharma-s-cancer-drug-ampligen-to-be-used-in-new-oncology-study-212180.html
<![CDATA[Media files - Hemispherx Biopharma advances expanded access program for its therapy Ampligen ]]> https://www.proactiveinvestors.com/companies/stocktube/11707/hemispherx-biopharma-advances-expanded-access-program-for-its-therapy-ampligen-11707.html Fri, 04 Jan 2019 13:21:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11707/hemispherx-biopharma-advances-expanded-access-program-for-its-therapy-ampligen-11707.html <![CDATA[News - Biotech companies dominate at Dawson James Securities Small Cap Growth Conference ]]> https://www.proactiveinvestors.com/companies/news/208357/biotech-companies-dominate-at-dawson-james-securities-small-cap-growth-conference-208357.html The Dawson James Securities Fourth Annual Small Cap Growth Conference in Jupiter, Florida, brought together some of the most dynamic companies in the US and Canada, showcasing the latest biotech and tech innovations and making their cases directly to investors.

Jack Stover, CEO of Interpace Diagnostics Group Inc (NASDAQ:IDGX) was among five panelists in the kick-off panel presentation exploring the impact of Artificial Intelligence and Bioinformatics -- the science of collecting and analyzing complex biological and genetic data -- on the future of health care.

Interpace, which focuses on developing molecular diagnostics for cancers of the thyroid and pancreas, is exploring new ways to use the bioinformatics data it collects, Stover explained.

READ: Interpace Diagnostics Group expands application of its cancer pathology test PancraGEN

“We have 10 years’ worth of data and hundreds of thousands of data points on patients, and ultimately what we’re doing is looking at those patients against a publicly available database to make determinations not only to where that patient is today, but where they’re going to be in five years,” Stover told moderator David Weinstein, managing partner of Dawson James.

Stover also gave a simple example of how bioinformatics data can be used to reduce the number of unnecessary cancer surgeries as a means of containing spiraling health care costs.

“That data is extremely important and extremely valuable to us,” Stover said. “We see it as a bridge to the pharmaceutical and biopharmaceutical world.”

Stover told Proactive Investors separately that the Parsippany, New Jersey, company experienced a huge turnaround over the past year and a half, punctuated by its acquisition of rival Rosetta Genomics earlier this year. 

With a growing sales force, Stover said the company is on track for full-year 2018 revenue above $20 million, a more than 26% increase over 2017.

Going all in on Ampligen

Another compelling rebound story is Hemispherx BioPharma Inc (NYSEAMERICAN:HEB), an Orlando, Florida, developer of therapeutics to treat multiple cancers, as well as immune-deficiency disorders. Its lead drug Ampligen is the only approved therapy for Chronic Fatigue Syndrome, or CFS.

Its other drug, Alferon N, is approved by the US Food and Drug Administration to treat genital warts.

Despite having two approved drugs, the company had to overcome what CEO Thomas Equels calls a “life or death scenario.”

“When I took over as CEO a little over two years ago we had a problem,” Equels told Proactive Investors. “We had no money, we had no Ampligen, and our Alferon facility had a flood and was shut down.”

Under Equels the company quickly pivoted from Alferon to focus on developing Ampligen as a potential treatment for multiple cancers. He restructured, raised money, and used that money to manufacture commercial-sized lots of Ampligen.  

READ: Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets

Meanwhile, he signed up major cancer research institutes in the US and Europe to work with Ampligen as an immuno-oncology agent.

Edward Woo, an analyst with Ascendiant Capital Markets, sees the upside. 

“Though we acknowledge that Hemispherx’s oncology drugs still have long development roads left (about two years), we believe the [billion-dollar] market potential presents a high reward for the risk.”

The analyst started coverage Monday with a Buy rating and a $0.75 price target. The shares closed Thursday at $0.34 per share.

Surgery at the cutting edge

Another company at the conference, Titan Medical Inc (NASDAQ:TMDI), is literally at the cutting edge of innovation in the field of surgery.  It designs and manufactures robotic surgical systems.

A restructuring in 2017 brought CEO David McNally to the Toronto-based company, and after some key hires, he said it’s now on a fast-track to commercialization.

Titan Medical expects to have applications for its SPORT Surgical System submitted to the FDA and European regulators for a CE Mark in 2019, with a rollout in mid-2020.

While robotic surgery is nothing new, McNally told Proactive Investors that SPORT will not only be the most advanced but the most user-friendly robotic system for abdominal surgery on the market. 

By concentrating on the abdominal area, the system will be able to support a wide range of minimally invasive surgeries, such as gynecological, urological and colorectal other procedures.

“Our system is designed to reduce trauma to the body while being easy to operate for the surgeon and the operating room staff,” McNally said.

The first goal, to reduce patient trauma, is achieved by making only a single incision. McNally said that numerous studies on live animals and human cadavers have shown positive results thus far.

“It’s a red-hot space and the problems covered by robotics are only beginning to be solved,” McNally said. “Market penetration is only 10% globally.”

The development-stage company has invested more than $140 million in the system, has about $30 million in cash on hand and no debt on its books.

Running with the big dogs

In the red-hot immuno-therapy space, Canadian company IMV Inc (NASDAQ:IMV) is making its presence known by attracting two giant players as partners – without giving up the rights to its clinical assets.

The Halifax-based company uses lipid-based, injectable nanoparticle technology to create artificial T-cells that kill cancer. CEO Frederic Ors describes it as a new way to deliver active ingredients to the immune system.

“We’ve already made clinical demonstrations that we can shrink solid tumors,” Ors told Proactive Investors. “Nobody yet in immuno-oncology has been able to prove they can shrink solid tumors.”

With reductions of more than 30% in solid tumors such as the kind found in ovarian cancer, IMV was able to attract and partner with Merck (NYSE:MRK) and Incyte (NASDAQ:INCY) and now has eight ongoing Phase 2 trials -- seven with Merck, which has invested more than US$50 million, and one with Incyte. 

Ors pointed out that IMV still retains the rights on its lead clinical asset DPX-Survivac.

The company, formerly known as Immunovaccine Inc, is well funded through the end of 2019, he said, with C$25 million in cash as of June 30. The company listed on the Nasdaq because the future of the company is in the US, Ors said, and he wants its flow of milestones to be accessible to investors through Nasdaq.

Betting on the nose

Altimmune Inc. (NASDAQ:ALT) is a clinical-stage vaccine maker that’s raised $40 million in the last few weeks to develop its internasal flu vaccine, NasoVAX, which CEO Bill Enright told Proactive will enter $2 billion flu market that he says is not well-served.

“About the same number of people die every year from the flu as from breast cancer,” Enright told Proactive. “We’ve got a vaccine that we believe will significantly improve vaccines on the market.”

Every year millions of doses of flu vaccine are created using chicken eggs, one egg per dose, at a huge cost to maintain a chicken population for a strategic supply in the event of a pandemic. And they take months to produce.

But Altimmune has come up with a faster and cheaper process using cell cultures that covers more strains of flu than traditional vaccines and minimizes mismatched strains. And the company can get a new flu vaccine to market in half the time.

A Phase 2A trial of 60 people has just been completed with 100% protection.

The key is the delivery system. Traditional flu vaccines are injected, whereas Altimmune’s vaccine is administered nasally. This increases absorption by the body because there’s a mucosal response in the nose that also stimulates a rapid T-cell response.

So Altimmune’s internasal dose will be effective in just days versus weeks via injectables.

Not to be overlooked is its anthrax vaccine, NasoShield, which is also internasal, and funded by a US government contract for $130 million in reimbursements for the research. It’s currently in Phase 1 trials.

Though Enright announced last week that he’ll be stepping down as CEO after 10 years of running the Gaithersburg, Maryland, company, he will continue to be a shareholder.

The mouse that roars

Cyclacel Pharmaceuticals Inc. (NAS:CYCC) CEO Spiro Rombotis describes his biopharma company as “a mouse in a ballroom full of elephants” because its main competitors include Merck and Bayer AG.

Rather than scurry about to avoid being stomped, the Berkeley Heights, New Jersey, company wants to dance. Cyclacel employs what it calls a “triple-hit strategy.” Hit the patient early, Rombotis said, before the disease goes off the rails and then hit twice more by combining its development drug with an already approved drug from an established player.

WATCH: Cyclacel looking to begin proof of concept study in CLL

He compares it to playing Whack-A-Mole. 

“If you hit the mole only once, it raises its head somewhere else," he told Proactive Investors. "But if you hit it twice, you have a better chance to get the patient to a prolonged period without disease recurrence and a higher quality of life.”

From a business perspective, the strategy is appealing because the companies selling the approved drug have an interest in owning the new molecule and extending the life of their product in the market, he explained.

“So, this idea of taking the approved drug, plus the new drug to make the approved drug better has caught on and we are one of the pioneers in this area,” he said.

 

Contact Paul Curcio at paul.curcio@proactiveinvestors.com

Follow him on Twitter at @GoCurcioGo

]]>
Thu, 01 Nov 2018 15:48:00 -0400 https://www.proactiveinvestors.com/companies/news/208357/biotech-companies-dominate-at-dawson-james-securities-small-cap-growth-conference-208357.html
<![CDATA[News - Hemispherx Biopharma started with a Buy rating at Ascendiant Capital Markets ]]> https://www.proactiveinvestors.com/companies/news/208270/hemispherx-biopharma-started-with-a-buy-rating-at-ascendiant-capital-markets-208270.html Florida-based biopharmaceutical company Hemispherx BioPharma (NYSEAMERICAN:HEB) has been awarded a Buy rating and a $0.75 price target by Edward Woo, an analyst with Ascendiant Capital Markets, which kicked off coverage of the stock.

In a note to investors Monday, Woo writes that Hemispherx has made significant advances with its oncology program for its therapy Ampligen, which is being evaluated as an immuno-oncology agent for the treatment of multiple types of cancer.

In collaboration with prominent cancer research centers in the US, clinical trials are underway to test that the combination of Ampligen with checkpoint blockade therapies will improve clinical tumor responses, time to progression and survival rates.

While Hemispherx operates in a “highly competitive environment,” such concerns are outweighed by Ampligen’s growth prospects and valuation, writes Woo.

“Though we acknowledge that Hemispherx’s oncology drugs still have long development roads left (approximately 2 years), we believe the [approximately] billion dollar market potentials present a high reward for the risks,” Woo wrote.

Hemispherx’s second product is Alferon N Injection, which is FDA-approved for the treatment of genital warts, a sexually-transmitted disease. But its commercialization is on hold as Hemispherx focuses on Ampligen as an immuno-oncology treatment and to address the symptoms of chronic fatigue syndrome (CFS).

Woo has tagged Hemispherx with a $0.75 12-month price target on the view that the valuation “appropriately balances out the company’s high risks with the company’s high-growth prospects and large upside opportunities.”

On top of the ongoing cancer studies, Ampligen is also being assessed as a treatment for chronic fatigue syndrome. It is already approved for this treatment in Argentina and is available through a US Food and Drug Administration-authorized expanded access program.

The FDA, however, has thus far declined to approve the new drug application for Ampligen for the treatment of chronic fatigue syndrome, pending its request for additional clinical trials and data.

All in on Ampligen

Hemispherx CEO Thomas K Equels elaborated in a letter to shareholders earlier this month about how Hemispherx is making great strides in using its therapy Ampligen as an immuno-oncology agent to fight multiple types of cancer.

The company is currently supporting the evaluation of Ampligen’s use in fighting eight solid tumors (urothelial carcinoma, renal cell carcinoma, melanoma, triple-negative breast, colorectal, ovarian, non-small cell lung and pancreatic carcinomas) as part of six separate clinical studies at major research institutions, Equels said.

The goal of the various studies, which are being carried out at the University of Pittsburgh Medical Center, the University of Nebraska Medical Center and Roswell Park Comprehensive Cancer Center, is to test the hypothesis that the combination of Ampligen with checkpoint inhibitors will “improve clinical tumor responses.”

Checkpoint inhibitors are powerful immune-therapy drugs that block proteins that restrain the body’s immune system from fighting cancer.

Especially encouraging was that clinical proof of concept findings using an Ampligen cocktail to fight colorectal cancer demonstrated a more favorable ratio of killer T-cells, which attack cancer cells, to regulatory T-cells in the tumor microenvironment.

“In collaboration with major cancer research centers in the US and around the world, we have been making tremendous progress and strongly believe in the future of our cancer-fighting efforts,” wrote Equels.

“It is important that you have the opportunity to see what these top experts in immune-oncology have to say about their recent successes with Ampligen and its importance as a promising agent for advance in oncology. Progress in oncology provides a clear opportunity for commercial success for Hemispherx,” he added.

Hemispherx added 8.4% to close at $0.23  Wednesday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

]]>
Wed, 31 Oct 2018 15:39:00 -0400 https://www.proactiveinvestors.com/companies/news/208270/hemispherx-biopharma-started-with-a-buy-rating-at-ascendiant-capital-markets-208270.html
<![CDATA[News - Hemispherx Biopharma to meet with FDA regarding Ampligen decision ]]> https://www.proactiveinvestors.com/companies/news/93726/hemispherx-biopharma-to-meet-with-fda-regarding-ampligen-decision-41796.html

Hemispherx BioPharma (NYSE MKT:HEB) has said it plans to request a meeting with the FDA regarding the regulatory agency's decision to to reject approval for its Ampligen drug for chronic fatigue syndrome (CFS), while also announcing its 2012 financial results.

The company, which ended the year with cash of around $43.95 million, said that its net loss increased year-over-year mainly due to its continued efforts to seek FDA approval of its Ampligen drug for chronic fatigue syndrome (CFS) and preparations for FDA inspections of its expanded New Brunswick, New Jersey manufacturing facility. 

The biopharma business is working on the FDA approval for its Amligen drug for CFS, after the regulatory agency declined approval last month. In the complete response letter, the FDA said the company should conduct at least one additional clinical trial and complete various non-clinical studies, as well as perform a number of data analyses. 

Hemispherx said in its statement on Monday that it plans to request an end-of-review conference with the FDA to discuss the agency's decision regarding this potential treatment. 

The drug, which is a 30-minute infusion into the bloodstream, works by stimulating the immune system through a receptor called TLR-3. 

According to the Center for Disease Control, there are around 4 million people affected by CFS in the US, costing the nation around $9.1 billion per year.  The illness, which has an unknown etiology thought in part to be related to immune dysfunction, causes profound fatigue and other debilitating symptoms, with much of the impacted population bedridden. 

In March last year, a peer reviewed analysis of data from the a trial of Ampligen was published showing that the proportions of Ampligen patients with exercise improvements of at least 25% and at least 50% respectively, were 1.7 and 1.9-fold greater than those patients on placebo, Hemispherx has said. 

Clinical trials of the drug have already been conducted by the company for the potential treatment of CFS, Hepatitis B, HIV and cancer patients. 

As well as getting this drug approved for CFS, Hemispherx has also been working to enhance its manufacturing facility in New Jersey, which is in the final stage, with construction complete. Around $7 million was spent on the project through to the end of last year, financed with a margin loan, the company said. 

The facility is designed to produce Ampligen, as well as its other drug Alferon. 

Earlier this month, the company said that ANMAT, the agency responsible for the regulation of drugs, foods and medical technology in Argentina, has approved the use of its Alferon N injection in the country for any patient that fails or becomes intolerant to treatment with "recombinant interferon" - expanding the indication for the drug widely. 

Alferon N Injection is an FDA-approved natural interferon and, as Naturaferon, was already previously approved in Argentina for the treatment of refractory or recurring external genital warts - one of the main culprits of cervical cancer.  

The timelines for when the drug -- which can now also be used for multiple sclerosis, certain cancers and hepatitis C -- can be shipped to Argentina, and when resulting revenues will occur cannot be determined at this time, the company has said. 

]]>
Tue, 19 Mar 2013 15:57:00 -0400 https://www.proactiveinvestors.com/companies/news/93726/hemispherx-biopharma-to-meet-with-fda-regarding-ampligen-decision-41796.html
<![CDATA[News - Hemispherx awaits FDA decision on Ampligen NDA for chronic fatigue syndrome - "The Pink Sheet Daily" ]]> https://www.proactiveinvestors.com/companies/news/91571/hemispherx-awaits-fda-decision-on-ampligen-nda-for-chronic-fatigue-syndrome-the-pink-sheet-daily-37948.html Hemispherx BioPharma (AMEX:HEB) was recently featured in an article in the "The Pink Sheet Daily", which outlines the boost in drug development efforts from the FDA for chronic fatigue syndrome (CFS), and discusses the progress of the company's Ampligen drug - a potential first approved treatment for the disease. 

The writer of the piece, Sue Sutter, says that the FDA has embarked on a drug development initiative for chronic fatigue syndrome and myalgic encephalomyelitis, and at the same time it is considering whether Hemispherx’s Ampligen should be the first drug approved for CFS.

The agency is planning a series of activities with patients, advocacy groups and other stakeholders focused on development of drugs to treat the symptoms of CFS/ME. 

These actions are aimed at exploring the burden of disease and its impact on quality of life, quantitative outcome measures or endpoints that determine if symptoms improve with intervention, and how drug efficacy should be clinically tested based upon these endpoints or measurements, the FDA announced on its website.

"The initiative is a major step in FDA’s efforts to raise the profile of CFS as a drug development target," Sutter writes. 

The agency suggested an accelerated approval route as an option, Sutter continues, and in doing so, "appears to be following the directive laid out in the FDA Safety and Innovation Act (FDASIA), which was signed into law on July 9."

In addition to reauthorizing PDUFA, FDASIA included provisions aimed at encouraging broader use of regulatory mechanisms, such as accelerated approval and fast track designation, to speed the approval of drugs for serious and life-threatening conditions.

Cue Hemispherx. The company, amid this regulatory environment, is on the cusp of a potential breakthrough as it sits on what could potentially be the first recognized commercial treatment for CFS – with just months away from anticipated FDA approval. 

Hemispherx’s resubmitted new drug application for Ampligen is currently under review by the Division of Pulmonary, Allergy and Rheumatology Products, with a February 2, 2013 deadline date. The company has said it expects an FDA advisory committee meeting on the application on December 20.

Ampligen, which has been in development for about 20 years, has faced a series of regulatory challenges, including a 2009 complete response letter in which the FDA requested an additional clinical trial. 

But in July, Hemispherx announced that the FDA had reversed its previous decision, agreeing to review new analyses of a previously completed phase III trial - in lieu of requiring an additional trial. 

This is in part because in January 2011, the Center for Drug Evaluation and Research announced plans to consolidate oversight of CFS treatments in the Division of Pulmonary, Allergy and Rheumatology Products, whereas previously, CFS applications were assigned to at least six different review divisions. 

In a recently filed 10Q report, Hemispherx said that Ampligen, which has orphan drug status, represents the first drug in the class of large RNA (nucleic acid) molecules to apply for NDA review.

Nucleic acid compounds represent a potential new class of pharmaceutical products that are designed to act at the molecular level for the treatment of human diseases. RNA is a group of naturally occurring informational molecules which orchestrate a cell’s behavior which, in turn, regulate the action of cells that compromise the body’s immune system.

The drug, which is a 30-minute infusion into the bloodstream, works by stimulating the immune system through a receptor called TLR-3. 

Clinical trials of Ampligen already conducted by the company include studies for the potential treatment of CFS/ME, Hepatitis B, HIV and cancer patients. 

"All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval," it said. Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug.

According to the Center for Disease Control, there are around 4 million people affected by CFS in the US, costing the nation around $9.1 billion per year.  The illness, which has an unknown etiology thought in part to be related to immune dysfunction, causes profound fatigue and other debilitating symptoms, with much of the impacted population bedridden. 

In March of this year, a peer reviewed analysis of data from the a trial of Ampligen was published showing that the proportions of Ampligen patients with exercise improvements of at least 25% and at least 50% respectively, were 1.7 and 1.9-fold greater than those patients on placebo, Hemispherx said. 

Along with this data, the new analyses contained in the resubmitted filing included an examination of quality-of-life parameters in patients who either met or failed the primary endpoint of exercise treadmill testing.

The NDA also included an analysis showing that compared to those taking placebo, patients on Ampligen were able to reduce their use of concomitant medications that may prolong the QT interval. Prolongation of the QT interval is a risk factor for arrhythmia and sudden cardiac death.

In a statement announcing the resubmission, Hemispherx said:  “Hemispherx believes that the data and analyses provided in its complete response may be relevant to the potential for approval of Ampligen under this expanded statutory authority. 

“There can be no assurance, however, how the FDA will implement the new FDASIA provisions.”

Hemispherx also owns Alferon N Injection, which is an injectable formulation of natural alpha interferon, which was approved by the FDA in 1989 for the treatment of certain categories of genital warts - one of the main culprits of cervical cancer.  

Commercial sales of Alferon were halted in March 2008 when the company's finished goods inventory expired, and since then, it has been working to build a bio reactor manufacturing facility with a 600 litre tank, investing around $8 million to expand its capacity. The FDA is expected to visit and inspect the facility soon, with sales anticipated to start following this sometime in 2013. 

]]>
Thu, 29 Nov 2012 10:36:00 -0500 https://www.proactiveinvestors.com/companies/news/91571/hemispherx-awaits-fda-decision-on-ampligen-nda-for-chronic-fatigue-syndrome-the-pink-sheet-daily-37948.html