Proactiveinvestors USA & Canada CytoDyn https://www.proactiveinvestors.com Proactiveinvestors USA & Canada CytoDyn RSS feed en Fri, 22 Mar 2019 09:19:36 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - CytoDyn's HIV drug leromlimab takes a big step forward ]]> https://www.proactiveinvestors.com/companies/stocktube/12632/cytodyn-s-hiv-drug-leromlimab-takes-a-big-step-forward-12632.html Mon, 18 Mar 2019 09:43:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12632/cytodyn-s-hiv-drug-leromlimab-takes-a-big-step-forward-12632.html <![CDATA[News - CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab ]]> https://www.proactiveinvestors.com/companies/news/216644/cytodyn-submits-first-part-of-biologics-license-application-to-fda-for-flagship-hiv-drug-leronlimab-216644.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Monday that it has filed the non-clinical portion of a Biologics License Application for its flagship leronlimab (PRO 140) as a combination therapy for HIV using the US Food and Drug Administration (FDA)’s rolling review process. 

Leronlimab is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of the human immunodeficiency virus (HIV).

The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of HIV, which causes acquired immune deficiency syndrome (AIDS).

DEEP DIVE: CytoDyn presses forward with HIV treatment after Phase 3​

In March, CytoDyn said the FDA reviewed and accepted the company’s request and plans to submit, on a rolling basis, its planned biologics license application for leronlimab.

“This is the most important milestone yet in CytoDyn’s history,” CytoDyn CEO Dr Nader Pourhassan said in a statement. “We continue to execute on the submission of our BLA and are well positioned for potential revenue in 2020, subject to final approval.”

Pourhassan said the company is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.

“We are also currently evaluating certain licensing opportunities relating to the commercialization of leronlimab upon approval,” said Pourhassan.

The biologics license application is a request for permission to introduce a biologic product for interstate commerce.

The non-clinical portion constitutes the first of three sections of the BLA submission for leronlimab as a combination therapy with HAART for HIV-infected patients. The FDA earlier granted Fast Track designation and recently agreed to a rolling review for leronlimab, which facilitates frequent interactions with the FDA review team.

The rolling review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on an FDA review until all three sections are completed and filed.

Leronlimab (PRO 140) is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.

Since Pourhassan became CEO at the end of 2012, CytoDyn’s work on leronlimab as a therapy for HIV has proceeded from Phase 2 to the conclusion of a Phase 3 trial that could lead to commercial use.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Mon, 18 Mar 2019 07:46:00 -0400 https://www.proactiveinvestors.com/companies/news/216644/cytodyn-submits-first-part-of-biologics-license-application-to-fda-for-flagship-hiv-drug-leronlimab-216644.html
<![CDATA[Media files - CytoDyn files for fast-track designation for leronlimab in breast cancer treatment ]]> https://www.proactiveinvestors.com/companies/stocktube/12550/cytodyn-files-for-fast-track-designation-for-leronlimab-in-breast-cancer-treatment-12550.html Mon, 11 Mar 2019 16:35:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12550/cytodyn-files-for-fast-track-designation-for-leronlimab-in-breast-cancer-treatment-12550.html <![CDATA[News - CytoDyn announces filing of FDA fast-track application for breast cancer treatment ]]> https://www.proactiveinvestors.com/companies/news/216200/cytodyn-announces-filing-of-fda-fast-track-application-for-breast-cancer-treatment-216200.html CytoDyn Inc (OTCMKTS:CYDY) said Monday that it has filed an application with the Food and Drug Administration seeking fast-track designation for its injectable antibody for patients with metastatic-triple negative breast cancer.

The biotech company said a preclinical study of its drug candidate leronlimab showed a 98% reduction of breast cancer tumor metastasis after seven weeks. The FDA, according to CytoDyn, recently cleared its investigational new drug (IND) application to initiate a Phase 1b/2 study for the addition of leronlimab, also known as PRO 140, to existing therapies for metastatic triple-negative breast cancer.

The target of leronlimab is CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling, according to Vancouver, Washington-based CytoDyn.

DEEP DIVE: CytoDyn presses forward with HIV treatment after Phase 3

“The sustained reduction in breast cancer metastatic spread in these preclinical studies with leronlimab is consistent with a growing understanding that CCR5, the target of leronlimab, plays an important role in the process of cancer spread by metastasis,” Dr Richard G. Pestell, the company’s chief medical officer, said in a statement.

The FDA’s fast-track designation is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

The FDA has granted a fast-track designation for leronlimab, also known as PRO 140, as a combination therapy with highly active antiretroviral therapy for HIV-infected patients. The company has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected, treatment-experienced patients. 

CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a related biologics license application in 2019.

The company is conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Shares of the company traded at $0.50 in Monday’s OTC markets trading.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Mon, 11 Mar 2019 09:59:00 -0400 https://www.proactiveinvestors.com/companies/news/216200/cytodyn-announces-filing-of-fda-fast-track-application-for-breast-cancer-treatment-216200.html
<![CDATA[Media files - CytoDyn presents 'stunning' data on treatment of HIV at Seattle conference ]]> https://www.proactiveinvestors.com/companies/stocktube/12530/cytodyn-presents--stunning--data-on-treatment-of-hiv-at-seattle-conference-12530.html Fri, 08 Mar 2019 13:41:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12530/cytodyn-presents--stunning--data-on-treatment-of-hiv-at-seattle-conference-12530.html <![CDATA[News - CytoDyn presses forward with HIV treatment after Phase 3 ]]> https://www.proactiveinvestors.com/companies/news/215750/cytodyn-presses-forward-with-hiv-treatment-after-phase-3-215750.html CytoDyn is working to develop a significant advance in HIV treatment beyond the “AIDS cocktail” combination of pills that has kept millions of people alive since the mid-1990s.

At the helm of the company is Nader Pourhassan, who immigrated to the US from Iran as a teenager in 1977, two years before revolutionaries deposed the Shah. He holds a Ph.D. in mechanical engineering from the University of Utah. For 20 years, he managed his family business as well as authoring three books.

What does CytoDyn own?

The company’s main product candidate is leronlimab, an injectable antibody that shows promise as an antiviral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS). The company agreed in 2012 to acquire leronlimab from its developer, Progenics Pharmaceuticals Inc (NASDAQ:PGNX).

Vancouver, Washington-based CytoDyn is exploring leronlimab's use in the treatment of cancer, inflammatory conditions and autoimmune diseases.

Inflection points

Since Pourhassan became CEO at the end of 2012, CytoDyn’s work on leronlimab as a therapy for HIV has proceeded from Phase 2 to the conclusion of a Phase 3 trial that could lead to commercial use.

In November, the company completed its $15.4 million stock acquisition of privately held ProstaGene LLC, whose CEO, Richard Pestell, an oncologist, became CytoDyn’s chief medical officer and vice chairman. Pestell has published 500 published papers in peer-reviewed journals and controls the patents to Merck & Co Inc (NYSE:MRK ) and Pfizer Inc (NYSE:PFE) HIV drugs for use in cancer treatment.

Preclinical studies conducted by Pestell, according to CytoDyn, show that CCR5 inhibitors blocked prostate cancer metastasis to the bones and brains of mice with competent immune systems and halted the spread of breast cancer to the lungs.

Until Cytodyn can generate significant revenue, the company is financing its cash needs primarily through public or private equity offerings, debt financings and strategic alliances. All told, the company has raised $200 million, according to Pourhassan.

In March, CytoDyn said the FDA reviewed and accepted the company’s request and plan to submit on a rolling basis its planned biologics license application (BLA) for leronlimab.  

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Wed, 06 Mar 2019 14:35:00 -0500 https://www.proactiveinvestors.com/companies/news/215750/cytodyn-presses-forward-with-hiv-treatment-after-phase-3-215750.html
<![CDATA[Media files - FDA accepted CytoDyn’s request and plan to submit BLA on rolling basis ]]> https://www.proactiveinvestors.com/companies/stocktube/12448/fda-accepted-cytodyns-request-and-plan-to-submit-bla-on-rolling-basis-12448.html Mon, 04 Mar 2019 16:28:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12448/fda-accepted-cytodyns-request-and-plan-to-submit-bla-on-rolling-basis-12448.html <![CDATA[News - CytoDyn granted rolling review by FDA for its Biologics License Application for its HIV therapy leronlimab ]]> https://www.proactiveinvestors.com/companies/news/215721/cytodyn-granted-rolling-review-by-fda-for-its-biologics-license-application-for-its-hiv-therapy-leronlimab-215721.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech developing its flagship leronlimab (PRO 140) antibody for multiple indications including HIV, announced Monday that the FDA has reviewed and accepted its plan to submit on a rolling basis, its planned Biologics License Application.

A biologics license application is a request to distribute a biologic across states. In most cases, it is generally submitted after an Investigational New Drug (IND) after the appropriate studies have been conducted, according to the FDA website.

READ: CytoDyn wins key concession from FDA for flagship HIV drug leronlimab trial

CytoDyn Inc is working to develop a significant advance in HIV treatment beyond the “AIDS cocktail” combination of pills that has kept millions of people alive since the mid-1990s.

The company’s main product candidate leronlimab, is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS).

“We are extremely proud of the effort of our entire team to reach this very important milestone,” CytoDyn CEO Dr Nader Pourhassan said in a statement. “We are grateful to the FDA for its timely and professional review and acceptance of our request for a rolling review of our planned BLA for PRO 140. As previously announced, we expect to complete the first section (of three) of the BLA for PRO 140 with submission to the FDA in March 2019.”

Pourhassan earlier said the company is already arranging meetings with potential commercial partners to assess distribution and prepare for the drug’s anticipated approval.

Leronlimab (PRO 140) is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.

Separately, CytoDyn was able to reduce the incidence of human breast cancer metastasis in a mouse model for cancer with flagship drug leronlimab, by more than 98%.

The biotech has filed for Orphan Drug designation to treat triple-negative breast cancer. It announced earlier this year that it will expand pre-clinical animal studies into eight cancer indications driven in part on prior research by Dr Richard G Pestell, suggesting that CCR5 inhibition may disrupt signaling and ultimately the spread of CCR5+ circulating tumor cells.

The company’s Philadelphia lab, led by Dr Pestell, will conduct eight pre-clinical studies on melanoma, pancreatic, breast, prostate, colon, lung, liver and stomach cancer. 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Mon, 04 Mar 2019 07:29:00 -0500 https://www.proactiveinvestors.com/companies/news/215721/cytodyn-granted-rolling-review-by-fda-for-its-biologics-license-application-for-its-hiv-therapy-leronlimab-215721.html
<![CDATA[News - CytoDyn to present data on monoclonal antibody treatment of HIV at Seattle conference ]]> https://www.proactiveinvestors.com/companies/news/215433/cytodyn-to-present-data-on-monoclonal-antibody-treatment-of-hiv-at-seattle-conference-215433.html CytoDyn Inc (OTCMKTS:CYDY) said Wednesday that data from the study of its monoclonal antibody treatment of HIV will be presented at a Seattle conference.

The biotech company said in a statement that the data will be presented at the Conference on Retroviruses and Opportunistic Infections on March 7.

The company’s leronlimab candidate is a once-weekly injection designed to block HIV-1 from entering and infecting human cells by binding to the CCR5 receptor, a protein on the surface of white blood cells that is related to the immune system.

DEEP DIVE: CytoDyn says it’s on the cusp of a breakthrough HIV treatment after Phase 3 trial

“CytoDyn’s commitment to providing groundbreaking therapeutic advances for those in need has never been stronger,” CEO Nader Pourhassan said. “We remain highly encouraged by the continued clinical and regulatory progress to bring the next generation HIV treatment to patients.”

The company is in the process of completing a biologics license application with the Food and Drug Administration for leronlimab, also known as PRO 140, as part of a combination with highly active antiretroviral therapies for HIV-infected patients.

Then, subject to the treatment's approval by the FDA as part of a combination therapy, CytoDyn plans to file for a label expansion for leronlimab as a monotherapy, providing the company can achieve positive results from a proposed Phase 3 trial.

The annual conference brings together clinical researchers from around the world to share the latest studies in the battle against HIV, AIDS and related infectious diseases. It will be held from March 4 to March 7 at the Washington State Convention Center in Seattle.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Wed, 27 Feb 2019 09:53:00 -0500 https://www.proactiveinvestors.com/companies/news/215433/cytodyn-to-present-data-on-monoclonal-antibody-treatment-of-hiv-at-seattle-conference-215433.html
<![CDATA[Media files - CytoDyn files for Orphan Drug designation to treat triple-negative breast cancer ]]> https://www.proactiveinvestors.com/companies/stocktube/12316/cytodyn-files-for-orphan-drug-designation-to-treat-triple-negative-breast-cancer-12316.html Thu, 21 Feb 2019 15:05:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12316/cytodyn-files-for-orphan-drug-designation-to-treat-triple-negative-breast-cancer-12316.html <![CDATA[News - CytoDyn’s leronlimab reduces by more than 98% human breast cancer metastasis in mouse xenografts ]]> https://www.proactiveinvestors.com/companies/news/214963/cytodyns-leronlimab-reduces-by-more-than-98-human-breast-cancer-metastasis-in-mouse-xenografts-214963.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Wednesday that it was able to reduce by more than 98%, the incidence of human breast cancer metastasis in a mouse xenograft (tissue graft) model for cancer through six weeks with its flagship leronlimab (PRO 140) antibody.

As part of CytoDyn's recent acquisition of ProstaGene, CytoDyn received control of a prestigious lab in Philadelphia led by the company’s chief medical officer Dr Richard G Pestell. The company announced on Tuesday that the Philadelphia lab will conduct eight pre-clinical studies on melanoma, pancreatic, breast, prostate, colon, lung, liver and stomach cancer. CytoDyn pegged the cost of running the preclinical studies for the eight cancers and submission of Phase 2 IND applications at roughly $1.5 million.

READ: CytoDyn to initiate 8 preclinical animal studies with leronlimab for multiple cancers

Leronlimab (PRO 140) is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.

Based on the results, CytoDyn announced its plans for the expansion of pre-clinical animal studies into eight cancer indications, driven in part on prior research by Dr Pestell, suggesting that CCR5 inhibition may disrupt signaling and ultimately the spread of CCR5+ circulating tumor cells.

In Dr Pestell’s research laboratory, pre-clinical studies were conducted on mice using Pfizer’s HIV drug maraviroc in breast and prostate cancer.  Results were most encouraging using these CCR5 inhibitors, which ultimately led Dr Pestell to design experiments applying leronlimab (PRO 140) to metastatic mouse models. The results of this pre-clinical study using leronlimab (PRO 140) in mice showed a reduction in breast cancer metastasis of more than 98% over the six-week period of the study.

The mouse xenograft model is designed to mimic human breast cancer metastasis. The biotech said it is optimistic after finding more than 98% reduction in tumor metastasis over a six-week period in the mouse model. The “temporal equivalency” of the six weeks study, may be up to six years in humans, pointed out the company.

“These positive pre-clinical results are very promising, and it gives new hope for future treatment options to cancer victims all over the world,” said CytoDyn CEO Dr Nader Pourhassan in a statement. “We are working diligently to present an abstract of this data in conference as soon as possible.”

The CEO said their findings could result in “new treatment options of this kind” for late-stage cancer patients, who often experience deadly metastasis.

“Should CytoDyn’s mouse xenograft breast cancer metastasis studies using leronlimab (PRO 140) correlate in humans as Pfizer’s drug maraviroc did in colon cancer, in a trial conducted in Germany, this could open new possibilities for treatment options for breast cancer,” said Dr Pourhassan.

He said the company was looking forward to interim data from its human trial in triple-negative breast cancer, which is expected to be available within the next few months.

“If interim results are positive, we will promptly file for breakthrough therapy designation,” said Dr Pourhassan. “Negotiation of potential licensing opportunities has started on several fronts. We hope to reach a definitive deal regarding a commercialization partnership for HIV and/or GvHD, which would further enhance the trajectory of our company.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Wed, 20 Feb 2019 07:51:00 -0500 https://www.proactiveinvestors.com/companies/news/214963/cytodyns-leronlimab-reduces-by-more-than-98-human-breast-cancer-metastasis-in-mouse-xenografts-214963.html
<![CDATA[Media files - CytoDyn to begin preclinical studies with leronlimab for 8 different cancers ]]> https://www.proactiveinvestors.com/companies/stocktube/12292/cytodyn-to-begin-preclinical-studies-with-leronlimab-for-8-different-cancers-12292.html Tue, 19 Feb 2019 16:26:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12292/cytodyn-to-begin-preclinical-studies-with-leronlimab-for-8-different-cancers-12292.html <![CDATA[News - CytoDyn to initiate 8 preclinical animal studies with leronlimab for multiple cancers ]]> https://www.proactiveinvestors.com/companies/news/214879/cytodyn-to-initiate-8-preclinical-animal-studies-with-leronlimab-for-multiple-cancers-214879.html CytoDyn Inc (OTCMKTS:CYDY) said Tuesday that its new lab in Philadelphia led by the company’s chief medical officer Professor Richard G Pestell will conduct eight pre-clinical studies on melanoma, pancreatic cancer, breast cancer, prostate cancer, colon cancer, lung cancer, liver cancer and stomach cancer.

As part of CytoDyn's recent acquisition of ProstaGene, CytoDyn received control of a prestigious lab that operates under the guidance of Dr Pestell who is an authority in cancer research. CytoDyn pegged the cost of running the preclinical studies for the eight cancers and submission of Phase 2 IND applications at approximately $1.5 million.

"We believe CytoDyn's model to concurrently evaluate several opportunities in pursuit of multiple Phase 2 clinical trials in cancer, if the animal studies are positive, may represent a significant acceleration to create therapeutic benefit for cancer patients," said CytoDyn CEO Dr Nader Pourhassan in a statement.

READ: CytoDyn wins key concession from FDA for flagship HIV drug leronlimab trial

Separately, CytoDyn announced Friday that it held a productive meeting with the US Food and Drug Administration (FDA) in which it won key concessions for its flagship HIV drug leronlimab.

On a recent conference call with the FDA, US regulators recognized that the higher dosage of 700mg in a monotherapy trial for leronlimab, an injectable antibody which takes aim at HIV, had a much higher response rate than the 350mg dose used in a combination therapy trial.

"Exploring these opportunities with our new laboratory will not slow down the filing of our Biologics License Application (BLA) or our monotherapy trial for HIV patients,” said Pourhassan. “We are also delighted that we have entered into discussions for commercializing leronlimab in 2020 and are currently considering a potential offer for royalties and milestone payments in connection with a commercialization partnership for HIV and GvHD indications."

To avoid a delay in the filing of the drug’s Biologics License Application (BLA) submission, the FDA has agreed to accept safety data from 100 patients in the monotherapy trial with the 700mg dose of leronlimab. This concession allows for the drug’s BLA submission for the combination therapy to use 700 mg of the drug instead of the original 350 mg dose.

Leronlimab is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS).

"The receptor, CCR5, has been shown to function as a lynchpin in both the progression of cancer metastasis and HIV," said Dr Pestell. "Most cancer deaths are linked to the metastasis not the primary tumor. Cancer can use CCR5 to spread the disease. Cancer metastasis has been reduced in animal studies and human pilot studies using CCR5 small molecule inhibitors. Leronlimab has a track record of safety, without serious adverse events related to leronlimab in over 670 patients from the HIV community.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Tue, 19 Feb 2019 07:40:00 -0500 https://www.proactiveinvestors.com/companies/news/214879/cytodyn-to-initiate-8-preclinical-animal-studies-with-leronlimab-for-multiple-cancers-214879.html
<![CDATA[Media files - CytoDyn CEO says FDA has offered 'a good path forward' for its HIV drug ]]> https://www.proactiveinvestors.com/companies/stocktube/12107/cytodyn-ceo-says-fda-has-offered--a-good-path-forward--for-its-hiv-drug-12107.html Tue, 05 Feb 2019 12:30:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12107/cytodyn-ceo-says-fda-has-offered--a-good-path-forward--for-its-hiv-drug-12107.html <![CDATA[News - CytoDyn wins key concession from FDA for flagship HIV drug leronlimab trial ]]> https://www.proactiveinvestors.com/companies/news/213816/cytodyn-wins-key-concession-from-fda-for-flagship-hiv-drug-leronlimab-trial-213816.html CytoDyn Inc (OTCMKTS:CYDY) announced Friday that it held a productive meeting with the Food and Drug Administration (FDA) in which it won key concessions for its flagship HIV drug leronlimab.

On a recent conference call with the FDA, US regulators recognized that the higher dosage of 700mg in a monotherapy trial for leronlimab, an injectable antibody which takes aim at HIV, had a much higher response rate than the 350mg dose used in a combination therapy trial.

READ: CytoDyn says it’s on the cusp of a breakthrough HIV treatment after Phase 3 trial

To avoid a delay in the filing of the drug’s Biologics License Application (BLA) submission, the FDA has agreed to accept safety data from 100 patients in the monotherapy trial with the 700mg dose of leronlimab. This concession allows for the drug’s BLA submission for the combination therapy to use 700 mg of the drug instead of the original 350 mg dose.

“The successful interim results in the 700 mg monotherapy arm prompted the FDA to allow CytoDyn to switch all remaining combination therapy patients from its CD02-Extension study from a 350 mg to a 700 mg dose,” a company statement explained.

In a statement, CytoDyn CEO Nader Pourhassan said the company is already arranging meetings with potential commercial partners to assess distribution and prepare for the drug’s anticipated approval.

 “We are extremely appreciative of the agency’s guidance for the approval process for the world’s first self-injectable antibody for HIV,” said Dr Pourhassan.

“We believe we can realize significant revenue opportunities by 2020 assuming the first approval of leronlimab,” he added.

Leronlimab is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS). 

CytoDyn shares slipped 1% to finish at $0.48 on Thursday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

 

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Fri, 01 Feb 2019 08:04:00 -0500 https://www.proactiveinvestors.com/companies/news/213816/cytodyn-wins-key-concession-from-fda-for-flagship-hiv-drug-leronlimab-trial-213816.html
<![CDATA[News - CytoDyn says it’s on the cusp of a breakthrough HIV treatment after Phase 3 trial ]]> https://www.proactiveinvestors.com/companies/news/213647/cytodyn-says-its-on-the-cusp-of-a-breakthrough-hiv-treatment-after-phase-3-trial-213647.html CytoDyn Inc (OTCMKTS:CYDY) is working to develop a significant advance in HIV treatment beyond the “AIDS cocktail” combination of pills that has kept millions of people alive since the mid-1990s.

The company’s main product candidate is leronlimab, an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS). 

Vancouver, Washington-based CytoDyn is also exploring PRO 140’s use in the treatment of cancer, inflammatory conditions and autoimmune diseases.

READ: CytoDyn's injectable treatment does well in AIDS trial

“We are on the brink of an HIV paradigm shift and on the brink of stopping cancer from killing people,” Nader Pourhassan, the CEO of CytoDyn, told Proactive Investors. 

Founded in 2002, the company struggled with the development of a drug known as Cytolin, and Pourhassan began looking for alternatives. On the brink of bankruptcy, the company agreed in 2012 to acquire leronlimab from the therapy’s developer, Progenics Pharmaceuticals Inc (NASDAQ:PGNX). 

After the deal was signed, Pourhassan, then managing director of business development at CytoDyn, had 35 days to raise $3.5 million for the initial payment, a busy period that ended with the company’s taking in $7 million. The deal calls for royalty payments to Progenics if CytoDyn succeeds in winning Food and Drug Administration approval of leronlimab.

Pourhassan draws on a variety of experiences at the helm of CytoDyn.

He emigrated from Iran to the US as a teenager in 1977, two years before revolutionaries deposed the Shah. His studies culminated with his earning a Ph.D. in mechanical engineering from the University of Utah. For 20 years, he managed his family’s business, but he was also busy authoring three books. He joined CytoDyn more than a decade ago.

Phase 3 trial

Since Pourhassan became CEO at the end of 2012, CytoDyn’s work on leronlimab as a therapy for HIV has proceeded from Phase 2 to the conclusion of a Phase 3 trial that could lead to commercial use.

Cytodyn is financing its cash needs primarily through public or private equity offerings, debt financings and strategic alliances. All told, the company has raised $200 million, according to Pourhassan.

Wainwright & Co recently reiterated its Buy rating for Cytodyn, saying data support leronlimab, also known as PRO 140, as a long-acting maintenance therapy.

Meanwhile, CytoDyn is looking beyond HIV and AIDS to other illnesses such as cancer. 

In November, the company completed its $15.4 million stock acquisition of privately held ProstaGene LLC, whose CEO, Richard Pestell, an oncologist, became CytoDyn’s chief medical officer and vice chairman. Pestell has published 500 published papers in peer-reviewed journals and controls the patents to Merck & Co Inc (NYSE:MRK ) and Pfizer Inc (NYSE:PFE) HIV drugs for use in cancer treatment.

Cancer studies

Preclinical studies conducted by Pestell, according to CytoDyn, showed that CCR5 inhibitors blocked prostate cancer metastasis to the bones and brain of mice with competent immune systems and blocked the spread of breast cancer to the lungs.

Until Cytodyn can generate significant revenue, the company is financing its cash needs primarily through public or private equity offerings, debt financings and strategic alliances. All told, the company has raised $200 million, according to Pourhassan.

Looking ahead, the company plans to seek FDA approval for leronlimab in combination HIV therapy for a so-called unmet-medical-need population and is looking to complete a filing of a biologics license application (BLA) in the first half of 2019. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-a-week monotherapy, which refers to use of a single drug or treatment.

Moreover, the company is conducting Phase 2 trials to evaluate leronlimab for the prevention of graft versus host disease (GvHD) and has started a clinical trial with leronlimab in metastatic triple-negative breast cancer.

“There have been quite a bit of surprises of how many indications this product could have,” said Pourhassan.  

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

 

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Wed, 30 Jan 2019 14:56:00 -0500 https://www.proactiveinvestors.com/companies/news/213647/cytodyn-says-its-on-the-cusp-of-a-breakthrough-hiv-treatment-after-phase-3-trial-213647.html
<![CDATA[Media files - CytoDyn aims to be 'paradigm-shifting' in cancer management with its platform drug leronlimab ]]> https://www.proactiveinvestors.com/companies/stocktube/11806/cytodyn-aims-to-be--paradigm-shifting--in-cancer-management-with-its-platform-drug-leronlimab-11806.html Fri, 11 Jan 2019 10:51:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11806/cytodyn-aims-to-be--paradigm-shifting--in-cancer-management-with-its-platform-drug-leronlimab-11806.html <![CDATA[News - CytoDyn's injectable treatment does well in Aids trial ]]> https://www.proactiveinvestors.com/companies/news/124921/cytodyn-s-injectable-treatment-does-well-in-aids-trial-124921.html An injectable AIDs treatment pioneered by CytoDyn Inc (OTC.QB:CYDY) suppressed the virus in 10 patients for 18 months and for 20 in several of these, the company revealed today.

CytoDyn now believes that complete HIV virologic suppression is possible through a once-weekly injection of its PRO 140 treatment, rather than the daily dosing of multiple pills under standard HAART treatment.

PRO 140 was tested as a single therapy treatment for patients with the R5 subtype of HIV. 

Patients are now being enroled for a  pivotal Phase 3 trial for PRO 140 as a combination therapy with HAART while a phase III trial for PRO 140 as a long-term monotherapy also starts enrolment soon.

“With currently approved drug therapy, HIV need no longer be the deadly disease it once was,” said Nader Pourhassan, CytoDyn’s chief executive. 

“However, the drawbacks of HAART therapy, including considerable drug toxicity, patient compliance with programmed daily dosing and drug resistance, pose serious issues for this patient population,”.

 “PRO 140 has demonstrated in multiple clinical trials a reduction in HIV viral loads and the maintenance of HIV viral load suppression with hardly any side effects.” 

“We see a significant opportunity with PRO 140 as a HIV monotherapy and in combination with HAART, and we believe that PRO 140 could lead to a new treatment paradigm for many patients living with HIV.”

PRO 140 belongs to a new class of HIV/AIDS therapeutics—viral-entry inhibitors—that are intended to protect healthy cells from viral infection, said Cytodyn.

The drug has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. 

It has been assigned as a “fast track” product candidate by the US Food and Drug Administration.

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Mon, 18 Apr 2016 09:28:00 -0400 https://www.proactiveinvestors.com/companies/news/124921/cytodyn-s-injectable-treatment-does-well-in-aids-trial-124921.html