Proactiveinvestors USA & Canada CytoDyn https://www.proactiveinvestors.com Proactiveinvestors USA & Canada CytoDyn RSS feed en Wed, 22 May 2019 07:59:37 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - CytoDyn takes major step forward filing trial protocol for HIV Monotherapy ]]> https://www.proactiveinvestors.com/companies/stocktube/13376/cytodyn-takes-major-step-forward-filing-trial-protocol-for-hiv-monotherapy-13376.html Thu, 16 May 2019 07:00:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13376/cytodyn-takes-major-step-forward-filing-trial-protocol-for-hiv-monotherapy-13376.html <![CDATA[News - CytoDyn files pivotal trial protocol with FDA for flagship drug leronlimab as monotherapy for HIV ]]> https://www.proactiveinvestors.com/companies/news/220325/cytodyn-files-pivotal-trial-protocol-with-fda-for-flagship-drug-leronlimab-as-monotherapy-for-hiv-220325.html CytoDyn Inc (OTCMKTS:CYDY) announced Wednesday that the late-stage biotechnology company has filed the pivotal trial protocol for its flagship drug leronlimab as a monotherapy for HIV patients with the US Food and Drug Administration.

The Vancouver-based biotech said the latest investigative monotherapy trial for HIV has now produced “sufficient data” for the company to design a pivotal monotherapy Phase 3 trial.

The company’s main product candidate leronlimab is 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.

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

The trial will include 10 weeks of induction therapy to identify which patients are likely to respond and which patients can safely return to their original HAART, or highly active antiretroviral therapy regimen.

The company said the objective of the trial is to assess the treatment strategy and clinical safety of using a leronlimab subcutaneous (SC) 700mg weekly dose as single-agent induction therapy followed by leronlimab SC 525 or 700mg as a maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

In the study, patients will receive a combination of existing retroviral regimen and leronlimab 700 mg (sub-cutaneous) for four weeks (the overlap phase) before shifting to weekly leronlimab 700 mg monotherapy for 10 weeks (the monotherapy induction phase).

Subsequently, patients will be randomized 1:1 to leronlimab 525mg (Group A) or leronlimab 700mg (Group B) for a 36-week monotherapy maintenance phase. Success with this monotherapy trial may allow the company to file a biologics license application (BLA) for label expansion in anticipation of leronlimab receiving FDA approval for HIV patients as a combination therapy with HAART.

Glowing patient testimony 

“The testimony of patients who have taken leronlimab as a monotherapy in our previous clinical trials is very clear; patients who respond to monotherapy simply love it, and after 48 weeks they ask for extension to continue on monotherapy,” said CytoDyn CEO Dr Nader Pourhassan in a statement. “We have not seen any extension patients ask to return to their HAART regimen of pills.”

Pourhassan said a monotherapy with leronlimab, if approved, may allow patients with “pill fatigue to maintain a disciplined compliance regimen.”

“In addition, it may provide patients concerned about the possibility of developing one or more drug class resistances, to potentially maintain a suppressed viral load without the typical side effects or toxicity associated with HAART,” added Dr Pourhassan.

Jacob P Lalezari, a director at Quest Clinical Research, said that as a longstanding investigator for CytoDyn he had seen many HIV positive patients express "a preference for the weekly subcutaneous leronlimab monotherapy and uniformly request extension treatment beyond 48 weeks" in order to avoid returning to the HAART therapy.

The FDA earlier granted fast track designation — which bring drugs that fill an unmet need to market faster — to leronlimab in combination with HAART, or highly active antiretroviral therapy, for HIV treatment. Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in more than 700 people, the company said.

—(Updates with quotes from Quest Clinical Research director)— 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 15 May 2019 08:53:00 -0400 https://www.proactiveinvestors.com/companies/news/220325/cytodyn-files-pivotal-trial-protocol-with-fda-for-flagship-drug-leronlimab-as-monotherapy-for-hiv-220325.html
<![CDATA[Media files - CytoDyn adds new talent to its management team ]]> https://www.proactiveinvestors.com/companies/stocktube/13349/cytodyn-adds-new-talent-to-its-management-team-13349.html Tue, 14 May 2019 15:56:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13349/cytodyn-adds-new-talent-to-its-management-team-13349.html <![CDATA[News - CytoDyn announces two new additions to management team ]]> https://www.proactiveinvestors.com/companies/news/220229/cytodyn-announces-two-new-additions-to-management-team-220229.html CytoDyn Inc. (OTCMKST:CYDY) announced Tuesday two new additions to its management team as it seeks regulatory approval of its flagship drug leronlimab (PRO 140) to treat cancer and HIV.

The Vancouver, Washington-based biotech company said in a statement that it has named Brendan Rae as senior vice president of Business Development and George Bitar as executive director, head of quality.

News of the appointments comes as the Food and Drug Administration has granted fast-track status to leronlimab for use in combination with carboplatin for the treatment of patients with triple negative breast cancer (mTNBC).

The FDA also has fast-tracked leronlimab in combination with HAART, or highly active antiretroviral therapy, for HIV treatment. And CytoDyn on Monday announced that it would test the drug to prevent fatty liver disease in mice.

READ: CytoDyn's flagship drug leronlimab to be tested to prevent fatty liver diease in mice

Given the potential of leronimab, CEO Nader Pourhassan said the “timing is ideal to have Brendan’s and George’s deep experience on the team, as we implement our commercialization plan and pursue new potential strategic agreements.”

Rae will lead CytoDyn’s business development initiatives, including all potential partnering and licensing opportunities for leronlimab, the company said, which added that Rae is an accomplished licensing and business development executive with a proven track record of deal-making. 

Rae comes to CytoDyn from Serina Therapeutics, a private company, where he was chief business officer, responsible for partnering, out licensing and overall company strategy. Previously, Rae was the executive director of NPS Pharmaceuticals and head of GI and Endocrinology Business Development until the acquisition by Shire Pharmaceuticals for $5.2 billion in 2015.

Prior to NPS, Rae held the role of chief business officer at Arrowhead Research and Vivaldi Biosciences, as well as senior leadership roles at VIA Pharmaceuticals Inc (OTCMKS:VIAP), Purdue Pharma and Hoffman-La Roche, according to the statement.

Rae was an attorney specializing in biopharmaceutical intellectual property law and earlier in his career was a research scientist focusing on metastasis and the molecular basis of cellular transformation, the company said.  

CytoDyn said Bitar will be responsible for overseeing all facets of the company’s quality systems, quality assurance, and compliance operations to ensure that the product is manufactured consistently to meet FDA standards.

READ: CytoDyn secures fast track FDA designation for leronlimab in treating metastatic triple negative breast cancer

As CytoDyn enters into a new era of manufacturing partnerships with contract manufacturing organizations (CMOs) in preparation for post-approval product launch of leronlimab, a knowledgeable head of quality is a critical component of the approval and the commercialization process, the company said.

Bitar brings over 25 years in quality management, technical operations, pharmaceutical manufacturing and R&D, to CytoDyn, most recently as the global head of quality at Hitachi Chemical Advanced Therapeutics Solutions, a cellular and gene therapy contract development and manufacturing organization.

Previously, Bitar led Pfizer’s (NYSE:PFE) generic oncology and biosimilars manufacturing through the approval process and was the site head of quality for Pfizer’s specialty injectable and biologic drug products.

Prior to Pfizer, Bitar was vice President – head of quality at InnoPharma Inc., which was acquired by Pfizer.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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Tue, 14 May 2019 08:40:00 -0400 https://www.proactiveinvestors.com/companies/news/220229/cytodyn-announces-two-new-additions-to-management-team-220229.html
<![CDATA[Media files - CytoDyn to begin proof-of-concept studies for leronlimab to treat liver damage caused by NASH ]]> https://www.proactiveinvestors.com/companies/stocktube/13325/cytodyn-to-begin-proof-of-concept-studies-for-leronlimab-to-treat-liver-damage-caused-by-nash-13325.html Mon, 13 May 2019 15:37:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13325/cytodyn-to-begin-proof-of-concept-studies-for-leronlimab-to-treat-liver-damage-caused-by-nash-13325.html <![CDATA[News - CytoDyn's flagship drug leronlimab to be tested to prevent fatty liver diease in mice ]]> https://www.proactiveinvestors.com/companies/news/220143/cytodyn-s-flagship-drug-leronlimab-to-be-tested-to-prevent-fatty-liver-diease-in-mice-220143.html CytoDyn Inc (OTCMKTS:CYDY) announced Monday that The Cleveland Clinic will test its flagship drug leronlimab (PRO 14O) to determined if it can prevent Non-Alcoholic Steatohepatitis (NASH) in mice.

The goal of the exploratory pre-clinical studies by Dr. Daniel Linder is to establish leronlimab’s ability to prevent the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) into NASH, the Vancouver, Washington-based company said in a statement.

CytoDyn noted that Pfizer’s (NYSE:PFE) HIV drug maraviroc has been a subject of several positive studies in this field. “Thus, CytoDyn intends to pursue this opportunity,” the company said.

READ: CytoDyn secures fast track FDA designation for leronlimab in treating metastatic triple negative breast cancer

“A successful proof-of-concept study of leronlimab in NASH will allow the company to immediately file with the FDA an (investigational new drug program) and protocol for a Phase 2 trial,” said CEO Nader Pourhassan.

NAFLD is an inflammatory disease caused by the build-up of fat in the liver of people who drink little or no alcohol. In severe cases, NAFLD progresses into NASH. It is estimated that 30% to 40% of adults in the US have NAFLD, while 3% to 12% of adults in the US have NASH, the company said.

If left untreated, NASH can progress to more serious disease stages, such as advanced fibrosis, cirrhosis, liver failure or liver cancer. CytoDyn said the disease is expected to become the leading cause of liver transplants by 2020.

Despite the growing awareness of NASH, it remains difficult to diagnose and there are currently no therapies approved by the US Food and Drug Administration.

Meanwhile, the CCR5 pathway has been shown in multiple clinical trials and in unrelated third-party research to be a potential key target in NASH, and leronlimab is a highly selective CCR5 inhibitor, CytoDyn said.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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Mon, 13 May 2019 08:40:00 -0400 https://www.proactiveinvestors.com/companies/news/220143/cytodyn-s-flagship-drug-leronlimab-to-be-tested-to-prevent-fatty-liver-diease-in-mice-220143.html
<![CDATA[Media files - CytoDyn reports positive preclinical data, gets FDA's fast-track designation ]]> https://www.proactiveinvestors.com/companies/stocktube/13263/cytodyn-reports-positive-preclinical-data-gets-fda-s-fast-track-designation-13263.html Wed, 08 May 2019 13:05:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13263/cytodyn-reports-positive-preclinical-data-gets-fda-s-fast-track-designation-13263.html <![CDATA[News - CytoDyn preclinical data shows leronlimab suppresses breast cancer tumor burden by more than 98% ]]> https://www.proactiveinvestors.com/companies/news/219912/cytodyn-preclinical-data-shows-leronlimab-suppresses-breast-cancer-tumor-burden-by-more-than-98-219912.html CytoDyn Inc (OTCMKTS:CYDY) shared positive preclinical data Wednesday that showed that its flagship drug leronlimab (PRO 140) suppressed breast cancer metastatic burden by more than 98% compared with untreated animals.

The company said that in a murine xenograft human breast cancer metastatic model, after nine weeks, compared with untreated mice at eight weeks, the leronlimab treated mice continued to have a more than 98% reduction in metastatic burden, or cancer cells the size of a tumor. 

Moreover, to test the ability of leronlimab to fight high tumor burden models, four of the mice in the control group with advanced metastatic disease, were treated with leronlimab. Two of these four mice were still alive at week 16, according to the company.

Based on the results, CytoDyn will expand preclinical animal studies in eight different cancer indications.

READ: CytoDyn secures fast track FDA designation for leronlimab in treating metastatic triple negative breast cancer

The Vancouver-based biotech plans to file for Orphan Drug Designation with the US Food and Drug Administration for leronlimab in metastatic triple-negative breast cancer (mTNBC).

On Tuesday, the FDA granted fast track designation to leronlimab for use in combination with carboplatin for the treatment of patients with mTNBC. This is a positive development for women suffering the particular type of persistent breast cancer, which relapses quickly. 

The preclinical data also validates prior research conducted by CytoDyn’s Chief Medical Officer Richard G Pestell linked to CCR5 inhibition and leronlimab’s ability to disrupt cell motility and inhibit tumor metastasis in a highly targeted way. 

“We anticipate presenting the findings at an appropriate medical conference and publish the results,” said Dr Pestell in a statement. “Should our mouse xenograft breast cancer metastasis studies using leronlimab correlate in humans, leronlimab may offer paradigm-shifting treatment options for metastatic cancer patients.”

Dr Pestell said the company is expecting interim data from its first human trial in triple-negative breast cancer this year that will "inform its future development and regulatory strategy."

Shares in CytoDyn were recently flat at $0.40.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 08 May 2019 11:57:00 -0400 https://www.proactiveinvestors.com/companies/news/219912/cytodyn-preclinical-data-shows-leronlimab-suppresses-breast-cancer-tumor-burden-by-more-than-98-219912.html
<![CDATA[Media files - CytoDyn sees progress with leronlimab to treat HIV-infected patients ]]> https://www.proactiveinvestors.com/companies/stocktube/13242/cytodyn-sees-progress-with-leronlimab-to-treat-hiv-infected-patients-13242.html Tue, 07 May 2019 14:18:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13242/cytodyn-sees-progress-with-leronlimab-to-treat-hiv-infected-patients-13242.html <![CDATA[News - CytoDyn secures fast track FDA designation for leronlimab in treating metastatic triple negative breast cancer ]]> https://www.proactiveinvestors.com/companies/news/219797/cytodyn-secures-fast-track-fda-designation-for-leronlimab-in-treating-metastatic-triple-negative-breast-cancer-219797.html CytoDyn Inc (OTCMKTS:CYDY) announced Tuesday that the US Food and Drug Administration (FDA) has granted fast track designation to its flagship drug leronlimab (PRO 140) for use in combination with carboplatin for the treatment of patients with triple negative breast cancer (mTNBC).

This is a positive development for women suffering the particular type of persistent breast cancer which relapses quickly.

READ: CytoDyn sees progress in trial using flagship drug leronlimab to treat HIV-infected patients

The company said in a statement that injection of the first patient is imminent. Clinical trial sites in Quest Clinical Research, in San Francisco along with four additional trial sites in Northwestern University Medical School, Methodist Houston, Vanderbilt University and Sidney Kimmel Cancer Center are in the process of initiating patient enrollment.

“This is an important acknowledgement of the potentially paradigm-shifting therapy option in metastatic triple-negative breast cancer,” said Dr Richard Pestell, chief medical officer at CytoDyn.  “Currently, there are no enduring treatment options for mTNBC patients. We thank the FDA for recognizing the potential of leronlimab for mTNBC patients.”

Shares in CytoDyn had closed 2.2% higher at $0.41 on Monday.

HIV treatment

The company’s main product candidate leronlimab, is also 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 FDA earlier granted fast track designation — which bring drugs that fill an unmet need to market faster — to leronlimab in combination with HAART, or highly active antiretroviral therapy, for HIV treatment. Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in more than 700 people, the company said.

READ: CytoDyn presses forward with HIV treatment after Phase 3

In March, 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.

“Our BLA for leronlimab as a combination therapy in HIV remains on track for completion in the third quarter of 2019, or sooner, and potential FDA approval before end of the first quarter of 2020, or sooner,” said Dr Pourhassan.

The Vancouver-based biotech alos announced on Monday that a monotherapy trial using leronlimab to treat HIV-infected patients has achieved some of it goals. It said patients taking 525 mg doses achieved a 95% response rate after the first 10 weeks.

In addition, more than 110 patients have reached nearly a one-year suppressed viral load with a monotherapy on original doses of 350 mg or higher, the company said in a statement.

“With the potential label extension as a monotherapy in HIV following the potential approval as a combination therapy, along with our Phase 2 development of leronlimab for GvHD and several other preclinical studies for metastatic solid tumors, the path to significant and enduring shareholder returns continues to take shape,” said Dr Pourhassan.

— (Updates with CEO quotes, biologics application, monotherapy in HIV)—  

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Tue, 07 May 2019 07:56:00 -0400 https://www.proactiveinvestors.com/companies/news/219797/cytodyn-secures-fast-track-fda-designation-for-leronlimab-in-treating-metastatic-triple-negative-breast-cancer-219797.html
<![CDATA[News - CytoDyn sees progress in trial using flagship drug leronlimab to treat HIV-infected patients ]]> https://www.proactiveinvestors.com/companies/news/219718/cytodyn-sees-progress-in-trial-using-flagship-drug-leronlimab-to-treat-hiv-infected-patients-219718.html CytoDyn Inc (OTCMKTS:CYDY) said Monday that a monotherapy trial using its flagship drug leronlimab (PRO 140) to treat HIV-infected patients has achieved some of it goals.

The Vancouver-based biotech company said patients taking 525 mg doses achieved a 95% response rate after the first 10 weeks.

In addition, more than 110 patients have reached nearly a one-year suppressed viral load with a monotherapy on original doses of 350 mg or higher, the company said in a statement.

Shares of CytoDyn added nearly 6% in midday trade to $0.42.

READ: CytoDyn to share data on flagship drug leronlimab at the American Association of Cancer Research

The US Food and Drug Administration has granted Fast Track designation — which bring drugs that fill an unmet need to market faster — to leronlimab in combination with HAART, or highly active antiretroviral therapy, for HIV treatment. Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in more than 700 people, the company said.

“We are excited to now have this new clinical data that enables us to more precisely design the protocol for our planned pivotal monotherapy trial with leronlimab,” said CEO Nader Pourhassan.

CytoDyn also is studying leronlimab to treat to breast cancer.

--UPDATES share price--

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @patrickmgraham

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Mon, 06 May 2019 08:30:00 -0400 https://www.proactiveinvestors.com/companies/news/219718/cytodyn-sees-progress-in-trial-using-flagship-drug-leronlimab-to-treat-hiv-infected-patients-219718.html
<![CDATA[Media files - Cytodyn has raised over 190 million dollars as they look to commercialize lead drug ]]> https://www.proactiveinvestors.com/companies/stocktube/13213/cytodyn-has-raised-over-190-million-dollars-as-they-look-to-commercialize-lead-drug-13213.html Thu, 02 May 2019 14:58:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13213/cytodyn-has-raised-over-190-million-dollars-as-they-look-to-commercialize-lead-drug-13213.html <![CDATA[Media files - CytoDyn CEO updates timeline for HIV drug, addresses share dilution concerns ]]> https://www.proactiveinvestors.com/companies/stocktube/13008/cytodyn-ceo-updates-timeline-for-hiv-drug-addresses-share-dilution-concerns-13008.html Mon, 15 Apr 2019 14:25:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13008/cytodyn-ceo-updates-timeline-for-hiv-drug-addresses-share-dilution-concerns-13008.html <![CDATA[Media files - CytoDyn teams with Samsung BioLogics, presents key data at cancer research meeting ]]> https://www.proactiveinvestors.com/companies/stocktube/12876/cytodyn-teams-with-samsung-biologics-presents-key-data-at-cancer-research-meeting-12876.html Thu, 04 Apr 2019 14:13:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12876/cytodyn-teams-with-samsung-biologics-presents-key-data-at-cancer-research-meeting-12876.html <![CDATA[News - CytoDyn to demonstrate superior potency of leronlimab in HIV patients at ASM Microbe 2019 ]]> https://www.proactiveinvestors.com/companies/news/217969/cytodyn-to-demonstrate-superior-potency-of-leronlimab-in-hiv-patients-at-asm-microbe-2019-217969.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Wednesday that it would share the final results of a pivotal study of its flagship drug leronlimab (PRO 140) in heavily treatment-experienced HIV patients at the 2019 American Society for Microbiology (ASM) Microbe Conference.

The company has been selected to make both oral and poster presentations at the five-day ASM Microbe Conference starting on June 20 at the Moscone Center in San Francisco. It is the main forum for microbial sciences and connects top scientists.

READ: CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab

“We are extremely proud to be able to present the results of our pivotal study for our lead drug candidate at this year’s ASM Microbe conference,” said CytoDyn Inc CEO Dr Nader Pourhassan in a statement. “The results of this pivotal study underpin the submission of our pending rolling Biologics License Application.”  

CytoDyn recently filed the non-clinical portion of a Biologics License Application for its flagship leronlimab as a combination therapy for HIV using the US Food and Drug Administration’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 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).

READ: CytoDyn forges deal with Samsung BioLogics to make $1B worth of leronlimab to meet expected demand

The CytoDyn team is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.

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

“As previously announced, we expect to complete the rolling review submission of the BLA for leronlimab with the FDA by the third quarter of 2019,” said Dr Nader Pourhassan.

"Fast Track" designation

The US FDA has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.

Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

On a separate note, pivotal human immunodeficiency virus (HIV) monotherapy trial results with leronlimab (PRO 140) recently topped expectations. New data showed that a weekly dose of 525 mg and 700 mg of leronlimab yielded approximately a 90% response rate for HIV-infected patients who pass the first ten weeks of monotherapy without virologic failure.

The company said that if a 700 mg weekly dose of leronlimab is approved for combination therapy, the approval will serve as a foundation for a potential label expansion for leronlimab as a monotherapy for HIV.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Thu, 04 Apr 2019 07:35:00 -0400 https://www.proactiveinvestors.com/companies/news/217969/cytodyn-to-demonstrate-superior-potency-of-leronlimab-in-hiv-patients-at-asm-microbe-2019-217969.html
<![CDATA[News - CytoDyn forges deal with Samsung BioLogics to make $1B worth of leronlimab to meet expected demand ]]> https://www.proactiveinvestors.com/companies/news/217765/cytodyn-forges-deal-with-samsung-biologics-to-make-1b-worth-of-leronlimab-to-meet-expected-demand-217765.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech developing its flagship leronlimab (PRO 140) candidate for multiple indications, said Tuesday that it is executing a strategic agreement with Samsung BioLogics Co Ltd to manufacture leronlimab.

The manufacturing agreement will support potential revenue of approximately $1 billion for CytoDyn, based on leronlimab costing nearly $120,000 per patient, per year.

Investors cheered the news and sent shares of CytoDyn up by nearly 5.7% to $0.51. 

The agreement starts immediately and entails the technology transfer of the fully validated commercial process and regulatory support during the pre- and post-approval process with the US Food and Drug Administration (FDA) and other global regulatory bodies.

READ: CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab

In the last four years, Samsung BioLogics has secured eight biologics drugs approvals from the FDA and 22 overall, when considering approvals from other regulatory agencies around the world.

CytoDyn’s financial obligations to Samsung will be met predominantly from sales from existing inventory of commercial grade leronlimab and non-dilutive financing, said the company.

The initial contract period starts on April 1, 2019 and extends to December 31, 2027, encompassing the multitude of potential indications for leronlimab for which CytoDyn anticipates pursuing regulatory approvals.

“We are elated at the distinction of partnering with the world’s preeminent biologics manufacturer for our franchise-defining drug,” CytoDyn CEO Dr Nader Pourhassan said in a statement. “In the last four years, Samsung BioLogics has been among the most successful, consistent and highest quality biologics manufacturers in the world. We are thrilled beyond measure that Samsung chose to partner with us.”

"Fast Track" designation

The US FDA has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.

Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn is conducting additional research with leronlimab in the cancer setting and plans to initiate additional Phase 2 human clinical trials, in addition to triple-negative breast cancer.

CytoDyn plans to seek FDA approval for leronlimab in combination therapy and has filed the non-clinical portion of a Biologics License Application for its flagship leronlimab as a combination therapy for HIV using the FDA’s rolling review process. 

Biologics license application

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

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 validation of Samsung is particularly important as we rapidly advance towards completing the rolling BLA,” said Pourhassan. “We are also currently evaluating several potential licensing deals for leronlimab to commercialization companies. We are getting closer to have such agreements in place which will provide CytoDyn non-dilutive funds to execute on our vision.”

The CEO earlier said CytoDyn continued to execute on the submission of its BLA and was “well positioned for potential revenue in 2020,” subject to final approval.

—(Upadtes with share price rise)—

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

 

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Tue, 02 Apr 2019 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/217765/cytodyn-forges-deal-with-samsung-biologics-to-make-1b-worth-of-leronlimab-to-meet-expected-demand-217765.html
<![CDATA[News - CytoDyn to share data on flagship drug leronlimab at the American Association of Cancer Research ]]> https://www.proactiveinvestors.com/companies/news/217645/cytodyn-to-share-data-on-flagship-drug-leronlimab-at-the-american-association-of-cancer-research-217645.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech developing its flagship leronlimab (PRO 140) candidate for multiple indications, announced Monday that it will present two studies at the annual five-day American Association of Cancer Research (AACR) meeting.

In March, CytoDyn filed an application with the US Food and Drug Administration (FDA) 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.

READ: CytoDyn announces filing of FDA fast-track application for breast cancer treatment

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.

The first study to be presented on April 1 will present data showing the expression of CCR5 in circulating tumor cells (CTCs) of HER2 metastatic breast cancer (mBC) patients and documents the correlation between CCR5 and HER2 expression in circulating tumor cells.

The second study will highlight murine xenograft data showing that CytoDyn’s leronlimab can effectively block human breast cancer metastases and enhance the cell killing ability of DNA damaging chemotherapy by selectively targeting the CCR5 receptor.

Groundbreaking treatment

“The key discoveries being announced today potentially contribute to a shift in the treatment paradigm for metastatic breast cancer patients,” said Professor Richard G. Pestell, who is the chief medical officer and vice chairman of CytoDyn.

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.

“There are three key findings from today’s presentations. First, we now know that CCR5 is overexpressed on CTCs of HER2 metastatic breast cancer patients. Second, we now show in xenograft models that leronlimab can effectively block CCR5 positive breast cancer metastasis,” said Dr Pestell.

“Third, the study has now shown in murine xenograft models that by reducing the ability of breast cancer cells to metastasize, thereby keeping the tumor more contained, leronlimab can potentially provide standard DNA damaging chemotherapies more time to work. Potentially providing significantly improved efficacy of existing cancer therapies with fewer side effects.”

CytoDyn has now opened a clinical trial (NCT03838367) that is assessing the efficacy of leronlimab in metastatic triple negative breast cancer and will measure circulating tumor cells in the enrolled 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 also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Mon, 01 Apr 2019 07:49:00 -0400 https://www.proactiveinvestors.com/companies/news/217645/cytodyn-to-share-data-on-flagship-drug-leronlimab-at-the-american-association-of-cancer-research-217645.html
<![CDATA[Media files - CytoDyn more than doubles recovery rate in its monotherapy HIV trial ]]> https://www.proactiveinvestors.com/companies/stocktube/12760/cytodyn-more-than-doubles-recovery-rate-in-its-monotherapy-hiv-trial-12760.html Wed, 27 Mar 2019 16:31:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12760/cytodyn-more-than-doubles-recovery-rate-in-its-monotherapy-hiv-trial-12760.html <![CDATA[News - CytoDyn’s monotherapy trial with flagship HIV drug leronlimab exceeds expectations ]]> https://www.proactiveinvestors.com/companies/news/217226/cytodyns-monotherapy-trial-with-flagship-hiv-drug-leronlimab-exceeds-expectations-217226.html CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Tuesday that pivotal human immunodeficiency virus (HIV) monotherapy trial results with flagship drug leronlimab (PRO 140) topped expectations.

New data showed that a weekly dose of 525 mg and 700 mg of leronlimab yielded approximately a 90% response rate for HIV-infected patients who pass the first ten weeks of monotherapy without virologic failure.

Approximately 30% of subjects fail within the first ten weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg. Patients who pass the first ten weeks of monotherapy on a 525 mg dose have reached an average total of 32 weeks with sustained viral load suppression, said the company.

READ: CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab

CytoDyn recently filed the non-clinical portion of a Biologics License Application for its flagship leronlimab as a combination therapy for HIV using the US Food and Drug Administration’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 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).

The CytoDyn team is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.

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

Potential label expansion 

The company said that if a 700 mg weekly dose of leronlimab is approved for combination therapy, the approval will serve as a foundation for a potential label expansion for leronlimab as a monotherapy for HIV.

CytoDyn said it is working with IncellDx, a single cell diagnostic company, to perform CCR5 genotyping and quantitative CCR5 expression profiling on cells potentially infectible by HIV to "bring precision medicine" to HIV therapeutics.

“We are excited to help development efforts for the first self-injectable, subcutaneous monotherapy for HIV patients,” IncellDx Inc founder CEO Dr Bruce K Patterson said in a statement.

Dr Patterson’s work has also identified a role of CCR5 in immune cells that regulate the immune response against cancer. The top expert in CCR5, has revealed that through certain lab tests looking at the genetics and expression of CCR5 in individual patients, CytoDyn may more closely match the most effective dose for each HIV monotherapy patient to achieve viral suppression. This dose could be 350 mg, 525 mg or 700 mg, depending on the individual CCR5 receptor density of each patient.

“If leronlimab is proven to be a successful monotherapy and is approved by FDA, it would be a game changer for HIV patients, offering a safe, highly effective, durable, once weekly treatment option,” said CytoDyn CEO Dr Nader Pourhassan. “We are excited that our response rate with the 525 mg and 700 mg dosages is close to 90% for those patients who pass the first ten weeks of monotherapy without virologic failure.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 26 Mar 2019 07:50:00 -0400 https://www.proactiveinvestors.com/companies/news/217226/cytodyns-monotherapy-trial-with-flagship-hiv-drug-leronlimab-exceeds-expectations-217226.html
<![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