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

Leronlimab shows promise as an antiviral agent with fewer side effects, lower toxicity and less frequent doses than daily HIV therapies now in use
A syringe
Leronlimab is an injectable antibody that shows promise as an antiviral agent

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 [email protected]


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