CytoDyn Inc. (OTCQB: CYDY) is entering a Phase 3 clinical trial with its leading product candidate, PRO 140, and the Washington-based biotech is showing a lot of progress nearing major milestones. PRO 140 is a viral-entry inhibitor, a new class of HIV/AIDS therapies that work by blocking the entry of the human immunodeficiency virus (HIV) to healthy cells. PRO 140 is presently at the Phase 3 clinical trial stage. For the millions worldwide with HIV/AIDS, PRO 140 could offer the promise of a more robust bodyguard from further viral insult with potentially fewer side effects and hardly any toxicity.
HIV, like many other dangerous viruses, has a formidable ability to reproduce itself. The virus will invade an immune system cell and employ that cell’s reproductive machinery to make copies of itself, often killing the host cell in the process. New viral particles then emerge from the host and go on to infect other cells.
Many of the current AIDS therapies slow HIV replication by inhibiting viral enzymes within cells already affected by HIV. However, a new class of drugs, known as viral entry inhibitors, is designed to protect healthy cells from HIV infection by blocking early steps in the viral life cycle.
HIV infection occurs when the virus gains entry to two ‘doorways’ or receptors on the cell surface. These are the CD4 receptor and the co-receptor CCR5. The GP120 protein of HIV first attaches to the CD4 receptor on the cell membrane and then is able to bind to the co-receptor CCR5. At that point, the chips are down. The membranes of the virus and the immune cell fuse, and genetic material from HIV enters the cell.
PRO 140 works by attaching to the same portion of the CCR5 co-receptor to which HIV normally binds. The PRO 140 monoclonal antibodies physically block the HIV from attaching to the CCR5 co-receptor and arrest the completion of the second step in the entry process. The HIV is, consequently, rendered ineffective.
The approach taken by PRO 140 has a distinct advantage over other therapies. The normal function of CCR5 is to bind chemokines, molecules that regulate inflammation. Other HIV drugs that target CCR5 interact with the pocket of the receptor and thereby inhibit binding of both HIV and chemokines, which may have a number of adverse consequences because of the disruption of the chemokine inflammatory response. However, PRO 140 blocks HIV yet permits normal chemokine binding leading to potentially less side effects.
Early clinical testing indicates that PRO 140’s half-life contributes to the masking of CCR5 receptors for up to two months. Thus, infrequent dosing with PRO 140 may be possible compared to small molecule drugs, which require daily dosing.
In addition, being an antibody and not a synthetic drug means that PRO 140 will, most likely, have fewer issues with toxicity. Previous short and long-term trials have shown that PRO 140 is less likely to induce the development of resistant viruses.
Earlier this month, CytoDyn Inc. announced that several patients had been treated in the first single-agent maintenance therapy, Phase 3 (instead of today’s standard of care of at least three agents) in virally suppressed subjects with HIV. PRO 140 is considered one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in more than 140 HIV-infected patients in placebo controlled and open label FDA-approved clinical trials. The drug has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test patients and being designated a “fast track” product candidate by the FDA.
CytoDyn is a biotechnology company focused on the clinical development and commercialization of humanized monoclonal antibodies for the treatment and prevention of human immunodeficiency virus infection.
For more information, visit www.CytoDyn.com
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