Attendees at the Conference on Retroviruses and Opportunistic Infections (February 13-16) at the Washington State Convention Center in Seattle received a two-year update on CytoDyn’s PRO 140 as a single-agent maintenance therapy for HIV-1 infection. The poster presentation is from Dr. Kush Dhody, Senior Director, Clinical Operations at Amarex Clinical Research, on behalf of CytoDyn Inc. (OTCQB: CYDY). A follow-up discussion reviewing five abstracts, hosted by Karl Salzwedel of the National Institutes of Health and under the theme ‘I Want a New Drug’, is also scheduled and expected to feature a panel of distinguished participants, including CytoDyn CEO Nader Pourhassan.
PRO 140 has, so far, demonstrated a remarkable efficacy in HIV therapy, with its unique characteristics as a fully humanized immunoglobulin (Ig) G4 monoclonal antibody. Antibodies are Y-shaped proteins used by the immune system as a first line of defense against pathogens, such as bacteria and viruses. Each antibody is uniquely created to counter a specific antigen, which it then counters by flagging the intruder as such, to be destroyed by microphages, or by neutralizing it.
Vaccines use this response of the human immune system to build a shield against diseases like polio, smallpox, and a host of others. By injecting a small amount of the germ into the body, the antibodies specific to those antigens develop and are on hand to fight off subsequent attack from the infection. However, the science behind PRO 140 is based on monoclonal antibodies.
Monoclonal antibodies are antibodies engineered in the lab to serve as substitutes that can restore, enhance, or mimic the immune system’s attack on pathogenic cells, and they have been developed, to a large extent, for treating cancer patients. Now, PRO 140 is bringing aspects of that technology to the fight against HIV/AIDS while being tested in animals to explore cancer and other non-HIV indications.
Since PRO 140 is a humanized antibody, it is likely to have fewer side effects than a synthetic drug. Humanized antibodies are antibodies from non-human species that have been modified to ‘look like’ human antibodies.
In comments about its science (http://nnw.fm/vDcZ4), CytoDyn notes: “Monoclonal antibodies have come to represent one of the fastest expanding opportunities in the biotechnology/pharma sector. The ability to transition from research reagents generated in mice to fully humanized structures suitable for clinical and commercial development has provided some of the most effective and largest selling therapeutics over the last 10 years.”
On January 11, CytoDyn announced it had filed a request with the FDA for Breakthrough Therapy Designation for PRO 140 as a treatment for HIV-1 infection in treatment-experienced patients with virologic failure. Just the month before, the company announced the first Phase III clinical trial with PRO 140 as a single-agent maintenance therapy 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 subjects 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 subjects and has been designated a “fast track” product candidate by the FDA.
For more information, visit www.CytoDyn.com
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