HIV/AIDS may not be as much in the news as it was back in the 1980s, but the disease has not gone away. According to the Centers for Disease Control and Prevention (CDC) (http://nnw.fm/7yEVU), it still affects ‘more than 1.2 million people in the US… and 1 in 8 of them don’t know it’.
Although, perennially lumped together, HIV and AIDS are not synonymous. Not all those infected with HIV (HIV positive) have AIDS (acquired immunodeficiency syndrome), which is the final stage of HIV infection. The goal of antiretroviral therapy, or ART, has been to stop that progression, and that is what PRO 140 from CytoDyn Inc. (OTCQB: CYDY) hopes to do. By minimizing the HIV viral load, PRO 140 could prevent HIV from turning into AIDS.
Viral load (VL), the number of virus (HIV) particles per milliliter of blood, is an important biomarker in the fight against HIV/AIDS. The lower the viral load, the less chance there is that an HIV-infected person will develop AIDS, and, although a viral load of less than 200 copies per milliliter of blood is considered a low level of viral suppression, the therapeutic goal is an ‘undetectable’ VL of 50 or less.
Viral load also affects HIV transmission. The greater the viral load, the greater the risk of transmitting the virus. However, effective antiretroviral therapy can reduce viral load (VL) considerably and thus the transmission of HIV by more than 96 percent. A VL of less than 40 copies per milliliter of blood reduces the transmission rate to practically zero.
For some of those who, like Charlie Sheen, are participating in the current Phase III clinical trials for PRO 140, this level of viral load has already been achieved. A December story in the U.K. Daily Mail (http://nnw.fm/l0Kn9) quoted the actor as saying he had been able to achieve an undetectable viral load by taking PRO 140. Sheen, who disclosed in late 2015 that he had tested HIV positive some four years earlier, has been part of the PRO 140 trials for about nine months.
The actor waxed eloquently on an ABC News (http://nnw.fm/rSx4d) interview about the hope brought into his life by using PRO 140: “I can feel the future with this thing and it’s much bigger and more important than I am”. The 51-year-old actor says he feels like he is carrying the torch for fellow sufferers of HIV/AIDS. Adding, “We are very close to being approved”.
Last Wednesday, CytoDyn announced (http://nnw.fm/ETlo9) 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. The company believes PRO 140 will be useful in caring for ‘heavily treatment-experienced HIV patients’ who have developed drug resistance to their current treatments. In contrast to the current highly active antiretroviral therapy (HAART), which is typically a ‘cocktail’ of drugs, PRO 140 works alone.
The ongoing clinical trials have yielded promising results. For approximately 24 months, enrolled patients showed no drug resistance, and viral load suppression was maintained for the same period. There was no impact on the immune function, nor were there any serious adverse events. Additionally, to date, there have been no serious side effects in the over 200 patients.
CytoDyn management is, understandably, excited at the progress. In a news release, Dr. Nader Pourhassan, CytoDyn’s President and CEO, stated, “We believe PRO 140 has demonstrated its value as a combination therapy and as a single agent in patients with the R5 strain of HIV and are hopeful that receiving Breakthrough Therapy Designation will speed our BLA (biologic license application) process to get this product to the market.”
The U.S. market size for HIV therapies is estimated at around $15 billion.
For more information, visit www.CytoDyn.com
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