By David Drake
#hiv has plagued the United States women and children alike for the last few decades. I never thought we would actually see a potential antidote to permanently suppress or even eradicate HIV (Human Immunodeficiency Virus) in my lifetime. That is until I came across a new biotech company that has developed the first self-administered, injectable antibody for HIV patients worldwide. The #fda has given PRO 140 a fast tracking designation and possibility of accelerated approval. Furthermore, the FDA just gave the phase 3 plan a green light and asked to receive the full protocol.
Today HIV is not a death sentence like it once was thanks to one man, Dr. David Ho. In 1996, he created the Highly Active Antiretroviral Therapy or HAART that is the base foundation for modern HIV treatment. We saw its first go to work on NBA hall of famer Magic Johnson more than 20 years ago and today Mr. Johnson is still his competitive self. It was first developed as a 3 drug regimen program with 2 different classes of daily pills taken for life.
It’s taken nearly 30 years but there is a new company making treatment of HIV easier and less invasive of a lifestyle change. The company is CytoDyn Inc. (OTCQB: CYDY), and they offer HIV patients a new alternative to the pills regimen with their PRO 140 weekly HIV antibody injection . I just got a chance to interview CytoDyn President and CEO Dr. Nader Pourhassan.
“The US had about 56,000 new HIV cases in 2014″ said Nader Pourhassan as we started talking. I grew up during the Acquired Immunodeficiency Syndrome (AIDS) epidemic and have endlessly and constantly worried about it. The fear of HIV and AIDS has always been a looming present threat and danger all my adult life, but not anymore.
Cytodyn finally may have an alternative to pills with “PRO 140″ as it just passed phase 2b FDA Clinical trials with a staggering 98% success rate. It is now facing a 25 week phase-3 clinical trial that could put this medicine on store shelves to give HIV patients a new option than just oral regimen.
How does it work? Fourteen (14) patients from the 40 persons that participated in the recently concluded phase 2b trial were allowed to continue taking the once a week self-administered injections of PRO 140. The antibody PRO 140 prevents HIV to bind to CCR5, co-receptor by simply binding to this co-receptor the HIV uses to enter and infect cells. It is like you are at a red stop light and the light never turns to green. The result is that the last year’s new HIV cases in the US could one day potentially have such a low virus count that they cannot infect anyone. Moreover, these HIV patients will have their own exposure in remission maintained.
How big of a concern is HIV business today, it’s a $15 billion annual industry in US and EU. Just over 1.1 million Americans have HIV while 56,000 new cases were added in 2014.
People with HIV will not be cured, yet they have to take several pills everyday just to fight HIV and AIDS, to stay alive. The current HAART program being used by HIV/AIDS patients has drawbacks, and poses three challenges:
Some of these drugs become toxic and patients face new exposure to dying; HIV grows resilient against medications and their combination, so a new format of medication has to be created to fight HIV.
If and when the patients forget to take a single one of their daily HIV pills, it renders the whole program dysfunctional and the HIV infection count increases.
With the PRO 140 once a week injection process, the patient may forget one day without jeopardizing their HIV count reduction. Moreover, the side effects of nausea and sleep deprivation have significantly improved with less pills challenging and damaging the body’s immune system.
Pfizer (NYSE: PFE) offers Selzentry (Maraviroc) as a pill in the HIV inhibitors market. However, its side effects include liver toxicity, heart problems that may lead to heart attacks and low blood pressure when standing up (postural hypotension). Interestingly enough, a 2013 report published by Red Orbit from New York University School of Medicine found Selzentry combat the deadly Staph disease (Staphylococcus bacteria) so both drugs may have additional applications.
The PRO 140 promises to reduce the HIV count in patients. The low count of infection will even prevent potentially the disease to spread through fluid interactions with other persons. Consequently, CytoDyn’s phase 2b clinical trial, give patients a drug holiday from all their pills and allow them to be only on PRO 140 once a week injection. With 98 percent success rate for one month drug holiday, and with the 14 patients that have continued to use it after the said trial, now on its 8 months trailing, and seeing success at controlling the virus without any pills (HAART).
After the phase 2a clinical trial back in 2006, PRO 140 obtained the FDA fast track designation and National Institute of Health (NIH) funding of over $20MM in last 12 years due to the following reasons:
- PRO 140 stops HIV replication without stopping any of the immune function
- Prolonged antiviral activity and tolerability
- different resistance profile compared to any HIV drug
- hardly any toxicity (unlike all HAART drugs)
- almost no side effects (unlike all HAART drugs)
It’s clear, the next step in reducing and containing today’s outbreak of HIV is to simplify the medication process until a cure if discovered, and PRO 140 promises to fill that easy to use solution for HIV carriers gap. I’m not yet relieved but I have hope.
Note: This article originally appeared on HedgeCo 6/13/2015