It is unknown exactly when HIV first became a threat to humanity, but researchers have been able to trace its origins back as far as 1981. Since that time, approximately 39 million people worldwide have died from the disease.
Additionally, 0.8 percent of all people between the ages of 15 and 49 who are currently alive have contracted HIV. Although there have been many improvements since the 1980s that can help prevent HIV from becoming an automatic death sentence, it is still considered to be a global threat. Due to this, research into potential HIV treatments and cures is constantly ongoing, and one company may have just found the answer to suppressing this deadly disease.
The PRO 140 Antibody
CytoDyn has been working on developing a vaccine for HIV, and their PRO 140 antibodies have proven to be extremely successful. In fact, there has been a 98 percent success rate so far for the world’s first self-injectable HIV antibody. As of June, the company was cleared by the FDA to move into the third phase of their PRO 140 study. To date, seven clinical trials have already been completed, and several of the participants experienced a complete suppression of their viral load for up to 11 months.
Dr. Nader Pourhassan, who serves as the CEO of CtyoDyn, indicated that Phase 3 will be a “25-week study with 300 HIV-positive patients.” If this latest step in the testing process is another success, it is highly likely that PRO 140 will be available commercially by 2017. The FDA has put this self-injectable antibody treatment option on their potential fast track list, which means that all of the currently available data makes PRO 140 look like a very viable option for treating HIV.
How Does Pro 140 Work?
The PRO 140 antibodies keep healthy T-cells from becoming infected with HIV. The viral loads have been demonstrably reduced by as little as one injection per week. The trial patients who experienced a complete viral load suppression were not only able to live healthier lives but also saw their risk of transmitting the disease to a sexual partner drop to almost zero.
When Will Phase 3 Begin?
The next phase of testing is anticipated to begin this year before the end of the third quarter. CrtoDyn is planning to run tests simultaneously at 30 U.S. locations so that they can quickly gather the necessary data to move forward with the next stage of their PRO 140 plans. Ultimately, CrytoDyn is pushing forward toward the goal of submitting their final application to the FDA by November 2016. If the results of Phase 3 are as promising as those from the last two phases, there does not appear to be any reason that the FDA would deny the company’s request for accelerated approval.
Dr. Pourhassan told the Portland Business Journal that PRO 140 is not the cure for HIV, but its ability to be self-injected makes it a much easier resource for HIV patients. When you combine this with the unprecedented success of the antibodies at suppressing viral loads for an extended period of time, it becomes easy to see why the National Institutes of Health was willing to invest $28 million in CrtyoDyn’s research. After all, even if PRO 140 cannot keep people from having HIV, it just might be able to suppress their viral loads well enough to give patients a highly improved quality of life that includes the ability to have a normal sex life.