Phase III Trials Have Begun For Injectable Antibody to Fight HIV
In an exclusive interview with HIV Equal, the CEO of CytoDyn Inc. said phase III clinical trials have begun in New Orleans for its PRO 140 injectable antibody to fight HIV.
HIV Equal first reported in July that PRO 140, a manmade antibody, demonstrated viral suppression to undetectable levels for 10 months in two patients and at least six months in 19 others in phase II trials. Not all of the patients began treatment at the same time which is why some have sustained viral suppression longer than others. Some now have up to nearly one year of viral suppression.
The phase III trials, the final step before FDA approval, involve 300 volunteers that will be enrolled in 39 cities in Louisiana, Colorado, Washington, New York and other states. Many of the trials still are enrolling people with HIV whose current treatment regimens have failed. They are being given PRO 140 plus a new, optimized, highly active antiretroviral therapy regimen (HAART).
CytoDyn CEO Nader Pourhassan said between 80,000 and 100,000 people in America with HIV are dying because their current treatment regimens have failed. “They could use PRO 140 right now,” Pourhassan said.
Because it already has shown safety and efficacy, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for PRO 140 to CytoDyn. If the product continues to show that it works in the phase III trials, CytoDyn may apply for a “breakthrough” designation and get the product to market as early as 2017.
PRO 140 is revolutionary because it is an antibody, not a toxic compound. It actually prevents HIV from entering a cell instead of inhibiting enzymes HIV needs for replication, which is how HAART works.
“Millions must take multiple HIV pills every day for the rest of their lives to keep viral loads in check. At times, these pills have been known to be toxic hindering further treatment, causing kidney and liver damage, and psychiatric problems," Pourhassan said. “Every HIV patient in a recent Phase 2b FDA clinical trial, monitored by Amarex Clinical Research, had a much improved quality of life during the trials. Only two sub-cutaneous injections of PRO 140, once a week, were necessary to dramatically reduce viral loads. Instead of the normal regimen of daily pills, they were all sleeping better, had no signs of harm to any organs, had higher energy levels, and their headaches were significantly diminished.”
Pourhassan said people interested in being a volunteer at phase III sites that still are enrolling can email him at firstname.lastname@example.org.
Pourhassan said if efficacy is demonstrated in those failing current treatment regimens, concurrent trials will begin testing PRO 140 as a monotherapy without HAART. Pourhassan said the threshold of suppression that PRO 140 needs to meet in these trials should easily be met given results of previous trials.
“One FDA official told me ‘I have a room full of adolescents right now that would love this,’ and that is a direct quote,” Pourhassan said. “Treatment interruption is very attractive for the patient.”
Pourhassan said if the product comes to market, CytoDyn likely will be acquired by a large drug manufacturer such as Gilead. He said the company already met with a Gilead representative a while back, but at that time PRO 140 only was on track to win FDA approval for use among people who inject drugs and do not adhere to traditional regimens. That would have given the drug a much smaller market share that what it is on track to potentially gobble up now.
At an investors meeting in July attended via teleconference by HIV Equal, financial backers were told PRO 140 has the potential to bring in $1 billion annually.
But would PRO 140 be affordable? Pourhassan said current monotherapy costs about $36,000. For those on second-line treatment who need a second medication, add another $24,000 annually. “We can beat that,” Pourhassan said.
When HIV Equal first reported on PRO 140 in July, several online commenters expressed queasiness about a treatment regimen that involves injections instead of taking pills. Pourhassan said PRO 140 uses a very small needle, much like an EpiPen used for an antidote to allergies.
“It is a very small needle, only takes a couple of seconds, and nobody has complained about pain,” Pourhassan said of those enrolled in clinical trials.