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You are here: Health Medicine Charlie Sheen on the Brink
Recently, Nader Pourhassan, PhD, and CEO of CytoDyn, appeared on the “Dr. Oz Show” with actor Charlie Sheen, who revealed in November that he is HIV positive. Together, they discussed the possibility of Sheen participating in a PRO 140 trial. Sheen said he was “very excited” to be considered as a patient in the PRO 140 monotherapy trial.

"We felt if we were able to use Charlie Sheen’s fame to bring clarity to HIV, to our product and its future enrollment, then this is something we should be accepting,” said Pourhassan. “We are excited to have him involved and help him just like any other patient who gets involved.”

In 2008, CytoDyn, Inc., a Vancouver, Wash.-based publicly-traded biotechnology firm focusing on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection, was on the verge of bankruptcy. A friend convinced Pourhassan to talk to the CEO and try to save it. Because the company could only earn revenue once the products were approved, it had remained unprofitable thus far.

“The company was a week away from bankruptcy,” explained Pourhassan, “I talked to my wife, and we decided to give it try, and if it didn’t work – then at least we gave it a try. If it was successful, it had the potential to be really good for humanity.”

Pourhassan, who was born in Iran and who has a doctorate in mechanical engineering from the University of Utah, joined the company in 2008 as chief operating officer. He refused a salary that first year, and instead used tens of thousands of his own dollars traveling and raising money to save the company. “I told the shareholders that I didn’t feel comfortable taking a salary until I turned it around,” he said.

Today, almost a decade later, the company just raised $33 million and is on the verge of a major breakthrough with PRO 140, an injectable therapy for HIV patients that could revolutionize how the disease is treated.

PRO 140, not a chemically synthesized drug, is an HIV therapy known as an “entry inhibitor,” used to shield healthy cells from becoming infected. It also blocks the transmission of the virus to other cells. In order for HIV viruses to spread in a patient’s bloodstream, they have to reproduce inside cells, after they’ve unlocked the cell membrane using certain receptors.

“The PRO 140 antibody docks to the exact location of the CCR5 receptor, and when it binds to the receptor, the binding is 106.5 percent so the area is covered completely. The virus cannot get into the cell and is dropped instantly,” added Pourhassan.

In early trials, the drug did better than anyone expected. There was only one failure out of 40 during the first month of the trial. Some patients were offered an extension after 13 weeks of the trial, and some have still not fail the trial.

“Key opinion leaders told us this has never happened in the world of HIV, and if our Phase 3 monotherapy trial is successful then we are on the brink of a huge discovery,” said Pourhassan. “We were shocked by the results.”

The results showed that PRO 140 was able to maintained viral suppression in patients who had viral suppression with their current HAART regimen before they entered the trial. These patients were taking only PRO 140 and no longer were taking any of their oral pills.

While there is no known cure for HIV, PRO 140 does offer many advantages to traditional forms of treatment, including reduced toxicity and fewer harmful side effects. To date, the only way to treat the 1.2 million Americans living with HIV is through a daily regimen of pills. PRO 140’s self-injectable subcutaneous delivery is the first such alternative to the existing HAART pill therapy. Not only does PRO 140 fully suppress the HIV virus, it also relieves the toxicity issues surrounding current medication. Patients inject the treatment at home in a process that literally takes just a few seconds.

“The repeatedly-proven PRO 140 antibody offers a more convenient experience with almost no side effects. One dose a week – or possibly in the future one dose a month, injected in each thigh – could suppress the viral load,” said Pourhassan. “Imagine telling an HIV patient to put away all of the drugs they are currently taking and take this injection, which data shows has a great safety profile.”

Not only has the product been shown to be effective, but the results have been safe enough for the U.S. Food and Drug Administration to designate PRO 140 as a “fast-track” drug candidate. The FDA’s fast-track process shortens the development and review phase of drugs so that they can get out to the market faster to treat serious conditions and fill unmet medical needs.  
“The FDA has been so positive in working with us. They have been so agreeable,” said Pourhassan.

PRO 140 has been the subject of seven clinical trials, each demonstrating its ability to significantly reduce or control the HIV load in test patients. PRO 140 has finished Phase 2 and is currently in Phase 3, which is the third and final phase of its clinical trials. If the drug is approved, once the trials are complete, it could be on the market as soon as 2017.

With all the excitement surrounding PRO 140 and its potentially game-changing improvements for HIV patients, Pourhassan says the company is also exploring the use of PRO 140 in GvHD by initiating a Phase 2 trial for this indication. “The FDA looked at our in-vitro studies and immediately allowed us to go to Phase 2, skipping all other phases,” said Pourhassan.

There is a lot of publicity surrounding the CCR5 receptor and the role that it plays in some cancers. While it’s early to make any claims, if made available to patients, it’s another product that has the potential to produce great results.

“We believe we have something that could really have applications in many autoimmune diseases – and in cancers – and we are excited to explore that,” added Pourhassan.

While the company pauses, potentially on the brink of a major medical breakthrough, Pourhassan, still recalls the people who passed it up to focus on other products specifically related to cancer treatment. “We knew we had something spectacular but the scientists thought that was the end of it. There was no money in it,” he said. “And we turned it around.”

“We ran with a gutsy trial product that gave unbelievable answers – and that’s why we are here.”

For more information on CytoDyn, Inc. or for patients interested in signing up for a clinical trial, visit: www.cytodyn.com
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