VANCOUVER’S THE COLUMBIAN–If all goes as planned, the Vancouver-based biotechnology company CytoDyn Inc. will introduce a “game-changing” HIV therapy for sale sometime in 2017.
“We could be commercialized in the first half of 2017,” said Nader Pourhassan, president and CEO of the company, which has seismic ambitions. “This is a very exciting time,” he added.
This is indeed an exciting time for CytoDyn, a firm that Pourhassan pulled from the verge of bankruptcy in 2008 and whose headquarters is tucked inside an upper-floor office on downtown’s Main Street. The reason for the excitement: PRO 140.
It’s a self-injectable antibody — not a chemically synthesized drug — that belongs to a class of HIV therapies known as “entry inhibitors” that shield healthy cells from viral infection and that block transmission of the virus to others.
Or, as Pourhassan put it: “You’re blocking the virus from opening the door.”
PRO 140 has gone through multiple clinical trials, each showing reduced or controlled HIV viral loads. What’s more, the U.S. Food and Drug Administration has designated PRO 140 as a “fast-track” drug candidate. The FDA’s fast-track process speeds the development and review of drugs to treat serious conditions and fill unmet medical needs.
To be certain, PRO 140 isn’t a cure. However, CytoDyn believes it has advantages, including less toxicity and fewer side effects, over current treatments. It also would replace gobs of daily pills with one shot per week. In a recent federal regulatory filing, the company, which is traded publicly as a penny stock, said PRO 140 “has the potential to be the first long-acting (weekly or every other week), self-administered HIV therapy.”
“In the world of HIV right now, the only thing you have is pills,” Pourhassan said. “Once the patient misses a pill, they become resistant to one class. Then (they) have to change to others. Now you’ve got AIDS.”
With PRO 140, he said, you have a “huge game-changer on many fronts.”
Challenges to CytoDyn loom, though. It remains unprofitable. As of May 31 of this year, the company said in a filing with the U.S. Securities and Exchange Commission, “we had an accumulated deficit of approximately $71.5 million.” The company has three local employees, including Pourhassan, and several independent consultants assisting with research and manufacturing activities.
It’s also up against pharmaceutical giants such as Pfizer and Gilead Sciences. “We expect that these companies will compete fiercely to defend and expand their market share,” CytoDyn said in its SEC filing.
Still, Pourhassen, who was born in Iran and who has a PhD in mechanical engineering from the University of Utah, exudes confidence about CytoDyn’s future. “I can tell you,” he said, “in the past we never failed to raise money.”
In fact, Pourhassen saved the firm from bankruptcy after joining it in 2008 as chief operating officer. He deferred his salary and used tens of thousands of his own dollars “doing road trips and raising money,” he said, to shore up CytoDyn.
The company found its home base in Vancouver after Pourhassen decided to relocate its headquarters from Lake Oswego,O Ore., to ease the commute for the firm’s chief financial officer, Mike Mulholland, who lives in Vancouver.
In the U.S. alone, Pourhassen said, PRO 140 could sell “at least a billion dollars.” If all goes as planned, “we help humanity,” he said. “That’s something that goes on our r?sum? for the rest of our lives.”
By Aaron Corvin, Columbian Port & Economy Reporter