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Report:
It’s not every day you see the CEO of a publicly held biotech company on a daytime talk show with a major celebrity who wants in on a clinical trial, but that’s just what happened on the Dr. Oz show yesterday. Actor Charlie Sheen, who has been documenting his fight against HIV on the show, admitted he made a mistake pursuing an alternative goat-milk based treatment in Mexico and said he would like instead to enroll in a clinical trial of an injectable treatment being developed by CytoDyn, a tiny Vancouver company that trades over-the-counter.
The company’s CEO, Nader Pourhassan, sat next to Sheen on the soundstage and said that if the actor qualifies he’ll be welcome into the trial. But investors clearly aren’t impressed: CytoDyn’s stock fell nearly 8% Thursday to $1.06 a share.
Actor Charlie Sheen has been documenting his experience fighting HIV on the Dr. Oz Show ever since revealing he tested positive for the virus on the Today Show in November (Photo by Andrew Burton/Getty Images).
Celebrity endorsements in pharma and biotech are not out of the ordinary once products are on the market—we’ve seen everyone from Blythe Danner to Arnold Palmer on TV in recent years pitching prescription drugs—but Pourhassan could be taking a big risk here. Sheen has agreed to document his HIV fight on Oz’s show and has vowed to talk on the air about his experience in the trial, should he join it. Seeing as the FDA often frowns on companies with overly enthusiastic CEOs, this might not be a smart course of action for CytoDyn.
CytoDyn’s drug, Pro 140, is a monoclonal antibody designed to block HIV from invading immune cells. It started Phase 3 clinical trials in October, so it has a long way to go before the FDA will consider approving it. On January 28, the company announced that 11 patients in an earlier study, all of whom self-injected the drug once a week, achieved “full virologic suppression.” It is meant to replace pills such as Gilead’s Viread and Atripla.
Sheen, whose viral load skyrocketed after he went off traditional HIV meds and on the alternative treatment, admitted on Dr. Oz that he made a mistake. “I got duped,” Sheen said. As for Pro 140, “I’m very excited about this,” Sheen said, adding that his confidence in CytoDyn is boosted by the fact that it’s a public company with no “back rooms and hidden agendas.”
Pourhassan, who joined CytoDyn when it was near bankruptcy in 2008, wasn’t shy about talking up his company’s drug on the show. “We have patients who have gone 18 months without any pills,” he told Dr. Oz.
Perhaps, but CytoDyn will be running a Phase 3 trial with extremely limited resources. In the six months ended November 30, the company reported a net loss of $14 million, up from a loss of $8 million in the same period a year ago. On January 29, the company disclosed it held an unregistered sale of equity, raising approximately $3.6 million. Whether that will be enough to get Pro 140 through late-stage development is unclear, however.
CytoDyn issued a statement after Pourhassan’s Dr. Oz appearance reiterating that Sheen will have to go through a screening process before being accepted into the trial, but that patients in earlier trials seemed to have reached low viral loads without suffering toxic effects. “The repeatedly-proven PRO 140 antibody offers a more convenient experience with almost no side effects,” Pourhassan said in the statement.
The FDA doesn’t exactly have a history of looking the other way when CEOs are chatty on TV. In 2013, the FDA sent a warning letter to Aegerion Pharmaceuticals after its then-CEO, Mark Beer, appeared on CNBC’s “Fast Money” and allegedly overstated the benefits of the company’s cholesterol-lowering drug Juxtapid. Beer resigned from the company last July.
There was one voice of reason on Dr. Oz: Robert Huizenga, associate professor of clinical medicine at UCLA. CytoDyn’s drug has “only been tested on a small number of people,” he warned during the broadcast. Investors seem to be wary, as well.
This story has been updated to reflect the correct amount of the proceeds from the equity sale.
Source: Forbes
Broad Street Alerts has not been compensated for the mention of __CYDY_ and we do not hold any positions.
