(EDGE) Early this month, Charlie Sheen spoke out about how he made the transition from a ticking time bomb taking hands-full of HIV pills, to "normal," in just four days.
Excited about the "drug of the future," as he calls PRO 140 from CytoDyn, Charlie wants all those suffering with HIV to know that PRO 140 is a "global game changer."
"When PRO 140 arrived, I was a little skeptical. But, in just four days, my viral load was lower than when I was on the cocktails," said Sheen. "It takes about two minutes a week. PRO 140 works. (Now), we have to get approval. We have to deliver the facts."
Currently in FDA trials, PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV.
But POZ.com posits that joining the clinical trial of PRO 140 is just the latest edition of Sheen's "apparently reckless quest for medical miracles."
CytoDyn CEO Nader Purhassan, PhD told POZ that participants in an extension phase of the Phase IIb trial of PRO 140 have maintained full suppression of HIV for almost 18 months without daily ARVs -- even those participants who stopped or failed the treatment.
"For such claims about recent research into PRO 140, the public only has CytoDyn's word," counters POZ. "Fourteen months after the official completion of the Phase IIb trial of PRO 140, results have neither been published in a peer-reviewed journal nor presented at a medical conference."
While POZ acknowledges that the FDA -- the only ones outside of CytoDyn to see the results -- has given the go-ahead for further research, they cautioned against what they called the "rocky financial past" of the company.
Sheen told Dr. Oz that "These are scientists and brilliant doctors and researchers. It's a public company. There's absolute transparency. There's no backrooms or hidden agendas."
Tim Horn, HIV project director at Treatment Action Group, said that, contrary to Sheen's assertion, he perceives CytoDyn as frustratingly opaque, noting that six years that have passed since the company last published any data from clinical trials of PRO 140.
"Everything since then has really been data by press release. That can be very frustrating to really understand what we're up against," said Horn. "There's certainly a place for products like PRO 140 in the HIV treatment paradigm, particularly for treatment-experienced patients [not new to ARVs] who really need novel therapies to treat drug-resistant HIV. That's absolutely critical. But where these weekly antibody injections fit in the general prevention and treatment landscape, particularly with monthly, bimonthly, and possibly quarterly injectables being developed, isn't clear."
Right now, the biggest promise for injectables seems to lie in the long-acting non-daily HIV treatment cabotegravir/Edurant, injected into the buttocks every eight weeks. ViiV and Janssen are gearing up for Phase III trials of long-acting cabotegravir/Edurant with the same dosing frequency, to begin later this year, with the hopes of securing FDA approval in 2019.
POZ noted, however that one advantage a weekly therapy like PRO 140 could have over longer-acting cabotegravir/Edurant is its shorter "tail," meaning it stays in the body a lot less longer, lowering the risk of drug resistance.
Sheen maintains his devotion to CytoDyn, with Pourhassan saying, "I feel like [Sheen] really wants to help HIV. He told me that even if he enrolls in this study and he fails, he still wants to help."
The celebrity's enthusiasm has even rubbed some the wrong way, with ACT Up veteran Peter Staley advising Sheen to "crawl back into your 'babe cave,' write a big check to amfAR, and call it a day."
For more information, visit www.cytodyn.com.