The Next Step for Hemispherx's Ampligen

Another week has passed and still no word from Hemispherx Biopharma ( HEB) on the approval of its chronic fatigue syndrome drug Ampligen.

Here's a prediction, more of a hunch, based on recent events: Hemispherx will soon announce that because of the current flu pandemic, the company has decided to withdraw its Ampligen application from the U.S. Food and Drug Administration. Instead, the company will focus all its resources on working with its "international partners" to develop Ampligen as an adjuvant flu vaccine booster.

Why would Hemispherx take this action? Because the company suspects that the FDA isn't going to approve Ampligen for chronic fatigue syndrome any time soon and certainly not before the company runs another lengthy and expensive clinical trial. The first study was a mess, as I've reported.

By pulling Ampligen from the FDA, Hemispherx wouldn't have to acknowledge the FDA's rejection but could spin the decision as its own choice. And the FDA couldn't say anything publicly, either.

And then, of course, CEO Bill Carter would be free to hype Ampligen as some magic elixir against the H1N1 and Avian flu strains, just like he's done in the past touting Ampligen as a treatment for HIV, the ebola virus, SARS, smallpox and whatever else he can think up to keep retail investors interested in the company.

And like all those past hoped-for-but-never-realized Ampligen claims, the new focus on flu won't amount to anything. Carter is a master at taking a kernel of truth and surrounding it with enough hype to make it sound believable.

Lately, Carter has been talking up his research "partners" in Japan and Italy who are desperate to work with Ampligen to develop new flu vaccines. Really? Where are the contracts? Why isn't there any definitive word from these partners about their Ampligen work? Where are the clinical trials?

The only thing investors get are vague Hemispherx press releases, studies published years ago in obscure medical journals and rambling interviews that Carter conducts with penny stock promoters.

Meantime, GlaxoSmithKline ( GSK) and Novartis ( NVS), separately, are among a handful of major drug companies actually working to finish vaccines to treat new strains of the flu. None of these new flu vaccines -- which will be sold and donated around the world -- have anything to do with Hemispherx or Ampligen.

That's something Carter doesn't like to talk about, but then making undeliverable promises about Ampligen is something he's been doing for 30 years.

This was a bit of rant, I confess, but one of these days, the Hemispherx flim-flam needs to end.

Moving on, I mentioned above the myriad of diseases that Hemispherx has tried to cure with Ampligen over the years, but one that doesn't get any press at all is probably the most eye-popping (and hilarious):

Ampligen-laced cigarettes.

No joke. In August 1987, Carter met with executives at Philip Morris to pitch his idea of adding Ampligen to cigarettes, according to a memo summarizing the meeting, which can be found at tobaccodocuments.org, a repository of tobacco company documents created after the landmark settlement between states and tobacco companies in 1999.

You can read the memo for yourself here.

According to the Philip Morris memo, "Dr. Carter's fundamental premise is that Ampligen delivered in cigarette smoke to the smokers would result in a multi-site stimulation of the immune system in the respiratory and cardiovascular system thus protecting the smoker from lung cancer, emphysema, chronic obstructive pulmonary disease and vascular disease. Ampligen could be applied to tobacco in the field (to prevent Tobacco Mosaic Virus infection), to tobacco in the cigarette manufacturing process or to the filter during cigarette manufacturing."

Carter wanted Philip Morris to sign on as a partner (and provide funding, of course.) The pitch never went anywhere because the tobacco giant said the idea of adding Ampligen to cigarettes had a "low probability of success."

Just like Ampligen's current chances at the FDA.

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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