An email From Pir M.:
"On Oct. 11,
(HEB - Get Report)
announced that it had filed an NDA [new drug application] with the FDA for Ampligen for the treatment of chronic fatigue syndrome (CFS). Any thoughts about this company, its drugs and the market potential for CFS?"
This week's Mailbag is chock full of single-digit-midget stocks, isn't it? Doesn't anyone want to know about real biotech companies? Sigh...
I knew nothing about Hemispherx before reading Pir's email. But plug the company into Google, and you'll find a lot of interesting stuff:
Hemispherx and renowned (or infamous) Wall Street short-seller Manuel Asensio had a pretty ugly
in the 1990s.
My old friend and former colleague Herb Greenberg even
in on Hemispherx back in the day.
At various times, Hemispherx has claimed that Ampligen could treat SARS, AIDS, West Nile virus and avian flu, among other maladies.
The clinical data on Ampligen and chronic fatigue syndrome look suspiciously thin to me. (The efficacy data from a "pivotal" study seems to change with every press release.) The side effects of Ampligen, at least the way the company describes them, are downright scary. I'll just quote from the company's 10-K, with my emphasis added:
"We believe that Ampligen has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely debilitating or life threatening diseases that have been treated. A mild flushing reaction has been observed in approximately 15% of patients treated in our various studies. This reaction is occasionally accompanied by a
rapid heart beat
, a tightness of the chest, urticaria (swelling of the skin), anxiety,
shortness of breath
, subjective reports of "feeling hot",' sweating and nausea. The reaction is usually infusion-rate related and can generally be controlled by slowing the infusion rate. Other adverse side effects include
liver enzyme level elevations
, itching, asthma, low blood pressure, photophobia, rash, transient visual disturbances,
slow or irregular heart rate, decreases in platelets and white blood cell counts, anemia
, dizziness, confusion, elevation of kidney function tests, occasional temporary hair loss and
various flu-like symptoms
, including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and vomiting. These flu-like side effects typically subside within
That's some list!
Pir, you probably know where I'm going with all this: Stay away from Hemispherx.
John B. is mad about my
"Thank you very much for your advice on Vion. I had 7,000-plus shares and sold yesterday morning. You should go crawl under a rock!"
Glad to help, John.