Last week, Dr. Strayer, Hemispherx Biopharma’s (NYSE Alternext US: HEB) Medical Director, presented new cytokine and cardiovascular data at the 9th International IACFS/ME conference. This week, Dr. Strayer and Dr Carter, Hemispherx’ CEO, held a conference call in which they gave an update on the Company’s FDA progress and the new released data.
In my previous Hemispherx update, which was published shortly after the conference call attendance was announced, I mentioned that when a Company announces data at such an important meeting, the results have to be positive. Dr. Strayer certainly didn’t disappoint me.
He said: “Yes, we’ve shown previous publications and presentations that the Ampligen patients actually can reduce the use of concomitant medications that they take to relieve the symptoms of CFS. CFS patients utilize numerous medications to try to ameliorate their symptoms, and we now wanted to look at a specific class of these drugs that they take to see whether or not we could show that this particular very important class that has cardiotoxic effects actually was reduced as well.”
“And this class are drugs that prolong the QT interval. The QT interval is part of the EKG complex, and the importance of it is that when this interval gets prolonged, it increases the risk of arrhythmias and of sudden death. And so what we did is we looked in the 516 study at the QT interval in the Ampligen group versus the placebo group. We actually found that the placebo group had a prolonged QT interval compared to the Ampligen group, and we began to probe this. We found it was directly related to the number of medications they were taking that prolonged the QT interval, and this was true in both the AMP 502 study, our first randomized placebo control study as well as the second one, the AMP 516 study.”
“So these results, from two independent clinical trials, suggested a therapeutic benefit of Ampligen allows patients to reduce their dependence on concomitant medications used to treat the symptoms of CSF and thereby specifically reducing exposure to these drugs that are known to prolong the QT interval. So I think this is a very important finding, and we’ve recently submitted this data to the FDA.”
I believe this is major news and don’t forget it’s the Cardiovascular and Renal Drugs Advisory Committee at the FDA that is responsible for reviewing Ampligen. I’m sure they too will be happy to see these results.
Results from the Phase III clinical trial indicate that Ampligen works. The difference in improvement in exercise treadmill duration in the Ampligen cohort compared to placebo was 13.6%, which is over twice the minimum considered medically significant (6.5%) (p=0.022).
Additionally, the safety data indicated no significant differences in week forty blood chemistry, hematology, or thyroid function parameters.
Also the Company’s production facility is OK. The facility actually received a nine day FDA inspection at the end of January – early February of this year and there were only a few minor infractions which will be resolved in the next couple of weeks.
I realize many people are still skeptical about Ampligen, and the Company in general, because it has taken them so long to get where we are today. However, it more and more feels as if all pieces of the puzzle are finally falling into place. I felt good about Hemispherx’ NDA before the conference call and I feel even better afterwards.
I believe, based on the above information, that Ampligen has a very high chance to be approved by the FDA. Knowing Ampligen has billion dollar potential and knowing HEB’s current market cap is about $32 million, I dare not guess what impact an approval would have on the stock price. HEB remains a buy recommendation.