This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Hemispherx's Ampligen Rehash Unlikely to Impress FDA

PHILADELPHIA ( TheStreet) --Three years after being rejected by U.S. Food and Drug Administration, Hemispherx Biopharma (HEB - Get Report) is back seeking regulatory approval for Ampligen, its controversial therapy for chronic fatigue syndrome.

Everyone loves a comeback story with a happy ending, but Hemispherx's second attempt won't turn out any happier than the first. FDA is likely to reject Ampligen again because Hemispherx ignored the agency's demand to run a new clinical trial in chronic fatigue syndrome.

Instead, Hemipsherx has spent the past three years doing essentially nothing but re-analyzing data from the old Ampligen phase III trial completed in 2004. FDA reviewed the original study already, deeming it "lacking credible evidence of efficacy of Ampligen."

It would be highly unusual -- unprecedented, even -- for FDA to reverse itself and find a retrospective rehash of old Ampligen data more compelling this time around. FDA has been facing political pressure to speed new drugs to market, particularly for diseases like chronic fatigue syndrome with no current treatments. But this hardly means FDA is going to throw out its drug-review rulebook.

FDA has scheduled an advisory panel for Dec. 20 to review Hemispherx's Ampligen resubmission. The agency is expected to issue a final approval decision on or before Feb. 2, 2013.

Ampligen's long odds haven't deterred speculators from bidding up Hemispherx's stock price, just like they did in 2009. At Wednesday's close of 90 cents, Hemispherx shares are up more than 220% since July 11 when the company announced plans to resubmit Ampligen for FDA approval.

For those that don't remember, the phase III study enrolled 234 patients with chronic fatigue syndrome, randomized to treatment with Ampligen or a placebo. The study's primary endpoint was improvement in treadmill exercise tolerance at week 40.

Hemispherx announced positive results from the Ampligen study in May 2004, claiming that Ampligen patients demonstrated a 17.4% improvement in treadmill exercise tolerance compared to a 4.3% improvement for placebo patients -- a net difference of 13.1%. The result was statistically significant with a p value of 0.047.

However, in May 2006, results from this same study were presented at a medical meeting showing a 12.9% difference in treadmill exercise performance between Ampligen and placebo that was not statistically significant.
1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
HEB $0.13 0.00%
AAPL $118.88 0.00%
FB $105.74 0.00%
GOOG $748.28 0.00%
TSLA $218.25 0.00%


Chart of I:DJI
DOW 17,812.19 +19.51 0.11%
S&P 500 2,089.14 +2.55 0.12%
NASDAQ 5,102.8080 +0.33 0.01%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs