HEB +11% on this:
Hemispherx Biopharma Addresses Ampligen(R) CFS Preclinical Issues
9:46a ET January 14, 2010 (GlobeNewswire)
Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") stated that on January 14, 2010, the Company submitted reports of new preclinical data regarding Ampligen (Poly I: Poly C12U), an experimental therapeutic being developed for potential treatment of Chronic Fatigue Syndrome ("CFS"), to the Food and Drug Administration ("FDA"). Hemispherx management believes these reports should be sufficient to address certain preclinical issues referenced in periodic reports filed by the Company with the Securities and Exchange Commission ("SEC"), including, most recently, the Company's Form 10-Q filed with the SEC on November 9, 2009, as well as in a Complete Response Letter from the FDA described in a December 1, 2009 press release. The preclinical studies discussed in these reports are the combined work-product of the staffs at Hemispherx and its subcontractor, Lovelace Respiratory Research Institute, Albuquerque, New Mexico.
The new preclinical data showed no evidence of antibodies against Ampligen(R) in primates and no evidence of an increase in certain undesirable cytokines (specific modulators of the immune system) at clinically used doses of Ampligen(R) for CFS. Although most other experimental immunomodulators have been associated with one or more features of aberrant immune activity, including toll-like receptor activators (of which Ampligen(R) is one), this was specifically not seen with Ampligen(R) in primates.
