Knobias Clip Report (07-18-2008) HEB
Submitted By Knobias ClipReport
HEB: CEO Discusses Plans for Ampligen(R) and New Initiatives for Growth
By Fain Hughes, fhughes@knobias.com
William A. Carter, M.D., the Chairman and CEO of Hemispherx Biopharma, Inc. (HEB), hosted a conference call on Thursday to provide an update regarding recent events.
The FDA recently accepted for review the Company’s New Drug Application (NDA) for Ampligen(R), an experimental therapeutic to treat Chronic Fatigue Syndrome (CFS).
CFS sufferers exhibit a wide range of profoundly disabling symptoms including the inability to overcome fatigue by rest, swollen lymph nodes and cognitive deficiencies. The CDC characterizes CFS as often equally disabling as multiple sclerosis, lupus, rheumatoid arthritis, congestive heart failure and similar chronic conditions, and estimates that less than 20% of Americans with CFS have been diagnosed.
Dr. Carter explained, “It is important to note that approximately 80% of appliations that reach this stage will be approved. Over the next several weeks, we will continue to supply data to the FDA to supplement our NDA. Much of this data relates to long-term public safety. We do not plan any additional trials.”
“Ampligen is the only product that shows, in advanced clinical studies, a constellation of symptoms treated. There is enormous corporate interest in our technology. We are actively engaged in negotiations in U.S./North America, Pacific Rim and Europe, and as far as Australia and Africa.”
Dr. Carter added, “Over the next several months, you are going to seee major papers appearing in publications related to Ampligen and Alferon N Injection(R), which is approved by the FDA for the intralesional treatment of refractory or recurring external condylomata acuminata in patients 18 years of age or older. We are also going to begin to evaluate Ampligen in cancer vaccines and other cancer initiatives.”
“We will also soon have major additions to our market development group. These are people who have successfully developed products in companies such as Merck, Bristol-Myers Squibb, ect.”
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