NEWSBRIEF: The immune-modulating drug that’s so far failed to gain FDA approval as a chronic fatigue syndrome treatment now has some data backing its use in cancer immunotherapy.
Stanford University researchers say Ampligen (rintatolimod) “shows promise” at making some cancer immunotherapies more effective. They also say that Ampligen enhanced T-cell stimulation and caused the release of proinflammatory chemokines an cytokines. They also say it had these effects without the toxicity of drugs currently in use. The peer-reviewed article was published in the American Journal of Obstetrics and Gynecology.
Ampligen’s manufacturer, Hemispherx Biopharma Inc., tried last year to get the drug FDA approved for chronic fatigue syndrome. In December, the application was denied, but in its Complete Response Letter the FDA made recommendations to the company about what would be needed for possible approval. Hemispherx has said it will try to fulfill those recommendations and try for approval once again. Ampligen currently isn’t approved for any use.
Ampligen also is being studied in Japan as a flu-vaccine enhancer.
In Related News: The FDA has reevaluated and approved a subcontractor working with Hemispherx to manufacture Ampligen. Problems with the subcontractor’s facility were noted in the Complete Response Letter mentioned above. This is at least the second goal Hemispherx has met in regards to the Letter, but it still would also need more clinical trial data to reapply for FDA approval.
- Learn more: Ampligen
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New Data on Ampligen’s Immune Impact originally appeared on About.com Fibromyalgia & Chronic Fatigue Syndrome on Wednesday, February 3rd, 2010 at 06:00:07.
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