Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - October 20, 2000
"It's become very apparent after the FDA IBT meeting on Monday, that it is essential to allow for access to Riticulose for the many hundreds of thousands of AIDS patients who cannot tolerate the dramatic complications of Antiretrovirals," said David Miller of the International HIV Immune Based Therapy (IBT) Working Group. "We expect regulatory developments to be forthcoming."
The Antiviral Committee of The Food and Drug Administration held a meeting on Monday October 16 to discuss the problems surrounding the regulatory review of Immune Based Therapies held at The Marriott on Washington Blvd. In Gaithersburg, MD.
For more information on this meeting contact: Nancy Chamberlin or Beverly O'Neil at The Center for Drug Evaluation and Research (HDF-21) Food and Drug Administration 5600 Fisherslane Rockville, MD. 20857, or by e-mail: CHAMBERLINN@CDER.FDA.GOV. Or contact by phone: 301-827-7001.
Riticulose is an emerging cytokine based immune modulator that has shown dramatic clinical efficaciously in a number of HIV patients resulting in testimonial reports of increased appetite, stabilization of CD4's and a decrease in some of the prominent side effects of HIV Antiretrovirals which have proven for many patients to make these therapies unendurable.
"A much anticipated white paper outlining the clinical benefits of Riticulose and other IBT's is going before the House Health and Finance Committee," said Jeannie Gibbs of The AIDS activist group ACT UP Brooklyn, who is also a member of The International HIV IBT Working Group. "This is about saving lives and deterring unnecessary health care costs. We are sure that the developments at the FDA will lead to the further development of Riticulose and immune based therapies in general."
The International HIV IBT Working Group is one of the most prominent AIDS advocacy organizations focusing on the development of immune based therapies for the treatment of HIV. Based out of New York, Boston and San Francisco the International HIV IBT Working group meets with regulatory bodies, legislatures and industry to encourage the research of novel therapeutic entities that show promise against HIV resistance such as monoclonal antibodies, onglionucleotides and cytokine therapies.
For more information on the International HIV IBT Working Group contact Jeannie Gibbs at 718-222-4600.
SOURCE International HIV IBT Working Group
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