AEGiS-PRn: Ampligen, IL-2, Other IBT's to be Discussed at FDA Meeting in D.C.

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

Ampligen, IL-2, Other IBT's to be Discussed at FDA Meeting in D.C.

PRNewswire - Monday October 16, 2000

NEW YORK, Oct. 16 /PRNewswire/ -- A much needed and long overdue meeting has been scheduled for Oct. 16 by the FDA Antiviral Committee to discuss Immune Based Therapies. This much anticipated effort by the FDA provides an encouraging signal to the pharmaceutical industry and biotech companies that meaningful progress is forthcoming from regulatory bodies in allowing for a greater interest in immune based therapies at a time when the need for clinical advancement in this particular field is at its greatest. ACT UP Brooklyn believes Ampligen and IL-2 are on the precipice of regulatory advancement that will reflect the clinical development of these important therapeutic options.

Adanti Acosta of ACT UP Brooklyn expressed his view of the meeting. "Ampligen and IL-2 are desperately needed drugs. Once a person with AIDS becomes immune to all of the FDA approved antiretrovirals, which takes about five years, they are presently left with no therapeutic options. Immune based therapies would strengthen the immune system allowing them to live longer and healthier lives.

Why this has not been a priority within the FDA and medical establishment is something I cannot understand. This meeting is long overdue."

The following is a September 13 notice from the FDA with details of this meeting:

"The Food and Drug Administration will be holding a meeting of its Antiviral Drugs Advisory Committee on October 16, 2000 to discuss questions related to the development of Immune Based Therapies (IBT) for the treatment of HIV. The agency is seeking advice about what guidance to provide sponsors developing immunomodulatory products for this disease. Discussion will include the use and development of surrogate markers in early product development. The meeting will review presentations that review current knowledge in the area of IBT, and examine important issues related to the development and clinical study of IBT."

"The meeting is scheduled from 8:30 a.m. to 5 p.m. at the Marriott Washingtonian Blvd., Gaithersburg, MD. For directions to the site, or if you will need accommodation, please contact the Marriott directly at 301-590-0044."

"The meeting is open to the public, and interested persons or groups are invited to attend, or submit input in writing."

"Interested persons may present data, information, or views, orally or in writing on issues pending before the committee. Written submissions may be made to the contact person (see below) by October 2, 2000, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the name and address of the purposed speakers, and an indication of the approximate time requested to make their presentation."

Contact Person: Nancy Chamberlin, or Beverly O'Neil, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, or by email: chamberlinn@cder.fda.gov. Contact persons can be reached by phone at 301-827-7001.

Please call the FDA Advisory Committee Information Line, 800-741-8183 (301-443-0572 in the Washington D.C. area), code 12531, for up to date information on this meeting.

For more information, contact ACT UP Brooklyn at 718-738-2704.

SOURCE: ACT UP Brooklyn

001016
PR001013

Copyright © 2000 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .