Immune-Based Therapies: FDA Meeting October 16

Immune-Based Therapies: FDA Meeting October 16

AIDS TREATMENT NEWS Issue #351, September 22, 2000
John S. James

Many scientists, physicians, and other experts believe that immune-based therapies will be the next great area of advance in HIV/AIDS treatment--with huge implications for HIV vaccines, as well as new treatments or vaccines for cancer and many other diseases. But progress has been held back by lack of a clear development path for treatments in this area. Because of the lack of widely accepted "surrogate markers" for quickly indicating if a treatment may be helping a patient, the FDA cannot tell pharmaceutical companies what it will require for approval, and therefore industry has not invested heavily in this research area. (The ultimate test--whether a new treatment helps people with HIV live longer--would be very difficult to do today because of the reduced risk of death due to antiretroviral treatment, the resulting need for thousands of patients in a trial lasting years, the ethical issues of running a trial for years until it gets enough deaths to prove a statistical difference, the need for ever-changing combination treatments, and the likelihood--probably near certainty--that the treatment combinations being tested would be obsolete before the trial was finished, meaning that the new drug would be used only in ways not tested in the trial.)

On October 16 the FDA is holding a one-day meeting near Washington D.C., at which its Antiviral Drugs Advisory Committee will hear from experts and discuss how the FDA should proceed in this area. Experts in HIV and immunity will address the panel. The entire meeting is open to the public, and one hour of it is scheduled for public comment.

Here 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 include presentations that will 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 Center, 9751 Washingtonian Blvd., Gaithersburg, MD. For directions to the site, or if you will need accommodations, 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 to 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. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Time allotted for each presentation may be limited, depending on the number of requests received.

"Those desiring to make an oral presentation should notify the contact person before 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 proposed speaker(s), 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 e-mail: CHAMBERLINN@CDER.FDA.GOV. Contact persons can be reached by phone at 301-827-7001.

"Please call the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12531, for up-to-date information on this meeting."

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