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First AIDS Drug Tested Under Parallel Track Policy; other d4T related press releases
Click here to view original press release.
Accession Number
A00093
Author
US Department of Health and Human Services (HHS), Food and Drug Administration (FDA)
Source
FDA Talk Paper
Release Date
October 5, 1992
Major Descriptors
Clinical trials
d4T
Parallel track
Stavudine (d4T)
Topic
Drugs and Treatment
Text
FIRST AIDS DRUG TESTED UNDER PARALLEL TRACK POLICY
The Food and Drug Administration announced that the AIDS drug d4T (stavudine), made available for expanded investigational use on October 5, 1992, will be the first drug available under the agency's "parallel track" policy. The following can be used to answer questions.
The parallel track policy announced in April 1992 (see press release P92-10 April 9, 1992), allows promising new drugs for treating AIDS and other HIV-related diseases to be made more widely available to people unable to take standard therapy, and who are not able to participate in controlled studies.
d4T, an experimental antiviral drug that acts by inhibiting HIV, is manufactured by Bristol-Myers Squibb Co. of New York. The drug will be available to patients who have not responded to or are intolerant of AZT or ddI and who are ineligible for the controlled clinical trial of d4T designed to demonstrate if d4T can extend life or delay the onset of AIDS. Patients enrolled in the parallel track study will include those who have experienced serious side affects from other antiviral drugs or whose conditions have worsened while taking those drugs. Bristol-Myers Squibb Co. has established a toll-free telephone number--1-800-842-8036--for information on how doctors can enroll their patients in the parallel track study.
Evidence from early clinical trials involving 259 patients indicates that the potential benefits of d4T outweigh the risks associated with early expansion of use because d4T meets a serious unfulfilled health need. These early trials demonstrated that many patients experienced a temporary increase in the number of CD4 cells, which may indicate a beneficial effect on the immune system. Although the drug was well tolerated by many patients, these trials identified peripheral neuropathy, a painful condition of the hands and feet, as a major side effect. This condition was usually reversible when the dose was decreased or the drug was discontinued.
As discussed in the parallel track policy, the AIDS Research Advisory Committee of the National Institutes of Health provided recommendations on the proposed protocol, and the National Human Subjects Protections Review Panel of AIDS Program Advisory Committee is functioning as a national institutional review board.
Research is continuing to determine if d4T can extend life or delay the onset of the disease in those who are infected with HIV.
BRISTOL_MYERS SQUIBB MAKES EXPERIMENTAL AIDS DRUG, d4T, AVAILABLE TO PATIENTS IN CRITICAL NEED
New York, NY (October 5, 1992) -- Bristol-Myers Squibb Company announced today it has received U.S. Food and Drug Administration approval of a Parallel Track Program protocol for d4T (stavudine), an experimental drug to treat AIDS that is under development by the company. Through the program, AIDS patients who are intolerant to or failing on the only two drugs approved for use as single agents -- AZT (zidovudine) and VIDEX (didanosine, ddI) -- may be eligible to receive d4T. Patients who qualify will receive d4T at no charge via their physicians.
Physicians interested in enrolling patients in this program should contact Bristol-Myers Squibb at 1-800-842-8036 to request registration kits and application forms. Completed applications for participation in the d4T Parallel Track program will be promptly reviewed by Bristol-Myers Squibb medical staff. The company is implementing the program voluntarily and will absorb the cost of d4T provided to Parallel Track participants.
Background on d4T
d4T is an experimental anti-HIV drug which was developed as a result of a collaboration between Bristol-Myers Squibb and Dr. William Prusoff of Yale University. It was originally synthesized by Jerome Horwitz of the Detroit Institute of Cancer Research as an anti-cancer agent. Like AZT and VIDEX, d4T belongs to a class of compounds called nucleoside analogues. Nucleosides are similar to the natural building blocks used to define the genetic information contained in DNA and RNA.
d4T works by inhibiting a vital enzyme that the AIDS virus needs for its growth. d4T is converted to d4T triphosphate in the cell. It is postulated that this triphosphate inhibits the activity of the reverse transcriptase enzyme of HIV.
d4T is now in Phase II/III clinical trials to determine its safety and efficacy profile. A double-blind, randomized comparison of d4T versus AZT in patients who have had more than six months prior experience with AZT began in May, 1992, and patient accrual has exceeded expectations.
Background on Parallel Track
Earlier this year, the U.S. Department of Health and Human Services announced initiatives "to provide earlier access to important new drugs, ease unnecessary regulatory burdens and strengthen U.S. competitiveness." The "Parallel Track" policy, an effort of the National Institutes of Health and FDA, permits people with life threatening illness to access experimental drugs, while the drugs are in clinical trials. d4T is the first drug to be made available through the official Parallel Track mechanism.
As a leading manufacturer of pharmaceuticals for life-threatening illnesses such as AIDS and cancer, Bristol-Myers Squibb has extensive experience in providing compassionate access to experimental drugs for patients lacking other therapeutic options. From September 1989 through December 1991, Bristol-Myers Squibb provided its now approved AIDS drug, VIDEX, to more than 23,000 patients concurrent with Phase II/III clinical trials. Many elements of the newly implemented Parallel Track program are similar to those pioneered in the VIDEX Expanded Access model.
Bristol-Myers Squibb is a research-based, diversified health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices.
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US PHYSICIAN INFORMATION
How to Obtain d4T (stavudine) for Your Patient through the Parallel Track Program
1. Bristol-Myers Squibb has established a toll-free number for calls regarding d4T. The number is 1-800-842-8036. Operators will be available Monday-Friday from 8:30 a.m. - 5:00 p.m. Eastern Time.
2. Patients calling will be given general information about d4T. If they wish to receive d4T under the Parallel Track Program, their physician must call. By law, no d4T can be released directly to a patient.
3. A package of information and instructions will be sent to licensed physicians on request. The package will include the protocol and patient entry and physician registration forms required to comply with Federal laws concerning investigational drugs.
4. In order to enroll patients who meet the entry criteria for d4T Parallel Track, the physician must complete and return both physician registration forms and patient enrollment forms. When a physician application is approved, the physician will be added to the list of registered investigators for the Parallel Track Program. Concurrently, patient entry forms will be reviewed by medical reviewers who will determine if the patient is eligible for the d4T Parallel Track Program.
5. If the patient is deemed not eligible to participate in the program, his or her physician will be contacted with an explanation for the decision.
6. If the patient is accepted into the program, a 30-day supply of the drug will be sent to his or her physician.
7. The physician must submit patient follow-up and adverse experience forms monthly. Only when these forms are received can additional drug be provided.
8. Patients may remain in the program as long as there is need, they do not voluntarily withdraw, they do not experience adverse effects, the program is still in effect, and d4T is not approved for sale in the U.S.
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