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Executive Summary

Warner-Lambert is supplying trimetrexate to the National Institute of Allergy & Infectious Diseases for distribution under a Treatment IND approved by FDA on Feb. 16. The drug will be available free of charge to treat patients with pneumocystis carinii pneumonia who are unresponsive to other therapies. Trimetrexate is the third Treatment IND approved by FDA and "the first AIDS-related drug to be granted Treatment IND status," FDA and NIAID noted in a joint press statement. Pneumocystis carinii pneumonia is an opportunistic, "potentially life-threatening infection which often afflicts AIDS patients," the statement added. NIAID is the sponsor of the Treatment IND, although the product is manufactured by Warner-Lambert. The institute, not the company, is conducting studies in pursuit of final FDA approval. FDA and NIAID said the drug will be made available to AIDS patients who have pneumocystis carinii pneumonia and "experience severe or life-threatening adverse reactions" to the standard, marketed drug therapies, trimethoprim/sulfamethoxazole (Burroughs-Wellcome's Septra or Roche's Bactrim) and injectable pentamidine (LyphoMed's Pentam). Approximately 60-70% of AIDS patients develop pneumocystis carinii pneumonia, and roughly half of that subpopulation become intolerant to the standard regimens, NIAID said. Physicians who wish to obtain trimetrexate for their patients under the Treatment IND protocol are instructed to call an NIAID hotline: 1-800-426-7527 (1-800-833-0014 in Michigan). If their AIDS patients have documented cases of pneumocystis carinii pneumonia and have experienced "severe or life-threatening adverse reactions" to the standard approved therapies, they are connected with an NIAID physician, who inquires about additional patient information and may arrange for shipment. For example, patients under the protocol must be more than 12 years of age, must not be pregnant, and must be hematologically stable (have adequate platelet and neuprophil counts), NIAID explained. In the interest of time, paperwork for documentation is sent with the drug to the physician. FDA and NIAID cautioned that because trimetrexate "is toxic to the bone marrow cells and gastrointestinal tract and is potentially lethal at the doses needed to treat pneumocystis carinii pneumonia, it is imperative that it be administered concurrently with leucovorin, an approved drug used for protecting human cells from the harmful effects of anti-folate drugs." The agencies speculated that trimetrexate used concomitantly with leucovorin might prove less toxic than Bactrim, Septra, or Pentam or might be effective in patients for whom adverse reactions to the standard approved therapies preclude further effective treatment. "Controlled clinical trials sponsored by NIAID have been initiated to address these questions and to evaluate the benefits and risks of trimetrexate in larger numbers of patients," the agency said. First synthesized in 1969 by Warner-Lambert, trimetrexate was developed as an anticancer agent. In summer of 1985 National Cancer Institute researchers proposed use of the anti-folate drug as a potential treatment for pneumocystis carinii pneumonia, and filed an IND that September. NIAID said it subsequently submitted a Treatment IND based on "promising data" from the NCI trials.

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