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NIH AEROSOL PENTAMIDINE CLINICAL STUDY

Executive Summary

NIH AEROSOL PENTAMIDINE CLINICAL STUDY will look at prevention of Pneumocystis carinii pneumonia as well as treatment of the AIDS-associated disease. The National Institute of Allergy and Infectious Diseases (NIAID) recently submitted an IND application to FDA. LyphoMed will supply the aerosol format of the anti-infective for the trial. LyphoMed said that the results from the NIAID trials may be added to the company's NDA submission. NIAID's study will complement LyphoMed's ongoing program with aerosol pentamidine, which includes a blinded multicenter trial involving 1,000 AIDS patients currently underway. In that study, aerosol pentamidine is being compared to trimethoprim/sulfamethoxazole (Roche's Bactrim and Burroughs Wellcome's Septra). The drugs are administered to patients after they have recovered from their first episode of Pneumoncystis carinii pneumonia (PCP). Efficacy will be determined by the drugs' ability to prevent relapse of pneumonia. At a March 7 Cowen & Company health care investment seminar, Senior Project Manager Cynthia Yost noted that LyphoMed is involved in multicenter trials both for treatment and prophylaxis of PCP with aerosol pentamidine. "These trials involve 80 institutions worldwide, more than 200 physicians as investigators, and we have committed to therapy for greater than 3,000 patients," Yost said. She added that the trials "will involve an R&D expenditure greater than $10 mil." LyphoMed's first published investigation was a pilot study of 15 mild to moderately ill patients who had experienced their first episode of PCP. The study was conducted at San Francisco General Hospital and was published in the Aug. 29 issue of The Lancet ("The Pink Sheet" Aug. 31, 1987, "In Brief"). A study investigating trimethoprim/sulfamethoxazole's efficacy in preventing PCP in AIDS patients with Kaposi's sarcoma was recently published in the Feb. 26 issue of the Journal of the American Medical Association. The trial, conducted by researchers at the University of Miami, involved sixty patients with Kaposi's sarcoma who were randomized to receive 800 mg of sulfamethoxazole and 160 mg of trimethoprim twice a day or no drug. None of the 30 patients receiving treatment developed PCP. Sixteen of the 30 patients receiving no therapy developed the pneumonia. On Feb. 16 NIAID received a Treatment IND approval for trimetrexate in the treatment of patients with PCP ("The Pink Sheet" Feb. 22, p. 5). Trimetrexate is the third Treatment IND approved by FDA and it is the first drug for an AIDS-related disease to obtain Treatment IND status. Warner-Lambert is supplying the drug free of charge to the institute for distribution. The drug is given to patients who do not respond to the standard marketed drug treatments, trimethoprim/sulfamethoxazole and injectable pentamidine, LyphoMed's Pentam. Both LyphoMed and the British company, Fisons, have received orphan drug designation for their respective aerosal pentamidine products. With Rep. Waxman's decision not to push for a change in the exclusivity provisions of the Orphan Drug Act ("The Pink Sheet" March 7, p. 10), the two firms are now in a race to win approval for aerosal pentamidine. Whichever product is approved first will receive seven years of exclusive marketing.
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