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Executive Summary

DEOXYCOFORMYCIN TREATMENT IND APPLICATION FOR HAIRY CELL LEUKEMIA has been submitted to FDA by the National Cancer Institute (NCI). NCI Division of Cancer Treatment (DCT) Cancer Therapy Evaluation Program Acting Associate Director Michael Friedman reported the filing to the DCT Board of Scientific Counselors meeting on Oct. 6. NCI is seeking Treatment IND status for use of the agent in hairy cell leukemia patients that are refractory to alpha interferon treatment. NCI still refers to the expanded investigatory use of products as "Group C" distribution. FDA has recently begun to treat NCI's Group C applications as Treatment INDs ("The Pink Sheet" Aug. 29, T&G-4). Friedman reported that Phase I studies with deoxycoformycin found that 85% of patients had an objective response. Of the 170 patients treated with the drug, 99 had a complete response and 46 a partial response. An NCI Phase III comparative trial of deoxycoformycin to alpha interferon is in progress. NCI is readying three other cancer treatments for Group C protocol submissions: a combination of WR 2721 (etheofos) and cisplatin (Bristol-Meyer's Platinol) for metastatic melanoma; a combination of cisplatin and dibromodulcitol (DBD) for cervical cancer; and taxol for refractory ovarian cancer. A combination of WR 2721 and cisplatin 150 mg/ml is currently be tested by the Eastern Cooperative Cancer Group in a randomized trial comparing the regimen to cisplatin alone in metastatic melanoma. In a separate trial of 36 metastatic melanoma patients, the combination therapy had an objective response rate of 53%, Friedman reported. NCI documentation indicates that dibromodulcitol has shown a 29% objective response rate in cervical cancer. The agent, which was studied by NCI in a 55-patient Phase II study conducted by the Gynecologic Oncology Group, produced a complete response in one patient and a partial response in 15 patients, Friedman said. NCI is planning a Phase I study to compare dibromodulcitol to cisplatin. The institute has plans for a Phase III trial with three arms that would compare dibromodulcitol v. dibromodulcitol and cisplatin v. cisplatin alone. DBD is being sponsored for approval in the U.S. by a San Antonio development stage company, Amswiss Pharmaceuticals Inc. The company maintains the product has an overal response rate worldwide of 38% in cervical cancer. The product has been in clinical trials since 1969. Amswiss, which licenses DBD from the Hungarian company Chinoin, is seeking approval for cervical cancer as an orphan product. Amswiss is the successor to a company previously called LifeQuest. It was founded by Larry Miller, MD, who previously ran two medical device companies in Texas. Amswiss lists two former U.S. pharmaceutical execs on its advisory board: ex-Lederle Labs President Robert Johnson and ex-Pfizer Pharmaceuticals VP Frederic Price. Taxol, the third drug targeted for Group C status, exhibited a 31% objective response rate in a refractory ovarian cancer trial conducted at Johns Hopkins. The 26-patient Phase II study found a complete response in one patient and a partial response in seven patients receiving the agent. Taxol, which is derived from the bark of the Western Yew, is in ongoing Phase II studies. Johns Hopkins is also planing Phase I study to examine a regimen of taxol with cosplatin. Freidman said that NCI will consider a randomized comparison of cisplatin plus taxol v. taxol alone if warranted by the ongoing Phase II studies. Friedman also reported on three other agents that DCT sees as potential Group C candidates: ICRF-187, which is being looked at for cardioprotection during metastatic breast cancer treatment; 4-ipomeanol, an agent with selective toxicity towards lung tissue that is currently in Phase I studies; and L-buthionine sulfoximine (BSO), an agent thereby decreasing intracellular glutathione levels."

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