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MGI PHARMA ACQUIRES NEW CHEMOTHERAPEUTIC TO TREAT NEOPLASTIC MENINGITIS

 MINNEAPOLIS, April 22 /PRNewswire/ -- MGI PHARMA, INC. (NASDAQ: MOGN), a specialty pharmaceutical company, announced today that it has acquired thel nervous system, particularly neoplastic meningitis (i.e., tumors of the leptomeninges, which is the lining of the brain and the spinal cord). MGI licensed the rights to the pending United States and international patents for 4-HC from Duke University and Johns Hopkins University.
 The central nervous system is a common site of metastasis for many cancers, particularly solid tumors such as carcinomas of the lung, breast and stomach and melanomas, and is frequently involved in leukemia and lymphomas. The dissemination of primary tumors to the central nervous system is a leading cause of morbidity and mortality in cancer patients. Despite the recognized clinical importance of this problem and advances in the treatment of the primary tumors, treatment options for patients with metastasized central nervous system tumors are limited and results are generally poor. Effective chemotherapy has been limited because conventional chemotherapeutic agents delivered systemically (i.e., orally or intravenously) tend to have trouble penetrating the blood-brain barrier resulting in inadequate drug concentrations in the central nervous system. Attempts to circumvent this problem have included delivering drug directly to the tumor site (regional therapy) to achieve higher drug concentrations. Unfortunately, the few drugs that are safe enough to be used in regional therapy have not shown to be very effective against the types of tumors that metastasize to the central nervous system.
 4-HC has the potential to be useful in treating tumors of the central nervous system. It is a preactivated derivative of cyclophosphamide, which is a chemotherapeutic drug widely used to treat the type of tumors that frequently metastasize to the central nervous system. 4-HC's preactivation status means it can be administered directly to the tumor site and thereby potentially achieve therapeutic concentrations of the drug without dose-limiting, systemic toxicities.
 Animal and early human studies with 4-HC as a treatment for neoplastic meningitis have thus far been encouraging. Animal studies in rats (bearing human tumors) and rabbits showed that the drug was effective in increasing survival time at well tolerated doses. Physicians at Duke University, Johns Hopkins University and other medical centers are conducting an ongoing Phase I/II clinical study with 4-HC that, to date, has accrued more than 60 patients with neoplastic meningitis (including both pediatric and adult patients). Preliminary results from this study, which will be presented at the American Association for Cancer Research in May, indicate that the administered doses of 4-HC show evidence of efficacy with acceptable tolerability.
 Kenneth F. Tempero, MGI PHARMA's chairman and chief executive officer, stated, "4-HC is an exciting addition to our product pipeline that builds nicely upon other recently acquired chemotherapeutic compounds. Its potential to address a significant medical problem that currently has few treatment options fits well into our strategy of developing innovative products that improve the quality of life for critically and chronically ill patients. We intend to conduct additional Phase I/II work and move into Phase II/III studies as quickly as possible."
 MGI PHARMA acquires, develops and markets pharmaceuticals prescribed by physician specialists. Its initial focus is on developing products that improve the quality of life for critically and chronically ill patients. It is currently marketing DIDRONEL(R) I.V. Infusion and Oratect(R) Gel to cancer specialists throughout the United States, developing several promising new drugs, and awaiting approval for
Salagen(R) tablets from the Food and Drug Administration (FDA). The company submitted its New Drug Application for Salagen(R) tablets to the FDA in February 1992.
 -0- 4/22/93
 /CONTACT: Lori Weiman of MGI PHARMA, 612-939-4666/
 (MOGN)


CO: MGI PHARMA, Inc. ST: Minnesota IN: MTC SU: PDT

AL -- MN005 -- 9182 04/22/93 08:36 EDT
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Date:Apr 22, 1993
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