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| |  AACR: Irofulven (Hydroxymethylacyfulvene) Effective In Ovarian Cancer, Interim Results Show MINNEAPOLIS, MN -- April 6, 2000 -- MGI PHARMA, INC. announced the release, at the annual meeting of the American Association for Cancer Research held in San Francisco, of interim Phase 2 clinical trial results for irofulven in ovarian cancer patients. Irofulven (also known as MGI 114, hydroxymethylacyfulvene, or HMAF) is the first product candidate being developed by MGI PHARMA from its family of proprietary cancer therapy compounds called acylfulvenes. The primary objective of this trial, which is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with MGI PHARMA, is to determine the response rate associated with irofulven in patients with recurrent or persistent ovarian cancer. To qualify for this trial, patients must have had no tumor response during or following treatment with another drug or combination of drugs or have had regrowth of their tumors within six months of treatment. The presentation at the AACR meeting included interim results for 17 ovarian cancer patients participating in the NCI irofulven trial. As of the date of presentation, two of those 17 patients were not yet evaluable, since they had received only a single course of therapy. Both patients remain enrolled in the trial. Of the 15 evaluable patients: -- Five patients, or 33.3 percent, experienced a partial response (greater than 50 percent reduction in measurable tumor mass), lasting from at least five to at least nine cycles of therapy; -- Two patients, or 13.3 percent, experienced stable disease (less than 50 percent tumor shrinkage), one for two and the other for at least eight cycles of therapy; -- Four patients, or 26.7 percent, withdrew due to malaise and fatigue after one cycle of therapy; and -- Four patients, or 26.7 percent, discontinued treatment due to progressive disease after two or three cycles of therapy. Other side effects reported from the trial included bone marrow suppression (decreases in platelets or white blood cell counts) and mild to modest nausea and vomiting. The American Cancer Society estimates that 23,100 new cases of ovarian cancer will be diagnosed in the United States this year and 14,000 women will die from the disease. Ovarian cancer represents a disease with a large unmet medical need. In addition to this trial, preclinical study results presented at the AACR meeting focused on irofulven's mechanism of action and its use in combination with radiation therapy or standard chemotherapy agents. Mechanism of action studies identified cell signaling pathways controlling irofulven-induced apoptosis (programmed cell death) in different tumor cell types. Additional preclinical studies demonstrated that irofulven maybe combined effectively with a number of standard antitumor treatments, including gemcitabine, mitoxantrone, the active metabolite of irinotecan (SN-38), and Gamma-radiation for different tumor cell types. MGI PHARMA, INC. is a pharmaceutical company focused on the acquisition, development and commercialization of drugs primarily for the treatment of cancer and rheumatology disorders. Related Link: MGI PHARMA, INC.
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