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Pancreas Cancer News and Archives | |
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MGI Pharma Initiates Drug
Combination Trial of Irofulven With Cisplatin in Patients With
Advanced Solid Tumors MINNEAPOLIS, Minnesota March 19, 2002 MGI PHARMA, INC., today announced that it has initiated a Phase 1 clinical trial of irofulven, its novel anti-cancer compound, in combination with the anti-tumor agent cisplatin in patients with advanced solid tumors. The primary objective of this dose-escalating trial is to determine the maximum-tolerated dose of the two drugs when used in combination. Secondary objectives are to determine the safety, anti-tumor activity, and the pharmacokinetic profile of irofulven and cisplatin when administered in combination. It is estimated that up to 40 patients will be enrolled in this international, multi-center study. Both drugs will be administered on an every-other-week dosing schedule. "This is an important first clinical step in determining the future role of irofulven in combination with platinum agents, like cisplatin, which have exhibited broad utility in the treatment of solid tumors," said Dr. Eric Raymond, Head of the Clinical Pharmacology Unit in the Department of Medicine at Institut Gustave Roussy in Villejuif, France, and principal investigator for MGI's trial. "While irofulven and cisplatin are both DNA-interactive agents, they feature contrasting mechanisms of anti-tumor action. Preclinical studies of the drugs in combination have demonstrated synergistic activity and an absence of cross-resistance in common drug-resistant cell lines. The clinical anti-tumor effect of the irofulven-cisplatin combination may be synergistic as well." "Irofulven is an ideal candidate for use in combination with other anti-tumor agents because of its unique mechanism of action and retention of activity against tumors with known drug resistance mechanisms," explained Dr. John MacDonald, senior vice president of Research and Development at MGI PHARMA. "This program will enable us to better understand how the DNA-interactive platinum agents, including cisplatin, fit into the growing spectrum of promising irofulven combination uses." Update on MGI's Pivotal Phase 3 Trial of Irofulven MGI is currently conducting a pivotal Phase 3 trial of irofulven in advanced-stage, gemcitabine-refractory pancreatic cancer patients, for which it received Fast Track designation from the U.S. Food and Drug Administration (FDA). To date, patient enrollment in this trial has progressed at a rate that should allow the trial to be fully enrolled sometime during the second half of 2002. Dr. MacDonald noted, "Based on our current progress in this pivotal Phase 3 trial of irofulven, we are updating our previous guidance about our anticipated timing of full patient enrollment, and reconfirming our goal of submitting a New Drug Application in the first half of 2003, assuming favorable trial results." About Irofulven Irofulven (also known as MGI 114, hydroxymethylacylfulvene, or HMAF) is the first product candidate being developed by MGI PHARMA from its family of proprietary anti-cancer compounds called acylfulvenes. Irofulven is currently being tested in a series of clinical trials for the treatment of solid tumors, across a variety of cancers. Irofulven has demonstrated promising anti-tumor activity as a single agent in clinical testing against pancreatic, ovarian and prostate cancers. Irofulven is also being studied for use in combination with Camptosar® (CPT-11 or irinotecan), Gemzar® (gemcitabine hydrochloride) and Taxotere® (docetaxel). Side effects from irofulven are similar to marketed chemotherapies and include bone marrow suppression (decreases in platelets or white blood cell counts), nausea, vomiting, fatigue, and visual disturbances. Patients and health care providers seeking more information on the various irofulven clinical trials may call MGI PHARMA's Medical Communications Help Line at 1-800-562-5580 or the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (TTY 1-800-332-8615). About Cisplatin Cisplatin (cis-diamminodichloroplatinum) is a platinum agent that has been assessed clinically against a variety of cancers because of its demonstrated anti-tumor activity against testicular and ovarian cancers. Since its approval for use, cisplatin has become a major chemotherapeutic agent and has been widely used both alone and in combination with other anti-cancer agents. About MGI PHARMA MGI PHARMA, Inc. is an oncology-focused pharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. MGI is building a balanced product portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. The Company focuses its sales efforts solely in the United States and collaborates with other pharmaceutical or biotechnology companies for its products in international markets. For more information about MGI, please visit the Company's Web site at www.mgipharma.com. This news release contains certain "forward-looking'' statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes,'' " expects,'' "anticipates,'' "intends,'' "will,'' "may,'' "should,'' or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the Company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's product candidates, such as irofulven, to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission including in Exhibit 99 to its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements to conform them to actual results. Camptosar® is a registered
trademark of Pharmacia Corporation. Press Release |
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