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Pancreas Cancer News and Archives | |
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For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer | |
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MGI PHARMA Initiates Drug
Combination Trial of Irofulven With Xeloda in Patients With Advanced
Solid Tumors MINNEAPOLIS, Minnesota, June 6, 2002
"This is an important first clinical step in determining the potential chemotherapeutic role of irofulven in combination with capecitabine, a prodrug that is converted to 5-fluorouracil (5-FU) in tumors," said Dr. Jerome Alexandre, assistant professor at Hopital Cochin in Paris, France, and principal investigator for MGI's trial. "Preclinical studies of 5-FU and irofulven in combination have demonstrated synergistic activity and an absence of cross-resistance in common drug-resistant cell lines. The clinical anti-tumor effect of combining irofulven with the 5-FU prodrug capecitabine has the potential to be synergistic as well." "Irofulven is an ideal candidate for use in clinically relevant combinations with other anti-tumor agents, such as capecitabine, because of its unique mechanism of action, retention of activity against tumors with known drug resistance mechanisms, and its impressive activity in combination with a wide variety of other agents in tumor cell culture and tumor-bearing animal models," explained Dr. John MacDonald, senior vice president of Research and Development at MGI. 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 anti-tumor activity as a single agent in clinical testing against pancreatic, ovarian, prostate and liver cancers. Irofulven is also being studied for use in combination with Camptosar® (CPT-11 or irinotecan), Gemzar® (gemcitabine hydrochloride), Taxotere® (docetaxel), and cisplatin. 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 toll-free at 1-800-562-5580 and press 1 to access our Medical Communications Help Line, or call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (TTY 1-800-332-8615). About Xeloda Xeloda (capecitabine) is an orally administered antitumor agent approved for the treatment of breast and colorectal cancer. Capecitabine is a prodrug of 5-fluorouracil (5-FU) that has been developed to be activated by conversion to 5-FU within tumor cells. 5-FU is one of the most extensively used chemotherapeutic agents. It is currently used, either alone or in combination with other anticancer agents, against a wide variety of tumors such as breast, head and neck and gastrointestinal cancers. Xeloda is manufactured and marketed by Roche Laboratories, Inc. 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 has 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. Gemzar® is a registered trademark of Eli Lilly and Company. Taxotere® is a registered trademark of Aventis Pharma AG. Xeloda® is a registered trademark of Roche Laboratories, Inc.
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