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| |  ASCO: Irofulven May Take Over Where Gemcitabine Fails In Pancreatic Cancer NEW ORLEANS, LA -- May 23, 2000 -- Results from a clinical trial of irofulven, a novel anti-cancer agent being developed by MGI PHARMA, demonstrate anti-tumor activity in patients with advanced pancreatic cancer for which gemcitabine has failed. Released this week at the annual meeting of the American Society of Clinical Oncology (ASCO), the interim Phase 2 results showed that of the 46 evaluable patients, 36 patients are assessable for the primary endpoint of six month survival, with seven of those patients achieving a six month survival benefit. Equally important, two patients demonstrated objective responses; one patient experienced a complete response and another patient experienced an 84 percent decrease in tumor mass. Irofulven (also known as MGI 114, hydroxymethylacylfulvene, or HMAF), is also being studied in ovarian cancer and in prostate cancer, and is the first product candidate being developed by MGI PHARMA from its family of proprietary anti-cancer compounds called acylfulvenes. "Pancreatic cancer is a lethal disease that is associated with significant pain and distress for the patient," observes S. Gail Eckhardt, M.D., Associate Professor of Medicine and Director of Developmental Therapeutics, University of Colorado. "The results observed in this study are encouraging in terms of survival and tumor response. In addition, the fact that these patients had failed standard therapy is particularly important. If these results achieve statistical significance, irofulven will be the first drug to show such a significant benefit for patients with previously-treated advanced pancreatic cancer." The multi-center open label study of 50 patients with metastatic pancreatic cancer who have progressive disease following gemcitabine therapy is ongoing. Patients will be evaluated for survival and tumor response. Irofulven was administered by five minute intravenous infusion once daily for five days every 28 days. Most common adverse events include nausea, vomiting, fatigue, and bone marrow suppression. According to the most recent American Cancer Society statistics, an estimated 28,300 new cases will be diagnosed in the United States in 2000- with 28,200 expected deaths this year alone. The incidence of pancreatic cancer in African Americans is higher than in white Americans. Since the early 1970s, mortality rates among white Americans have decreased slightly while mortality among African Americans has increased. Cancer of the pancreas generally occurs without symptoms until it is in advanced stages, and for all stages combined, the 5-year relative survival rate is only four percent. Data from two other irofulven studies were released at the ASCO meeting this week. Results of a Phase 2 study of irofulven in 16 patients with advanced ovarian cancer who showed no response to initial platinum or paclitaxel, treatment, suggest a beneficial effect. Two patients experienced an objective response; one patient showed a confirmed partial response, and another had an unconfirmed partial response following one cycle of therapy. A third patient had stable disease for four therapeutic cycles. Adverse events were similar to those observed in the pancreatic cancer study. This data follows study findings recently presented at the American Association for Cancer Research (AACR) annual meeting, which showed that five of 11 evaluable patients, or 45 percent, achieved an objective response (5 partial responders) and 18 percent of patients experienced stable disease (less than 50 percent tumor reduction). "Ovarian cancer is frequently diagnosed in later stages, making successful treatment that much harder. Complicating this further is the fact that many patients have recurrent disease, and can develop resistance to existing therapies," said John R. MacDonald, Ph.D., Vice President, Research and Development, MGI PHARMA. "We are very encouraged by the measurable activity of irofulven in platinum and paclitaxel resistant patients." MGI PHARMA is also conducting a Phase 2 study in 42 patients with hormone-refractory prostate cancer, designed to evaluate anti-tumor activity of irofulven as monotherapy. Results show that irofulven is well tolerated and demonstrates anti-tumor activity sufficient to warrant additional trials assessing it when used alone and in combination with other compounds and/or radiation. Additionally, data from other studies of irofulven were released this week at the ASCO meeting. These studies, in non-small cell lung cancer (the most common type of lung cancer) and pediatric solid tumor cancers, are sponsored by the National Cancer Institute (NCI). "The results of these studies of irofulven are clearly exciting," said Steven Weitman, M.D., Ph.D., Director of Translational Research, Institute for Drug Development, University of Texas. "The research reported on at this meeting point to a compelling range of applications for this product, either alone or in combination with other therapies." MGI PHARMA, INC., located in Bloomington, MN, is a pharmaceutical company focused on the acquisition, development and commercialization of drugs primarily for the treatment of cancer and rheumatology disorders. Irofulven (also known as MGI 114, hydromethylacylfulvene, or HMAF) is the first product candidate being developed by MGI PHARMA from its family of proprietary anti-cancer compounds called acylfulvenes. Related Link: MGI PHARMA, INC.
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