MGI 114 Anti-Cancer Drug from MGI PHARMA, Inc. Shows Significant Anti-Tumor Activity Against Prostate Cancer
PR Newswire - May 17, 1999 09:16
Results of Phase 2 Clinical Trials Presented at ASCO
MINNEAPOLIS, May 17 /PRNewswire/ -- MGI 114, a new cancer-fighting drug being developed by MGI PHARMA, Inc. (Nasdaq: MOGN), has shown significant antitumor activity in patients with hormone-refractory prostate cancer, according to a study presented today at the annual meeting of the American Society for Clinical Oncology (ASCO) in Atlanta. Patients involved in the study have prostate tumors that have stopped responding to hormone-based therapies.
"Prostate cancer is the most frequently diagnosed malignancy in American men," said Dr. Neil Senzer, a lead investigator of the MGI 114 prostate study at Sammons Cancer Center, Dallas. "We are encouraged by the anti-tumor activity we have seen with MGI 114 against hormone-resistant prostate tumors. As a result of early positive responses, we expanded the trial late last year. Patient enrollment is now nearly complete."
The phase II clinical study in patients with hormone-refractory prostate cancer was designed to assess the anti-tumor activity of MGI 114 as a single agent, measured by a decrease in serum prostate specific antigen (PSA) in up to 30 patients. To date, 76 percent of the patients evaluable for PSA response (16/21) have shown stable or decreasing PSA levels. The drug is well tolerated in this patient population and nine patients have received four or more courses of treatment.
"The favorable interim results of this study are further evidence of the potential for MGI 114," said Chuck Blitzer, MGI PHARMA's president and chief executive officer. "We continue to be very encouraged by its progress in clinical trials."
In 1998, there were approximately 184,500 new cases of prostate cancer diagnosed in the United States and more than 39,000 men died from it. More than $2 billion is spent annually on prostate cancer treatment in the United States.
Derived from a mushroom, MGI 114 is the lead member of MGI PHARMA, Inc.'s family of novel chemotherapy agents called acylfulvenes that appear to have several potential advantages over existing cancer therapies. Tumor cells die as a result of MGI 114 binding to DNA and/or protein targets within the cell that initiate apoptosis (programmed cell death), leading to tumor shrinkage or elimination.
In previous preclinical studies, MGI 114 has demonstrated activity against a wide variety of tumor types, including drug-resistant tumors such as ovarian and pancreatic cancers. Presently, MGI PHARMA is sponsoring phase 2 human clinical trials on the drug's effectiveness against prostate, pancreatic and ovarian cancers at major medical centers across the country. Additionally, MGI PHARMA is sponsoring a phase 1 safety study combining MGI 114 with Camptosar(R) (irinotecan), a drug approved to treat colon and rectal cancers.
The National Cancer Institute (NCI) is also sponsoring a series of phase 2 clinical studies with MGI 114 on a variety of tumor types under a Clinical Trials Agreement with MGI PHARMA. Patients have been enrolled in several NCI- sponsored studies, including studies in kidney, colon, ovarian and non-small cell lung cancer. A phase 1 study in pediatric cancer patients with solid tumors is also under way and a phase 1 study in leukemia patients is planned. Further, the drug's inventors at the University of California, San Diego, and the NCI continue to evaluate a number of other acylfulvene analogs for their anti-tumor activity in cooperation with MGI PHARMA.
Patients and healthcare providers seeking information on clinical trial participation should call MGI PHARMA's Medical Communications Help Line at 800-562-5580.
MGI PHARMA is a pharmaceutical company, headquartered in Minnetonka, Minn., that acquires, develops and markets differentiated specialty pharmaceutical and medical products for therapeutic markets of unmet needs. MGI PHARMA's current product portfolio is comprised of products that address specific needs in the fields of cancer and rheumatology. The company plans to expand its scope as the business grows. MGI PHARMA focuses its efforts solely in the United States and creates partnerships with other pharmaceutical or biotechnology companies for its products in international markets.
For more information on MGI PHARMA, you may visit the MGI PHARMA Web site at mgipharma.com or call 612-939-4666. For information on ASCO and the annual meeting proceedings, you may visit the ASCO Web site at asco.org
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