MINNEAPOLIS--(BUSINESS WIRE)--Nov. 18, 2003--MGI PHARMA, INC. (Nasdaq:MOGN), an oncology-focused biopharmaceutical company, provided a summary of two poster presentations made today at the AACR-NCI-EORTC conference in Boston. Data from phase 1 clinical trials that support the clinical development of irofulven in a variety of cancers in combination with other anti-cancer agents were presented. Irofulven (hydroxymethylacylfulvene) is the first chemotherapeutic drug candidate in MGI's family of proprietary anti-cancer compounds called the acylfulvenes, and is currently being studied in a broad clinical development program designed to evaluate its activity in several types of cancer.
Interim results from a phase 1 study designed to evaluate the safety and pharmacokinetics of irofulven in combination with capecitabine in patients with solid tumors were presented. Irofulven was dosed as a 30 minute infusion (0.3 to 0.5 mg/kg) on days 1 and 15, and capecitabine (1700 or 2000 mg/m2/day) was given twice daily as a divided dose from day 1 through day 15 every 4 weeks. The recommended dose of the combination is 0.4 mg/kg irofulven and 2000 mg/m2/day capecitabine. Of the 29 efficacy evaluable patients, one patient with anaplastic thyroid carcinoma had a partial response, one patient with hormone refractory prostate cancer demonstrated a confirmed partial PSA response, and 18 patients had disease stabilization. Grade 1-2 neutropenia and thrombocytopenia were the most commonly observed hematologic toxicities. Patient enrollment in this study is ongoing.
Final data from a phase 1 safety and pharmacokinetic study of irofulven in combination with cisplatin were also presented. Cisplatin and irofulven were administered to 33 patients with solid tumors using an every other week dosing schedule. Four dose levels were evaluated utilizing cisplatin doses of 30 or 40 mg/m2 and irofulven doses of 0.3 to 0.5 mg/kg. The recommended dose of the combination is 30 mg/m2 cisplatin and 0.4 mg/kg irofulven. Of the 32 patients evaluable for objective response, one patient with synovial sarcoma has a major confirmed partial tumor response that is ongoing more than 13 months after initiating treatment, one patient each with renal and ovarian cancer had unconfirmed tumor responses, and ten patients had disease stabilization. Of the nine enrolled patients with hormone refractory prostate cancer, one patient has a complete PSA response ongoing after nine months on study and two had partial PSA responses. Grade 1-2 neutropenia and thrombocytopenia were the most commonly observed hematologic toxicities.
"We are pleased to see additional data demonstrating antitumor activity of irofulven in a variety of solid tumor types," said John MacDonald, Ph.D., sr. vice president of research and development of MGI PHARMA. "The data presented at AACR-NCI-EORTC indicates that irofulven in combination with other anti-tumor drugs is well tolerated and may have significant clinical utility. We are continuing to evaluate data from our ongoing phase 1 and phase 2 studies of irofulven and plan to announce our next clinical development steps and registration strategy early in 2004."
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(R) (irinotecan or CPT-11), Gemzar(R) (gemcitabine hydrochloride), Taxotere(R) (docetaxel), cisplatin, and Xeloda(R) (capecitabine). 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 MGI PHARMA
MGI PHARMA, INC. is an oncology-focused biopharmaceutical 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. MGI markets Aloxi(TM) (palonosetron hydrochloride) injection, Salagen(R) Tablets (pilocarpine hydrochloride), and Hexalen(R) (altretamine) capsules in the U.S. For more information about MGI, please visit 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 Aloxi(TM) to compete successfully with other anti nausea and vomiting treatments; continued sales of MGI PHARMA's other marketed products; development or acquisition of additional products; reliance on contract manufacturing and third party supply; 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.
MGI PHARMA, INC., Minneapolis Investors: Jennifer Davis, 212-697-1976 IR@mgipharma.com or
Media: Dave Melin, 952-346-4749 MEDIA@mgipharma.com