Upbeat (a little too so for my taste) news release on the start of Phase II for pancreatic cancer:
MGI PHARMA Begins a Phase II Study in Pancreatic Cancer Patients With MGI 114, Its Novel Anti-Cancer Drug
MINNEAPOLIS, Nov. 17 /PRNewswire/ -- MGI PHARMA, INC. (Nasdaq: MOGN - news), a pharmaceutical company, has started to enroll patients in a phase II clinical study with MGI 114, the company's anti-cancer drug, to evaluate the drug's ability to treat pancreatic cancer. The study will include approximately 50 advanced pancreatic cancer patients who are not responding to treatment with gemcitabine (Gemzar®), an approved chemotherapy drug commonly used to treat pancreatic cancer. The study is a multi-center, open-label, single-arm, phase II trial that will collect data on patient survival and tumor size following treatment with MGI 114.
''We have high hopes for MGI 114 in pancreatic cancer due to the objective response we have observed in a pancreatic cancer patient in our phase I safety study and the outstanding activity previously observed in animal studies,'' explained Charles N. Blitzer, MGI PHARMA's president and chief executive officer. ''One pancreatic patient who is still being treated with MGI 114 has shown more than a 70 percent reduction in the size of his measurable tumor mass. This individual has now been in our study for six months, which is important considering he was a very late-stage cancer patient who had failed conventional therapy by the time he enrolled in our study. We are hopeful that MGI 114 will show similar results in other pancreatic cancer patients.''
Pancreatic cancer is the fourth most common cause of cancer-related death in the United States. It is an aggressive and difficult to diagnose disease that has few effective treatment options Currently, the most common chemotherapy drug used to treat pancreatic cancer is gemcitabine (Gemzar®), which was approved by the U.S. Food and Drug Administration in May 1996 and sold approximately $45 million for this use in 1997. The American Cancer Society estimates that 29,000 new cases of pancreatic cancer are diagnosed in the United States each year and the death rate virtually equals that incidence rate.
MGI 114 is the lead compound of a family of cytotoxic agents, called the acylfulvenes, that appear to have several potential advantages over existing therapies, including: a unique mechanism of action; activity against tumor cell lines that are resistant to standard antitumor therapies; and a synergistic effect against tumor cells when combined with certain approved drugs. Preclinical tests with the drug have demonstrated excellent anti-tumor activity, including increased life span and tumor regressions. MGI PHARMA initiated a Phase II trial with the drug in hormone refractory prostate patients in July 1998 and expects to begin a Phase II trial in ovarian patients before the end of the year.
''Of particular relevance to the present Phase II human study is the fact that MGI 114 has demonstrated excellent antitumor activity in animal tests where human pancreatic tumors were implanted in mice,'' explained Blitzer. ''At half the maximum tolerated dose, one of 10 mice showed complete elimination of the tumor, while the remaining nine mice exhibited tumor growth inhibition of about 37 percent. At the maximum tolerated dose, nine out of 10 mice showed complete tumor shrinkage. This compares very favorably to the results produced by gemcitabine, which only produced tumor growth inhibition of 23 percent at its maximum tolerated dose.''
Dose-limiting toxicities associated with MGI 114 include bone marrow suppression, nausea, vomiting, fatigue, facial flushing, phlebitis (venous inflammation), and reversible kidney effects.
Under a Clinical Trials Agreement with MGI PHARMA, the National Cancer Institute (NCI) also has initiated a series of Phase II trials that will ultimately include at least two studies each in breast, colon, renal, ovarian and non-small cell lung cancer, and one study in cervical cancer. The NCI is also conducting a Phase I study in pediatric cancer patients with solid tumors.
Patients and healthcare providers seeking information on the various clinical trials 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 innovative products for niche medical markets of unmet medical need. The company currently markets Salagen® Tablets (pilocarpine hydrochloride), INFeD® (iron dextran injection 50mg/ml) and Didronel® I.V. Infusion (etidronate disodium) in the United States. The company's website address is mgipharma.com
Gemzar® is a registered trademark of Eli Lilly & Company.
This press release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the company and its management. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that may cause the company's actual future prospects to differ materially from the results discussed in these statements. Factors that might cause such differences include, but are not limited to, the ability of MGI 114 to be proven safe and effective in humans as a chemotherapy agent in pancreatic or other tumors or to ultimately successfully compete against other therapies, and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission.
SOURCE: MGI Pharma, Inc. |
