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MGI PHARMA and MethylGene Commence Phase 2 Trial of MG98 to Treat Head And Neck Cancer.

MINNEAPOLIS and MONTREAL, Nov. 16 /PRNewswire/ --

MGI PHARMA, INC. (Nasdaq: MOGN) and MethylGene Inc. have initiated a Phase 2 trial in Canada and the United States with MG98 in recurrent or metastatic squamous cell cancer of the head and neck. MG98, a second-generation mRNA inhibitor compound, has been well tolerated and demonstrated anti-cancer activity in an ongoing Phase 1 dose escalation trial involving a variety of solid tumor types. Up to 30 patients may be enrolled in this multicenter Phase 2 trial.

Dr. Andrew Maksymiuk, the principal investigator for this trial at CancerCare Manitoba, the provincial center for cancer treatment, observed, "The studying of MG98 in head and neck cancer provides one of the first opportunities to attempt to modify gene expression as a therapeutic modality in cancer. This exciting approach targets basic mechanisms and specificity of attack in cancer not traditionally seen in more non-specific cytotoxic cancer therapies."

MG98 inhibits the enzyme DNA methyltransferase by interfering with its production through binding to its messenger ribonucleic acid (mRNA). Hypermethylation, which leads to the silencing of tumor suppressor genes, has been associated with overproduction of DNA methyltransferase in a variety of cancers including colon, kidney, prostate and head and neck cancers. In particular, the p16 tumor suppressor gene has been reported to be hypermethylated and inactivated in approximately fifty percent of head and neck cancers. Preclinical studies with MG98 have suggested its potential to reduce the methylation of the p16 gene, thereby allowing restoration of normal tumor suppressor gene expression. This ability of MG98 to decrease the methylation of the p16 gene and observations of anti-cancer activity in a Phase 1 trial form the basis for initiating this Phase 2 trial in head and neck squamous cell cancer.

John MacDonald, vice president, research and development at MGI PHARMA, observed, "Targeting the re-expression of silenced tumor suppressor genes at the molecular level is one of the most exciting new approaches for cancer therapeutics today. This Phase 2 trial provides an excellent opportunity to directly measure the ability of MG98 to reduce the methylation of the p16 gene. Tumor biopsies may be available during the treatment of these patients, allowing for the potential assessment of DNA methyltransferase levels and the methylation status of these tumors as a function of the treatment. During 2001, we expect to initiate other Phase 2 trials with MG98 in other cancers where inactivation of tumor suppressor genes by hypermethylation is common."

In the United States, 30,200 patients are expected to be diagnosed with head and neck cancer in the year 2000 and 7,800 patients are expected to die from the disease. Worldwide, the comparable annual statistics are 363,000 and 197,000, respectively. Chemotherapy has a limited role in standard treatment of head and neck cancer. It is mostly used in recurrent or metastatic disease. Chemotherapy response rates when given as single agents range from 10 to 30 percent, with short response durations of two to six months. The combination of cisplatin and 5-flourouracil has frequently been used for recurrent disease, with response rates of 30 to 40 percent, but this improved response is not associated with increased duration of response or survival. The five-year survival rate of head and neck cancer patients with metastatic disease is approximately 20 percent. Consequently, the role of traditional chemotherapy is chiefly one of palliation of recurrent disease following standard therapy with surgery and/or radiation.

11th NCI-EORTC-AACR Symposium on New Drugs in Cancer Therapy

Interim results from Phase 1 dose escalation trials with MG98 were recently presented at the 11th NCI-EORTC-AACR Symposium on New Drugs in Cancer Therapy in Amsterdam. The trials were conducted to determine the recommended dose for MG98 in Phase 2 trials using two different dosing schedules. Antitumor activity of MG98 has been confirmed in the trial using the intermittent administration schedule selected for Phase 2 trials, two-hour infusions given twice weekly for three weeks out of every four weeks. One renal cell cancer patient has had a durable partial response lasting more than nine months and two mesothelioma patients have had stable disease lasting six and fourteen months, respectively. MG98 was generally well tolerated in the Phase 1 trials. At the recommended dose, the following transient side effects were occasionally seen: fatigue, anorexia, fever and chills, and elevated liver enzymes.

Credit Suisse First Boston Healthcare Conference

On Friday, November 17, 2000, at 10:30 a.m. Eastern Standard Time, Chuck Blitzer, president and CEO of MGI PHARMA, will present an overview of MGI PHARMA's business at the Credit Suisse First Boston Healthcare Conference being held in Scottsdale, Ariz. A webcast of the presentation will be available through http://www.csfb.com . Credit Suisse First Boston is a leading global investment-banking firm.

MGI PHARMA, INC. is an oncology focused pharmaceutical company. It acquires, develops and commercializes differentiated pharmaceutical products that meet patient needs. MGI PHARMA focuses its sales efforts solely in the United States and collaborates with other pharmaceutical or biotechnology companies for its products in international markets. Patients and healthcare providers seeking information on MG98 clinical trials may call MGI PHARMA's Medical Communications Help Line at 800-562-5580.

MethylGene Inc. is a privately held, Canadian biopharmaceutical and chemistry-driven drug discovery company engaged in the application of mechanism-based small molecule enzyme inhibitors, mRNA inhibitors and functional genomic technologies to discover, patent, develop and commercialize novel and proprietary medicines for the treatment of cancer and infectious diseases. MG98 was licensed by MethylGene Inc. to MGI PHARMA in North America and will be co-developed during Phase 2 trials.

This news 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 results to differ materially from the results discussed in these statements. Factors that might affect MGI PHARMA's results include, but are not limited to the ability of MG98, or MGI PHARMA's other product candidates, to be proven safe and effective in humans and to ultimately compete successfully with other therapies, continued sales of Salagen(R) Tablets, development or acquisition of additional products, reliance on contract manufacturing, changes in strategic alliances, and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission. MGI PHARMA does not intend to update any of the forward-looking statements after the date of this news release to conform them to actual results.
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Date:Nov 16, 2000
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