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Investigational Therapy for Ovarian Cancer is Subject of Magee-Womens Hospital Study

PITTSBURGH, August 21, 2001Magee-Womens Hospital is now enrolling newly diagnosed ovarian cancer patients in a clinical study to evaluate the safety and efficacy of a treatment combining traditional chemotherapy with a peptide that has shown cancer-fighting properties. A peptide is a combination of amino acids.

The peptide, called IM862, appears to interfere with tumor blood vessel development, said Robert P. Edwards, M.D., medical director of gynecological oncology at Magee-Womens Hospital and director of the gynecologic oncology center at the University of Pittsburgh Cancer Institute.

“The treatment is given in nose drops that patients can administer themselves,” added Edwards, who also is an associate professor and medical director in the division of gynecologic oncology at the University of Pittsburgh School of Medicine. “So far, initial testing indicates few side effects, and the peptide also seems to be very active. It’s exciting.”

Developed by suburban Seattle, Wash.-based Cytran Inc., IM862 is also being tested as a possible immune system booster. Magee-Womens Hospital is among 18 centers nationwide now taking part in clinical trials using IM862, which is also being evaluated for its effectiveness in treating patients with prostate, breast and colorectal cancers. Cytran is funding the Magee study.

“Since the symptoms of ovarian cancer can be subtle, many women are not diagnosed until the disease is in an advanced stage,” said Holly H. Gallion, M.D., director of the National Center of Excellence in Ovarian Cancer at Magee. “So these sorts of trials are essential to the development of possible new treatments.”

Approximately 24,000 new cases of ovarian cancer are diagnosed each year in the United States, said Edwards, who is principal investigator for the IM862 study in Pittsburgh. About 14,000 women die yearly from the disease.

“Most patients respond to treatment initially very well, but then fail,” said Edwards. “There is often remission followed by recurrence.” In fact, nearly half of patients who receive treatment for ovarian cancer will have a recurrence, experts say.

Aggressive surgery followed by chemotherapy is the current “standard of care” for ovarian cancer treatment. Women 18 years of age or older who are newly diagnosed and have had surgery but not chemotherapy are being targeted to take part in the study. Patients who have had previous chemotherapy treatment are ineligible.

Patients will be randomly assigned to one of three study groups that receive different doses of IM862 along with six cycles of traditional chemotherapy. At the conclusion of treatment, a “second look” surgery will be performed to assess the presence of the disease. Those who have no, or microscopic, evidence of disease recurrence will receive treatment with IM862 for an additional 24 weeks. The study is a “double-blind” trial, meaning that neither the physician nor the patient will know which dose of IM862 is being given. Patients who have no clinical evidence of disease at the end of the additional 24 weeks will be followed periodically for a year.

To date, IM862 has been tested in clinical trials involving more than 400 cancer patients with a range of cancers

“We hope that if the results of this trial are positive, the treatment may be broadened to other cancers,” said Edwards.

Founded in 1911, Magee-Womens Hospital is an acute care, research and teaching center that serves the Pittsburgh region and beyond. Magee’s philosophy of care focuses on treating women with dignity, empowering them through education and providing accessible healthcare for all women through a network of neighborhood centers.

Cytran Inc. is a privately held biopharmaceutical company that researches cancer treatments aiming to stimulate immune system response and inhibit blood-vessel formation.

For information on the IM862 trial at Magee-Womens Hospital, call Kelly Colonello, study coordinator, at 412-641-5318.

Additional information on IM862 is available on the Cytran Inc. website at http://www.cytran.com or by calling Anne Bugge, vice president of corporate communications at Cytran Inc., at 425-889-8822.

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