May 2001

From University of Southern California

Nose drops help hold off growth of ovarian cancer

University of Southern California study finds new drug given nasally to fight tough cases of women’s cancer is well tolerated, even at higher dosages

SAN FRANCISCO, May 2001—A cancer-fighting nose drop shows promise in treating patients with recurrent ovarian cancer, one of the most devastating women’s diseases, according to research presented this weekend by a USC/Norris Comprehensive Cancer Center oncologist at the American Society of Clinical Oncology annual meeting.

Medical oncologist Agustin Garcia, M.D., assistant professor of medicine at the Keck School of Medicine of USC, studied the drug—known as IM862—in a trial with 81 women with very resistant ovarian tumors. All patients had previously been treated with chemotherapy before receiving IM862, yet the new drug succeeded in halting the growth of many tumors in the phase I/II trial, says Garcia, who directed the study.

"For example, 20 percent of patients in the study survived longer than one year, which is fairly unusual in patients with cancers as resistant as the ones entered in the study," Garcia says. Results are encouraging, considering the typical enrolled patient in the study already had used five chemotherapy agents.

"Based on the results of the study, IM862 will now be combined with standard chemotherapy in clinical trials," says Garcia, medical director of the Clinical Investigation Support Office at USC/Norris.

Other participating medical centers in the trial included the Cleveland Clinic in Cleveland, Roswell Park Cancer Institute in Buffalo, N.Y. and US Oncology in Dallas.

Garcia notes the drug differs from those typically associated with chemotherapy: It is not given in intravenous form. "It is very easy for the patient to administer it, since it is taken as a nose drop," Garcia says. It was also well tolerated by patients at all dosage levels tested in the study, and many patients remained on the medication for six months or longer.

IM862 (glufanide disodium) was developed by Cytran Inc., of Kirkland, Wash. IM862 is a synthesized version of a naturally occurring small peptide and could be destroyed by stomach acids if given orally, such as in pill form. But when given through the nose, the drug easily and efficiently enters the bloodstream through nasal membranes. Research suggests that IM862 stimulates the body’s immune system and inhibits the development of blood vessels needed by tumors to grow and spread, a process known as angiogenesis.

Much of the early work on IM862 was done at USC/Norris by Parkash Gill, M.D., USC professor of medicine and pathology. Gill and colleagues showed that IM862 was effective in significantly shrinking—or even eliminating—lesions due to the AIDS-related cancer known as Kaposi’s sarcoma.

A phase III trial of IM862 for Kaposi’s sarcoma is underway at medical centers in the United States, Canada, Europe and Australia. A phase II study adding IM862 to standard chemotherapy in women with newly diagnosed stage III ovarian cancer is enrolling patients at 15 centers across the country. Researchers also are investigating the drug’s application for prostate, breast and colorectal cancers.

Ovarian cancer is the fifth most deadly cancer among women in the U.S. Doctors will diagnose about 23,400 new cases of ovarian cancer in the nation this year, according to American Cancer Society estimates, and about 13,900 women will die of the disease.

Cytran is a privately held biopharmaceutical company developing and commercializing small peptides/molecules for the treatment of cancer.












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