FDA advisory committee recommends approval for Ethyol(R); U.S. Bioscience Inc. reaches important milestone with major oncology product.

WEST CONSHOHOCKEN, Penn.--(BUSINESS WIRE)--June 9, 1995--The U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) today recommended that the FDA approve Ethyol(R) (amifostine), a selective cytoprotective agent developed by U.S. Bioscience (AMEX:UBS). The committee voted 8-to-0 that the FDA approve Ethyol, at least under an accelerated approval mechanism, for cumulative renal injury associated with cisplatin chemotherapy for treatment of ovarian cancer.

Dr. Charles Schiffer, chairman of the committee, complemented the company on what he described as its clear and skilled presentation.

The FDA will make the final determination regarding the approval of Ethyol for commercial sale in the United States, including whether an approval would be unconditional or under the accelerated mechanism. The company will work with the FDA to determine final labeling for Ethyol. Accelerated approval can be granted for new drugs to treat serious or life-threatening illnesses that provide meaningful therapeutic benefit to patients over existing treatments. Drugs approved under the accelerated approval mechanism are subject to post-marketing study requirements.

Chemotherapeutic agents are not selective in their effects, and can destroy healthy tissue along with cancer cells. Ethyol is one of a new class of cytoprotective agents, which when administered prior to chemotherapy, can help protect healthy cells from the damaging effects of chemotherapy.

"One of the most important and unaddressed issues in cancer chemotherapy is cumulative toxicity -- the progressive and frequently permanent damage to normal organs with anti-cancer drug treatment," said David Alberts, M.D., professor of medicine and pharmacology, deputy director, Arizona Cancer Center, University of Arizona College of Medicine. "Ethyol is a selective cytoprotective agent, reviewed and recommended for approval by the Oncology Drug Advisory Committee, that allows patients to receive chemotherapy with greater safety, and therefore represents a much needed adjunct to management."

In addition to clinical trials with other chemotherapeutic regiments and other tumor types, Ethyol is also being studied to determine its ability to protect normal tissues and organs from the toxicities of radiation therapy.

Based in West Conshohocken, U.S. Bioscience, Inc. is a pharmaceutical company specializing in the development and commercialization of products for patients with cancer and AIDS.

CONTACT: U.S. Bioscience

Robert I. Kriebel, Sr.

610/832-0570

or

Harrison Star Wiener & Beitler PR

Wendy Dougherty, 212/727-0013