Aeson Therapeutics Continuing Fluasterone Development.

Business Editors & Health/Medical Writers

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TUCSON, Ariz.--(BUSINESS WIRE)--Oct. 28, 2002

Encouraged by results from a variety of preclinical and clinical studies, Aeson Therapeutics continues development of fluasterone, for treatment of lipid disorders, inflammatory diseases, and as a cancer chemoprevention agent.

"We are excited with the tremendous progress we have made in developing fluasterone," said Aeson Chairman Jeffrey Jacob. "We are in the middle of a pivotal Phase II clinical trial of fluasterone as a lipid-lowering drug. Add to this our dominant patent position, and Aeson can offer an ideal partnering opportunity to interested companies."

The Aeson technology was previously under an option agreement with Hollis-Eden Pharmaceuticals in San Diego, however Hollis-Eden failed to exercise its option to acquire the company at a pre-determined price.

"Given unfavorable market conditions and Hollis-Eden's many internal development projects, we understand their decision," Jacob said. "We appreciate their past support and wish them future success."

Over the past two years, Aeson has generated additional preclinical and clinical data about the lipid-lowering effects of fluasterone. Fluasterone has shown marked anti-diabetic and triglyceride-lowering activity in preclinical models of Type II diabetes. Fluasterone appears to work through a mechanism different from that of known anti-diabetic and triglyceride-lowering drugs.

Following earlier positive results from a study to evaluate the lipid-lowering effects of oral fluasterone in patients with elevated triglyceride levels, a larger study began this summer with a new and improved formulation of fluasterone.

"This formulation promises increased potency relative to the previous form," Jacob said.

A multi-center Phase II study is ongoing using this formulation in patients with Metabolic Syndrome. Patients with the syndrome have multiple risk factors including some combination of high triglycerides, large waist circumference, high serum glucose, high blood pressure and low HDL cholesterol.

Fluasterone also has shown robust cancer preventive activity in numerous preclinical models, including tumors of the breast, liver, colon, prostate, skin and lymphatic tissue.

The National Cancer Institute has provided substantial support for fluasterone development under a collaborative Clinical Trials Agreement with Aeson. Through the RAPID program, NCI plans to conduct chronic dog and rat toxicology studies, synthesis of carbon-14 labeled fluasterone, and preclinical pharmacokinetic, absorption, distribution and metabolism studies. The NCI is currently conducting studies with an inhaled formulation of fluasterone in preclinical models of lung-cancer prevention.

For additional information about Aeson or development collaborations, contact Jeffrey Jacob, Aeson Therapeutics, 520/748-4417.