News Release
Sent March 12, 1998
Media contact
Jan McCoy Hutchinson
(520) 748-4458
Aeson Therapeutics/Research Corporation Technologies
101 N. Wilmot Road, Suite 600
Tucson, AZ 85711-3365
(520) 748-0025 fax
Phase I Clinical Trials Prove Fluasterone's Safety and Low Androgenicity
Phase I clinical trials of fluasterone, a synthetic steroid with many potential therapeutic and preventive uses, show it is safe at high doses, well tolerated and not metabolized to testosterone or estrogen in men or women.
"The results of our clinical trials are good news for Aeson Therapeutics," said Chairman Jeffrey E. Jacob. "Fluasterone is safe and without the side effects of other steroids, even at high doses. We have a proprietary compound with blockbuster potential."
Aeson Therapeutics Inc. (ATI) in Tucson, Ariz., has supported the initial clinical development of fluasterone since Aeson's formation in 1995.
Studies of fluasterone show it may be useful in cancer prevention and in treating a variety of autoimmune-related diseases and metabolic disorders without the unwanted side effects of other steroids. ATI's development plan is designed to establish its effectiveness in preventing breast, colon and prostate cancer, and treating Type II diabetes and autoimmune diseases such as lupus erythematosus, rheumatoid arthritis and multiple sclerosis. Laboratory studies of fluasterone's anti-inflammatory properties suggest it may suppress the formation of reactive oxygen, reactive nitrogen and prostaglandins.
ATI began clinical trials of fluasterone in January 1997 in Basel, Switzerland. Fluasterone proved safe and well tolerated in an ascending single-dose study and a multiple-dose study. The single-dose study included doses ranging from 100 mg to 1,600 mg. The multiple-dose study included an 800 mg per day dose (400 mg, twice a day) and a 1,600 mg per day (800 mg, twice a day) dose.
The researchers also tested the subjects who received the highest doses of fluasterone for androgenic effects. Both the men and women of the studies showed normal ranges for testosterone, estrogen and other biomarkers.
ATI now is planning pilot studies for 1998 to continue efficacy testing of fluasterone against diabetes and autoimmune diseases. Jacob said the company plans to develop various dosage forms of fluasterone with appropriate partners in the United States, Europe and Japan.
ATI welcomes inquiries from potential industrial partners in the continued development of fluasterone.
Fluasterone was developed by Arthur Schwartz, Ph.D., and colleagues at the Temple University Fels Institute for Cancer Research and Molecular Biology in Philadelphia. Research Corporation Technologies in Tucson formed ATI through its Venture Development Group to further ongoing development of therapeutic agents from fluasterone.
Contact Jeffrey E. Jacob, ATI chairman, (520) 748-4471, (520) 748-0025 fax.
###
RSS