From: Aeson Therapeutics Inc.
101 N. Wilmot Rd., Suite 600
Tucson, AZ 1-3335 Tel.
(520) 748-4471 Fax (520) 748-0025
News Release
For release Jan. 14, 1997
Contact Jan McCoy Hutchinson,
Research Corporation Technologies
(520) 748-4458, Fax (520) 748-0025
[email protected]
DHEA Analog, Fluasterone, Entering Clinical Trials
TUCSON, Ariz.--While DHEA is lauded as possibly the nutritional supplement of the decade, Phase I clinical trials of a synthetic version believed to be more effective and without the side effects of the natural steroid begin late this month.
Aeson Therapeutics Inc. (ATI) in Tucson, Ariz., is supporting the initial clinical development of fluasterone, a synthetic version of DHEA (dehydroepiandrosterone). ATI designed its plan to show fluasterone's nonandrogenicity in humans and to establish its effectiveness in preventing breast cancer and treating other diseases such as lupus erythematosus and Type II diabetes.
Laboratory experiments suggest DHEA could be useful with immune-related diseases such as lupus erythematosus, rheumatoid arthritis, multiple sclerosis and cancer. The steroid also shows promise in managing Type II diabetes and obesity. Currently, DHEA is popular for its supposed ability to slow aging processes. Still, DHEA is a precursor of androgens and estrogens and can produce undesirable side effects, such as masculinization in women. Because of this problem, DHEA dose levels must be limited. Data from current studies of DHEA reflect the use of limited doses of the steroid.
Fluasterone was developed by Arthur Schwartz, Ph.D., and other scientists at the Temple University Fels Institute for Cancer Research and Molecular Biology. Research Corporation Technologies in Tucson, Ariz., formed ATI through its Venture Development Group in 1995 to further ongoing development of therapeutic agents from fluasterone. ATI has funding to carry out its initial clinical development plan.
"Because of the enormous potential of this drug," said ATI Chairman Jeffrey E. Jacob, "ATI may choose to continue fluasterone development in partnership with a major pharmaceutical company after our initial clinical trials."
ATI's Phase I clinical trials will be conducted in Basel, Switzerland, and in Oxford, England. Besides testing the general safety of fluasterone, researchers will compare it to DHEA for its effect on various biomarkers of androgenicity and estrogenicity such as testosterone and estrogen, sex hormone-binding globulin and others. This trial is expected to finish by the end of the first quarter of 1997.
If fluasterone proves significantly safe and nonandrogenic, the National Cancer Institute's Division of Cancer Prevention and Control (DCPC) will begin Phase II clinical trials of fluasterone as a preventive treatment for breast cancer.
"The NCI recognizes the importance of the pharmaceutical industry in developing new anticancer agents," said Gary J. Kelloff, M.D., chief of the NCI's Chemoprevention Branch. "We wish to collaborate on clinical trials with these companies because these trials are vehicles to the New Drug Applications and Product License Applications that make new anticancer agents available to eligible patients."
ATI and the DCPC signed an agreement recently to collaborate on developing fluasterone as a chemopreventive agent. This type of treatment is distinctly different from chemotherapy, which treats established cancer. Chemopreventive drugs are designed to prevent occurrence of precancerous lesions or markers, or to delay or reverse progression to cancer.
ATI will share its preclinical and Phase I clinical data with the DCPC and provide the oral formulation of fluasterone for the studies. The DCPC expects to begin a short-term trial in about mid-1997. The study will examine the breast cancer tissue of women newly diagnosed with the disease. Following a two- to four-week treatment with fluasterone, biopsied breast cancer tissue will be compared pre- and post-treatment to determine whether fluasterone retards tumor growth. Similar studies are expected also with prostate and colon cancer patients.
"If we can document the regression of a particular neoplastic stage for certain chemoprevention indications," Jacob said, "ATI believes development and approval times will be similar or better than traditional anticancer drugs."
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