Zonagen Presents Promising Data From Research Conducted On New Class of Compounds for the Treatment of Endometriosis
18-May-2001
Zonagen, Inc. (Nasdaq:ZONA)(PCX:ZNG) announced today that the results of the
Company's research funded by a Phase I Small Business Innovation Research Grant (SBIR) in August of 2000 has been selected for the Clinical
Ligand Assay Society (CLAS) Best Abstract Award. The abstract entitled "Effect of a SPRM on Cynomolgus Endometrium and Serum Hormones"
was awarded since, from those abstracts submitted, it best described and supported original research in the most clear and sound manner. Dr. Ron
Wiehle, Senior Scientist at Zonagen and Principal Investigator for the SBIR, will present the findings tomorrow, May 18th, at the CLAS meeting in
Dearborn, Michigan.
The abstract describes findings from a study of the activity of a new class of compounds for the treatment of endometriosis. The compounds, known
as Selective progesterone Receptor Modulators (SPRMs), were developed by the National Institute of Health (NIH). Zonagen licensed worldwide
rights to the technology from the NIH in 1999.
Endometriosis affects 5,000,000 women in the U.S. alone and is a major female health issue. Symptoms include abdominal pain and cramping
during the menstrual cycle, and in severe cases, may lead to infertility. Existing therapies to treat endometriosis are not optimal. Operations to destroy
lesions of endometriosis are expensive, and gonadotrophin releasing hormone (GnRH) agonist therapy has unpleasant side effects and causes bone
loss. A great need exists for therapies that potentially can be used for extended periods of time without serious side effects.
The SBIR grant provided funds to study the activity of a lead compound selected from several compounds covered by an NIH patent application.
The funded experiments utilized a primate model developed by Gary Hodgen, Ph.D., Professor of Obstetrics and gynecology at Eastern Virginia
Medical School, Norfolk, Virginia and President of the Jones Institute for Reproductive medicine. This primate model was used to study the effect of
the lead compound on the endometrium, the target tissue for the treatment of endometriosis. The new lead compound being developed by Zonagen acts
through an entirely different mechanism of action than existing therapies and is targeted to reduce endometrial lesions in the primate model with no
negative effects on bone density. The study clearly showed the anticipated effects on the monkey endometrium without negative impact on hormone or
glucocorticoid levels.
"We are encouraged by the results from this first primate study," said Joseph Podolski, President and CEO of Zonagen. "These findings further
confirm our belief that this compound has the potential to effectively treat endometriosis." He continued, "Besides endometriosis, this compound may
have utility in treating uterine fibroids and breast cancer and potentially as an adjunct drug in providing more effective hormone replacement therapy.
We will begin the process of securing sufficient compound to conduct the necessary preclinical studies required for filing an Investigational New
Drug Application (IND) in the United States."
Zonagen, Inc. is engaged in the development of pharmaceutical products for the reproductive system, including sexual dysfunction, vaccine
adjuvants, products for fertility and female health as well as urological applications, specifically prostate cancer.
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