Breaking news:
Tuesday August 10, 8:07 am Eastern Time
Company Press Release
Zonagen Reports FDA Reaction to Preliminary
Findings From Ongoing Rat Study
THE WOODLANDS, Texas--(BW HealthWire)--Aug. 10, 1999--Zonagen, Inc. (Nasdaq: ZONA - news; PLX: ZNG)
today announced that the Food and Drug Administration (FDA) has advised the Company that further clinical trials of
Zonagen's phentolamine-based drugs have been placed on clinical hold until certain issues surrounding the Company's two-year
rat study are satisfactorily resolved. FDA is allowing Schering-Plough to complete the fully enrolled ongoing 12-week study in
humans of Vasomax for erectile dysfunction.
FDA's decision was based on preliminary findings from an ongoing two-year, rat carcinogenicity study being conducted by
Zonagen. The study, which is scheduled to be completed in the fourth quarter of this year, has yielded preliminary results which
suggest that male rats receiving long term daily doses of phentolamine mesylate develop a higher incidence of proliferation of
brown fat tissue than control rats. The implications of these findings need to be further evaluated with regard to their potential
for adverse effects on humans. To date, such abnormalities have not been observed in female rats in the study.
Prior to these latest findings, Zonagen had completed and submitted to the FDA a complete genotoxicity profile as well as
results from a six month mouse p53 assay and six month daily usage studies in dogs and rats. None of these studies showed
any abnormal effects, including brown fat tissue proliferation.
''Phentolamine has been on the market for 50 years,'' said Joseph S. Podolski, President and Chief Executive Officer of
Zonagen. ''Given this and the fact that our previous trials showed no abnormalities, we believe we can provide sufficient
information to the FDA to remove the clinical hold. We are pleased that our licensee, Schering-Plough, will be able to complete
its ongoing trial. We believe we will be able to continue the clinical development of our phentolamine products for both men and
women in a timely fashion.''
Zonagen Inc. is engaged in the development of pharmaceutical products for the reproductive system, including sexual
dysfunction, urology, contraception and infertility.
A copy of this press release may be obtained via facsimile by dialing 1-888-329-0920 or via the Internet by accessing
www.zonagen.com.
ZONAGEN FORWARD LOOKING STATEMENT: Any statements that are not historical facts contained in this release are
forward looking statements that involve risks and uncertainties, including but not limited to the Company's early stage of
development, clinical trial results and the regulatory process in the U.S. and in other jurisdictions, substantial dependence on
one product, history of operating losses, future capital needs and uncertainty of additional funding, litigation, governmental
regulation, and dependence on collaborators, and reliance on third parties, competition and technological change, and other
risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1998, as filed with the
Securities and Exchange Commission. |
