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Friday June 13 9:49 AM EDT
Company Press Release
Source: Zonagen, Inc.
Zonagen Announces Vasomax(TM) Second Phase 3 U.S.
Trial Results and Expands Data From First Phase 3 Trial
THE WOODLANDS, Texas, June 13 /PRNewswire/ -- Zonagen, Inc. (Nasdaq:ZONA) today
announced the results of the second pivotal Phase 3 clinical trial for Vasomax(TM), its oral
treatment for male erectile dysfunction. In addition, the Company expanded upon the data
reported from its first Phase 3 trial to include sexual intercourse rates and adverse event
experience.
The trial was a double-blinded, placebo-controlled study involving 293 men at 14 centers
across the United States, testing 40mg doses of Vasomax against placebo. Vasomax
yielded a statistically significant (p<0.01) improvement over placebo, with 34% of the men in
the study responding to the 40mg dose as compared to 21% responding to placebo using
the Erectile Function Domain from the International Index of Erectile Function (IIEF) primary
endpoint.
The trial included an in-office dose of 40mg on all the men considered for participation in
the study to assess heart rate and blood pressure changes before exposing men to
at-home use of Vasomax. No serious adverse events were reported during either the
in-office test period or the at-home study period. During the in-office test period, 4.3% of the
patients reported adverse events, the most common of which was nasal congestion. The
Company and PPD Pharmaco are continuing to evaluate the efficacy and safety data from
the at- home portion of the clinical trial.
``It is encouraging to see that this data demonstrated statistically significant improvement,
which is statistically similar to the data reported from the first study on May 27, 1997,''
commented Joseph Podolski, President and Chief Executive Officer of Zonagen, Inc. ``With
the two studies completed, we will now compile the human clinical data in preparation for
our planned NDA submission for Vasomax.''
In the first of the two Phase 3 U.S. clinical trials, 435 men were studied at 20 centers
across the United States, testing 40mg and 80mg doses of Vasomax against a placebo.
As previously announced, Vasomax yielded a statistically significant (p<0.001) improvement
over placebo, with 40% of the men in the trial responding to the 40mg dose of Vasomax
and 48% responding to the 80mg dose of Vasomax, as compared to 17% responding to
placebo, using the primary IIEF endpoint. When evaluating intercourse rates, Vasomax also
yielded a statistically significant (p<0.001) improvement over placebo, with 42% of the men
in the trial responding to the 40mg dose of Vasomax, as compared to 22% responding to
placebo.
Physician diagnoses revealed that a majority of the patients enrolled suffered from erectile
dysfunction with one or more physiological causes; the erectile dysfunction of only 2% of
enrolled patients were classified as having purely psychogenic causes by attending
urologists. The study included an in- office test dose of 80mg on all of the men considered
for participation in the study to assess heart rate and blood pressure changes before
exposing men to at-home use of Vasomax. Although one patient exhibited both an increase
in heart rate and a decrease in blood pressure greater than 30% in the in-office 80mg
study, and another exhibited chest pain, no other serious adverse events related to the drug
were reported in the trial.
Zonagen is a biopharmaceutical company engaged in the research, development and
marketing of products which address conditions and diseases associated with the human
reproductive system. The Company's lead product candidate, Vasomax, is an oral treatment
for male erectile dysfunction, commonly referred to as impotence. The Company is also
engaged in the research and development of new approaches to contraception, including
zona- pellucida-based vaccines in collaboration with Schering AG, treatments for urological
diseases such as benign prostatic hyperplasia (BPH) and prostate cancer, and an adjuvant
to enhance the effectiveness of vaccines. In addition to its proprietary development
activities, the Company markets and distributes a variety of third-party fertility related
products to obstetrics/gynecology, urology and fertility specialists through its wholly owned
subsidiary, Fertility Technologies, Inc.
Any statements which are not historical facts contained in this release are forward-looking
statements that involve risks and uncertainties, including but not limited to those relating to
the Company's future capital needs and uncertainty of additional funding, uncertainties
related to early stage of development, uncertainties related to clinical trial results,
substantial dependence on one product, history of operating losses, uncertainty of
protection for patents and proprietary technology, governmental regulation, limited sales
and marketing and dependence on future collaborators, manufacturing uncertainties and
reliance on third parties, competition and technological change, product liability and
availability of insurance, and other risks identified in the Company's Annual Report on Form
10-K as amended, for the year ended December 31, 1996 as filed with the Securities and
Exchange Commission.
SOURCE: Zonagen, Inc.-----------with pleasure! Regine |
