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Zonagen Presents Three Month Results From Study of Progenta in the Treatment of Uterine Fibroids

Posted on: Thursday, 24 February 2005, 06:00 CST

Zonagen, Inc. (Nasdaq:ZONA)(PCX:ZONA) today announced that Dr. Ronald Wiehle, the Company's Director of R&D, today delivered a poster at the "Advances in Uterine Leiomyoma Research: NIH 2nd International Congress" reporting results after three months of dosing from its study of Progenta(TM) in the treatment of uterine fibroids. The study included three dose levels of Progenta(TM) as well as placebo and positive control arms. The positive control was Lucrin(R), an approved gonadotropin releasing agonist (GnRHa), commonly used for the treatment of fibroids. Progenta(TM) was administered as a daily oral dose of either 12.5mg, 25mg, or 50mg capsules.

After three months of exposure the mean change in fibroid cross sectional area, reported as a percent of time zero area, was 95% for placebo, 83.8% for 12.5mg Progenta(TM), 64.9% for 25 mg Progenta(TM), 59.1% for 50 mg Progenta(TM) and 62.5% for Lucrin(R). Both the 25 mg and 50 mg Progenta(TM) doses, as well as Lucrin(R), achieved a statistically significant reduction in mean fibroid size after three months compared to time zero (p less than .05).

The drug was well tolerated at all doses, with headaches being the most common adverse event to be reported over the course of the study. The incidence of headaches across all groups was 3, 0, 5, 5 and 15 events for placebo, 12.5 mg, 25 mg, 50 mg and Lucrin(R), respectively.

The study initially enrolled 30 women diagnosed with uterine fibroids, and 28 women actually completed the study. One woman was discontinued due to the finding of a uterine tumor on the initiation visit and the other was dropped due to her inability to adhere to the clinical visitation schedule. Six women were randomized into each group. The early discontinuations occurred in the 50 mg Progenta(TM) and Lucrin(R) groups.

The women were referred to the trial by several gynecological practices in Warsaw, Poland. The placebo and Progenta(TM) groups were blinded and remained blinded to the attending physicians and enrolled patients. The study consisted of three phases. The initial phase consisted of a Day 1 dosing for both initial safety and pharmacokinetics. Following a one week washout and safety assessment, women entered phase two taking the drug for 30 days after which time they were readmitted into the clinic to evaluate steady state pharmacokinetics, effects on fibroid size, bone mineral density and hemoglobin. At that time, women could elect to switch to the GnRHa for the duration of the study or stay on their blinded medication (phase three). At the end of the study, women on Progenta(TM) were evaluated for changes in bone mineral density, hemoglobin levels and fibroid size and compared against the changes experienced by the positive control group dosed with a GnRHa.

None of the women in the study elected to switch to the Lucrin(R) treatment group. The assessment of changes in bone mineral density and hemoglobin levels is ongoing. Although the women in both the mid and high dose Progenta(TM) groups had fibroid reduction, as measured by ultrasound, numerically equivalent to or superior to the GnRHa, it should be cautioned that this was a small study.

Joseph S. Podolski, President and CEO of Zonagen, noted, "This study represents an important first step in the development of Progenta(TM). Although the study was small, this early evidence suggests that Progenta(TM), with a completely different mechanism of action than the GnRH agonists, may offer an alternative therapy that may not only be used preoperatively but may also offer the potential for chronic treatment to avoid surgery altogether." He further noted that the Company has requested a pre-IND meeting with the FDA in preparation for submission of an IND.

The slides from the presentation will be posted on the Company's website at www.zonagen.com under Presentations.

ABOUT ZONAGEN

Zonagen is engaged in the development of new drugs to treat hormonal and reproductive system disorders.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including Zonagen's ability to have success in the clinical development of its technologies, Zonagen's ability to have success in meeting governmental regulations and the costs and time required to meet such regulatory requirements, manufacturing uncertainties related to Progenta(TM), the need for additional funding in order to complete clinical trials for Progenta(TM), our reliance on independent contractors for development and manufacturing needs, and such other risks identified in Zonagen's Annual Report on Form 10-K for the year ended December 31, 2003, as filed with the Securities and Exchange Commission (SEC) and other SEC filings. These documents are available on request from Zonagen or at www.sec.gov. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Business Wire

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