Zonagen Receives IRB Approval to Commence Phase III Study of Androxal(TM) for the Treatment of Testosterone Deficiency
January 09 2006 - 6:00AM
Business Wire
Zonagen, Inc. (Nasdaq:ZONA)(PCX:ZONA), a biopharmaceutical company
focused on the development of new drugs to treat hormonal and
reproductive system disorders, today announced that the Company has
received Investigational Review Board (IRB) approval for the start
of its Phase III study of Androxal(TM), a once-a-day oral therapy
for the treatment of testosterone deficiency resulting from a
condition known as secondary hypogonadism. The 200 patient trial
will be conducted in the U.S. under an existing U.S.
Investigational New Drug application and will enroll patients at up
to 20 clinical sites. The 200 patient Androxal study is designed to
assess both the safety of Androxal and its efficacy in restoring
normal pituitary and testicular function in men that are
hypogonadal due to secondary hypogonadism. Secondary hypogonadism
is a failure of appropriate signaling from the pituitary to the
testes. The condition is most common in aging males but can result
from a variety of causes, including the use of androgens. The
double-blind study will test two doses of Androxal versus placebo
and will include an open-label arm of the commercially available
drug Androgel(R). The dosing is of 24-week duration with an
efficacy assessment made at 12 weeks. Initial data after 12 weeks
of dosing is anticipated in late summer 2006. The extension of the
trial dosing to 24 weeks is to satisfy the U.S. Food and Drug
Administration (FDA) request regarding the safety of restoring
normal testicular function as compared to placebo or the currently
approved testosterone replacement therapies. We believe that at
least two additional Phase III pivotal studies beyond the currently
planned study will be required before an NDA can be submitted.
Doses to be used in the Phase III trial were previously tested in a
52 patient, 2-week study of Androxal in men in the U.S. with low
testosterone. In the study, Androxal demonstrated statistically
significant positive effects on restoring normal pituitary
signaling to the testes resulting in the achievement of normal
testosterone levels within 2 weeks. In contrast, that study also
found that Androgel, while replacing testosterone levels, further
suppressed normal pituitary secretions. Additionally, men on
Androgel experienced more deviations above the normal level of
testosterone than men on Androxal. Androxal was also well tolerated
over the course of the study. Pharm-Olam International Ltd ("POI")
had previously been awarded the contract for the study. Up to 20
clinical sites will participate in the trial. Cities where
investigator sites are located include: Augusta, GA; Boston, MA;
Carmichael, CA; Columbia, SC; Ft. Lauderdale, FL; Huntsville, AL;
Mission Viejo, CA; Nashville, TN; Ocala, FL; Oklahoma City, OK;
Salt Lake City, UT; San Diego, CA; Tacoma, WA; and Tallahassee, FL.
Patients interested in participating in the study should contact
Dr. Fred Lowrey, Director of Clinical Affairs for POI, or Jocelyn
Kerr, Project Manager for the study at 713-463-8075. ABOUT ZONAGEN
Zonagen is a clinical stage biopharmaceutical company 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, the need for additional funding in
order to complete clinical trials for Zonagen's product candidates,
reliance on independent contractors, uncertainty relating to
Zonagen's patent portfolio and such other risks identified in
Zonagen's Annual Report on Form 10-K for the year ended December
31, 2004, 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.
Zonagen (NASDAQ:ZONA)
Historical Stock Chart
From May 2024 to Jun 2024
Zonagen (NASDAQ:ZONA)
Historical Stock Chart
From Jun 2023 to Jun 2024