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8-K - REPROS THERAPEUTICS INC. | v188068_8k.htm |
Exhibit
99.1
Contact:
|
Repros
Therapeutics Inc.
|
Joseph
Podolski (281) 719-3447
President
and Chief Executive Officer
FDA
LIFTS FULL CLINICAL HOLD ON REPROS’ PROELLEX®
Company
allowed to conduct low dose study to determine whether a safe and potentially
effective dose of Proellex can be developed
THE
WOODLANDS, Texas – June 11, 2010 – Repros Therapeutics Inc. (NasdaqCM:RPRX)
today announced it has received written confirmation from the FDA noting the
full clinical hold on Proellex® has been
lifted. The Company will be allowed to run a single study under the new partial
clinical hold status. The new low dose study is designed to explore both safety
and signals of efficacy in an escalating dose fashion.
The new
study will test 5 different doses of Proellex (1, 3, 6, 9 and 12 mg) with 1 mg
being the first dose tested. Each dose will be compared to placebo with weekly
assessments of liver function during both the placebo and drug period. Higher
doses will not be studied until the Company is confident that it is safe to
proceed to the next dose and has reported the safety findings to the FDA.
Subjects will be dosed with the active drug for 10 weeks, which will allow for
adequate time to determine the impact of a given dose on trends in liver
function. Each dose will be tested in 12 different subjects and assessment of
pharmacokinetic parameters will be obtained at start of dosing and end of the
dosing period to determine overall and maximum drug exposure for a given dose.
The Company will also monitor changes in menstrual bleeding patterns and
ovulation as well as changes in endometrial thickness. The FDA requires that an
independent Drug Safety Monitoring Board be established and that the “Informed
Consent” clearly state the liver toxicity previously experienced with Proellex.
The Company believes the toxicity experienced was dose dependent and that the
lower doses being tested now are outside the range where toxicity was previously
seen.
In a 120
patient study of Proellex as a treatment of uterine fibroids conducted in the
United States (roughly 40 subjects per arm) both a 12.5 and 25 mg dose of
Proellex were compared to placebo. In this study both the 12.5 and 25 mg doses
achieved highly statistically significant results when compared to placebo when
menstrual bleeding was assessed (p< 0.0001). The two doses also achieved
highly statistically significant improvement in quality of life measures using
the Uterine Fibroid Symptom Quality of Life questionnaire developed and
validated by Georgetown University and used in the development of device like
treatments of uterine fibroids such as uterine artery embolization. There was no
statistical difference in efficacy measures between the two doses. Importantly
in the Phase II US trial a significant percentage of women stopped menstruating.
Over 80% of women on both the 12.5 and 25 mg doses exhibited no menses during
the three month trial whereas all women on placebo exhibited at least one
menses. The Company believes that the evaluation of ovulation and menstrual
bleeding patterns in the low dose trial will provide strong evidence for
efficacy warranting further development.
The
Company plans to proceed with the manufacture of the lower doses of Proellex
capsules and hopes to begin dosing subjects this summer. Though the new study is
more complex than that originally submitted to the FDA, the Company believes it
can complete the trial within roughly 18 months after first
dose. Presuming a safe and effective dose is identified and the FDA
is in agreement, Repros anticipates that it will be able to proceed with large
efficacy trials for both uterine fibroids and endometriosis, subject to
available funds, or outlicense of the product to a major pharmaceutical
company.
Repros is
presently sufficiently capitalized to commence the study due to the proceeds it
has generated from the direct sales of shares of common stock into the capital
market from its shelf registration statement, with Ladenburg Thalman as
placement agent. To date the Company has raised over $5.5 million since it has
begun the trading program. No warrants or discounted shares have been offered or
issued as part of this "at the market" financing.
About
Repros Therapeutics Inc.
Repros
Therapeutics focuses on the development of oral small molecule drugs for major
unmet medical needs that treat male and female reproductive
disorders.
Any statements that are not
historical facts contained in this release are forward-looking statements that
involve risks and uncertainties, including Repros' ability to have the partial
hold on Proellex lifted and to determine a safe and effective dose for Proellex,
maintain its listing on the NASDAQ Capital Market, raise needed additional
capital on a timely basis in order for it to continue to fund its operations and
pursue its development activities, and such other risks which are identified in
the Company's most recent Annual Report on Form 10-K and in any subsequent
quarterly reports on Form 10-Q. These documents are available on
request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
For more
information, please visit the Company's website at
http://www.reprosrx.com.