Repros Requests Meeting With FDA to Discuss Phase 3 Requirements for Proellex® in the Treatment of Symptomatic Uterine Fibro...
December 12 2016 - 4:01PM
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has
requested a meeting to discuss Phase 3 requirements for the
development of Proellex® (telapristone acetate) for the treatment
of symptomatic uterine fibroids. The Company anticipates a meeting
will be scheduled during the first half of 2017.
The Company has completed studies on both oral
and vaginal delivery and will propose further development of the
oral form of the drug. The objective of the meeting with the FDA is
primarily to agree on the Phase 3 clinical program. To date, the
Company has administered Proellex® at various doses and strengths
in over 700 women. In efficacy studies of uterine fibroids the
formulations of Proellex® have consistently exhibited both
clinically and statistically significant reduction of excessive
menstrual bleeding due to the presence of uterine fibroids. This
clinical feature is due to the action of Proellex® which induces a
state of amenorrhea (cessation of menses). In addition to
induction of amenorrhea, the studies have shown that Proellex®
reduces fibroid volume which can significantly reduce the bulk
symptoms many women with fibroids experience.
The Company has also completed a thorough
toxicity panel in animal models that meets ICH guidelines. This
includes two successfully completed carcinogenicity studies. Of
particular note, in the two year rat study, animals dosed with
Proellex® exhibited a lower incidence of mammary tumors than
control animals.
The Company has also completed a full battery of
drug interaction and special population studies, including a pilot
QT interval study at significant multiples of the highest intended
dose, 12 mg, that did not exhibit QT prolongation.
The current formulation of Proellex® allows for
continuous dosing for up to 18 weeks which, is 50% longer than a
competing product. In addition, the Proellex® studies have not
demonstrated any apparent racial or BMI effect on overall
efficacy.
About Repros Therapeutics
Inc.®
Repros Therapeutics focuses on the development
of small molecule drugs for major unmet medical needs that treat
male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not
historical facts contained in this release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and are subject to various risks, uncertainties
and other factors that could cause the Company’s actual results,
performance or achievements to differ materially from those
expressed or implied by such forward-looking statements. These
statements often include words such as “may,” “will,” “expect,”
“anticipate,” “continue,” “estimate,” “project,” “intend,”
“believe,” “plan,” “seek,” “could,” “can,” “should” or similar
expressions. These statements are based on assumptions that the
Company has made in light of the Company’s experience in the
industry, as well as the Company’s perceptions of historical
trends, current conditions, expected future developments and other
factors the Company believes are appropriate in these
circumstances. Forward-looking statements include, but are not
limited to, those relating to ongoing and future clinical studies
and the timing and results thereof, the Company’s plans to
communicate with the FDA, possible submission of one or more NDAs
and the commercial potential of Proellex®, risks relating to the
Company’s ability to protect its intellectual property rights and
such other risks as 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.
CONTACT:
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com
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