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Repros Requests Meeting With FDA to Discuss Phase 3 Requirements for Proellex® in the Treatment of Symptomatic Uterine Fibroids
- Focus on oral formulation
- Phase II complete
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
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.
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
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 firstname.lastname@example.org
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