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Ovaprene® is a clinical stage, non-hormonal vaginal contraceptive ring intended to provide protection over multiple weeks of use, require no intervention at the time of intercourse, and fill a void in today's contraception method mix. There are 40 million women in the US alone using contraception today, and half of them prefer a short acting (meaning daily, weekly or monthly), quickly reversible method.
In a pilot PCT clinical trial conducted in 21 women and published in the
While the original pilot PCT clinical trial was not designed to be utilized as part of a regulatory submission, its data provide preliminary proof-of-concept contraceptive efficacy. PCT clinical trials have been used to assess the preliminary efficacy of other contraception methods that work by preventing or blocking the progression of sperm into the cervical mucus.
Daré intends to commence a PCT clinical trial
of Ovaprene® with CONRAD, and has begun the series of study initiation activities that include manufacturing as well as other clinical trial related activities, to prepare for enrolling the first subjects in the PCT clinical trial in early 2018. Based on current projections, Daré believes it is adequately funded to advance Ovaprene® through the completion of the PCT clinical trial within the next two years. A successful PCT clinical trial outcome would represent a meaningful milestone and should allow Daré to proceed directly to a pivotal contraceptive efficacy trial in
Daré's business model is built around licensing the rights to promising product candidates (many with clinical proof-of-concept data), advancing their clinical development, and if successful, implementing a comprehensive global commercialization strategy in combination with established pharmaceutical partners and regional distributors. Daré is committed to developing a portfolio that expands options, improves outcomes, and enhances safety for women across a broad spectrum of categories relating to women's reproductive health. In addition to contraception, women's reproductive health encompasses categories including vaginal health, fertility, pain, among others, and in parallel to advancing the Ovaprene® development program Daré is actively evaluating other portfolio opportunities that are also clinical stage products that address unmet needs in women's health.
About Daré Bioscience
Daré Bioscience is a healthcare company committed to the development and commercialization of innovative products in women's
reproductive health. Daré believes there is an unmet need in
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Forward Looking Statements
This press release contains "forward-looking statements" regarding matters that are not historical facts,
including statements relating to Daré's expectations regarding the timing and availability of results from its clinical trials, the timing of commencement of manufacturing its products, the safety and effectiveness of its products, Daré's projected capital needs and its ability to raise additional funds as needed, and the continued ability of Daré to develop and market Ovaprene® under its license with ADVA-Tec. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "feel," "hypothesize," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether cash resources will be sufficient to fund the operations of Daré it will undertake; the uncertainties inherent in the initiation and completion of clinical trials; availability and timing of data from ongoing and future clinical trials and the results of such trials; whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials; whether the company will maintain its NASDAQ listing, expectations for regulatory approvals; claims of infringement and other risks relating to Daré's owned and licensed intellectual property rights; and other
factors discussed in the "Risk Factors" section of Daré's Quarterly Report on Form 10-Q filed with the
For more information on Daré, please visit www.darebioscience.com Phone: 858-926-7655 email@example.com
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