SAN DIEGO, Aug. 03, 2017 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE) discussed with Wall Street Analyzer key goals over the next twenty-four months, including the Ovaprene® clinical development program, the memorandum of understanding with CONRAD to enter into an agreement in connection with a postcoital test (PCT) clinical trial of Ovaprene®, and the opportunities to license product candidates in women’s reproductive health.
The interview is available for two days via the following link:
http://wallstreetanalyzer.com/2017/08/02/dare-bioscience-inc-nasdaq-dare-ceo-interview/
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 Journal of Reproductive Medicine in 2009, Ovaprene® demonstrated the following:
- Ability to immobilize sperm and prevent their progression into the cervical mucus
- Acceptability of the device to both partners
- No serious adverse events were reported
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 the United States.
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 the United States, in other developed countries, and in developing countries, for innovative product candidates that expand options, improve outcomes and are easy to use. Product development in women’s reproductive health is fragmented creating a potential opportunity for Daré. Daré’s goal is to fill the gap by taking products from innovation through development and believes its management team is well-suited to ensure Daré’s current and potential future product candidates and products advance and one day become commercially available. Daré’s founders, including its executive management team, bring experience in global women’s healthcare as well as success in prior ventures in funding, achieving regulatory approvals, partnering, and launching a number of products, including devices, therapeutics and diagnostics.
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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 SEC on May 12, 2017, and in other filings that Daré made with the SEC, including the definitive proxy statement relating to the transaction with Daré Bioscience Operations, Inc. filed with the SEC on June 19, 2017. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. Daré specifically disclaims any obligation to update any forward-looking statements included in this press release.