Press Release
Daré Bioscience, Inc. announces Memorandum of Understanding with CONRAD for the conduct of the Ovaprene® postcoital test clinical trial
CONRAD is a non-profit organization established to improve reproductive health globally under a cooperative agreement between
"CONRAD has played a leadership role in the development of multiple intravaginal rings for the vaginal delivery of contraceptive agents and drugs and of barrier
method contraceptives. We feel this expertise combined with their experience in running PCT assessments on other barrier method contraceptives that are currently
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. In a pilot PCT clinical trial conducted in 21 women and published in the
- 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 this memorandum of understanding is an important step in the series of study initiation activities, that will 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
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
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.comSource:Sabrina Martucci Johnson , 858-769-9145Lisa Walters-Hoffert , 858-365-0145 innovations@darebioscience.com
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