Daré Bioscience, Inc. announces Memorandum of Understanding with CONRAD for the conduct of the Ovaprene® postcoital test c...
July 24 2017 - 8:30AM
Daré Bioscience, Inc. (NASDAQ:DARE) announced today that it has
entered into a memorandum of understanding with CONRAD to enter
into an agreement in connection with a postcoital test (PCT)
clinical trial of Ovaprene®, wherein CONRAD will provide certain
clinical and regulatory services related to the PCT clinical trial
that Daré will sponsor. Final details will be negotiated
under a separate agreement.
CONRAD is a non-profit organization established to improve
reproductive health globally under a cooperative agreement between
Eastern Virginia Medical School and the U. S. Agency for
International Development (USAID). CONRAD oversaw the successful
development and approval of the Caya® diaphragm, the U.S. Food and
Drug Administration’s (FDA’s) most recently approved barrier
contraceptive device in combination with a locally-acting
spermiostatic agent. Since its founding in 1986, CONRAD has been
internationally renowned for its leadership in developing new
contraceptive products.
“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 FDA approved, make them an ideal
partner for the conduct of Ovaprene®’s PCT clinical trial,” stated
Sabrina Martucci Johnson, President and CEO of Daré. “Daré has
established relationships, and intends to work closely, with
non-profit developers such as CONRAD, with clinical and regulatory
expertise in reproductive health and with a proven track record of
FDA success. We believe working with CONRAD will provide for the
efficient use of capital and time to advance Ovaprene®.”
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 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 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 the United States.
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.
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
Operations 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 and Daré Operations specifically disclaim any obligation to
update any forward-looking statements included in this press
release.
For more information on Daré, please visit www.darebioscience.com
Sabrina Martucci Johnson, 858-769-9145
Lisa Walters-Hoffert, 858-365-0145
innovations@darebioscience.com
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