Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced that it has received notification from
the American Association of Pharmaceutical Scientists (AAPS) of a
Best Abstract Award for the abstract titled, Vaginal Tamoxifen for
Treatment of Vulvovaginal Atrophy: Pharmacokinetics and Safety in a
Rabbit Model. The abstract was among the top 10% of abstracts
highly ranked by AAPS Abstract Screeners.
The abstract presented topline findings from a pharmacokinetic
and local tolerability study of vaginal tamoxifen in female
rabbits. Daré’s product candidate, DARE-VVA1, incorporates
tamoxifen in a proprietary formulation designed for vaginal
delivery.
Daré is investigating the use of tamoxifen, a commonly
prescribed treatment for breast cancer, as a new way of addressing
vulvar and vaginal atrophy (VVA) for women unable or unwilling to
use hormone-based therapies to treat their condition. VVA is an
inflammation of the vaginal epithelium due to the reduction in
levels of circulating estrogen. Historically, estrogen creams,
rings, and tablet supplements have been prescribed for the
treatment of VVA. These products, however, can be contraindicated
for women undergoing treatment for hormone receptor-positive breast
cancer.1
“This work is fundamental to the further development of a
vaginally delivered tamoxifen for the treatment of symptoms
associated with VVA in hormone receptor-positive breast cancer
patients,” said Dr. David Friend, Chief Scientific Officer of Daré
Bioscience. “These results are highly encouraging and support the
further development of vaginally delivered tamoxifen for the
treatment of VVA.”
Many breast cancer survivors experience menopausal symptoms,
including VVA, as a direct consequence of their anti-cancer
treatment with aromatase inhibitors. Breast cancer patients treated
with aromatase inhibitors refer to VVA as one of the most
unpleasant side effects of treatment.2
“If successful, vaginally delivered tamoxifen will address a
critical unmet need for women diagnosed with hormone
receptor-positive breast cancer experiencing the effects of VVA as
a result of their anti-cancer therapy,” said Sabrina Martucci
Johnson, President & CEO of Daré Bioscience. “Consistent
with our portfolio of first-in-category opportunities, we believe
this novel application of tamoxifen has the potential to be the
first therapy that will specifically address VVA in the hormone
receptor-positive breast cancer market segment.”
Tamoxifen is systemically metabolized to active metabolite
4-hydroxy-N-desmethyl-tamoxifen, otherwise known as endoxifen.3 In
breast tissue, tamoxifen acts as an estrogen antagonist. In other
tissue, including vaginal tissue, tamoxifen has been reported to
exert an estrogen-like response on vaginal cytology by a mechanism
yet to be understood and not expected based upon its anti-estrogen
activity.
-
https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/The-Use-of-Vaginal-Estrogen-in-Women-With-a-History-of-Estrogen-Dependent-Breast-Cancer?IsMobileSet=false
- Biglia N., Bounous V.E., D’Alonzo M., Ottino L., Tuninetti V.,
et al.: “Vaginal Atrophy in Breast Cancer Survivors: Attitude and
Approaches Among Oncologists”. Clin. Breast Cancer, 2017, 17,
611.
- Etienne M.C., Milano G., Fischel J.L., Frenay M., Francois E.,
et al.:“Tamoxifen metabolism: pharmacokinetic and in vitro study”.
Br. J.Cancer, 1989, 60, 30.
About Daré Bioscience
Daré Bioscience is a clinical-stage biopharmaceutical company
committed to the advancement of innovative products for women’s
health. The company’s mission is to identify, develop and bring to
market a diverse portfolio of differentiated therapies that expand
treatment options, improve outcomes and facilitate convenience for
women, primarily in the areas of contraception, vaginal health,
sexual health, and fertility.
Daré’s product portfolio includes potential first-in-category
candidates in clinical development: Ovaprene®, a non-hormonal,
monthly contraceptive intravaginal ring; Sildenafil Cream, 3.6%, a
novel cream formulation of sildenafil to treat female sexual
arousal disorder utilizing the active ingredient in Viagra®;
DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2%
to treat bacterial vaginosis via a single application; and
DARE-HRT1, a combination bio-identical estradiol and progesterone
intravaginal ring for hormone replacement therapy following
menopause. To learn more about Daré’s full portfolio of women’s
health product candidates, and mission to deliver differentiated
therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances,
product candidates, clinical trials and other matters using its
investor relations website
(http://ir.darebioscience.com), SEC filings, press
releases, public conference calls and webcasts. Daré uses
these channels to communicate with its investors and the public
about the company and other company-related matters. The
information Daré posts on its investor relations website may be
deemed to be material information. Daré encourages investors, the
media, and others interested in the company to review the
information Daré posts on its investor relations
website: www.darebioscience.com.
This press release includes information obtained from, and makes
reference to, trade and statistical services and other third-party
publications and sources. Daré has not independently verified
such information and, although the company is not aware of
inaccuracies in such third-party information, there can be no
assurance as to its accuracy.
Forward-Looking Statements
Daré cautions you that all statements, other than statements of
historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to DARE-VVA1’s
potential to be successfully developed and approved for the
treatment of VVA and to become a first-in-category therapy for
hormone receptor-positive breast cancer patients with VVA.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Daré’s actual
results, performance or achievements to be materially different
from future results, performance or achievements expressed or
implied by the forward-looking statements in this press release,
including, without limitation, risk and uncertainties related to:
Daré’s ability to raise additional capital when and as needed, to
advance its product candidates; Daré’s ability to develop, obtain
regulatory approval for, and commercialize its product candidates;
the failure or delay in starting, conducting and completing
clinical trials or obtaining FDA or foreign regulatory
approval for Daré’s product candidates in a timely manner; Daré’s
ability to conduct and design successful clinical trials, to enroll
a sufficient number of patients, to meet established clinical
endpoints, to avoid undesirable side effects and other safety
concerns, and to demonstrate sufficient safety and efficacy of its
product candidates; Daré’s ability to retain its licensed rights to
develop and commercialize a product candidate; Daré’s ability to
satisfy the monetary obligations and other requirements in
connection with its exclusive, in-license agreements covering the
critical patents and related intellectual property related to its
product candidates; developments by Daré’s competitors that make
its product candidates less competitive or obsolete; Daré’s
dependence on third parties to conduct clinical trials and
manufacture clinical trial material; Daré’s ability to adequately
protect or enforce its, or its licensor’s, intellectual property
rights; the lack of patent protection for the active ingredients in
certain of Daré’s product candidates which could expose its
products to competition from other formulations using the same
active ingredients; the risk of failure associated with product
candidates in preclinical stages of development that may lead
investors to assign them little to no value and make these assets
difficult to fund; and disputes or other developments concerning
Daré’s intellectual property rights. Daré’s forward-looking
statements are based upon its current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. All forward-looking statements are expressly qualified
in their entirety by these cautionary statements. For a detailed
description of Daré’s risks and uncertainties, you are encouraged
to review its documents filed with the SEC including
Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Daré undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
Contacts:
Investors on behalf of Daré Bioscience, Inc.: Lee Roth
Burns McClellan lroth@burnsmc.com 212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.: Jake Robison
Canale Communications jake@canalecomm.com 619.849.5383
Source: Daré Bioscience
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