Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the article entitled “Vaginal tamoxifen
for treatment of vulvar and vaginal atrophy: Pharmacokinetics and
local tolerance in a rabbit model over 28 days” was published
online in the International Journal of Pharmaceutics.
The article highlights the positive findings from the animal
study which include availability and local tolerability of
vaginally delivered tamoxifen. DARE-VVA1 is a novel vaginal
application of tamoxifen, the well-known and well-characterized
selective estrogen receptor modulator (SERM), and is being
developed by Daré as an alternative to estrogen-based therapies for
the treatment of vulvar and vaginal atrophy (VVA) in women with or
at risk for hormone-receptor positive (HR+) breast cancer. In
breast tissue, tamoxifen acts as an estrogen antagonist, while in
other tissue, including vaginal tissue, tamoxifen has been reported
to exert an estrogen-like response on vaginal cytology.
The goal of the study was to evaluate tamoxifen at two dose
levels (1 mg or 20 mg) administered intra-vaginally to female
rabbits once-daily over a 28-day period to assess its
pharmacokinetics, systemic exposure and local vaginal tolerance.
The findings revealed that there was little to no vaginal or
systemic accumulation of tamoxifen following once-daily dosing for
28 days and that vaginal irritation was minimal to none at both
doses.
“We are highly encouraged by these findings as tamoxifen was
minimally metabolized at both doses with essentially no detectable
vaginal irritation evident over the course of the study,” said
David Friend, PhD, co-author of the article and Chief Scientific
Officer of Daré Bioscience.
VVA is an inflammation of the vaginal epithelium due to the
reduction in levels of circulating estrogen. Commonly used
therapies for VVA are estrogen-based and often contraindicated in
HR+ breast cancer patients, or patients with a genetic
predisposition or history of familial disease, because of the
concern that estrogen use will promote recurrence of
disease.1 Many breast cancer survivors experience
menopausal symptoms as a direct consequence of cancer treatment.
Breast cancer patients treated with aromatase inhibitors refer to
VVA as one of the most unpleasant side effects of
treatment.2 A prior study of DARE-VVA1 published
in Clinical and Experimental Obstetrics and Gynecology,
demonstrated that weekly vaginal administration of tamoxifen for
three months in post-menopausal women with VVA showed improvements
in vaginal pH and vaginal dryness without significant systemic
absorption of tamoxifen.3
The abstract of the scientific paper entitled “Vaginal tamoxifen
for treatment of vulvar and vaginal atrophy: Pharmacokinetics and
local tolerance in a rabbit model over 28 days” is available at
https://doi.org/10.1016/j.ijpharm.2019.118691
-
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.
- Clin. Exp. Obstet. Gynecol. - XLVI, n. 2, 2019 (doi:
10.12891/ceog4948.2019)
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 hormone-free,
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.
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 treat 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; the risk that promising results
in pre-clinical studies may not be replicated when a product
candidate is tested in human subjects; 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 RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake@canalecomm.com619.849.5383
Source: Daré Bioscience
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Apr 2023 to Apr 2024