Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the publication of clinical findings
for vaginally-administered tamoxifen in Clinical and Experimental
Obstetrics and Gynecology, a leading international journal for
publication of research focused on the development of new
therapeutic interventions for obstetrics and gynecology. Daré’s
product candidate, DARE-VVA1, incorporates tamoxifen in a
proprietary formulation designed for vaginal delivery. Daré holds
the exclusive worldwide rights to patents issued in the U.S. and
Japan covering the use and delivery of DARE-VVA1 for vulvar and
vaginal atrophy (VVA) and a U.S. patent covering composition, use
and delivery of DARE-VVA1 for VVA.
The publication entitled, “Weekly vaginal administration of
tamoxifen for three months in post-menopausal women with vulvar and
vaginal atrophy: a possible new treatment approach?,” reported that
a self-administered vaginal suppository containing tamoxifen (20
mg), dosed daily for one week followed by twice weekly for three
months, administered to four healthy postmenopausal women with VVA
showed significant improvements in reducing vaginal pH and vaginal
dryness without significant systemic absorption of tamoxifen.
This exploratory study demonstrated that tamoxifen was effective
when delivered intravaginally for three months in postmenopausal
women suffering with VVA. The median vaginal pH at the time of
enrollment was 7.1 (range 6.5 to 7.5). At the end of month 3, the
median vaginal pH was 5.0 (range 5.0 to 5.2). The median paired
difference between baseline and month 3 was -2.0, with a range of
-2.5 to -1.5. The self-assessment of vaginal dryness improved
between baseline and month 3. Vaginal dryness was rated using a
visual analogue scale (VAS) that ranged from 0 (participant was not
bothered by the dryness) to 10 (participant was extremely bothered
by the dryness). At baseline, the median vaginal dryness
rating was 8.0, with a range of 7.5 to 9.0. At the end of month 3,
the median vaginal dryness rating was 3.0, with a range of 2.0 to
3.0. The median change between baseline and month 3 was -5.5,
(range -6.0- to -4.5).
In addition, systemic exposure was at least an order of
magnitude lower following vaginal administration compared with oral
tamoxifen. After eight weeks of study treatment, median plasma
concentration of tamoxifen was 5.8 ng/ml, with a range of 1.0 to
10.0 ng/ml. In comparison, after three months of oral
administration of 20-mg tamoxifen once daily, the average steady
state plasma concentration of tamoxifen is 122 ng/ml, with a range
of 71 to 183 ng/ml.1
VVA is an inflammation of the vaginal epithelium due to the
reduction in levels of circulating estrogen. Historically,
estrogen-based therapies delivered through creams, rings, and
tablet supplements have been prescribed for the treatment of VVA
symptoms. However, estrogen-based products can be worrisome for
women undergoing treatment for hormone-receptor positive breast
cancer and are often contraindicated in such breast cancer patients
and in patients with a genetic predisposition or history of
familial disease, because of the concern that estrogen use will
promote recurrence of disease.2 Many breast cancer
survivors undergo 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.3
Tamoxifen has been a commonly used treatment for breast cancer
and is systemically metabolized to active metabolite
4-hydroxy-N-desmethyl-tamoxifen, otherwise known as
endoxifen.4 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 an anti-estrogen activity.
This exploratory study demonstrated that vaginal administration
of tamoxifen for three months in postmenopausal women with VVA is a
possible new, non-estrogen-based treatment approach. Daré is
currently conducting activities in preparation for future clinical
work with DARE-VVA1, its proprietary vaginal formulation of
tamoxifen. If successful, DARE-VVA1 could be the first and only
vaginally administered tamoxifen product approved by the FDA for
the treatment of VVA in hormone-receptor positive breast cancer
patients. According to the American Cancer Society, roughly 2 out
of every 3 cases of breast cancer are hormone receptor-positive.
Most of these cases are ER-positive, meaning that there are
estrogen receptors on the surface of the cell that bind to
estrogen.5
- US Food and Drug Administration: “Drug Approval Package:
Nolvadex (Tamoxifen Citrate) NDA# 21-109.2002”. Available
at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21109_Nolvadex.cfm
-
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.
-
https://www.healthline.com/health/breast-cancer/er-positive-prognosis-life-expectancy
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-class
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.
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: Daré’s
future clinical development of DARE-VVA1 and the potential of
DARE-VVA1 to be the first and only FDA-approved vaginally delivered
tamoxifen product for treatment of VVA in hormone-receptor positive
breast cancer patients. 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.: Alex Gray
Burns McClellan agray@burnsmc.com 212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.: Amanda Guisbond
Canale Communications amanda@canalecomm.com 781-405-8775
Source: Daré Bioscience
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