Daré Bioscience Announces Presentation of Two Posters at American Association of Pharmaceutical Scientists 2019 PharmSci 360
“We are pleased to present positive findings from these studies that further validate continued development of two of our candidates, DARE-VVA1 and DARE-HRT1, with the potential to be first-in-category treatments for their respective areas,” said Dr. Friend. “This supports our mission to accelerate a diverse portfolio of novel therapies for women that expand treatment options, improve outcomes, and facilitate convenience.”
Title: Vaginal Tamoxifen for Treatment of Vulvovaginal Atrophy: Pharmacokinetics and Safety in a Rabbit Model
Date and Time:
Category: Preclinical Development
Poster Number: M1330-09-57
Title: Evaluation of Different Suppliers of Ethylene Vinyl Acetate Used in Intravaginal Rings
Date and Time:
Category: Formulation and Quality
Poster Number: M1030-07-45
Copies of the posters will be made available on the Events and Presentations page of Daré’s investor relations website (http://ir.darebioscience.com).
Vaginal Tamoxifen for Treatment of Vulvovaginal Atrophy: Pharmacokinetics and Safety in a Rabbit Model:
Tamoxifen has been found to be an estrogen agonist in vaginal tissue and thus has pharmacologic effects similar to vaginally applied estrogen (orally, tamoxifen is an estrogen antagonist in breast tissue). This study was designed to evaluate the pharmacokinetics and local tolerability of vaginal tamoxifen in female rabbits. This work is part of an effort to develop a vaginal tamoxifen product capable of treating symptoms of vulvar and vaginal atrophy (VVA) in hormone-receptor positive breast cancer patients.
Vaginally administered tamoxifen showed minimal metabolism which is in contrast to oral administration in other small animal models. The upper dose of 20 mg tamoxifen is the dose administered orally to women diagnosed with breast cancer and thus represents a relatively high exposure per kg in rabbits. The findings of this study support the clinical evaluation of tamoxifen to study the pharmacokinetics and safety in women (initially in post-menopausal women).
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 VVA, 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, however, these products are often contraindicated for women undergoing treatment for hormone receptor-positive breast cancer.1
Evaluation of Different Suppliers of Ethylene Vinyl Acetate Used in Intravaginal Rings:
An investigative study evaluated ethylene vinyl acetate (EVA) copolymer from three different suppliers used to prepare segmented intravaginal rings (IVRs) for the sustained release of estradiol (E2) and progesterone (P). The findings of this study support the conclusion that EVA (28% VA content) from the three different suppliers can be used to prepare IVRs capable of the controlled release of E2 and P. While there were some minor differences between the EVA used (one EVA had a lower melt-flow index than the other two sources) there was remarkable consistency in the results obtained.
1 – Committee on Gynecologic Practice, Farrell, R, et al., The Use of Vaginal Estrogen in Women With a History of Estrogen-Dependent Breast Cancer, the
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),
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 the potential of DARE-VVA1 and DARE-HRT1 to be successfully developed and become first-in-category treatments for their respective areas. 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
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