Estradiol

Ongoing Phase 1 study is funded by a foundation grant Daré received a royalty-free, exclusive license to the US patents SAN DIEGO and LONDON, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, and Theramex, a leading, global specialty pharmaceutical company dedicated to women and their health, announced today that they entered into a co-development and licensing agreement for a potential first-in-category biodegradable contraceptive implant called Casea S recently acquired by Theramex. “We are thrilled that Theramex selected Daré as its development partner for this potentially disruptive long-acting, minimally-invasive contraceptive candidate. The fully funded ongoing Phase 1 study is external validation of this important technology, and enables Daré and Theramex to make future development decisions based on results of the study,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The in-license of these US patents to add to our portfolio is another example of how we leverage non-dilutive funding to advance first-in-category product candidates, and this collaboration with Theramex is a testament to our development track record in women’s health.” “We are excited to partner with Daré to develop Casea S, a potential first-in-category contraceptive candidate for women,” said Rob Stewart, CEO of Theramex. “A biodegradable implant for contraception resonates with what we hear from women as does the idea that she can make that choice every 18-24 months as to whether it is right for her. With its innovative design, Casea S would only require a single surgery visit, offering a more convenient, reversible alternative to existing long-acting contraceptive methods that would enable women to take control of their reproductive health with confidence.” Casea S is designed to control release of a well-characterized contraceptive for a set period of time (18-24 months) before dissolving. It is designed to provide women with a long-acting, minimally-invasive contraceptive method that will not require surgical removal by a healthcare provider, which would improve convenience and could eliminate one of the barriers to use associated with existing implanted contraceptives. FHI 360 is conducting a fully-funded Phase 1 trial to investigate pharmacokinetics, removability, safety and tolerability of Casea S with support from a foundation grant (ClinicalTrials.gov ID: NCT05174884). Daré received a royalty-free, exclusive, fully paid up, sublicensable license to the US patents Theramex recently acquired for Casea S. Given that the product candidate is in an ongoing Phase 1 study that is funded by a grant, there are no development costs for Daré or Theramex at this time. If Daré determines that the results from the study are positive, it would be responsible for conducting the Phase II study in the US, and funding for such study and for a future Phase III study in the US will be shared by Daré and Theramex on terms to be agreed upon by the parties, taking into account the size of the opportunity for Casea S in their respective markets. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing 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 prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. 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 Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. About Theramex Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women of all ages by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause, and osteoporosis. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them, and is committed to listening to and understanding its patients, serving their needs, and offering effective healthcare solutions that care for and support women through different stages of their lives. For further information about Theramex, please contact: info@theramex.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,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the potential future development of Casea S and its potential to be a first-in-category product, and that funding for future studies of Casea S may be shared between Daré and Theramex. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate if it were to receive marketing approval for the use for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing FDA-approved products. 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, risks and uncertainties related to: the risk that the results of the ongoing Phase I study of Casea S may not be positive; Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; the inherent uncertainty of outcomes of clinical trials; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct 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 dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or 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 and product candidates; 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; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; 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: Daré Bioscience Investor Relations innovations@darebioscience.com Theramex info@theramex.com Source: Daré Bioscience, Inc. Source: Daré Bioscience, Inc.

点击上方蓝字 关注我们 编者按：雄激素剥夺治疗（ADT）是转移性前列腺癌患者的标准治疗方案，但其可能引起不良反应，如血管舒缩症状（面色潮红）、疲劳等，并且相关研究尚不明确。晚期前列腺癌的有效治疗药物快速发展，今年ASCO GU年会公布了一项经皮雌激素在转移性前列腺癌患者中的研究，为这类患者提供了另一种ADT治疗选择。本刊特别总结，以飨读者。 亮点抢先看： 2期研究结果表明，雌二醇贴片或可为正在服用雄激素受体通路抑制剂的转移性前列腺癌患者提供雄激素剥夺疗法（ADT）。 目前，促黄体生成素释放激素类似物（LHRHa）是前列腺癌患者的标准ADT选择，但与雌激素耗竭相关的不良反应有关，尤其是潮热和疲劳，以及骨密度降低。 结合2项早期研究数据的结果表明，雌二醇贴片可能是使用LHRHa患者的良好替代方案。 2025年ASCO GU大会上公布的一项研究结果表明，雌二醇贴片或可为正在服用雄激素受体通路抑制剂的转移性前列腺癌男性提供ADT治疗。 STAMPEDE试验中的2期研究结果显示，经皮雌二醇可以在转移性疾病患者中实现与LHRHa类似的前列腺特异性抗原反应，同时减少副作用。LHRHa是前列腺癌男性的标准ADT治疗，但由于它们同时抑制睾酮和雌激素，因此与雌激素耗竭相关的不良反应有关。 作为伦敦皇家马斯登NHS基金会癌症研究所的主要研究专家，Nick James教授表示，潮热和疲劳是患者最困扰的问题之一；此外，骨密度降低会增加脆性骨折的风险——尤其是越来越多的转移性前列腺癌患者存活时间延长。 James教授表示，经皮雌二醇（如用于更年期激素疗法的雌二醇）是一种潜在的ADT替代方法，其优势在于可以抑制睾酮，而不会消耗雌激素；它会增加而非减少骨密度；价格低廉；并且可避免口服雌激素相关的血栓风险。 早期STAMPEDE和PATCH试验的综合数据显示，对于患有局部晚期或转移性前列腺癌的男性，雌二醇贴片在雄激素抑制率方面与LHRHa相当，同时可改善代谢参数、生活质量和骨密度。至于肿瘤学结局，2024年ESMO大会公布的数据表明，经皮雌二醇在局部晚期疾病男性的无转移生存率方面不劣于LHRHa。 今年ASCO GU大会中的这项研究评估了经皮雌二醇联合雄激素受体通路抑制剂用于转移性（M1）前列腺癌患者的疗效和安全性。该研究随机分配了79名计划接受雄激素受体途径抑制剂治疗（阿比特龙、恩扎卢胺或阿帕他胺）的患者（中位年龄69岁），分别接受LHRHa或经皮雌二醇治疗（释放100 µg/24小时，一旦睾酮水平降至1.7 ng/mL或以下，每2周更换3个贴片）。 研究结果显示，在6个月内，每组中61%的患者前列腺特异性抗原水平达到0.2 ng/mL或更低。正如预期的那样，使用雌二醇贴片的患者潮热发生率低于使用LHRHa的患者（2级潮热发生率分别为5%和24%）；患者出现任何级别高血压的几率也较低（分别为5%和17%）；相比之下，雌二醇贴片组的男性乳房发育率更高：出现1级或2级男性乳房发育的比例分别为35%和8%，而LHRHa组分别为10%和0%。 “我们没有发现任何意外毒性，”詹姆斯教授指出，“无转移生存率不劣于其他药物的数据正在分析，可能会在今年晚些时候公布”。 James教授表示，雌二醇贴片对使用LHRHa并受到潮热等副作用困扰的患者可能具有特别价值。从成本角度来看，雌二醇贴片也具有吸引力，无论是对于医疗系统，还是对于美国等地没有保险或保险额度不足的患者。 “这种对较旧的廉价药物的重新利用，同样可以改善患者结局，并且无需开发新药”，James教授表示。 ▌参考文献： [1] Nicholas David James, HannahRush, MatthewGuyNankivell, et al. Transdermal oestradiol (tE2) patches as androgen deprivation therapy (ADT): Efficacy and safety of combining with androgen receptor pathway inhibitors (ARPIs) in metastatic (M1) prostate cancer—Randomised comparison from the STAMPEDE trial platform. ASCO GU 2025, 21. [2] Gilbert DC, Nankivell M, Rush H, et al. A repurposing programme evaluating transdermal oestradiol patches for the treatment of prostate cancer within the PATCH and STAMPEDE trials: Current results and adapting trial design. Clin Oncol (R Coll Radiol). 2024;36(1):e11-e19. [3] Langley RE, Nankivell M, Gilbert D, et al. LBA69 - Prostate cancer efficacy results from a randomised phase III evaluation of transdermal oestradiol (tE2) versus luteinising hormone releasing hormone agonists (LHRHa) for androgen suppression in non-metastatic (M0) prostate cancer. Ann Oncol. 2024;35(suppl 2):1-72. Nicholas James教授 英国癌症研究所和皇家马斯登NHS信托基金会 James教授是伯明翰伊丽莎白女王医院的临床肿瘤学顾问，也是伯明翰大学癌症和基因组科学系的临床肿瘤学名誉教授。 James教授因其在泌尿系统癌症方面的工作而享誉国际，尤其是开创性的STAMPEDE试验，该试验迄今已用于评估10,000多名男性晚期前列腺癌的10种不同疗法。STAMPEDE的结果（包括一线多西他赛化疗和阿比特龙）表明，在新诊断患者中使用现有治疗方法可以大大提高生存率。这些发现改变了全世界的临床实践。 在膀胱癌领域，他领导了一系列放化疗试验，最终形成了该领域最大的随机试验，发表在《新英格兰医学杂志》上，随附的评论将该研究描述为“里程碑”和“改变实践”（该试验表明，低剂量同步化疗可将侵袭性膀胱癌复发率降低43%）。James教授也是2013-2016年欧洲泌尿外科协会（EAU）膀胱癌指南小组成员。 （来源：《肿瘤瞭望-泌尿时讯》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。