Bremelanotide Acetate

AGOURA HILLS, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) in collaboration with the Brush and Key Foundation, today announced the publication of a peer-reviewed research article in the International Journal of Molecular Sciences titled “Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter.” Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. International Journal of Molecular Sciences 2025, 26, 11920. The study presents a comprehensive, data-driven analysis of two emerging biomarkers—DNMT3A (DNA methyltransferase 3A) and GMPS (guanine monophosphate synthetase)—across hepatocellular carcinoma (HCC) and pancreatic ductal adenocarcinoma (PDAC). By integrating survival outcomes, transcriptomic profiling, and tumor microenvironment (TME) analyses from more than 7,000 patients, the authors demonstrate that the prognostic significance of these biomarkers is highly context-dependent, shaped by immune composition, metabolic reprogramming, and innate immune sensing pathways. Training the Next Generation of Scientists The publication also reflects the educational mission of the Brush and Key Foundation, which supports young scholars through mentored research experiences that bridge scientific inquiry, critical thinking, and professional development. The paper’s author- Drashya Shah, an intern supported by the Brush and Key Foundation, shared the following reflection: “My experience working with the Brush and Key Foundation for Young Artists has been truly valuable and enriching. Throughout the research and writing process, I received consistent guidance and insightful feedback at every stage, which helped me refine my ideas and present my findings with clarity and precision. This collaborative environment not only strengthened the quality of my paper but also significantly boosted my confidence as a researcher. The skills and knowledge I gained through this journey are lifelong, and I will undoubtedly carry them forward into my future education and professional work. I am deeply grateful to everyone involved for their unwavering support and encouragement.” “This work exemplifies how advanced bioinformatics, translational oncology, and structured mentorship can intersect to generate meaningful scientific insight,” said Dr. Vuong Trieu, co-author and contributor to the study. “Equally important, it demonstrates how hands-on research training helps prepare the next generation of scientists.” Dr. Wen-Han Chang, corresponding author, added, “The work highlights why biomarkers cannot be interpreted in isolation. Tumor context—immune composition, metabolic state, and innate sensing—fundamentally alters prognostic meaning and therapeutic opportunity.” About the Brush and Key Foundation The Brush and Key Foundation is a nonprofit organization dedicated to mentoring and educating young scholars through hands-on research, structured guidance, and interdisciplinary learning. The foundation emphasizes critical thinking, scientific communication, and real-world research experience to help students build durable skills applicable to future academic and professional pursuits. About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma “DIPG” (through OT-101) through its 45% joint venture, melanoma (through CA4P), and Acute Myeloid Leukemia “AML” (through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019. Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed for Female Sexual Dysfunction ("FSD"). Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder ("HSDD") in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective therapy against FSD and HSDD. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for supporting the development of OT- 101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners for the joint venture, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof: building and the success of our nanoparticle platform and the related success of launching the platform; the expected valuation of the JV, and therefore a corresponding increase in the valuation of the Company, by virtue of it’s ownership in the JV; the success of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated by reference herein or therein. Contact Information:For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com

编者按：多肽药物已成为多种疾病的重要治疗方式。近二十年来，该领域蓬勃发展。2025年以来，这类药物也在癌症、代谢性疾病、心血管疾病、罕见病等多个疾病治疗研究领域迎来一系列新进展，为患者带来新的治疗希望。作为全球医药创新的赋能者，药明康德旗下专注于寡核苷酸和多肽及相关化学偶联药物研发的一体化CRDMO平台WuXi TIDES，围绕多肽药物建立了一体化CRDMO平台，提供包括线性、环状和高度修饰的多肽，以及非天然氨基酸、连接子、毒素和多肽偶联物的合成服务，支持从药物发现、CMC开发到商业化生产的各个阶段。本文将回顾2025年多肽药物在代谢性疾病领域取得的部分重要进展。 据不完全统计，目前全球已有约100款多肽药物获批上市，覆盖糖尿病、肥胖症、癌症及罕见病等多个治疗领域，为患者提供了重要的治疗新选择。与此同时，多肽类药物在研管线在2025年也取得了持续进展。 在代谢性疾病领域，多肽类药物研发的新进展主要集中在胰高血糖素样肽-1（GLP-1）及其相关多靶点新药的开发上。随着口服、长效等制剂技术日趋成熟，这些在研药物进一步拓展了多肽类药物的应用范围，有望为肥胖症、2型糖尿病等代谢性疾病带来更多治疗选择。 2025年多肽新药研发迎新进展，持续拓宽代谢疾病治疗边界 2025年，有多款多肽疗法在治疗代谢性疾病研究领域取得诸多进展。这些研发管线主要包括胰淀素受体激动剂、GCG/GLP-1双受体激动剂、GLP-1RA月制剂、GLP-1RA双周制剂、cAMP偏向型GLP-1受体激动剂、GLP-1R/GIPR双靶点激动剂等，覆盖超重和肥胖、2型糖尿病、代谢功能障碍相关脂肪性肝炎（MASH）等多种代谢性疾病。以下仅根据公开资料，介绍其中部分管线的研发进展新闻。 11月，礼来宣布，其在研多肽疗法eloralintide（LY3841136）在一项2期临床试验中达到主要终点。该试验共纳入263名肥胖或超重且至少伴有一种肥胖相关共病、但未合并2型糖尿病的成年受试者。在第48周时，所有eloralintide治疗组均达到主要终点，平均体重下降幅度从9.5%至20.1%不等，而安慰剂组仅为0.4%，显示出显著的疗效差异。Eloralintide是一款每周一次皮下注射的选择性长效胰淀素受体激动剂。基于这一结果，礼来计划启动eloralintide用于治疗肥胖的3期临床研究的患者入组。 同月，诺和诺德公司公布了其在研新药amycretin在2型糖尿病患者中的积极2期临床试验顶线结果，这些患者尽管接受了标准治疗，但其血糖控制仍然不足。研究结果显示，治疗36周后，amycretin可实现最高达14.5%的体重下降，并带来具有统计学意义的糖化血红蛋白（HbA1c）降低，HbA1c达到<7和≤6.5个百分点的比例最高分别为89.1%和76.2%，并且治疗安全性良好。Amycretin是一款单分子、长效GLP-1和胰淀素受体激动剂，设计用于每周一次皮下注射及每日一次口服使用，旨在为超重或肥胖成人提供高效且便捷的治疗方案，同时也用于治疗2型糖尿病。 此外，诺和诺德还于9月公布了其在研新药cagrilintide在无糖尿病的肥胖或超重且伴有与体重相关共病成年患者中的3期临床研究的一个亚组分析数据。试验结果显示，如果所有受试者均坚持治疗，cagrilintide可带来具有临床意义的体重下降：68周后平均体重降低11.8%（12.5公斤），而安慰剂组仅为2.3%（2.5公斤）。此外，约三分之一（31.6%）接受cagrilintide治疗的受试者实现了≥15%的体重下降，而仅约二十分之一（4.7%）的安慰剂组患者达成此标准。Cagrilintide是一款下一代长效胰淀素类似物，可模拟人体内天然存在的胰淀素。 信达生物在研的GCG/GLP-1双受体激动剂玛仕度肽在今年也迎来多项进展：11月，信达生物递交了玛仕度肽高剂量9 mg用于成人中重度肥胖患者长期体重控制的上市申请。3期研究结果显示，治疗第60周时，玛仕度肽9mg组受试者平均体重降幅为18.55%（安慰剂组3.02%）；9mg组受试者中，有44.0%实现了20%及以上的体重降幅，安慰剂组这一比例仅为2.6%。该产品还分别于今年6月和9月在中国获批，用于成人肥胖或超重患者的长期体重管理，以及成人2型糖尿病患者的血糖控制。 9月，质肽生物宣布在EASD 2025大会报告GLP-1RA每月制剂-佐维格鲁肽的2期研究结果。佐维格鲁肽80 mg Q4W组、160 mg Q4W组、80 mg Q2W组和160 mg Q2W组至24周的疗效均优于安慰剂组，且未观察到疗效平台期；至24周体重较基线下降≥5%的受试者比例分别为89.9%、97.1%、93.6%和93.9% vs. 13.0%。该结果支持佐维格鲁肽每月一次给药在超重或肥胖受试者中开展关键性3期临床研究。佐维格鲁肽是GLP-1受体激动剂多肽，通过双脂肪酸链修饰设计，增强了分子与白蛋白的结合能力，从而实现了较长的药物半衰期。 同月，甘李药业公布在研GLP-1RA双周制剂博凡格鲁肽注射液在中国2型糖尿病患者中的2期临床研究结果。治疗24周后，每两周一次12 mg、18 mg和24 mg博凡格鲁肽注射液组受试者HbA1c分别较基线降低1.87%、2.28%和 1.94%，每周一次24 mg组受试者HbA1c降低2.32%。甘李药业还同步公布了基础胰岛素周制剂GZR4注射液在中国2型糖尿病患者中的2期临床研究结果。 6月，先为达生物宣布，其在研的cAMP偏向型GLP-1受体激动剂埃诺格鲁肽在中国超重或肥胖成人中的3期临床试验（SLIMMER）结果发表于《柳叶刀·糖尿病与内分泌学》。研究显示，埃诺格鲁肽在48周时实现了15.4%的平均体重降幅，92.8%的受试者体重降幅超过5%。 6月，D&D Pharmatech公司公布了其在研药物GCG/GLP-1受体双重激动剂DD01针对MASH的2期临床试验COaST-02研究的积极数据。为期12周的安全性和有效性评估结果显示，DD01耐受良好，达到了研究的主要终点。DD01治疗12周后，75.8%的患者实现了至少30%的肝脏脂肪减少，72.7%的患者减少了超过50%，48.5%的患者肝脏脂肪降至正常水平，显著优于安慰剂组。 同月，Altimmune公司公布了GLP-1/胰高血糖素双重受体激动剂pemvidutide治疗MASLD的2b期试验的积极结果。该研究中，212名经活检证实的MASH和纤维化F2/F3期伴或不伴糖尿病的受试者被随机分配接受pemvidutide或安慰剂，持续24周。Pemvidutide高剂量组患者中有59.1%达到了MASH缓解，且未出现纤维化的恶化；34.5%的受试者出现了纤维化改善，且没有发生MASH的加重。 4月，Palatin Technologies公司公布了其肥胖症2期临床试验BMT-801的积极结果。该研究评估了黑皮质素4受体（MC4R）激动剂bremelanotide与GLP-1/GIP双重激动剂tirzepatide联用、bremelanotide单药以及tirzepatide单药的效果。研究表明，三组在食欲抑制、增加饱腹感和满足感方面均有显著改善。其中，联用组食欲抑制提升71%，饱腹感提升65%，满足感提升56%。在tirzepatide减重后改用低剂量bremelanotide的患者体重未出现显著反弹，表明MC4R激动剂具有作为长期体重维持疗法的潜力。 9月，恒瑞医药宣布其在研新药GLP-1和GIP双重受体激动剂HRS9531注射液在中国的上市申请获受理，用于成人长期体重管理。该公司同期宣布其在研的长效胰岛素类似物舒地胰岛素注射液（INS068）在中国的上市申请获受理，拟用于治疗成人2型糖尿病。 在GLP-1/GIP双重激动剂领域，还有多项新进展。例如，今年8月，Viking Therapeutics公布了其口服GLP-1/GIP双重激动剂VK2735在2期临床试验中的积极顶线结果。在治疗13周后，VK2735治疗组患者平均体重较基线水平显著降低，降幅最高达12.2%。此外，体重减轻≥5%和≥10%的患者比例在VK2735组分别高达97%和80%，而安慰剂组对应比例仅为10%和5%。 除此之外，还有多款GLP-1R/GIPR双靶点激动剂公布新的临床结果，涉及2型糖尿病、体重管理等适应症，比如博瑞医药在研的BGM0504、众生睿创在研的RAY1225注射液、华东医药在研的HDM1005注射液，等等。 除了前述较后期的临床研发进展，2025年以来还有更多早期多肽用于治疗代谢性疾病的临床研发管线取得新进展。这些管线覆盖GHSR、INSR 、AMYR/CTR、ALMS1等靶点，涉及肥胖、糖尿病、MASH等疾病。限于篇幅，此处不再一一列举。 一体化CRDMO平台赋能多肽疗法创新，加速惠及患者 根据公开资料，目前全球有数百项多肽类新药管线正在聚焦代谢性疾病开展临床研究，适应症主要为肥胖、2型糖尿病，还包括脂代谢紊乱及其相关并发症等多个方向。除了当前较为热门的GLP-1R、GCGR、GIPR等靶点外，研发人员也在积极拓展多重机制靶点，包括调控能量代谢稳态的MC4R、胰淀素相关靶点AMYR、以及胰岛素信号通路关键受体INSR及IGF1R等。 尽管前景可期，多肽药物在研发生产中仍面临诸多挑战，包括稳定性低、膜渗透性差，体内清除速度快、口服生物利用度有限等。与传统的小分子药物相比，多肽药物更为复杂，涉及非天然氨基酸（UAA）合成、肽库合成、偶联化合物合成、放大生产工艺开发以及制剂开发等多个环节，对专业技术能力提出了更高要求。 作为全球医药创新的赋能者，药明康德凭借其一体化、端到端CRDMO模式， 持续支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，助力客户加速创新疗法研发进程、早日惠及患者。 为更好地满足全球合作伙伴在多肽药物研发方面的需求，药明康德旗下WuXi TIDES围绕多肽药物建立了一体化CRDMO平台，提供包括线性、环状和高度修饰的多肽，以及非天然氨基酸、连接子、毒素和多肽偶联物的合成服务，支持从药物发现、CMC开发到商业化生产的各个阶段。 展望未来，药明康德将继续秉持“让天下没有难做的药，难治的病”的愿景，依托全球研发生产网络，凭借一体化、端到端CRDMO模式，持续助力全球合作伙伴充分发挥多肽疗法的潜力，为患者带来更多创新疗法。 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号回复“转载”，获取转载须知。