加利福尼亚州圣迭戈, Dec. 06, 2025 (GLOBE NEWSWIRE) -- Sapu Nano 今日公布了最新的药代动力学 (PK) 和组织分布研究结果，证实基于该公司 Deciparticle™ 专利技术的依维莫司静脉注射 (IV) 制剂 Sapu003 可显著减少药物在胃肠道的蓄积，从而解决了口服依维莫司（Afinitor®）最显著且广为人知的局限性之一。 数据显示，Sapu003 能提供更高的耐受性，同时保留该药物固有的代谢特性，并能提升不同患者之间全身暴露量的一致性。 相较于口服给药，静脉注射的 Sapu003 可将胃肠道部位的依维莫司暴露量降低 67 倍 新的组织分布数据显示，通过静脉给药的 Sapu003 消除了依维莫司口服给药特有的胃肠道部位极端药物蓄积现象。口服给药后，依维莫司的药物浓度在胃部达到血浆浓度的 2,448 倍，在小肠达到血浆浓度的 750 倍，在大肠则达到了血浆浓度的 323 倍，这证实了肠道是依维莫司口服制剂的主要暴露部位。 相比之下，静脉注射的 Sapu003 在相同的胃肠道部位的药物浓度仅为血浆浓度的 36 至 48 倍，这意味着胃部暴露量降低了 67 倍，小 ...

AGOURA HILLS, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new biomarker data identifying a molecular signature that predicts sensitivity to Sapu003, the company’s intravenous Deciparticle™ formulation of everolimus. These data will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) Dec 9-12. This work describes the first prospective biomarker framework for intravenous everolimus and establishes a fo ...

AGOURA HILLS, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new pharmacokinetic (PK) and tissue-distribution results demonstrating that Sapu003, the company’s intravenous (IV) Deciparticle™ formulation of everolimus, substantially reduces gastrointestinal (GI) drug accumulation, addressing one of the most significant and well-recognized limitations of oral everolimus (Afinitor®). The data indicate that Sapu003 may offe ...

AGOURA HILLS, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new pharmacokinetic (PK) and tissue-distribution results demonstrating that Sapu003, the company’s intravenous (IV) Deciparticle™ formulation of everolimus, substantially reduces gastrointestinal (GI) drug accumulation, addressing one of the most significant and well-recognized limitations of oral everolimus (Afinitor®). The data indicate that Sapu003 may offe ...

Core Insights - Oncotelic Therapeutics, Inc. announced that its investigational intravenous Deciparticle everolimus (Sapu003) will be presented at the 2025 San Antonio Breast Cancer Symposium, highlighting its focus on innovative cancer treatments [1][2] Company Overview - Oncotelic Therapeutics, Inc. was founded to develop transformative medicines for cancer patients, utilizing its PDAOAI platform and expertise in nanomedicines [1] - The company has a history dating back to 1988, originally formed as OXiGENE, Inc., and has undergone several name changes and reincorporations [5][6] Product Development - Sapu003 is a novel formulation of everolimus designed for intravenous use, addressing limitations of oral mTOR inhibitors such as poor bioavailability and dose-limiting toxicity [2] - The ongoing Phase 1 trial of Sapu003 targets hormone receptor-positive (HR⁺)/HER2⁻ metastatic breast cancer, renal cell carcinoma (RCC), and neuroendocrine tumors (NET) [2] Clinical Trials and Collaborations - The studies related to Sapu003 are conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, focusing on molecular biomarker discovery and pharmacokinetic modeling [4] - Accepted abstracts for presentation at the symposium include research on predictive biomarkers and pharmacokinetic rationale for Sapu003 [4] Market Context - The FDA has previously approved oral everolimus for advanced RCC and pancreatic NET, indicating a market for mTOR inhibitors in oncology [5] - The company aims to leverage its expertise to improve treatment outcomes, particularly for rare pediatric cancers [6][7]

Core Viewpoint - Sapu003 aims to overcome the limitations of Afinitor (FDA-approved oral Everolimus) by providing full efficacy delivery through intravenous injection, enhancing treatment for breast cancer patients [1][2]. Group 1: Product Development - Sapu Nano has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate patient recruitment for Phase I clinical trials of Sapu003, an injectable formulation of Everolimus for breast cancer treatment [1]. - The proprietary Deciparticle™ technology allows Sapu003 to deliver 100% of the drug into the bloodstream, compared to only about 10% absorption with the oral tablet form [2]. - The Phase I clinical trial aims to determine the optimal dosing for future studies, including Phase III trials, addressing the unmet need for next-generation mTOR inhibitors [2][3]. Group 2: Market Implications - The new delivery method of Sapu003 is expected to significantly improve tumor shrinkage compared to existing oral formulations, which have limited efficacy [2][3]. - The development of Sapu003 represents a milestone in cancer treatment, potentially offering breast cancer patients more effective and longer-lasting therapeutic options [2][3].

Core Insights - Sapu Nano has received approval from Australia's Human Research Ethics Committee to initiate a Phase 1 clinical trial for Sapu003, an injectable form of Everolimus aimed at treating breast cancer [1][3] - Sapu003 utilizes Deciparticle™ technology to deliver 100% of the drug intravenously, significantly improving absorption compared to the oral form, which only allows about 10% absorption [2][4] - The trial aims to address the unmet need for more effective mTOR inhibitors, as current therapies often provide less than one year of progression-free survival [3] Company Overview - Sapu Nano is part of a joint venture between Oncotelic Therapeutics, Inc. and Dragon Overseas Capital Limited, focusing on innovative cancer treatments [1] - The company is positioned to potentially enhance treatment outcomes for breast cancer patients through improved drug delivery methods [4] Industry Context - Everolimus, marketed as Afinitor®, is an FDA-approved drug for various cancers, including advanced breast cancer, but has limitations in its oral form [2] - The introduction of Sapu003 could represent a significant advancement in cancer treatment, offering hope for longer-lasting benefits and improved quality of life for patients [4]

Core Insights - Sapu Nano has received approval from Australia's Human Research Ethics Committee to begin a Phase 1 clinical trial for Sapu003, an injectable form of Everolimus aimed at treating breast cancer [1][3] - The injectable Sapu003 utilizes Deciparticle™ technology to deliver 100% of the drug into the bloodstream, overcoming the limitations of the oral form, which only allows about 10% absorption [2][4] - The trial aims to address the unmet need for more effective mTOR inhibitors, as current therapies often provide less than one year of progression-free survival [3] Company Overview - Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products, targeting high-unmet-need cancers and rare pediatric indications [5] - The company holds a 45% stake in GMP Bio, a joint venture that is advancing its own pipeline of drug candidates, enhancing Oncotelic's strategic position in oncology and rare disease therapeutics [6]