AGOURA HILLS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, announced today that Sapu Nano will be featuring its investigational intravenous Deciparticle™ everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Bre ...

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]