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 Insights - Roche announced positive results from the phase III evERA Breast Cancer study, showing that giredestrant combined with everolimus significantly reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and 62% in the ESR1-mutated population compared to standard-of-care endocrine therapy plus everolimus [1][4] Study Results - The evERA study evaluated giredestrant in patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer previously treated with CDK 4/6 inhibitors and endocrine therapy [1][5] - The median progression-free survival (PFS) was 8.77 months for the giredestrant group versus 5.49 months for the comparator in the ITT population, and 9.99 months versus 5.45 months in the ESR1-mutated population [3][4] - Overall survival (OS) data were immature, but a positive trend was observed in both populations [3][4] Safety and Tolerability - The giredestrant combination was well tolerated, with no new safety signals reported, including no instances of photopsia [4][3] - Adverse events were manageable and consistent with the known safety profiles of the individual medicines [3][4] Clinical Need and Implications - There is a high unmet need for effective treatments for patients who become resistant to endocrine therapies and CDK inhibitors [2][3] - Giredestrant plus everolimus could potentially become a new standard-of-care treatment in the post-CDK inhibitor setting [2][4] Company Commitment - Roche has a comprehensive clinical development program for giredestrant, reflecting its commitment to delivering innovative treatments for ER-positive breast cancer [6][8] - The company has been advancing breast cancer research for over 30 years, focusing on addressing the complexities of all breast cancer subtypes [8][10]

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]