Oncotelic Therapeutics' IV Sapu003 Shows 67-Fold Reduction in GI Exposure Compared to Oral Everolimus

Oncotelic Therapeutics, Inc. (OTCQB: OTLC), which owns 45% of the Sapu Nano joint venture, has released new pharmacokinetic and tissue-distribution data demonstrating that its intravenous Deciparticle formulation of everolimus, Sapu003, significantly reduces gastrointestinal drug accumulation when compared with oral everolimus administration. According to the company's findings, oral dosing results in extreme gut exposure—reaching up to 2,448 times plasma levels in the stomach—while intravenous Sapu003 limits gastrointestinal tissue levels to just 36–48 times plasma concentrations. This represents reductions of up to 67-fold in gastrointestinal exposure, a substantial difference that could have important clinical implications.

The company stated that this dramatic shift in drug distribution may lead to improved tolerability for patients, maintain the drug's intrinsic metabolic profile, and provide more consistent systemic exposure. Everolimus is an mTOR inhibitor used in oncology and transplant medicine, but its oral administration is often associated with significant gastrointestinal side effects that can limit patient compliance and treatment effectiveness. By reducing gastrointestinal accumulation while delivering the drug systemically, Sapu003 could potentially preserve therapeutic efficacy while minimizing adverse effects that commonly occur with oral formulations.

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products, with a mission to address high-unmet-need cancers and rare pediatric indications. The company's CEO, Dr. Vuong Trieu, has filed more than 150 patent applications and holds 39 issued U.S. patents, contributing to the company's robust portfolio of inventions. Beyond its internal programs, Oncotelic also licenses and codevelops select drug candidates through joint ventures, including its 45% ownership of GMP Bio, which advances its own pipeline of drug candidates that complement Oncotelic's strategic position in oncology and rare disease therapeutics.

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