Oncotelic Therapeutics, Inc. has released new pharmacokinetic data showing that its intravenous Deciparticle formulation of everolimus, called Sapu003, substantially decreases gastrointestinal drug accumulation when compared to oral administration of the same medication. The findings indicate that oral dosing leads to extreme gut exposure, with drug levels in the stomach reaching up to 2,448 times those found in plasma. In contrast, intravenous Sapu003 limits gastrointestinal tissue concentrations to just 36–48 times plasma levels, representing reductions of up to 67-fold.
The company suggests this significant reduction in gastrointestinal exposure could lead to improved tolerability for patients receiving everolimus treatment. By minimizing drug accumulation in the gut while maintaining the drug's intrinsic metabolic profile, the intravenous formulation may provide more consistent systemic exposure to the medication. This development is particularly relevant for cancer patients who often experience gastrointestinal side effects from oral targeted therapies, potentially allowing for more effective dosing with fewer adverse effects.
Oncotelic Therapeutics operates as a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products, with particular attention to high-unmet-need cancers and rare pediatric indications. The company's CEO, Dr. Vuong Trieu, has contributed significantly to its intellectual property portfolio with more than 150 patent applications and 39 issued U.S. patents. Additional information about the company's developments is available through their newsroom at https://ibn.fm/OTLC.
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The implications of this announcement are significant for cancer treatment, as gastrointestinal toxicity remains a major limitation of many oral targeted therapies. The substantial reduction in gut exposure demonstrated by Sapu003 could translate to fewer dose reductions or treatment interruptions, potentially improving patient outcomes. This development addresses a critical challenge in oncology where maintaining therapeutic drug levels while minimizing side effects is essential for treatment success. The intravenous formulation's ability to provide more consistent systemic exposure while reducing gastrointestinal accumulation represents a potential advancement in drug delivery technology that could benefit patients across multiple cancer types treated with mTOR inhibitors like everolimus.
