Oncotelic Therapeutics Joint Venture Receives Approval for Phase 1 Trial of Injectable Everolimus for Breast Cancer

Oncotelic Therapeutics, Inc. (OTCQB: OTLC) announced that its joint venture through GMP Biotechnology Limited, Sapu Nano, has received approval from Australia's Human Research Ethics Committee to begin enrolling patients in a Phase 1 human clinical trial of Sapu003, an injectable form of Everolimus for breast cancer. Everolimus, marketed as Afinitor(R), is FDA-approved in oral form but has limited absorption of about 10%. Using Sapu Nano's Deciparticle(TM) technology, Sapu003 is delivered intravenously, allowing full drug absorption into the bloodstream.

The significance of this development lies in the potential to overcome the pharmacokinetic limitations of oral Everolimus. With only approximately 10% absorption when taken orally, the current formulation requires higher doses that can lead to increased side effects without corresponding therapeutic benefits. The intravenous delivery system developed by Sapu Nano represents a technological advancement that could transform how this established cancer treatment is administered. Preclinical data suggest this approach could improve efficacy over the oral version, potentially offering better disease management for breast cancer patients.

The Phase 1 trial will focus on determining optimal dosing for future studies, including a potential Phase 3 trial. This initial study phase is critical for establishing safety parameters and understanding how the injectable formulation behaves in human subjects. The research aims to provide longer-lasting disease control and improved outcomes for breast cancer patients who may benefit from more efficient drug delivery. The approval from Australia's Human Research Ethics Committee indicates that the trial protocol has met rigorous ethical standards for human subject research.

This milestone represents an important step forward in cancer treatment innovation, particularly for breast cancer patients who may have limited options after first-line therapies fail. The injectable formulation could potentially allow for more precise dosing and reduced side effects compared to the oral version. The trial's success could pave the way for new treatment protocols that leverage existing cancer drugs through improved delivery systems. Additional information about the company's developments is available through their newsroom at https://ibn.fm/OTLC.

The broader implications of this research extend beyond breast cancer treatment, as successful development of injectable Everolimus could establish a precedent for reformulating other oral cancer medications. The Deciparticle(TM) technology platform may have applications across multiple therapeutic areas where improved drug bioavailability is needed. This approach represents the growing trend in pharmaceutical development of enhancing existing drugs through advanced delivery systems rather than developing entirely new chemical entities, which can be more time-consuming and costly.