Oncotelic's Joint Venture Sapu Nano Receives Australian Approval for Injectable Breast Cancer Drug Trial

Sapu Nano, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and GMP Biotechnology Limited, has received approval from Australia's Human Research Ethics Committee to begin patient enrollment for a Phase 1 clinical trial of Sapu003, an injectable formulation of Everolimus for breast cancer treatment. The approval marks a significant advancement in cancer therapeutics as it addresses the limited absorption issues associated with the current oral version of the drug.

Everolimus, marketed under the brand name Afinitor, is currently FDA-approved in oral form but suffers from poor bioavailability with only approximately 10% absorption. Sapu Nano's innovative Deciparticle technology enables intravenous delivery of the drug, allowing for complete absorption into the bloodstream. Preclinical data suggests this delivery method could substantially improve efficacy compared to the oral formulation currently available to patients.

The Phase 1 trial will focus on determining the optimal dosing regimen for future studies, including potential Phase 3 trials. The primary objective is to establish a treatment approach that provides longer-lasting disease control and improved outcomes for breast cancer patients. The injectable formulation represents a potential paradigm shift in how this established cancer drug is administered and could open new therapeutic possibilities for patients who have limited options.

Oncotelic Therapeutics maintains a 45% ownership stake in GMP Bio through this joint venture arrangement. The company's latest developments and updates are available through their corporate communications channel at https://ibn.fm/OTLC. The successful development of Sapu003 could have significant implications for breast cancer treatment protocols worldwide, particularly for patients who have developed resistance to current therapies or who require more effective drug delivery systems.

The approval from Australian regulatory authorities demonstrates the global interest in improving cancer treatment methodologies. As noted in the official announcement available at https://ibn.fm/NoIQt, the trial represents an important step forward in oncology drug development. The research ethics committee's approval indicates that the trial protocol meets rigorous safety and ethical standards required for human clinical studies.

This development is particularly important given the high unmet medical needs in breast cancer treatment. The ability to deliver Everolimus through intravenous injection rather than oral administration could potentially transform treatment outcomes for thousands of patients worldwide. The trial's success could lead to more effective cancer management strategies and improved quality of life for those battling the disease.