Oncotelic Therapeutics Inc. (OTLC) Venture Sapu Nano Receives Approval to Begin Human Clinical Trials of Sapu003, an Injectible Form of Afinitor(R) (Everolimus) for Breast Cancer Treatment

• Sapu Nano received approval from Australia’s Human Research Ethics Committee (“HREC”) to start enrolling patients in clinical trials for Sapu003
• Sapu003 uses Sapu Nano’s Deciparticle(TM) technology to deliver more of the Everolimus drug into the bloodstream, which could be more effective than taking the drug in pill form
• Sapu Nano is a part of a family of companies formed through GMP Biotechnology Limited, which itself is a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited

Sapu Nano, part of a group of companies formed through GMP Biotechnology Limited, which is a joint venture between Oncotelic Therapeutics (OTCQB: OTLC) and Dragon Overseas Capital Limited, recently received approval from the HREC in Australia to begin enrolling people in clinical trails of Sapu003 for the treatment of breast cancer.

Sapu003 is an injectible from of Affinitor(R) (Everolimus), which is an FDA-approved drug for treating different types of advanced cancer including breast cancer, kidney cancer, and affiliated rare tumors.

When taken orally in pill form, only about 10% of the drug is absorbed by the body, limiting how effective it can be. With that in mind, using Sapu Nano’s novel Deciparticle(TM) technology, Sapu003 that’s injected intravenously opens 100% of the drug reach the bloodstream.

As a result, Sapu003 represents a new approach to administering an existing cancer drug. Delivering the drug intravenously lets researchers give it at full strength, which may make it more effective at reducing the size of tumors.

This first trial aims to see if this improved version of the drug gives breast cancer patients not only new hope, but also more long-term and enduring benefits.

Dr. Vuong Trieu, the CEO of Sapu Nano, stated, “We are extremely pleased to receive approval from HREC to proceed with human clinical trials,”. He also added that “Despite advances in treatment, a critical unmet need for next generation mTOR inhibitors remains. Current therapies often extend progression-free survival for less than one year and rarely deliver long-term disease control. This Phase 1 trial will allow us to determine the best dose for future studies, including a Phase 3 trial. (ibn.fm/dY3G0)”

Dr. Sud Agarwal, CEO of Ingenu, a contract research organization (“CRO”) in Australia, added that “the approval of Sapu003 to enter human trials is a landmark moment. By enabling full drug absorption through intravenous delivery, this program has the potential to achieve meaningful tumor shrinkage where oral formulations have been limited. We are proud to support Sapu Nano in advancing this therapy, potentially giving breast cancer patients better outcomes and improved quality of life.”

About Oncotelic Therapeutics, Inc. 

Oncotelic Therapeutics is a biopharmaceutical company that develops therapeutics for cancer and other underserved diseases. The company has a portfolio of clinical-stage candidates and is focused on transforming outcomes for patients suffering from rare and/or difficult-to-treat conditions.

For more information, visit the company’s website at www.Oncotelic.com.

NOTE TO INVESTORS: The latest news and updates relating to OTLC are available in the company’s newsroom at ibn.fm/OTLC

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