USA - BioSapien, a pioneering biotechnology company developing next-generation cancer drug delivery technologies, has received the required regulatory approvals to advance Phase I clinical trials in Abu Dhabi, UAE for MediChip™, its novel localised cancer drug delivery platform.

The milestone marks the latest example of Abu Dhabi's growing role as a destination for clinical research and innovation, demonstrating the Emirate's ability to support the efficient progression of promising health technologies from scientific discovery into clinical development.

BioSapien has received approvals from the Department of Health – Abu Dhabi (DoH) for its IND (Investigational New Drug) submission; the EDE (Emirates Drug Establishment) for clinical trials; and the IRB (Institutional Review Board) – which is part of DoH – for shortlisted clinical sites. BioSapien expects patient enrolment, and Phase One trials to commence in Abu Dhabi, in the next few weeks.

The announcement highlights the strength of Abu Dhabi's clinical research ecosystem and its living lab for intelligent life sciences, which brings together enabling regulation, advanced healthcare infrastructure, research excellence and innovation within a single connected environment. Through this model, Abu Dhabi is helping innovators build, test and scale promising new health technologies while accelerating the pathway from research to real-world patient impact.

Dr. Asma Ibrahim Al Mannaei, Executive Director of the Health Life Sciences Sector at the Department of Health – Abu Dhabi (DoH) said:

“As we continue to strengthen Abu Dhabi's position as a global hub for clinical research and innovation, our focus remains on accelerating access to promising new therapies while maintaining the highest standards of safety, quality and scientific rigour. The advancement of BioSapien's Phase I clinical trial reflects the value of bringing together enabling regulation, research excellence and world-class healthcare infrastructure within a single ecosystem.”

Dr. Khatija Ali, CEO and Founder of BioSapien, said:

“The UAE has always had a special place in BioSapien’s journey - from supportive investors to clinical partners. It has been a delight to continue this with such a rapid and professional regulatory experience with the Department of Health – Abu Dhabi, and we are ready for Phase One trials to begin imminently. The approvals announced today accelerate our mission to revolutionise how chemotherapy is delivered and demonstrate the UAE’s growing leadership in enabling cutting-edge biotech innovation.”

MediChip™ is a drug delivery, 3D-printed, slow-release delivery platform attachable to any tissue with minimal systemic side effects. Local delivery means more of the drug stays in the tumor microenvironment (i.e., where the tumor is located) to aid more efficient oncology, such as downsized tumors, alleviate symptoms and prevent potentially life-altering surgeries. Local delivery also requires fewer quantities of drugs to be used while maintaining safety.

BioSapien is initially developing its platform for clinical trials in colorectal cancer patients, with scope to branch out to other cancers (pancreatic, lung), and non-cancer indications. Colorectal cancer is a high priority area for the DoH, with it being the most common cancer in men, the third most common cancer in women after breast and thyroid cancer, and the third most common cancer in both men and women.

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