ABU DHABI, October 31, 2026 — A clinical-stage biotechnology company based in Abu Dhabi has dosed the first patient in a Phase I trial testing a biodegradable implant designed to deliver chemotherapy directly to rectal tumors, the company and trial sites said on Sunday.
BioSapien announced the first patient was dosed on October 30, 2026, at Burjeel Cancer Institute. The trial, named OPTIMISE-REFORM, evaluates MediChip-5-FU in patients with localized rectal cancer. The implant is designed to release the chemotherapy agent 5-fluorouracil over a 28-day period.
MediChip is a biodegradable, 3D-printed implant designed to deliver 5-fluorouracil (5-FU), a widely used chemotherapy agent, directly at the tumor site through controlled local drug release. The approach is intended to concentrate drug delivery where it is needed while limiting exposure to surrounding healthy tissues and the rest of the body. For patients with rectal cancer, the longer-term ambition is to investigate whether localized chemotherapy could contribute to organ-preserving treatment strategies and reduce the need for major surgery. These potential benefits remain to be established through clinical evaluation.
The Phase I study, OPTIMISE-REFORM, is evaluating MediChip-5-FU in patients with localized rectal cancer, with an initial focus on safety and tolerability. An independent review committee comprising oncology and clinical research experts is providing oversight as the platform enters first-in-human evaluation. A strong surgical team at Burjeel Cancer Institute supported the procedure.
Today, MediChip moves from years of development into human clinical evaluation. That is what we have been building toward, said Dr. Khatija Ali, founder and CEO of BioSapien. Getting an investigational therapy to its first patient takes far more than a promising idea. It takes rigorous science, clinical-grade manufacturing, regulatory execution, and a team that can deliver across every one of those disciplines. Today, that work enters its next chapter.
The first patient dosing follows the opening of the world’s first clinical site for MediChip at Burjeel Cancer Institute, announced earlier this month. The study brings together BioSapien’s drug-delivery technology and the clinical expertise and research infrastructure of its partners in Abu Dhabi.
BioSapien is a clinical-stage biotechnology company developing MediChip, a localized drug-delivery platform designed to deliver therapeutic agents directly to the tumor site. The company maintains operations in both Abu Dhabi and San Diego to connect research with clinical delivery. The clinical batch was manufactured at Roswell Park Comprehensive Cancer Center in the United States.
BioSapien joined the Hub71 community through the Access Programme. Its progress reflects the kind of market access that specialist startups need: relationships with government, healthcare institutions, researchers and commercial partners, alongside a base from which to operate in the UAE capital. For health and life sciences companies, that path is rarely linear. Scientific evidence, quality systems, regulation and clinical operations must advance together. Abu Dhabi offers a setting where those capabilities can meet, helping high-growth ventures move from laboratory development towards responsible clinical evaluation.
Dr. Mohammad Adileh, Principal Investigator for the study and Director of the Surgical Oncology Division at Burjeel Cancer Institute, leads the clinical evaluation at the site with institutional support from Professor Humaid Al-Shamsi, CEO of Burjeel Cancer Institute. I am excited to see the first patient under my care enrolled and treated in this pioneering clinical trial. This milestone reflects our commitment to bringing innovative therapies to our patients at the earliest stages of clinical development, while contributing to the generation of evidence that could shape the future of cancer care, said Prof. Al-Shamsi.
The study is supported by an independent review committee comprising oncology and clinical research experts, providing independent oversight as the platform enters first-in-human evaluation. First patient dosing is an important step, but it is the beginning of the clinical evidence-generation process, Dr. Ali added. Our focus now is on the patient, the quality of the data and executing this trial to the highest standards.
Patients should talk to their doctor or oncologist about whether clinical trials are appropriate for their situation.
Sources
- BioSapien Doses First Patient in First-in-Human MediChip Clinical Trial at Burjeel Cancer Institute
- Hub71 Startup BioSapien Opens First MediChip™ Clinical Site
Photo: Usman Yousaf / Unsplash (Unsplash License)
