Living Cell Technologies Limited, a company pioneering the development of a cell implant to treat diabetes, has obtained approval to commence a Phase II DIABECELL clinical trial in Buenos Aires, Argentina, DIABECELL's third jurisdiction to date which has approved human trials. Up to eight adult patients with Type 1 diabetes, including those with unstable diabetes and severe hypoglycaemia, will each receive two implants of DIABECELL, three months apart with a dose seeking component. The trial is expected to begin in the second half of this year.
The trial has received ethical approval from the relevant Bioethics authority of the Eva Perón Hospital in San Martín, Argentina (Comité de Investigación y Comité de Bioética del Hospital Eva Perón de San Martín), the approval of the Central Ethics Committee of the Minister of Health of the Buenos Aires Province (CEC), CUCAIBA, the coordinating committee for transplantation in Buenos Aires (Centro Unico Coordinador de Ablación e Implante de la Prov. de Bs. As.), and the Minister of Health of the Buenos Aires Province, Dr Alejandro Collia.
Dr Adrian Abalovich, MD, has been appointed principal investigator of the Argentinean trial, with Dr Boris Draznin, MD, PhD, Professor of Medicine, Endocrinology, and Diabetes at the University of Colorado Health Sciences Center agreeing to provide external supervision of the trial.
The Argentinean trial approval follows a positive assessment from the New Zealand Data Safety and Monitoring Board of the first twelve patients to receive DIABECELL implants in its Phase II trial in New Zealand, as well as favourable two-year follow up data from its Phase I/IIa clinical trial in Russia. LCT was recently granted registration of DIABECELL as a medical technology in Russia, and has announced plans for collaborative development of DIABECELL in Asia following the strategic investments made in LCT by ASK in China and Otsuka in Japan.
Professor Bob Elliott, LCT's Medical Director, said: "Dr Abalovich, the principal investigator for the proposed trial in Argentina, has a published record as a researcher in the area of porcine islet implantation. He provides excellent leadership of a group who will expand the dose seeking trials of DIABECELL. The healthcare infrastructure in Argentina is one of the more sophisticated in Latin America with clinical trials run to international GCP standards."
DIABECELL is LCT's treatment designed to normalise the lives of people with insulin-dependent diabetes. DIABECELL comprises encapsulated porcine insulin-producing cells (islets) that are implanted into the abdomen of patients using a simple laparoscopic procedure, and work by self-regulating and efficiently secreting insulin in the patient's body. LCT's breakthrough proprietary encapsulation technology, IMMUPEL(tm), means that patients receiving DIABECELL treatment do not require immunosuppression after implantation.
Dr Ross Macdonald LCT's CEO concluded: "This trial is intended to build upon encouraging clinical data to date and will provide additional robust clinical information relevant to our future pivotal clinical study program. Strategically, the trial creates the potential for future commercialisation in a new jurisdiction."