MELBOURNE, Australia, Jan. 29 /PRNewswire-FirstCall/ -- Living Cell Technologies Ltd today announced its DiabeCell(R) Type 1 diabetes treatment has been approved for a Phase I/IIA clinical trial in Russia designed according to FDA guidelines and monitored by a Boston-based Contract Research Organisation.
DiabeCell(R) is a porcine pancreatic cell product for the treatment of insulin-dependent diabetes. The natural neo-natal pig islet cells are encased in capsules that allow insulin to be released but prevents the patient’s immune system from attacking the cells. The islets are simply injected into the body and produce insulin as needed in response to the levels of glucose in the blood.
The trial may enable an expedited route to commercialisation within the region. Initial response to treatment will be evident within six months. The trial will use cells from fully-screened and biocertified pigs, bred according to US FDA (Food and Drug Administration) guidelines.
“Along with international biopharmaceutical firms, LCT is taking advantage of the growing interest and availability of funds for biotechnology in Russia,” said LCT CEO, Dr Paul Tan. “The pharmaceutical industry has noted Russia’s centralised medical infrastructure and efficient recruitment of patients into clinical trials. The rapid regulatory process in Russia and the accepted use of animal cells in treating human disease may shorten the time to market.”
“The approval of the DiabeCell(R) human clinical trial is a significant milestone for this new treatment option for type 1 diabetes,” said Dr John Court, expert on adolescent diabetes and scientific advisor to LCT. “This is the only human clinical trial of this kind approved anywhere in the world and recognises LCT’s thorough pre-clinical testing of the product in animal models showing no adverse safety effects and a significant reduction in insulin requirements.”
“DiabeCell(R) offers considerable advantages over other available treatments as there is no need for immuno-suppressive drugs and the supply of cells from LCT’s natural biocertified pig herds are readily available, unlike human organ donors. Type 1 diabetes urgently needs a new treatment that is better than current regimens of insulin treatment,” Dr Court said.
“As a Company at the forefront of the xeno-cell therapy industry -- and clearly ahead of the competition, LCT’s intention is to conduct more than one Phase I/IIA Clinical Trial,” said Dr Tan.
In Russia, DiabeCell(R) would be trialled in six Type 1 (insulin-dependent) diabetics in two stages. It is anticipated that the trial would start in the second quarter of 2007, with potential patients already identified. The 12-month phase I/IIA trial will be led by Professor Skaletsky of the ANO Institute of Biomedical Research in Moscow. Professor Skaletsky and the Institute have extensive experience in organ transplantation and xenotransplantation, having performed over 1,500 animal cell transplants in patients.
Boston-based GenyResearch Group will act as the project manager to ensure all elements of the trial adhere to international and FDA standards. They will oversee the protocols and be responsible for all data analysis and management, and provide a trial report that may be submitted along with data from international studies for regulatory approval in any jurisdiction.
Further information: Dr Paul Tan CEO Cell: +64 21 608 784
Living Cell Technologies Ltd
CONTACT: Dr Paul Tan, CEO, Cell: +64-21-608-784
