http://www.lctglobal.com/latest-news.php
April 6, 2009 - Sydney, Australia, Auckland, New Zealand- Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) reports insulin independence in a patient with insulin dependent type 1 diabetes who received DIABECELL®, its encapsulated insulin-producing porcine cells, as part of an on-going Phase I/IIa clinical trial. The patient is a 37 year old woman who was on daily insulin injections for 15 years and now maintains good blood glucose control without insulin injections. Live porcine cells in intact capsules have been biopsied from the site of implants in the abdomen and porcine insulin was detected in the patient’s blood.
LCT Medical Director, Professor Bob Elliott said, “Patients who have received the initial doses of the implants have clearly shown benefit.”
Professor Elliott explained, “Early in the study, one patient attained insulin independence for eight weeks following the lowest dose of 5,000 islet equivalents (IEQ per kg body weight). She was given another implant at the lowest dose six months after the first. Subsequently, she required half the daily pre-implant insulin dose to maintain satisfactory blood glucose levels for the following year. A third implant of 8,000 IEQ per kg was administered and she again did not need insulin injections to maintain normal blood glucose levels.”
Dr Paul Tan, LCT Chief Executive Officer, said, "These encapsulated cells offer not only an alternative but a physiological replacement therapy to provide new hope and improved lifestyles for people with diabetes.
At this early stage of clinical trials, results show that insulin independence is potentially achievable at least in some patients and that repeat implants are safe. LCT has narrowed product quality release specifications and responses to higher doses at first implants in future patients will clarify when and if repeat doses are necessary."
DIABECELL® is LCT’s encapsulated porcine insulin-producing cell product designed for the treatment of type 1 diabetes without the use of immunosuppressive drugs.
A total of seven patients have received DIABECELL® implants in the safety and dose finding study. Patients were administered low or medium dose implants (5,000 to 10,000 islet equivalents (IEQs) per kg body weight) and some have had a repeat implant at least six months after the first. There have been no remarkable adverse events attributed to repeat implants.
Interim results from the trial conducted in Moscow has shown good blood glucose control as reflected by a reduction in glycated hemoglogin (% HbA1c) levels following the implants with reduction in daily insulin doses of varying magnitude for the implant doses administered to date.