nz trial update, page-2

you still in Sleeping Wolf?
some more updates on trials back in February, intersting stuff. Be interesting when higher doses are given in further trials:

Living Cell Technologies Ltd
COMPANY ANNOUNCEMENT
Living Cell Technologies Reports Interim Results Showing Sustained
Benefit With DIABECELL® Implants for Insulin Dependent Diabetes
February 11, 2009 – Sydney, Australia, Auckland, New Zealand– Living Cell
Technologies Limited (ASX: LCT; OTCQX: LVCLY) reports positive interim results from the
long term follow-up of insulin dependent diabetes patients in the Phase I/IIa clinical trial of its
lead product, DIABECELL®.
A total of seven patients have received DIABECELL® implants, five of whom have had two low
dose (5,000 islet equivalents (IEQs) per kg body weight) implants at least six months apart.
There have been no remarkable adverse events attributed to double implants. Two patients have
received a single higher dose (10,000 IEQs/kg) with no safety concerns to date.
The results of 36 to 68 weeks follow-up from the first four patients showed that good blood
glucose control was maintained as reflected by a reduction in glycated hemoglogin (% HbA1c)
levels from a mean of 8% pre-enrolment to 6.8% at time of clinical review. The American
Diabetes Association target for good blood glucose control is HbA1c below 7% and the normal is
less than 6.2%. This control was attained despite a reduction of 10% - 38% in the required daily
insulin dose.
It is too early to assess the second implant for the fifth patient. However, the patient’s HbA1c
improved markedly from 9.8% before enrolment to 7.2% accompanied with a small reduction in
the average daily insulin dose of 6%.
LCT Medical Director, Professor Bob Elliott said, “The patients clearly benefited from the implants
administered at the lowest dose. The second implant maintained this benefit. Remarkably none
of the patients have had problems with clinically relevant episodes of low blood glucose. Most
people with diabetes cannot attain this degree of blood glucose control shown by these patients
without large swings of very low or high blood glucose levels that are often fatal.”
Two more patients have received the higher dose of DIABECELL®. Patient six declined further
follow-up at 20 weeks after the first implant when there was no change in glucose control or
insulin dose. To improve consistency, LCT narrowed product quality release specifications for all
subsequent implants. Patient seven has been followed up for only four weeks at which time
HbA1c improved dramatically from 8.3% to 4.8% and daily insulin requirement dropped by 60%.
Professor Elliott further stated, “We can expect better outcomes with higher doses. The
encapsulated cells offer not only an alternative but a physiological replacement therapy to
provide new hope and improved lifestyles for people with diabetes.”
Dr Paul Tan, LCT Chief Executive Officer, said, “The next three patients in Russia are scheduled
to receive the 10,000 IEQ/kg dose by April this year before testing the top dose of 15,000
IEQs/kg. Steps to initiate a pivotal trial and a commercialization strategy in Russia have been
taken.”
DIABECELL® is LCT’s encapsulated porcine insulin-producing cell product designed for the
treatment of type 1 diabetes without the use of immunosuppressive drugs.