[IP] Scientists See Success in Trials for Diabetic Nerve Therapy
Scientists See Success in Trials for Diabetic Nerve Therapy
A potentially ground-breaking treatment for nerve damage caused by diabetes has
shown promising results in preclinical and early patient trials.
A University of Manchester team has discovered that injection of a novel
therapeutic that works by stimulating a person's genes may prevent nerve damage
- primarily to the hands and feet - caused by the disease.
The positive preclinical results - reported in the journal Diabetes - are
further evidence that the research could lead to a new treatment for diabetic
nerve damage or 'neuropathy'; initial-stage clinical trials on patients in the
United States have also been encouraging.
Lead researcher Professor David Tomlinson said the study has massive potential
for managing the condition and preventing thousands of foot amputations each
"The vast majority of non-traumatic hand and foot amputations carried out in
U.K. hospitals are caused by diabetes and there are currently no treatments
available to prevent or slow the progress of nerve disease in diabetic
patients," he said.
"Our tests have shown that a single injection of a DNA-binding protein
protected nerve function, stimulated nerve growth and prevented tissue damage
that in humans can lead to limb loss."
An estimated 50% of patients with long-term diabetes develop some form of
neuropathy that can cause numbness and sometimes pain and weakness in the hands,
arms, feet and legs. Progression to amputation is not inevitable, but it is
always a threat.
Problems may also occur in other organs, including the heart, kidneys, sex
organs, eyes and digestive tract.
"Diabetic neuropathy is a major problem in insulin-dependent diabetes,
particularly in patients who have had the disease for a period of time," said
Professor Tomlinson, who is based in the University's Faculty of Life Sciences.
"Our approach to gene therapy is quite different to previous attempts at
treatment: we use a DNA-binding protein called ZFP TFTM to poke life into the
patient's own genes and produce a growth factor that has a role in nerve
protection and regeneration. As the data in the paper demonstrate, we have had
some striking success."
The US clinical trials - carried out by Professor Tomlinson's collaborators at
biotech firm Sangamo BioSciences Inc - have also been encouraging with the only
adverse event reported being mild injection-site reaction in four of the 12
diabetic patients tested, all of which resolved quickly.
"We are delighted by the progress of our clinical programme in diabetic
neuropathy and by the reception it has received from the medical and scientific
community," said Edward Lanphier, Sangamo's President and CEO.
"We believe our DNA-binding protein may provide a novel and much-needed
therapeutic approach to diabetic neuropathy and optimistically look forward to
the next stage of development of this novel therapeutic when phase-two clinical
trials start later this year."
The incidence of diabetes, a condition in which the amount of glucose in the
blood is too high, is increasing dramatically with the World Health Organization
estimating that some 300 million people worldwide could be affected by 2025.
The causes of diabetic neuropathy are not fully understood but researchers
investigating the effect of glucose on nerves believe it is likely to be a
combination of factors. This article was prepared by Obesity & Diabetes Week
editors from staff and other reports. Copyright 2006, Obesity & Diabetes Week
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