Nerve Therapy Trial Success for Diabetics

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Trial Success For Diabetic Nerve Therapy

http://www.medicalnewstoday.com/medicalnews.php?newsid=44308

A potentially ground-breaking treatment for nerve damage caused by

diabetes has shown promising results in preclinical and early patient

trials.

The 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 Tomlinson says the study has massive

potential for managing the condition and preventing thousands of foot

amputations each year.

" The vast majority of non-traumatic hand and foot amputations carried

out in UK 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 per cent 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 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 Organisation 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.

* Sangamo Biosciences Inc is a Californian biotech firm focused on

the research and development of novel DNA-binding proteins for

therapeutic gene regulation and modification.

Faculty of Life Sciences

The University of Manchester

http://www.manchester.ac.uk