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New drug trial in Manchester could help relieve the pain of diabetes

Ajith GeorgeA clinical trial involving patients from Manchester hopes to find an effective and non-addictive drug to relieve diabetic neuropathy, a painful complication of the condition.

A trial taking place at the Trafford General Hospital will be the first in the world to investigate the potential of an innovative drug for chronic pain conditions, such as diabetic neuropathy. For many patients this condition is unsatisfactorily managed by current drugs.

"Patients with diabetic neuropathy experience a painful tingling in their nerves, hands and feet, even with well-managed diabetes. For many, current treatments are not effective in managing pain and new alternatives will be welcomed by patients," comments Dr Ajith George, Consultant in diabetes and endocrinology, who is delivering the trial at Trafford General Hospital.

Pharmaleads, the company leading the clinical trial, is looking to recruit patients with diabetes from Manchester to take part in the four week study which could help change the impact of the disease for future generations.

"With the help of volunteers we may uncover a more effective treatment to manage the pain that some people with diabetes face," adds Dr George.  "Trafford General Hospital was chosen as it has a comprehensive diabetes service, which includes a foot service.  In our clinics, we see a considerable amount of neuropathy and are often frustrated by the inability to achieve effective pain relief."

Trafford General Hospital is still looking for more local people to take part in the trial, which is supported by the NIHR.

The trial will investigate a new drug called PL37. This is a Dual Enkephalinase Inhibitor or "DENKI" - a novel and exciting class of analgesic which can prolong the body's own natural painkillers.

Earlier studies with patients have shown that DENKI PL37 effectively targets the actual site of pain and enhances the benefit of other pain medications - and, unlike opiates such as morphine, is non-addictive. It was very well tolerated even at high oral doses, although some subjects reported mild side-effects such as loose stools and headaches.

However it is DENKIs' mechanism in the body that is attracting excitement within the science community. The body's natural painkillers degrade quickly, but DENKIs are able to prolong the life of these peptides; in essence, assisting the body's own natural pain relieving processes.

The study is open to patients with diagnosed diabetic neuropathy (type 1 or type 2 diabetes) who are currently prescribed a pain medication which is not effective enough. The trial will explore if DENKI PL37 is effective in reducing pain intensity. The Trafford General Hospital is one of 11 hospitals in the UK taking part in this trial.

If you are a person with diabetes and feel your current pain treatment is unsatisfactory, and would like to find out more information on the 'DENKI PL37 for diabetic neuropathy' trial, you can ask your physician if you can be referred to the investigative site at the Trafford General Hospital.

Alternatively, for more information contact Pharmaleads on 0800 612 5430.

-ENDS-

Notes to editors

About the clinical trial

A 4 week phase 2a, multicentre, randomised, double-blind, placebo-controlled add-on study into safety, tolerability and efficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin.

https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004876-37/GB

Participants will receive PL37 or placebo, in addition to their existing treatment of either pregablin or gabapentin.  PL37 or placebo will be taken as a capsule three times a day before each meal.

Diabetes Day - 14th November
Each year, World Diabetes Day, which is co-ordinated by the International Diabetes Federation (IDF), carries a particular theme and between 2014 to 2016 the theme is healthy living and diabetes.  For further information see: http://www.idf.org/wdd-index/.

Central Manchester University Hospitals NHS Foundation Trust is a leading provider of specialist healthcare services in Manchester, treating more than a million patients every year. Its eight specialist hospitals (Manchester Royal Infirmary, Saint Mary's Hospital, Royal Manchester Children's Hospital [RMCH], Manchester Royal Eye Hospital, University Dental Hospital of Manchester and Trafford Hospitals) are home to hundreds of world class clinicians and academic staff committed to finding patients the best care and treatments. (www.cmft.nhs.uk)

About Pharmaleads

Founded in 2000 and based in Paris, France, Pharmaleads has developed a coherent set of first-in-class molecules, thanks to its world-class medicinal chemistry expertise, providing solutions in pain treatment. Pharmaleads designs and manages the early-stage development of small protease-inhibiting compounds for diagnostic and therapeutic use.

The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government's strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk ).