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Midatech Pharma gets key clinical trial underway for cancer product

The US phase IV study will assess Gelclair's use in patients undergoing stem cell transplant therapy
Midatech Pharma gets key clinical trial underway for cancer product
The world-renowned Dana-Farber Institute will be on of two sites for the study

Midatech Pharma Plc(LON:MTPH, NASDAQ:MTP) said patient enrolment has begun for a clinical trial that could expand the market for its cancer treatment.

Gelclair is already prescribed for an after effect of radiation and chemo therapies called oral mucositis, a painful and debilitating inflammation and ulceration of the surface of the mouth.

The US phase IV study will assess the product's use in patients undergoing stem cell transplant therapy.

Two Massachusetts sites

It is being conducted at two sites - Dana-Farber/Brigham and Women's Cancer Centre and Massachusetts General Hospital - with recruitment expected to be completed by the middle of next year.

The trial will be randomised and double blind, which means one group will receive the medication and the other a dummy treatment called a placebo. Only at the end of the trial is it revealed who received what.

The main objective is to confirm the efficacy and tolerability of Gelclair for the treatment oral mucositis in people receiving allogeneic stem cell transplants alongside high-dose chemotherapy.  

Debilitating side-effects

"Oral mucositis is a debilitating side-effect often suffered by patients undergoing stem cell transplantation therapy, resulting in significant morbidity, pain, and discomfort," said David Benharris, the president of Midatech's US arm.   

"The expert treatment centres at Dana Farber and MGH are renowned for their work in stem cell transplant therapy therapy, and in this regard are already enrolling appropriate patients for trial participation.

"The trial aims to establish how Gelclair can assist healthcare professionals and stem cell transplant therapy units to better manage patient care, as well as improve upon the health care economics, relative to the treatment of oral mucositis, which is commonly seen in this patient population."


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