Midatech begins next clinical trial of Gelclair

Specialty pharmaceutical company Midatech Pharma announced on Wednesday that its US subsidiary has initiated a Phase IV clinical trial at Dana-Farber/Brigham and Women's Cancer Center to study the effects of ‘Gelclair’ bio adherent oral gel on various aspects of oral mucositis (OM) - a common side effect experienced by patients undergoing stem cell transplant.

The AIM-traded company said around 200 centers across the United States treat 20,000 patients with stem cell transplant therapy (SCT) on an annual basis.

One of the most frequently-observed side effects of SCT was severe OM, which the board sadi is an “intensely painful” inflammation of the surface of the mouth, which could lead to the need for supplemental prescription pain products such as opioids, parenteral nutritional therapy and which may result in extended time to patient discharge from highly specialised SCT units, resulting in increased healthcare costs.

Midatech said the trial would be a blinded, randomised, controlled study designed to investigate the efficacy and tolerability of Gelclair and the ideal timing of initiation of therapy for the management of OM in allogeneic stem cell transplant recipients conditioned with high-dose chemotherapy.

Understanding how best to use Gelclair to address OM pain, incidence, and severity, as compared to the use of standard of care practices, would help to optimise how health care providers supported their patients as they managed the common side effect of stem cell transplantation.

Based on Symphony Health Solutions data, Midatech said Gelclair was the leading gel barrier prescription product prescribed for OM in the retail sector.

It said Gelclair had been used effectively on thousands of ambulatory patients who suffered from OM due to various cancer therapies such as radiation and chemotherapy.

The newly-initiated trial in SCT would provide data on the applicability of Gelclair therapy for OM caused by SCT which - if positive - would support the use of Gelclair in the in-hospital setting.

“Oral mucositis causes significant discomfort and pain in SCT patients, and may delay hospital discharge or result in the use of additional and costly therapies,” said Midatech Pharma US president David Benharris.

“We have worked collaboratively with the experts at Dana Farber to design a trial that will provide health care professionals the necessary information to determine if Gelclair can help SCT units better manage or prevent the symptoms and additional issues related to oral mucositis which are commonly seen in this patient population.”

Midatech anticipated that the trial would complete enrollment in the second half of 2018.