Trial to be conducted at the Dana-Farber / Brigham and Women’s Cancer Center to determine ability to improve OM outcomes and reduce overall hospitalisation costs
Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, today announced 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® (bioadherent oral gel) on various aspects of oral mucositis (OM), a common side effect experienced by patients undergoing stem cell transplant.
Approximately 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 is severe OM, an intensely painful inflammation of the surface of the mouth, which may 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.
This trial is 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, will help to optimise how health care providers support their patients as they manage this common side effect of stem cell transplantation.
Based on Symphony Health Solutions data, Gelclair is the leading gel barrier prescription product prescribed for OM in the retail sector. Gelclair has been used effectively on thousands of ambulatory patients who suffer from OM due to various cancer therapies such as radiation and chemotherapy. The newly initiated trial in SCT will 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 David R. Benharris, Midatech Pharma U.S. President. “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.”
The company anticipates that the trial will complete enrollment in the second half of 2018.