Midatech Pharma plc (AIM: MTPH) (Nasdaq: MTP) has enrolled the first patient in its Gelclair Phase IV trial in stem cell transplant (SCT), the pharmaceutical company said on Friday.
The study will examine the effects of Gelclair (bioadherent oral gel) on various aspects of oral mucositis (OM) in patients undergoing SCT therapy.
Severe OM is a painful and debilitating inflammation and ulceration of the surface of the mouth. The most common side effect of SCT, it can lead to complications such as inability to eat and increased risk of infection due to open sores in the mucosa.
The trial aims to confirm the efficacy and tolerability of Gelclair for the management of OM, and determine the ideal timing for initiation of therapy in allogeneic stem cell transplant recipients conditioned with high-dose chemotherapy.
Results from the study will provide valuable data on the treatment of OM in SCT patients and could significantly increase the use of Gelclair in the in-hospital setting, Midatech said.
Led by the group's US subsidiary, Midatech Pharma US, the trial is being conducted at both Dana-Farber/Brigham and Women's Cancer Centre and Massachusetts General Hospital.
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