Patients now being enrolled at the Dana-Farber/Brigham and Women’s Cancer Center and Massachusetts General Hospital
Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focussed on developing and commercialising products in oncology and immunotherapy, today announces that, further to the Group’s announcement dated 20 December 2017, patient enrolment is now underway in its Gelclair® Phase IV trial in the US.
The Phase IV trial, which is being conducted at both Dana-Farber/Brigham and Women’s Cancer Centre and Massachusetts General Hospital by the Group’s US subsidiary, Midatech Pharma US, has enrolled its first patient. The trial has been designed to study the effects of Gelclair® (bioadherent oral gel) on various aspects of oral mucositis (“OM”) in patients undergoing stem cell transplant therapy (“SCT”). 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.
Up to 20,000 patients annually suffering from illnesses such as leukemia, lymphoma, or other life-threatening diseases might be treated with, and benefit from, stem cell transplant therapy. The most common side effect of SCT is severe OM, an intensely painful and debilitating inflammation and ulceration of the surface of the mouth, that can lead to complications such as inability to eat and increased risk of infection due to open sores in the mucosa. SCT patients experiencing OM often require supplemental prescription analgesia products (such as opioids) for pain, and/or parenteral nutritional therapy to address their eating difficulties; patients experiencing OM may also require extended time in highly specialized specialised SCT units until their condition resolves, leading to significantly higher overall treatment costs.
The primary objective of this blinded, randomised, controlled study is 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. Establishing how best to use Gelclair for the treatment of OM pain as well as its possible impact on the incidence and severity of OM as compared to the use of standard of care practices, will enable health care providers to optimise support for their patients as they manage this common and traumatising side effect of stem cell transplantation regimens.
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. “Oral mucositis is a debilitating side effect often suffered by patients undergoing stem cell transplantation therapy, resulting in significant morbidity, pain, and discomfort. The expert treatment centres at Dana Farber and MGH are renowned for their work in SCT therapy, and in this regard are already enrolling appropriate patients for trial participation,” said David R. Benharris, Midatech Pharma US President. “The trial aims to establish how Gelclair can assist health care professionals and SCT 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.”
Midatech expects to complete patient enrolment in mid-2019.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).