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news.Galera Therapeutics' GC4419 has secured a Promising Innovative Medicines (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral mucositis in head and neck cancer patients.
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GC4419 is a novel dismutase mimetic designed to prevent the damaging effects of radiation in normal tissue by rapidly converting superoxide to hydrogen peroxide, and is currently in a 223 patient randomized, controlled phase 2b trial with top line results expected in 4Q 2017.
The PIM allowance is an early indication that a product is a promising candidate for the Early Access to Medicines Scheme (EAMS), intended for the treatment of a life-threatening or seriously debilitating condition with the potential to address an unmet need following an early review of the clinical data by the agency. A compound must meet the following criteria to obtain a PIM designation:
The condition should be life-threatening or seriously debilitating with a high unmet need;
The medicinal product is likely to offer a major advantage over methods currently used in the UK; and
The potential adverse effects of the medicinal product are likely to be outweighed by the benefits.
Such a designation is based on early clinical data and is a prerequisite to enter the EAMS scientific opinion assessment step.
"We are pleased that GC4419 has been granted a PIM designation, demonstrating the MHRA’s commitment to facilitate the development of GC4419 as an important new therapy for head and neck cancer patients experiencing the debilitating side effect of severe oral mucositis,” said J. Mel Sorensen, M.D., Galera Therapeutics President and Chief Executive Officer. “With a positive EAMS opinion, GC4419 could be available to patients prior to receiving marketing authorization in the UK."