CellProthera has signed a Memorandum of Understanding (MoU) with Alfresa Holdings Corporation to establish a strategic collaboration for the development and future distribution of its lead product candidate ProtheraCytes in Japan.

The agreement follows the recent publication of the EXCELLENT clinical trial results, supporting the therapeutic potential of ProtheraCytes, an autologous CD34+ stem-cell product expanded through CellProthera’s unique manufacturing process, designed to regenerate cardiac tissue and improve cardiac function following acute myocardial infarction.

Under the terms of the MoU, the 2 companies intend to negotiate a definitive collaboration and licensing agreement covering the execution and financing of a phase 3 clinical trial in Japan as well as the future distribution of ProtheraCytes in the Japanese market.

Jérôme Koch, Chairman of the Board, CellProthera, said, “Japan is a strategic market for regenerative medicine and an important next step in the global development of ProtheraCytes. We are very pleased to enter this collaboration with Alfresa Holdings, a recognised leader in the Japanese healthcare ecosystem. Together, we aim to advance phase 3 development and prepare the future commercialisation of ProtheraCytes for patients suffering from severe myocardial infarction.”

The collaboration combines CellProthera’s expertise in regenerative cardiology and advanced cell therapy manufacturing with the Alfresa Group’s extensive healthcare infrastructure and nationwide pharmaceutical distribution capabilities.

Yusuke Fukujin, Representative Director and Executive Vice President (EVP), Alfresa Holdings Corporation, said, “We are delighted to initiate this collaboration with CellProthera. Regenerative medicine represents a major opportunity to address significant unmet medical needs in Japan. We believe CellProthera’s innovative CD34+ cell therapy has strong potential, and we look forward to working together to support its clinical development and future availability for Japanese patients.”