CellProthera and Alfresa Holdings have signed an MOU covering potential Phase 3 development and future distribution of ProtheraCytes in Japan for severe myocardial infarction.

Collaboration targets Phase 3 development in Japan

French regenerative medicine company CellProthera has signed a Memorandum of Understanding (MOU) with Japanese healthcare and pharmaceutical distribution group Alfresa Holdings to explore the development and future distribution of ProtheraCytes in Japan.

ProtheraCytes is an autologous CD34+ stem-cell therapy developed using CellProthera’s manufacturing process. The company is developing the therapy to regenerate cardiac tissue and improve cardiac function following acute myocardial infarction.

The MOU follows the recent publication of results from the EXCELLENT clinical trial, which the companies say support the potential of ProtheraCytes in patients following severe myocardial infarction.

Under the proposed collaboration, CellProthera and Alfresa Holdings intend to negotiate a definitive collaboration and licensing agreement.

This would cover the execution and financing of a Phase 3 clinical trial in Japan, as well as potential future distribution of ProtheraCytes in the Japanese market.

The agreement therefore does not yet represent the start of a Phase 3 trial or a completed licensing agreement. The companies will first need to agree the terms of a definitive collaboration.

ProtheraCytes uses expanded autologous stem cells

ProtheraCytes is made from a patient’s own CD34+ stem cells, which are expanded using CellProthera’s manufacturing process before being used as a regenerative cell therapy.

The approach is intended to support the repair of damaged cardiac tissue after an acute myocardial infarction.

CellProthera chairman of the board Jérôme Koch said: “Japan is a strategic market for regenerative medicine and an important next step in the global development of ProtheraCytes.”

Koch added that the collaboration aims to advance Phase 3 development and prepare for the future availability of ProtheraCytes for patients with severe myocardial infarction.

The potential Japanese Phase 3 programme would represent a further stage in the clinical development of the cell therapy following the EXCELLENT trial.

Japanese distribution partnership could support future access

Alfresa Holdings operates across Japan’s healthcare supply chain, giving the potential collaboration a route towards future distribution if ProtheraCytes is successfully developed and approved in the country.

Alfresa Holdings representative director and executive vice president Yusuke Fukujin said: “Regenerative medicine represents a major opportunity to address significant unmet medical needs in Japan.”

Fukujin added that the company believes CellProthera’s CD34+ cell therapy has potential and that it looks forward to supporting its clinical development and future availability for Japanese patients.

The proposed partnership combines CellProthera’s expertise in regenerative cardiology and cell therapy manufacturing with Alfresa Holdings’ healthcare infrastructure and pharmaceutical distribution network.

For CellProthera, Japan represents a potential new market for ProtheraCytes as the company progresses its clinical development programme. The next step will be negotiations towards a definitive agreement covering the proposed Phase 3 trial and future commercial distribution.

A sophisticated medical illustration showing cardiac tissue following a myocardial infarction alongside stem cells or regenerative cell therapy. A heart-and-cell visual would work well; avoid a generic hospital or pharmaceutical distribution image.