DDW’s Reece Armstrong speaks to Hendrik Streefkerk, Chief Medical Officer and Drug Safety Officer of CellProthera about the company’s cell therapy for acute myocardial infarction (AMI) and why regenerative medicine could be key to treating cardiac diseases.
ITV News Central | Marc Goug 28 July 2023...
Peter Altman, CEO of BioCardia, and Matthieu de Kalbermatten, CEO of CellProthera, comment on trans-endocardial intramyocardial delivery systems for biotherapeutics to treat heart failure, ischemia, and infarction, and the importance of the right delivery solution.
"Cell-based therapies have the potential to regenerate heart tissue as an alternative to heart transplante. Here, Dr Ibon GARITAONANDIA, Chief Scientific Officer at CellProthera, shares how CD34+ cells are demonstrating promising results in clinical studies."
"Autologous cell therapies are made from living cells, harvested from specific people. Every batch of inputs is different which makes predicting how each will perform in manufacturing a major challenge.Indeed, for Matthieu de Kalbermatten, CEO of France-based cell therapy developer CellProthera, starting material variability is the major issue facing the industry."
" BioCardia and CellProthera Enhance Collaboration for Development of ProtheraCytes™ for the Treatment of Acute Myocardial Infarction in Europe and Potential Early Access for Patients"
"Through its Phase I/IIb EXCELLENT clinical trial, CellProthera, a France-based biotechnology research company focusing on cardiac tissue regeneration, is demonstrating the safety and efficacy of a cell therapy approach to regenerating tissue following myocardial infarction. Here, CEO Matthieu de Kalbermatten shares his ambition to fulfil the promise of stem cell research"...
Investment landscape In 2023, Matthieu de Kalbermatten, CEO of CellProthera, looks forward to presenting the final safety and efficacy results of the company’s Phase II clinical trial, and for moving into Phase III. He says "Significantly, there is a new scheme set up in France whereby innovative biotherapies that address unmet medical needs can enter the market following a successful Phase II clinical, while running a Phase III in parallel. This will give us the opportunity to open dialogues with the regulatory body and gain invaluable experience in the marketing of our CGT product." For the industry, especially in Europe, initiatives and government regulatory reforms represent a great opportunity for companies such as CellProthera to bring their therapies to patients more easily. De Kalbermatten says the accelerated regulatory pathways will be key to getting more CGTs to market, however, in order to make it to approval pathways, many start-ups and smaller biotechs need to secure investments. He says: “The investment landscape has been tough this year and that looks to be carrying over into 2023. However, there is solid hope that the situation should come back to normal by the end of 2023 according to the usual 'up and down' cycle in the industry.”
Posted in DDW Exclusive Content, Market Reports | Tagged Advanced Therapy Medicinal Products (ATMPs), Alliance for Regenerative Medicine, Cell and gene therapy, EFPIA, EU, European Commission, European Federation of Pharmaceutical Industries and Associations, Market reporting