CellProthera enters final recruitment stage for phase I/IIb post-myocardial infarction therapy study

CellProthera enters final recruitment stage for phase I/IIb post-myocardial infarction therapy study

• Study of ProtheraCytes(R) cell therapy to treat patients following severe heart attack on track to read out in Q1 2024
• Final patient cohort recruitment underway at Queen Elizabeth Hospital Birmingham in UK

Mulhouse, France, May 25, 2023 – CellProthera, a regenerative cell therapy developer specializing in cardiology and myocardial infarction, today announces the final stage of its phase I/IIb clinical trial for its ProtheraCytes(R) cell therapy to prevent heart failure in patients following severe acute myocardial infarction (AMI). As the EXCELLENT (Expanded Cell Endocardiac Transplantation) trial nears completion, CellProthera has admitted the first patient in its final cohort at the Queen Elizabeth Hospital Birmingham, UK trial site. Enrollment in EXCELLENT remains on schedule for completion this summer, with a final readout anticipated in early 2024.

In just the US, Europe and Japan, over a million patients per year suffer from AMI. Approximately 30 percent of these patients are left with severely damaged heart tissue which until recently has been irreversible and frequently led to life-threatening heart failure. Advances in the cardiac regeneration field are reshaping possibilities. ProtheraCytes, CellProthera’s lead advanced therapy medicinal product (ATMP), would be the first therapeutic solution to restore the heart’s function following AMI. ProtheraCytes has been developed as a one-shot, minimally invasive autologous cell therapy to improve patients’ quality of life, as well as reduce ongoing hospitalizations and invasive medical treatments such as heart transplants.

“Bringing ProtheraCytes to market as a minimally invasive therapy is vital to tackle from the root the harmful effects of myocardial infarction and improve quality of so many lives,” said Matthieu de Kalbermatten, CEO, CellProthera. “The impressive progress of the CellProthera EXCELLENT trial is a testament to the work of our team and our stakeholders. All of the trial sites in the UK and France are committed to admitting and treating the final patients as quickly as possible. We will look to start a pivotal phase III trial in 2024 following to aim for potential market authorization.”

The EXCELLENT trial is a multi-center, randomized, controlled phase I/IIb clinical trial to evaluate the safety and efficacy of ProtheraCytes, which is patient-derived PB- CD34+ stem cells expanded in vitro. CellProthera is currently evaluating the feasibility of applying ProtheraCytes to other cardiovascular diseases, including ischemic strokes and refractory angina.

“There have been considerable advancements in treating AMI and subsequent heart failure with surgical procedure and medical treatment. However, there are few clinical options that propose to repair and regenerate heart tissue following AMI. As a result, the only option for many patients that have suffered severe AMI and developed advanced heart failure is a fully invasive heart transplant. This is in itself still a very serious procedure for the patient, and very costly for society. There are no currently approved therapies to repair existing hearts, and a severe shortage globally of hearts for transplants,” said Professor Sohail Khan, Consultant Interventional Cardiologist, Queen Elizabeth Hospital Birmingham and lead investigator at the Queen Elizabeth Hospital for the EXCELLENT study. “The development of a cell therapy to regenerate cardiac tissue will be transformative for a considerable number of patients globally. As a minimally invasive, autologous cell therapy, could also considerably reduce treatment costs.”

About CellProthera

CellProthera is a regenerative cell therapy developer specializing in cardiovascular diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of a large quantity of purified, CD34+ stem cells. Its lead therapy, ProtheraCytes(R), is an autologous cell therapy and has been developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicine Agency (EMA). CellProthera’s proprietary technology platform comprises an automated expansion device called StemXpand® and its disposable kit StemPack(R). CellProthera is headquartered in France and has 22 employees.