CellProthera achieves a revolutionary breakthrough in the treatment of myocardial infarction with the support of the Alsace Region and the Alsace BioValley biocluster

CellProthera, a medical biotechnology company set up in 2008 at the heart of Europe has achieved a unique clinical milestone in terms of regenerative cell therapy following myocardial infarction (MI)

Strasbourg, France | January 26th, 2010 | CellProthera, a medical biotechnology company set up in 2008 at the heart of Europe (Mulhouse, in the French region of Alsace) has achieved a unique clinical milestone in terms of regenerative cell therapy following myocardial infarction (MI). CellProthera has developed a novel and revolutionary treatment for MI that will be a real alternative to heart transplant. A proof of concept study has recently confirmed the tremendous benefit of this therapeutic innovation, which is unprecedented worldwide.

CellProthera proposes a therapeutic approach that first consists in selecting and expanding the patient’s own adult stem cells collected from a simple blood sample withdrawn in the days following the occurrence of an MI. Thereafter, a non surgical delivery of these cells into the damaged cardiac area would lead to its progressive regeneration within the following months instead of the inevitable development of irreversible necrosis, to the benefit of the patient’s life expectancy.

The beneficial effects of this breakthrough treatment have been observed in a benchmark pilot study carried out over the past six years in collaboration with the "Institut de Recherche en Hématologie et Transplantation" (IRHT) in Mulhouse, and recently reported in Cytotherapy, the official journal of the International Cell Therapy Society1. Seven patients suffering from a severe MI (three of whom were considered candidates for heart transplant) were treated with a direct intracardiac injection of their own stem cells (ASC). A progressive improvement of the left ventricular ejection fraction (an established parameter of the cardiac contractile function) was observed in six of the seven patients from the third month onward, with a mean improvement rate of 64% from pre-treatment values by the 24th month. This outstanding functional improvement reflects a true myocardial tissue and vascular regeneration in the ischemic cardiac zone, as demonstrated by PET Scan imaging.

“Given that we have now an average follow-up of 57 months after the injection of the ASC graft, these results are quite impressive and unparalleled compared to interventional or surgical cardiac techniques (angioplasty, stenting or coronary artery bypass surgery), but also to those of competing teams using other types or source of cells.” commented Professor Philippe Hénon, Chairman and Chief Scientific Officer of CellProthera, a pioneer in the clinical use of ASCs in leukaemia who was the lead investigator in this clinical trial. “The majority of patients, including those who have initially required a heart transplant, recovered a nearly normal cardiac function allowing them to return to an active life. In addition, since the grafted adult stem cells come from the patients (autologous cells), there are no rejection or ethical concerns.”

According to Jean-Yves Neveux, Emeritus Professor at the University of Paris-Sud and an internationally renowned heart surgeon, there is no doubt about the therapeutic and economic impact of this revolutionary biotechnological treatment. “The unique therapeutic concept developed by CellProthera is based on a strong and internationally recognized scientific expertise. It opens up the prospect of a complete break with existing treatments. In addition, such cell regenerative therapy results in a highly significant increase in patients’ life expectancy and quality of life, while reducing the huge health cost associated with MI patients care. Moreover it may even represent a true alternative to heart transplant.”

An industrial solution to the benefit of the largest number of patients

As performed during the preliminary clinical trial, the process used for producing cell grafts is manual, lengthy, complex and costly, and requires highly specialized personnel and equipment. It could thus only be performed in few institutions for the benefit of a small number of patients. To make this innovation accessible to a larger number, it should be possible to produce autologous cell grafts quicker and at a reasonable cost.
CellProthera has raised seed funding of €1.6 million, one of the largest amounts raised in France in 2009. It was provided equally by public organizations [the Alsace Region, OSEO (the French state innovation and small business promotion agency), the French Ministry of Higher Education and Research, CAMSA and Alsace Amorçage) and by private regional investors (SODIV, Alsace Business Angels and Financière Bendélé). This funding will enable CellProthera to develop a proprietary prototype of an automated cell graft production device. Following the filing of several patent applications in Europe and the United States, CellProthera is now focusing on the development, industrial production and commercialization of a set of medical equipment incorporating individual disposable kits. Such dedicated equipment will permit the automated GMP production of autologous cell grafts for cardiac applications that ensures complete quality control through certified Cell Therapy centers throughout the world. The broad dissemination of this automated proprietary medical device, once validated by an international pivotal clinical trial, will enable Interventional cardiology centers to provide patients suffering severe MI the opportunity to benefit from this revolutionary treatment and thus to prevent the occurrence of secondary congestive heart failure, which would otherwise be unavoidable. This automated equipment is being developed in partnership with Bertin Technologies, which is providing CellProthera access to its recognized know-how in the area of automated biotechnology process engineering.

Much is at stake in socio-economical terms worldwide. Congestive heart failure following severe MI affects around 1 million new patients a year in the United States, Europe and Japan, and it remains the leading cause of death in developed countries, with an annual health cost above €50 billion.

An innovative R&D project that received in 2008 the full Alsace BioValley cluster's label

CellProthera developed its biotechnology platform from premises in Semia, the Alsatian incubator for innovative start-ups with the financial support provided by its public partners, including the Alsace Region, together with private investors. “It is an innovation with a broad social impact that Alsace is proud to have fully supported.” declared Nicolas Carboni, Director of the Alsace BioValley Competitiveness Pole. “For us, CellProthera is an exemplary project: it is materializing through the creation of a company with very serious industrialization prospects. This single project is generating activities and jobs, ready to bring clinical benefits to a large patient population and creating wealth while reducing healthcare costs, which is at the heart of the raison d’être of our Health Competitiveness Poles.”

About CellProthera

CellProthera is a leading medical biotechnology company located in Mulhouse, in eastern France, specialized in the development of autologous cell therapy for the regeneration of cardiac tissue after myocardial infarction. This treatment consists in the automated production of a graft of adult stem cells collected in the patient’s own blood followed by delivery of this graft directly into the cardiac lesion. This highly innovative concept has brought CellProthera several national and regional awards in recognition of its know-how:
* Laureate of the OSEO / Ministry of Higher Education and Research National Concours for the Creation of Innovative High-Tech Companies in 2008,
- Laureate of the RETIS Prize at Start Est 2008,
- Laureate of the Excellence Award of the 6th Innovation Trophy awarded by the Mulhouse Technopole and CEEI Alsace in 2009.

Chaired by Professor Philippe Hénon, CellProthera is run by an experienced team with complementary skills not only at the biological level but also at the clinical, pharmaceutical and financial levels. It currently employs five people (which will rise to seven by January 2010).

CellProthera is engaged in research partnerships with the following:

* The Institut de Recherche en Hématologie et Transplantation (IRHT ), a private non-profit medical research centre in Mulhouse that has been pioneering research into adult stem cells for over 20 years.
* The team of Professor Luc Douay at Inserm unit UMR S938 at Pierre and Marie Curie University (Paris), devoted to researches on stem cell proliferation and differentiation . Prof. Douay is a member of CellProthera’s Scientific Board.
* The Department of Physiology & Pharmacology at the University of Toledo (Ohio, U.S.A.), headed by Professor Nader Abraham, who is also a member of CellProthera’s Scientific Board.

CellProthera has also an industrial partnership with Bertin Technologies, in Montigny le Bretonneux, south-west of Paris, which provides it with essential advanced technology and industrial experience in the technical development of automated systems.

About the Alsace BioValley and Biovalley clusters

Alsace BioValley is a French cluster dedicated to life sciences and healthcare. It is the ideal entry point for any bio-business to develop effectively and fast on a European scale.

Situated in Alsace, at the heart of Europe, it offers an environment that is particularly favorable to life sciences and healthcare. The presence of experts with a worldwide reputation, a multiplicity of scientific services and a dynamic network of 400 companies, 60 laboratories and 20,000 people all testify to this.

Its mission is to bring together all the players – companies, research labs, universities in life sickens and help them grow in Alsace. The Alsace BioValley cluster offers them easy access to a multitude of resources and specialized services, thanks to a strong structured network of institutional and socio-economic partners (www.alsace-biovalley.com/fr/un-modele-unique).

Alsace BioValley acts in three main areas:

• Increasing the competitiveness of Alsatian life science and healthcare players by offering specialized services to the sector including commercial representation at international trade shows, search for partners and technologies, help in setting up affiliates.
• Helping the Alsace region to be more competitive through a structured approach including specialized buildings, scientific services platforms, logistics and shared services.
• Strengthening and developing its position internationally though for example the development in inter-cluster partnerships and exploratory missions.

Alsace BioValley is the French representative of Biovalley, the trinational life science cluster stretching over the frontiers of France, Germany and Switzerland. A force for successful opening to Europe and the world.

Alsace BioValley was considered one of the best performers among 71 poles of French competitiveness, thus confirming its status as an international pole.

SOURCE: CellProthera

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