MULHOUSE, Frankrijk–(BUSINESS WIRE)– Na deze zomer Europese toestemming te hebben verkregen, heeft CellProthera ook toestemming van Franse en Britse toezichthouders voor het begin van zijn eerste I/IIB-faseonderzoek bij mensen. Het onderzoek begint in januari 2016.
Onlangs presenteerde CellProthera zijn regeneratieve cardiologische therapie aan Marisol Touraine, Franse minister van sociale zaken, volksgezondheid en vrouwenrechten. Bij de presentatie was veel publiek aanwezig, onder wie journalisten, investeerders, dokters en kabinetsleden. Het initiatief positioneert CellProthera als een van de belangrijkste Franse startups in medische diensten.
Cellular Regenerative Therapy Greeted by French Minister of Health
MULHOUSE, France–(BUSINESS WIRE)– After European authorization was obtained this summer, the French and British regulatory agencies have authorized CellProthera to begin its first phase I/IIB clinical trial in Humans, starting January, 2016.
Recently, CellProthera presented its regenerative cardiac therapy to Marisol TOURAINE, French Minister of Social Affairs, Health and Women’s Rights, before a large audience of journalists, investors, doctors and cabinet members. This initiative firmly places CellProthera among the key French startups in health services.
Upcoming launch of the 1 st clinical trial on Humans
Two cell therapy centers devoted to clinical trials – EFS ABG Nantes for France and Newcastle Cellular Therapies Facility for UK – have already been equipped with the StemXpand® automated system developed by CellProthera. Within nine days, the automated system increases by 20 times the blood stem cells selected in blood samples from patients who have suffered a severe heart attack.
As of January 2016, 9 clinical investigation centers, 6 in France and 3 in UK – Edinburgh, Leeds, Newcastle – will be operational. 44 patients who have just suffered from a severe heart attack will be selected and recruited by the study investigating cardiologists.
The CellProthera ProtheraCytes® treatment
About 220 ml of blood are withdrawn on an outpatient basis from each eligible patient and sent to one of the participating cell therapy centers. After the blood stem cells of each patient are expanded during 9 days in the StemXpand® automated system, the cell graft obtained will be re-injected directly into the patient’s cardiac lesion at the end of the 3 rd week after the heart attack.
Beginning of 2016, the first graft should be performed by Pr. Jérôme RONCALLI – Principal Investigator of the study at the University Hospital of Toulouse-Rangueil Hospital.
After this phase of patients’ enrollment scheduled to be completed within 6 months, an additional 6-month period of data-monitoring and analysis will follow.
Next steps: extended clinical trial and new round of fundraising
A phase III clinical trial enrolling 150 patients will further be launched in Europe, US and Canada to which the marketing phase will follow. The Mulhouse biotechnological firm, which has at this point already raised almost 20M€, half of which is public funding, intends to conduct a new round of fundraising of about 25M€ very shortly.