CellProThera® and BioCardia® have announced an agreement to expand their current collaboration to the SIngXpand Clinical Trial in Singapore.
France-based CellProThera is developing a cell therapy product for the regeneration of the damaged heart short after a severe heart attack. CellProThera has developed a proprietary technology to expand human peripheral blood CD34+ cells and turn them into a stem cell graft ProtheraCytes®. The graft is then directly injected into the heart tissue of the patient during a minimally invasive procedure. Californian company, BioCardia, Inc. is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company’s current products include the Helix™ Biotherapeutic Delivery System and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. CardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells to potentially stimulate the body’s natural healing response through a minimally-invasive, catheter-based procedure.
The newly expanded SIngXpand study will evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process and delivered via BioCardia’s Helix™ Biotherapeutic Delivery System for the treatment of patients soon after a heart attack.
Under the terms of the agreement, CellProThera will fund completion of all regulatory and clinical activities undertaken by both firms for the clinical investigation. If the study results in regulatory approval of the product, CellProThera will have exclusive commercial rights in Singapore to the Helix Biotherapeutic Delivery System for the delivery of culture expanded CD34+ cells to treat patients who have suffered a recent heart attack. BioCardia will receive double-digit royalty payments on future sales of the combination product.