The C4C consortium Announces the Implementation of France's First Ever Facility for the Industrialization of Cell …

PARIS--(BUSINESS WIRE)--

The C4C consortium today announced the implementation of France's first ever dedicated technical facility for the manufacture of cell therapy products. The C4C project (coordinated by CELLforCURE, a subsidiary of the leading French biopharmaceutical company LFB Biotechnologies) brings together the skills of two biotech companies (Celogos and CleanCells) and seven public-sector organizations and university medical centers (the French Blood Agency's [Etablissement Franais du Sang, EFS] directorates in the Aquitaine-Limousin and Pyrnes-Mditerrane regions of France, Bordeaux University Medical Center [CHU de Bordeaux], Lille University Medical Center/University of Lille 2 [CHU de Lille], Nantes University Medical Center, [CHU de Nantes] and the Biological Resource Center at Lyons University Medical Center [Banque de Tissus et de Cellules des Hospices Civils de Lyon]. The first five products are currently being developed, with a view to validating the facility dedicated to the routine production of clinical trial and therapeutic batches. This facility is located on LFB's site in Les Ulis, close to Paris.

C4C is an ambitious project that has attracted 80 million euros in investment from the consortium members and 30 million euros in public-sector financial aid (provided by OSEO, France's state innovation agency). In fact, C4C was selected by OSEO as part of the "Investing in the Future" call for tenders for France's first industry-academic gateway in the field of cell therapy research, development and industrial production. The project has attracted 30 million euros in public-sector financial aid. Thanks to C4C, academic, public- and private-sector stakeholders are provided with an industrial tool for producing both their Phase 3 clinical trial batches and commercial batches.

Lastly, the C4C project corresponds to Europe's first ever modular unit for the large-scale industrial production of novel, cell-based advanced therapy medicinal products.

Cell therapy: definitions and issues

Cell therapy involves the administration of human cells to prevent, treat or alleviate an illness. In some situations, the administered cells repair and/or rebuild damaged tissue. In others, modified cells are used to provide tissue with compounds that it previously lacked. The cell therapy market is set to be worth an estimated 5.2 billion US dollars by 2015 and could double again to reach 10 billion US dollars in 2020.

The five therapeutics currently under development and their target diseases are as follows:

1. The GRAPA Program in Phase I/II development at Bordeaux University Medical Center in collaboration with Frances National Blood Service (EFS). Hematopoietic stem cells are obtained from placental blood and amplified ex vivo prior to use for the treatment of bone marrow or lymph node malignancies (leukemia, lymphoma, myeloma), aplastic anemia, congenital immunodeficiencies and congenital enzyme deficiencies.

2. The CEL-02 cell therapeutic from Celogos, in Phase II clinical development for the treatment of anal incontinence A Phase II clinical trial is currently recruiting at Rouen University Medical Center and the start of the Phase III clinical program (to include investigators across Europe) is scheduled for 2014.

3. Autologous islet of Langerhans grafts (Lille University Medical Center/University of Lille 2), in Phase I/II clinical development for the treatment of post-pancreatectomy diabetes The procedure developed by Professor Franois Pattous group in Lille is based on an intramuscular, autologous transplant of islets of Langerhans that makes it possible to obtain long-term insulin independence in the majority of patients.

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The C4C consortium Announces the Implementation of France's First Ever Facility for the Industrialization of Cell ...