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 Français du Sang, EFS] directorates in the Aquitaine-Limousin and Pyrénées-Méditerranée 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 France’s 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 François Pattou’s 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.
4. A cell-based immunotherapeutic in Phase III clinical
development for the treatment of melanoma at the loco-regional invasion
stage (Nantes University Medical Center)
There are currently no
approved treatments for lymph node metastatic melanoma in Europe.
It is hoped that combination therapy with TILs and IL-2 will prevent or
slow metastatic recurrence and improve overall survival in stage III
melanomas after lymph node excision with a single invaded lymph node.
5. The MESAMI (Mesenchymal and Myocardial Ischemia) program
(Toulouse University Medical Center), in Phase II development: the
potential use of mesenchymal stem cells from bone marrow to combat left
ventricular myocardial ischemia.
This innovative cell
therapeutic has been developed for cardiovascular applications by the
Toulouse University Medical Center, in partnership with the EFS. It
involves the culture of autologous bone marrow cells according to a
well-defined procedure that makes it possible to expand the patient’s
mesenchymal stem cells.