Celogos and Stem Cell Sciences KK (SCSKK) have reached an agreement on the licensing of technologies for myoblast cell implantation for the treatment of stress urinary incontinence.
Under this license, Celogos has granted SCSKK exclusive rights to commercialize in Japan therapeutic products developed under Celogos’ patent and know-how related to myoblast implantation.
The alliance is based on Celogos’ fundamental technology platform known as Rational Cell Design (RCD) that is applicable to the development, optimization, production and transplantation of novel cells.
Celogos is developing a therapy for urinary incontinence and is currently in Phase I/II clinical trials in France. RCD technologies have enabled Celogos to establish a complete process for myoblast implantation, from removal of muscular tissue biopsy, cell-isolation and cultivation, to their transplantation into the urethral sphincter of urinary incontinence patients. In this process line, cell-separation and cell-cultivation are conducted under tight quality control in a GMP compliant Cell Processing Center (CPC).
SCSKK is currently working to develop its own technologies and has already obtained an exclusive license related to human Multipotent Adipose-Derived Stem (hMADS) cells for therapeutic use and research use from University of Nice/CNRS in 2005 and 2006, respectively.
This new technology from Celogos will provide SCSKK with a more clinically advanced product to expand and diversify the range and development stages of the SCSKK cell therapy pipeline. SCSKK plans to promote further research and development of these products to facilitate commencement of early clinical trials.
Mr. Kenzo Nakajima, President and CEO of SCSKK, said “We are very pleased to be able to complement our therapeutic pipeline with these clinically advanced Celogos technologies. These technologies will facilitate the production of autologous cell transplantation treatments for stress urinary incontinence for women, and urinary incontinence for men after prostatectomy.”
Nakajima said, “With clinical trials now ongoing in France and the highly refined nature of the technological process we can have confidence in the anticipated safety and efficacy profiles of this therapeutic product. We further expect that the necessary authorizations required from the Ministry of Health, Labor and Welfare in Japan, including authorization for commencement of clinical trials, should not require a complex procedure. We plan to launch a clinical trial in the first quarter of 2008.”
Dr. André Ulmann, Executive Director and President of Celogos, commented: “We are delighted to have established this collaboration with Stem Cell Sciences KK, a pioneer in the development of stem cell-based therapies. This agreement is a further validation of the unique potential of our RCD technology platform.”
“Preliminary results on RCD1, the Company’s product for the treatment of stress urinary incontinence, are very promising and we anticipate receiving regulatory approval for its commercialization before 2010. This agreement also represents our first deal with a company in Japan, the world’s third largest pharmaceutical market,” Ulmann continued.