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Spanish Biotechnology Company, Cellerix, S.L., Receives Orphan Status Designation By The European Medicines Evaluation Agency For A Stem Cell Medicinal Product



10/19/2005 5:09:04 PM

Madrid, July 2005 - Cellerix, a company belonging to the Genetrix group and specialised in the development of cell-based therapies, has received Orphan Status designation by the European Medicines Evaluation Agency (EMEA) for one of its products in development. Cellerix’s medicinal product is currently in clinical trials and uses stem cells taken from adipose tissue coming from the same patient, and will be used for the treatment of fistulas. Cellerix was founded in 2004 with the objective of exploring the therapeutic potential offered by the latest developments related to the use of adult stem cells for the regeneration and repair of tissue.

The company has the first, and only GMP certified installation in Spain for the production of cellbased medicines. For Cristina Garmendia, Chairman of the Genetrix Group, this is of key importance: "we are the only lab in Spain authorised by the EMEA to undertake this kind of development." In addition to the indication for which Cellerix has gained Orphan Status, "the company is exploring products for the regeneration of soft tissue, biomaterials as support matrices, and their equivalents for skin," added Garmendia.

The product from the Spanish Biotechnology company Cellerix has demonstrated both safety and efficacy in phase I clinical trials and is currently in a phase II trial with a larger number of patients. For Jorge Alemany, Chief Executive Officer of Cellerix, "with this milestone the company positions itself a European reference in the emerging sector of cell-based therapy, and has been able to convert a field which has, until now, been considered as pure research, into a therapeutic reality."

The technique developed by Cellerix is based on the use of stem cells taken from adipose tissue coming from the same patient. Using a simple liposuction, the required quantity of fat is extracted to isolate the stem cells which are then multiplied in the labs of Genetrix. The cells processed in this manner are subsequently applied to the site of the fistula and the patient may be cured within a few weeks of treatment.

Dr. Damián Garcia-Olmo, Director of the Cell Therapy Unit at the Hospital La Paz in Madrid explains, "this approach is particularly attractive since it offers much higher yields for obtaining adult stem cells than from using other sources, for example, such as bone marrow, and is easy to perform by way of a simple liposuction. An important advantage of this method is that the implant is performed using cells coming from the same patient, eliminating any problems associated with rejection, often typical of transplants from different donors."

Orphan Drugs CIF B-82826546 ¦Inscrita en el Registro Mercantil de Madrid, Tomo 15909, Folio 140, Sección 8, hoja M-268899 Marconi, 1¦ Parque Tecnológico de Madrid ¦ 28760 Tres Cantos, Madrid ¦ Tel. +34 (91) 804 92 64 ¦ Fax +34 (91) 804 92 63 www.genetrix.es

Orphan status designation is awarded to those medicinal products that are for preventing or treating life-threatening or very serious conditions that are rare. Up until July 200, only 284 medicinal products have received Orphan status by the EMEA, and up until now, none of those have been for a cell-based medicinal therapy.

This designation allows Cellerix to benefit from the incentives provided to these types of medicinal products, which amongst others, includes market exclusivity for 10 years, fee reductions, and access to EU-funded research as well as promoting a faster time to market. Cell-based medicinal products

In the different tissues that make up the human body, so called stem cells can be found which are capable of transforming themselves into any type of human tissue. At present, it is possible to isolate and multiply these cells for subsequent transplantation into the body in places where tissue regeneration is needed. It allows for cells to be used as authentic living medicines, paving the way for new therapeutic applications, impossible up until now. Treatment of fistulas

Anal fistulas are abnormal connections between the anus and the rectum, with other epithelia (skin, vagina....), which under normal circumstance should not be connected together. It is a pathology that seriously affects the quality of life of sufferers given that in many cases, anal incontinence develops and leads to a high risk of infections Surgery is the only current treatment, which is both expensive and shows poor efficacy, particularly in fistulas arising from other pathologies, such as in Crohn’s disease.

Cellerix, S.L. Cellerix is a Spanish Biotechnology company founded in 2004 with the objective of exploring the therapeutic potential offered by the latest developments related to the use of adult stem cells for the regeneration and repair of tissues.

For more information, please contact Vicente Díaz Martínez, Communication (Genetrix) Tel. +34 (91) 804 92 64 ext. 209 Email: vdiaz@genetrix.es


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