Cellerix registers the name Ontaril® for its medicine Cx401
Madrid, 15th of April 2008.- Cellerix, a product-focused biopharmaceutical company developing innovative medicines based on cell therapy, has registered the name Ontaril® for its medicine Cx401. At the same time, Cellerix has developed a new corporate identity for Ontaril® to be used on its containers and other material related to the product.
Ontaril® is an innovative medicine based on cell therapy and is currently being developed to treat complex perianal fistulas with the use of stem cells that are isolated from a sample of the patient’s own adipose tissue. The clinical trials in Phase II have confirmed the safeness and efficiency of Ontaril® in the treatment of perianal fistulas in patients with or without Crohn disease.
Ontaril® has been designated an Orphan Drug by the European Medicines Agency.
Currently, Ontaril® is in Phase III of clinical testing and is expected to be on the market in 2010/2011. Cellerix will use its own infrastructure to commercialize the product in Europe, while it has a licensing and development agreement with Axcan Pharma Inc for the North American market (the United States, Canada and Mexico).
Notes to the Editor
ABOUT CELLERIX
Cellerix is a biopharmaceutical company developing innovative medicines based on cell therapy. The company has two products undergoing clinical trials: Cx401 for the treatment of perianal fistulas, currently in Phase III, and Cx501 for skin regeneration, currently in Phase II. Cx401 and Cx501 have been designated orphan status by the European Medicines Agency (EMEA). Cellerix closed in September 2007 a €27.2 million financing round led by international venture capital companies. In October 2007 it entered into an exclusive license and development agreement with Axcan Pharma for the North American rights to Cx401.
PERIANAL FISTULAS
Fistulas are abnormal communications between organs or tissues. Perianal fistulas (abnormal connections between the anus or rectum and the outer surface of the skin) are debilitating pathologies that cause incontinence and other infections, seriously undermining the quality of life of patients. An enormous medical need exists for a new treatment of fistulas, as the current treatments are all surgery based, making them highly expensive and reducing their success rate.
About 12% of patients with Crohn’s disease suffer from perianal fistulas, and there are an estimated 500,000 people with Crohn in the United States alone. There are about 10,000 cases of patients with other types of fistulas. Current treatments for fistulas in patients with Crohn’s disease include use of anti-TNF-alpha, with a response rate of about 36%. Surgery also is used to treat perianal fistulas in patients with Crohn’s disease, but it has a low success rate and carries a high risk of anal incontinence.
PRODUCT AND TECHNOLOGY
The human body is composed of cells that are differentiated into specialized tissues (such as the skin, the heart and other organs) and of cells that aren’t completely differentiated. The latter are stem cells, which are able to produce more stem cells, as well as differentiate into a range of specialized cell types. This discovery holds tremendous potential for the future of modern medicine.
Stem cells are found in various tissues of the human body. These cells can be isolated, processed and re-implanted in the patient for therapeutic purposes or to regenerate a specific tissue without the risk of rejection.
Ontaril® is an innovative product developed by Cellerix and employing stem cells derived from the patient’s own adipose tissue. The use of fatty tissue as a source of stem cells has clear advantages over other alternatives, such as bone marrow, because of the easy access it provides to stem cells and because the tissue is richer in cells (between 100 and 1000 times more cells are present). Only a small quantity of a patient’s body fat is needed to obtain stem cells with a high capacity for healing fistulas.
The anti-inflammatory properties of Ontaril® are what heal the trajectory of the fistula. This healing mechanism explains the excellent clinical results so far obtained by the product.
CLINICAL RESULTS
A Phase I study was carried out to evaluate the viability and safeness of Ontaril®, and it confirmed the medicine has the potential for treating fistulas in patients suffering from Crohn. The main conclusion of the study was that the product is safe and that 75% of the patients responded with the sealing and healing of their fistulas within eight weeks after treatment. This was the first clinical trial in the world carried out using stem cells derived from adipose tissue and demonstrating its effectiveness. (Garcia-Olmo, D. et al “A Phase I Clinical Trial of the Treatment of Crohn’s Fistula by Adipose Mesenchymal Stem Cell Transplantation”. Dis Colon Rectum 2005; 48: 1416-1423
A later Phase II trial with 50 patients in Europe confirmed the efficiency and safeness of Ontaril®.
The main objective of this test was to provide an objective clinical evaluation of the ability of the product to completely seal and heal the fistula. It showed a response rate of 71% in the acute phase of patients suffering from Crohn. The findings of the study, which are in the process of being published, were presented at the international congress Digestive Disease Week held in Washington in May 2007.