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txcell (TXCL) Details

TxCell Promesses develops cell-based immunotherapies for the treatment of severe chronic inflammatory and autoimmune diseases. The company’s product candidates include OvaSave, which has completed phase I/II clinical trials for the treatment of severe refractory Crohn’s disease; and Col-Treg, which is under preclinical stage for the treatment of autoimmune uveitis. Its other product candidates include Myelin that is under development for the treatment of central nervous system inflammatory diseases; and HSP60, which is under development for the treatment of autoimmune and inflammatory diseases. The company was formerly known as TxCell S.A. and changed its name to TxCell Promesses in April 2014. TxCell Promesses was founded in 2001 and is headquartered in Valbonne, France.

40 Employees
Last Reported Date: 10/2/14
Founded in 2001

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txcell (TXCL) Key Developments

TxCell SA Receives EU Orphan Drug Designation for Col-Treg in Treatment of Non-Infectious Uveitis

TxCell SA announced that the European Commission has granted orphan drug designation to company's investigational medicinal product Col-Treg, a T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of autoimmune uveitis. Autoimmune uveitis is a debilitating inflammatory condition of the eye, often resulting in permanent vision damage. Uveitis is one of the causes of blindness in the developed world. It is a rare disease with a prevalence of around 35-50/100,0001. Autoimmune uveitis constitutes 80-90% of cases2. No treatment is currently approved for the patients that become refractory to corticosteroid compounds. In addition, these products are known to cause serious side effects when used for a prolonged period. Because of the low safety and the increased resistance to existing drugs, the development of new and safer class of therapeutics to treat autoimmune uveitis is essential. In the EU, the benefits of Orphan Drug Designation from the European Commission include protocol assistance and possible exemptions or reductions in regulatory fees during development. Another benefit from the classification is 10 years of market exclusivity from product launch.

TxCell SA Announces Start of Phase IIb Clinical Trial with Ovasave for Refractory Crohn's Disease

TxCell SA announced that it has enrolled the first patient in its phase IIb clinical trial of its lead product Ovasave in refractory Crohn's disease. TxCell has received approval for this multi-center, multinational trial from the regulatory authorities in all six European countries in which the trial will be performed. Top line results of this study are expected at the end of 2016 to early 2017. The phase IIb study, named CATS29 (Crohn's And Treg Study) includes 32 study sites in 6 countries (Austria, Belgium, France, Germany, Italy and United Kingdom). The trial has been designed to include 160 severe refractory Crohn's disease patients. The primary objective of the CATS29 study is the evaluation of the response rate for a single intravenous injection of 1.10(6) cells dose of Ovasave compared to placebo 6 weeks post administration. Response is defined as a decrease greater than or equal to 100 points in the Crohn's Disease Activity Index (CDAI), the gold standard regulatory measure of response in Crohn's disease. The CATS29 study is a multicentre, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel groups study. It will evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn's disease. Patients will receive, double-blinded, two intravenous (iv) injections 8 weeks apart of either 1.10(4), 1.10(6), or 1.10(7) cells of Ovasave or placebo. Patients will then receive either an open-label treatment with 2 additional iv injections of 1.10(6) cells of Ovasave or a safety follow-up with no injection. Finally, there will be an extended safety follow-up for all patients.

Txcell Reports Revenue Results for the Third Quarter and Nine Months Ended September 30, 2014

TxCell reported revenue results for the third quarter and Nine Months ended September 30, 2014. For the quarter, the company reported revenue of EUR 83,000 compared with no reported revenues during the same period in 2013. For the nine months, the company generated revenues of EUR 245,000 compared with no reported revenues during the same period in 2013.


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