Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The French regulatory agency AFSSAPS has approved TxCell to extend Phase I/II Crohn And Tr1 Study (CATS1) with Ovasave for the treatment of the patients suffering from crohn's disease.
Subscribe to our email newsletter
CATS1 Phase I/II trial intends to investigate the tolerability and efficacy of Ovasave, a type 1 regulatory T cell based immunotherapy, in patients with severe chronic active Crohn’s Disease, who failed current treatments, including biologics.
Ovasave demonstrated evidence of a beneficial effect in the overall population of patients and was well tolerated in the first part of the study, completed in April 2010.
TxCell chief medical officer Miguel Forte said the open label study extension now approved will help to address the unmet medical need in some of the severe patients recruited in CATS1.
TxCell CEO François Meyer said they are now committed to confirm these results in a controlled phase IIb study and to progress the development plan of our lead product candidate, Ovasave.