TxCell Announces Start of Phase IIb Clinical Trial with Ovasave®

TxCell SA has 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.

“TxCell anticipates that the CATS29 study with Ovasave in refractory Crohn’s disease will confirm the exciting data from our first study CATS1 in this population and prepare the ground for the final phase of clinical development,” said Dr Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs. “Ovasave’s targeted, multi-target, multi-mechanism activity together with the personalized nature of the product, offers the chance of real innovation for refractory Crohn’s disease patients who currently have no treatment options. There are currently over 100,000 such patients per year in Europe and in the US alone.”

“The management of refractory Crohn’s disease poses a major challenge today,” said Dr. Severine Vermeire, Professor of Gastroenterology, University Hospital Leuven and Principal Investigator of the CATS29 study. “We urgently need new approaches like Ovasave to reduce the heavy burden of this disease on both patients and health systems. All the clinical centers look forward to participating in this important study for the field.”

The CATS29 study is a multicentre, randomized, 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.

“The launch of the phase IIb CATS29 study on schedule with our lead product Ovasave is another key milestone for the company,” said Damian Marron, CEO, TxCell. “We are well on track to rapidly move this innovative therapeutic approach through the development process with our partner Ferring International Center, so that it can become available to sufferers of refractory Crohn’s disease. This achievement is central to TxCell's strategy of targeting orphan/niche indications with poor or no treatment options.”