Date: 2016-05-25
Type of
information: Clinical trial authorisation
phase: 2b
Announcement: clinical trial authorization
Company: TxCell (France)
Product: Ovasave® (antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy)
Action
mechanism:
- cell therapy/immunotherapy product. OvaSave® is an antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy. The Ag-Treg cells utilized in Ovasave® are isolated from whole blood of the patient, activated by the specific antigen, ovalbumin. The cloned Ag-Treg cells are expanded ex vivo before their reinjection into that same patient. The injected Ag-Treg cells home to sites of inflammation and are activated locally by the specific food antigen, ovalbumin.
Disease: Crohn disease
Therapeutic
area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Austria, Belgium, France, Germany, Italy, UK, USA
Trial
details:
- The CATS29 study is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel groups study. The study includes 32 study sites in 6 countries. This study could now be extended to include US sites. 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 1.106 cells dose of Ovasave® (ovalbumin-specific autologous Treg cells (OvaTreg)) 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. Patients will receive, double-blinded, two intravenous (iv) injections 8 weeks apart of either 1.104, 1.106, or 1.107 cells of Ovasave or placebo. Patients will then receive either an open-label treatment with 2 additional iv injections of 1.106 cells of Ovasave or a safety follow-up with no injection. Finally, the patients will be followed in an additional long-term safety follow-up, of maximum duration of 3 years from the first administration. (NCT02327221)
Latest
news:
- • On May 25, 2016, TxCell announced that it has received authorization from European regulatory authorities to restart its Phase IIb, placebo-controlled clinical trial with Ovasave® in patients with moderate to severe Crohn’s disease refractory to existing treatments (CATS29). The authorization for TxCell to restart the CATS29 clinical study includes using a new manufacturer, MastherCell , and an amended protocol, through the Voluntary Harmonized Procedure (VHP). TxCell is therefore preparing to resume CATS29 as soon as possible. Topline data are expected within 18 to 21 months of trial resumption.
- The CATS29 clinical study aims primarily at comparing Ovasave® at the 106 dose vs. placebo. The objective is to achieve a response rate of 70 per cent in the experimental arm vs. 30 per cent in the control arm. 56 patients with moderate to severe refractory Crohn’s disease will be evaluated. The patients will be recruited in 29 clinical centers in 6 European countries. The 32-week treatment will be split into two phases: firstly an 8-week blinded phase, where patients will receive at week 0 either placebo or Ovasave® 106 (randomized 1:1) and secondly a 24-week unblinded phase, where all patients will receive Ovasave®) 106 (three further open label injections at 8-week intervals). TxCell now plans to amend its US IND (Investigational New Drug) accordingly. The CATS29 Data and Safety Monitoring Board (DSMB) met ahead of the VHP approval to review all available data on previously treated patients, as well as updates on the study design and plans for the resumption of the study. The objective of the DSMB is to monitor patient safety during the conduct of the study. Upon reviewing of the data, the DSMB also allowed TxCell to proceed with the resumption of the CATS29 study as planned.
- • On December 2, 2015, TxCell announced that it has agreed with Trizell to terminate the agreement concerning TxCell’s lead product Ovasave®. The agreement granted Trizell an exclusive option to in-license development and commercialization rights to Ovasave® in inflammatory bowel disease, including Crohn’s disease. TxCell has now regained full rights to Ovasave®. Following this reacquisition, TxCell now proposes to amend the CATS29 phase IIb trial for Ovasave®, currently underway in refractory Crohn’s disease patients. The primary endpoint of the trial (1 million cell dose vs placebo) is intended to be maintained. The dose exploring arms are however expected to be omitted. Following the amendments to the CATS29 trial, TxCell intends to recommence the trial in Q2 2016, with the drug product manufactured by MaSTherCell, a contract manufacturing organization. TxCell expects to complete recruitment in CATS29 at the end of 2017 and announce topline data by Q4 2017 or Q1 2018.
- • On June 29, 2015, TxCell announced that the FDA has accepted its Investigational New Drug (IND) application for Ovasave®, currently in a phase 2b clinical trial for the treatment of patients with refractory Crohn’s disease. The study is currently one of largest ever-controlled studies for a personalized T cell immunotherapy product. The activation of the IND authorizes TxCell to extend the CATS29 study to the US. The CATS29 study is currently on-going in Europe following its start in December 2014. There are currently 30 study sites operating the study in 6 countries in the EU.
• On December 4, 2014, TxCell 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 primary objective of the CATS29 study is the evaluation of the response rate for a single intravenous injection of 1.106 cells dose of Ovasave compared to placebo 6 weeks post administration.
Is
general: Yes
