Cell therapy and regenerative medicine provider, Orgenesis, Inc., recently disclosed that its wholly-owned subsidiary, MaSTherCell, a contract development and manufacturing organization (CDMO), has signed an agreement of understanding with TxCell in France. The memorandum covers the manufacturing of clinical supplies of Ovasave, the company’s leading therapeutic.
Ovasave is classified as an antigen-specific autologous T-regulatory somatic cell treatment, currently still undergoing tests as a potential drug for inflammatory bowel disease (IBD), such as Crohn’s disease and ulcerative colitis. As per the memorandum of understanding, the two companies have agreed to hold discussions on the long-term clinical and commercial production of TxCell products by MaSTherCell.
Ovasave supplies produced by MaSTherCell will be utilized by TxCell in an ongoing Phase 2b study, dubbed CATS29, as a treatment for Crohn’s disease. The production of the initial clinical batch is estimated to reach completion as early as the second quarter of 2016. CATS29 is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection 4-parallel group study that will involve 160 patients with severe refractory Crohn’s disease. The study will take place in 30 sites across Austria, Belgium, France, Germany, Italy, UK, and may soon be extended to sites in the US. Ovasave was recently granted Fast Track Designation by the US FDA for the treatment of moderate to severe Crohn’s disease.
“MaSTherCell is a European leader in cellular therapy products manufacturing with a significant track record in production of clinical materials. This strategic relationship with MaSTherCell is very important to TxCell,” said Stéphane Boissel, chief executive officer of TxCell.
Vered Caplan, chairperson and chief executive officer of Orgenesis, said, “We are pleased that MaSTherCell has entered into a substantial cell manufacturing agreement with TxCell for Ovasave, in an indication that has a clear unmet need which may best be treated through a cutting edge cell therapy like Ovasave. We look forward to working very closely with TxCell to deliver unparalleled manufacturing services for its trial.”
British medical technology firm 11health has announced UK availability of what it claims is the first ever patient-developed medical technology device. The Ostom-i Alert is projected to help the roughly 20,000 people in the UK who have stoma surgery annually address conditions resulting from surgeries performed to address colorectal cancer, bladder cancer, ulcerative colitis and Crohn’s disease.
The Ostom-i Alert sensor is a discrete innovative device that alerts patients as to the fullness of their ostomy/stoma bags to help the wearer decide its time to empty them in plenty of time to prevent both fluid and solid leakage, enabling patients to avoid embarrassing situations when out, or in particular when asleep. Patients can also use the device to send output levels automatically to nurses and clinicians.