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Phase I/II: Promethera® Biosciences successfully enrolls twenty patients in its multicentric Phase I/II trial

 

On November 12, 2013, Promethera Biosciences announced the completion of patient enrolment for its first clinical trial. 

 

Promethera Biosciences is conducting the trial in five countries: Belgium, France, United Kingdom, Italy and Israel. In total, 11 clinical centers actively participate in the study: Cliniques Universitaires Saint-Luc, Belgium, Universitair Ziekenhuis Antwerp, Belgium, Hopital Jeanne de Flandre in Lille, France, Centre Hospitalier Universitaire Bicetre in Paris, France, Centre Hospitalier Universitaire de Toulouse, France, Birmingham Children’s Hospital, UK, Great Ormond Street Hospital, UK, IRCCS Ospedale Pediatrico del Bambino Jesu, Italy, Meyer Children’s Hospital at Rambam Health Care Campus, Israel, Hadassah Ein-Kerem Medical Center, Israel, Schneider Children’s Medical Center of Israel. The study started in March 2012 with the first patient treated in Belgium.

 

As of today, 20 patients aged from six weeks to 16 years have been treated with Promethera® HepaStem.

 

Phase I/II: Promethera® Biosciences opens the Italian part of its clinical trial in cell therapy

On April 15, 2013, a 6-year-old girl suffering from Carbamoylphosphate Synthetase I Deficiency (CPS-ID) was treated with Promethera® HepaStem in a phase I/II trial studying the safety and preliminary efficacy of this innovative cell-therapy. The patient received the high dose of HepaStem. The administration of the cells took place at the Bambino Gesu Hospital (Rome) and was performed by the teams of Drs Torre and Dionisi-Vici. This patient is the first to have been treated in Italy and the ninth out of the 18 scheduled in our clinical trial.

The treatment was successfully applied over four days. The cell formulation was performed at the hospital using the closed formulation system installed in a room near the room of the patient. Noteworthy is that this system has been validated and approved by Italian Competent Authorities to prepare the cells in a non-aseptic environment.

 

Phase I/II: Promethera® Biosciences opens the United Kingdom part of its clinical trial in cell therapy

On February 26, 2013, a 2,5-year-old toddler suffering from Ornithine Transcarbamylase Deficiency (OTCD) was treated with Promethera® HepaStem. This patient is the sixth in a series to have been treated with Promethera® HepaStem. The administration of the cells took place at the Birmingham Children's Hospital (UK).

 

So far six paediatric patients have been treated with Promethera® HepaStem in three countries. Indeed, two patients with OTCD) and two patients suffering from Crigler-Najjar syndrome) received the treatment in Belgium, one adolescent with OTCD was treated in France by means of cells prepared in Promethera’s mobile formulation unit on site and at this time, another OTCD boy received cells in the United Kingdom. The safety data collected so far supports the good tolerability of Promethera® HepaStem in the phase I/II clinical study and warrants further enrollment of new patients.

 

Phase I/II: Promethera® Biosciences opens the French part of its clinical trial in cell therapy

On January 25, 2013, a 14-year-old adolescent suffering from Ornithine Transcarbamylase Deficiency (OTCD, one of the Urea Cycle Disorders) was treated with Promethera® HepaStem. The patient is the first to have been treated in France. The administration of the cells took place at Hôpital Jeanne de Flandre in Lille (France).

 

The treatment was successfully applied over three days. The cell formulation was performed both on clinical site in Promethera’s mobile formulation unit and at the premises in Mont-Saint-Guibert (Belgium).

 

Contacts

PROMETHERA Biosciences S.A./N.V.
Watson & Crick Hill
Rue Granbonpré, 11
B-1435 Mont-Saint-Guibert
(Belgium)
Tél.: +32 (0)10 39 43 00
Fax: +32 (0)10 39 43 01

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