TheAdmiral schreef op 2 november 2015 22:14:
Bron KBC securities (Jan De Kerpel)
€ 5.4m EU-grant for Cx611 severe sepsis phase Ib/II
News:
Tigenix and its academic members of the SEPCELL consortium have been awarded € 5.4m from the European Union’s Horizon 2020 programme to conduct a phase 1b/II trial of Cx611 in patients with severe sepsis secondary to severe community-acquired pneumonia. (sCAP).
Our View:
Severe sepsis is a devastating systemic illness due to an attack of host pro-inflammatory cytokines and other substances commonly induced by a bacterial infection. Current molecular approaches for the treatment of sepsis have inadequately addressed the complex immune-modulatory pathways involved in the sepsis pathogenesis. In animal models, stem cells have shown to down-regulate pro-inflammatory cytokines and up-regulate T-regulatory cells which modulate the immune system.
The SEPCELL project is a Phase Ib/IIa randomised, double-blind, parallel group, placebo-controlled, multicentre study designed to evaluate the safety and efficacy of Cx611 for the treatment of adult patients with severe sepsis secondary to sCAP and admitted to the intensive care unit.
The trial is expected to enrol a total of 180 patients across Europe. The study will start before YE15. Given the size of the patients to be enrolled, enrolment will last until 2Q17 and final results by YE17.
Cx611 is an intravenously-administered (systemic) product of allogeneic expanded adipose-derived stem cells (eASC's). This route of administration is different from lead product Cx601, which showed positive phase 3 results fistula, which is a local administered cell suspension.
Back in May, Tigenix announced that the results of its phase I sepsis challenge study confirmed safety and tolerability, though was not able to show signs of efficacy, as no significant effect of Cx611 on the LPS-induced symptoms could be detected. LPS is considered a marker for anti-inflammatory activity. The company stated that the timeframe of the LPS model might have been too short to show a therapeutic effect. It is believed that in severe sepsis patients inflammation levels are much higher, such that Cx611 could show effect in such patients.
Tigenix as project coordinator will receive € 1.3m of non-dilutive funds, and will be responsible for managing the remaining € 4.1m to fund the activities of the consortium's clinical and research partners.
Conclusion:
The award of the Horizon2020 grant underscores the unique character of the research to investigate the effects of an allogenic cell therapy in the life-threatening disease that severe sepsis is. Thanks to the non-dilutive funding, the cash investments for Tigenix will remain modest while the company maintains full ownership of the entire value of the project.
Buy rating and target price maintained.