The continuation of the
In interpretating the DMB’s recommendation, it can be concluded that the overall safety profile of the company’s lead product PHP appears acceptable without signals or trends which might require modification or suspension of the trial. Consequently, the pivotal study will be continued according to the plan with the following key milestones:
To date more than 300 of the 454 target patients have been enrolled in the study. The next step will be the last interim analysis on 75% of the patients envisaged in Q4/2011 and the completion of recruitment by the end of 2011. Final top-line results are likely to be available in Q2 / 2012.
Scientists from Apex Bioscience, Inc. (Chapel Hill, North Carolina), Curacyte’s wholly-owned US subsidiary, have developed the modified haemoglobin product with the intention to exploit the natural NO-scavenging and metabolizing properties of haemoglobin. There is compelling evidence that NO is responsible for vasodilation and hypotension in distributive shock. In the successfully conducted Phase II clinical development program PHP has previously been demonstrated to reverse vasodilation and resolve hypotension associated with this form of shock.
About the PHOENIX trial
For inclusion into the trial the patients must be adequately resuscitated with fluids and must require a norepinephrine dose of ≥0.3 mcg/kg/min to maintain a mean arterial blood pressure of ≥ 65 mmHg. Furthermore, patients must at least fulfill two criteria indicative of a systemic inflammatory response (“SIRS” criteria). PHP as active compound or placebo will be administered by continuous intravenous infusion at 0.25 ml/kg/hr for a maximum of 150 hours.
Efficacy will be demonstrated by PHP significantly reducing 28-day all-cause mortality. Secondary endpoints will include: Survival time, survivor days in the intensive care unit (“ICU”) and time on mechanical ventilation and on vasopressors.
The trial is being conducted in 72 hospitals in six European countries and led by Prof. Jean-Louis Vincent from the
About Curacyte - www.curacyte.com
Curacyte AG is an advanced biopharmaceutical company dedicated to the development of new therapeutics for acute and critical care. After sale of its preclinical technology platform for low molecular weight protease inhibitors to The Medicines Company in 2008, Curacyte has focussed all its efforts on the development of PHP.
Tel: 49-(0)89 2000142 10
Dr. Erwin Böhm