Munich, June, 5th 2009

Curacyte AG reports today the inclusion of the first patient in the pivotal Phase III clinical trial with its lead drug PHP (Pyridoxalated Hemoglobin Polyoxyethylene / Hemoximer). The modified hemoglobin preparation is being tested in patients suffering from distributive shock and who are not responsive to standard therapy with catecholamines. These patients are currently lacking treatment alternatives and suffering a mortality rate of more than 75%.
The placebo-controlled randomized study is being conducted in seven different European countries and aims to enroll more than 450 patients within the next two years. The trial examines the effectiveness of nitric oxide (NO) scavenging in distributive shock patients in addition to standard of care and its primary endpoint will be 28-day all-cause mortality.

The mythical bird, Phoenix, provided the acronym for the study. It is derived from: PHP for the Treatment of Excess Nitric O xide in Distributive Shock.

“I am extremely pleased that the study has come off to a good start“ commented Prof. Jean-Louis Vincent (Erasmus University Hospital Brussels, Belgium and Lead Investigator of the PHOENIX study) and continued: ”This trial is designed to demonstrate that scavenging of nitric oxide can rescue patients suffering from distributive shock. The targeted subgroup of patients has currently no further treatment options and for this reason, the results of this trial will be clearly of medical significance. A positive outcome of the trial could have major impact on future treatment modalities.”

About PHP / Hemoximer:
Scientists from Apex Bioscience, Inc. (Chapel Hill, North Carolina), Curacyte’s wholly-owned US subsidiary, have developed the modified hemoglobin product with the intention to exploit the natural NO-scavenging and metabolizing properties of hemoglobin. Compelling evidence suggests that NO is the causative agent responsible for vasodilation and hypotension in shock. PHP has previously been demonstrated to reverse vasodilation and resolve hypotension associated with distributive shock in the successfully conducted Phase II clinical development program.

About the Phoenix trial:
This Phase III, multi-center, randomized, placebo-controlled study compares the effectiveness of continuous infusion of PHP / Hemoximer plus conventional vasopressor therapy against placebo (normal saline) plus conventional vasopressor therapy in patients with catecholamine-resistant distributive shock. In addition, the safety and tolerability of this new treatment modality will be evaluated.

For inclusion into the trial the patients must be adequately resuscitated with fluids and must require a norepinephrine dose of ≥0.5 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 / Hemoximer 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 will be conducted in seven European countries with enrollment currently initiated in Austria, Belgium and Germany. It is estimated that 80 hospitals will treat more than 450 patients over the next 18 – 24 months.

About Curacyte:
Curacyte AG is an advanced biopharmaceutical company dedicated to the development of new therapeutics for acute and critical care. After the recent sale of its preclincal technology platform for low molecular weight protease inhibitors to The Medicines Company, Curacyte has focussed all its efforts on the development of PHP / Hemoximer.
Apart from distributive shock, Hemoximer is also being studied as an adjunct to high-dose interleukin-2 (IL-2) for patients with metastatic melanoma and renal cell carcinoma. Shock is a frequent doselimiting side effect of high-dose IL-2 therapy.