Curacyte AG Presents Positive Phase II Clinical Trial Results For PHP In The Treatment Of Distributive Shock

Munich, April 5^th 2004…. Curacyte AG, a Munich-based drug development company, presented encouraging results from its completed Phase IIc study of its lead product PHP (Pyridoxalated Hemoglobin Polyoxyethylene) in patients with distributive shock at the 24^th International Symposium on Intensive Care and Emergency Medicine (ISICEM), Brussels, Belgium, 30^th March – 2^nd April. The data was presented by Dr Gary T Kinasewitz, University of Oklahoma, USA, a principal investigator in the Phase II study. The trial was a pilot study of a Phase III protocol that addressed key protocol design issues related to patient selection criteria, PHP dosing regimen, PHP vasoactivity, and its impact on catecholamine use, morbidity and mortality in patients with distributive shock.

PHP is a scavenger of nitric oxide (NO), the main causative agent responsible for vasodilation and hypotension in distributive shock. By scavenging NO, PHP can reverse the vasodilation and resolve the hypotension. The hypothesis under test is that reduction of excess NO by PHP will result in better outcomes than the current standard of care for this type of shock. Current therapies use exogenous catecholamines to treat the symptom of hypotension without treating the cause of the hypotension.

Results from the trial clearly demonstrated that PHP was active in the 62 enrolled patients with distributive shock. Measurements of plasma nitrites and nitrates at baseline, showed excess levels of NO, confirming selection of an appropriate patient population; all were receiving catecholamines to maintain blood pressure. Comparison of patients receiving standard of care plus PHP treatment with those receiving standard of care plus a placebo solution showed positive trends in the time to catecholamine withdrawal and morbidity endpoints, comparable mortality rates, trends to reduced ICU stay for survivors (medians of 13.6 days with PHP versus 17.9 days with placebo) and earlier hospital discharge after the active treatment.

Commenting on the results, Dr Helmut Giersiefen, CEO, Curacyte AG, said

“Although this trial was not powered to definitely establish the efficacy of PHP, the promising trends support continued testing of PHP in a Phase III trial. Our strategy is to partner with a pharmaceutical company for the Phase III trial, who will then seek marketing approval.”

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Notes:

1. Further information on the 24^th ISICEM can be found via the website: http://www.intensive.org.

2. About Curacyte www.curacyte.com

Curacyte was founded in 1999 as a research-based biopharmaceutical company dedicated to the discovery and development of innovative and clinically meaningful new medicines. In 2002 the Company announced its merger with VitaResc Biotech AG, a development-stage company focused on novel treatments of inflammatory diseases, thrombotic disorders and cancer.

The Company’s lead product, Pyridoxalated Hemoglobin Polyoxyethylene (PHP), has reached Phase III clinical development as a treatment for patients suffering from distributive shock and there are several other programs in pre-clinical development. In July 2003 Curacyte received clearance from the FDA for initiating clinical trials of PHP as an adjunct to IL-2 cancer therapy.

Curacyte also focuses on inhibition of therapeutically relevant proteases. Several development projects are derived from Curacyte’s proprietary protease technology, including small molecule inhibitors of Factor Xa, plasma kallikrein and urokinase. Inhibitors of Factor Xa are currently in the lead optimization stage as oral anticoagulants. In October 2003 Curacyte announced that it had been awarded a €1.2M grant for its Factor Xa program. Plasma kallikrein inhibitors are being evaluated for preventing activation of the blood clotting cascade on surfaces of hemodialysis membranes. CJ-463 represents the first highly specific inhibitor of urokinase and has been in formal preclinical development since Q3 2002. Curacyte anticipates initiating first clinical studies with this anti-metastatic agent in 2004. Curacyte intends to apply its technology to other pathomechanisms that involve serine proteases and received a grant (€ 0.5 M) in December 2003 to pursue serine protease targets in cancer research.

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