12/07/2005
Curacyte starts clinical trial with PHP in first line extension
Leipzig, Germany, December 7, 2005 - Curacyte AG, a Leipzig-based drug development company, and its wholly-owned subsidiary, Apex Bioscience, Inc. based in Chapel Hill, North Carolina, announced today the enrolment of the first patients in a clinical trial of its experimental drug PHP in patients receiving high-dose interleukin-2 (IL-2) therapy for malignant melanoma and renal cell carcinoma.
In this open-label study, IL-2 cancer patients that begin developing shock are randomized to receive either a continous infusion of PHP or control in form of standard catecholamines. The study is scheduled to enroll a total of 20 patients. Apart from safety and tolerance, the study will also investigate the hemodynamic effects of PHP and IL-2-related, dose-limiting side effects.
Laboratory studies performed on the mechanism of IL-2 side effects identified PHP as a promising means of counteracting low blood pressure and "vascular leak syndrome" that currently limit IL-2-based cancer treatment.
Joseph De Angelo, Chief Development Officer at Curacyte, said, "In this trial, PHP will be administered before patients develop shock and require catecholamines. This is the first time that PHP will be used as the first-line agent to prevent shock in contrast to treating shock after it develops. The goal in this patient population is to reduce dose-limiting side effects. This will allow pateints to receive more doses of IL-2 and improve their chances of a significant response."
Curacyte's PHP is a scavenger of nitric oxide (NO), the main causative agent responsible for vasodilation and hypotension in distributive shock. PHP has been demonstrated to reverse the vasodilation and resolve the hypotension associated with distributive shock. PHP has completed Phase II clinical studies in distributive shock and is entering a Phase III study. Additional clinical studies of PHP in patients with cardiogenic shock are also planned.
