09/14/2005
Huntsman Cancer Institute Receives NIH Grant for Clinical Trial of Curacyte's PHP
Huntsman Cancer Institute will conduct a NIH-supported clinical trial of PHP in patients receiving Interleukin-2 for cancer
Leipzig, Germany September 14th, 2005 - Curacyte AG, a Leipzig-based drug development company, and its wholly-owned subsidiary, Apex Bioscience, Inc. based in Chapel Hill, North Carolina, have announced that the Huntsman Cancer Institute (HCI) Multidisciplinary Melanoma Translational Research Program has received notice of funding by the NIH for National Institutes of Health R21 Quick Trial Award - Clinical trial of PHP with high-dose interleukin-2 (IL-2), Wolfram Samlowski, MD, Principal Investigator. This study is designed to test Curacyte's experimental drug, PHP, in patients receiving melanoma and kidney cancer treatment with IL-2. Laboratory studies at the HCI of the mechanism of IL-2 side effects identified this drug as a promising means of counteracting low blood pressure and "vascular leak syndrome" that currently limit IL-2-based cancer treatment.
Dr. Samlowski, the principal investigator on the trial, said, "There is a great need for new and innovative approaches to treating patients with melanoma and kidney cancer. High-dose IL-2 remains one of the most successful treatments but its dosing is limited by side effects. If these side effects can be limited and the number of IL-2 doses tolerated by patients increased, we may be able to obtain improved outcomes. We are excited about the trial and the potential utility of PHP as an adjunct in treating these patients."
Joseph De Angelo, Chief Development Officer at Curacyte, said, "Clinical trials of PHP have been conducted in patients who are in shock and being treated with vasopressors. This is the first trial of PHP in a pre-shock population where the goal is to prevent the patients from developing shock. This may be an important adjunct to IL-2 therapy but would also have the potential to impact a broader population at risk for distributive shock."
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.
