Curacyte receives FDA clearance for clinical trial of PHP as an adjunct to IL-2 cancer therapy to reduce the effects of shock, which frequently limits the dose of IL-2 that can be given
Curacyte, a Munich-based drug development company focused on novel treatments of inflammatory diseases, thrombotic disorders, and cancer has announced that its US IND for conducting a phase I study with pyridoxalated hemoglobin polyoxyethylene (PHP) as an adjunct to high-dose interleukin-2 (IL-2) therapy in patients suffering from metastatic renal cell carcinoma (RCC) or melanoma has passed FDA review and that all requirements have been established to initiate this study.
PHP is currently in a phase III pivotal study as a treatment for patients suffering from distributive shock and this phase I trial seeks to establish an additional indication for PHP in an area of unmet medical need. PHP has been shown to be a scavenger of nitric oxide (NO). NO-related hypotension is a dose-limiting side effect of high-dose IL-2 treatment in metastatic RCC and melanoma.
Shock is a frequent adverse event, and patients can rarely receive their full dose of IL-2 and as a consequence may not optimally benefit from IL-2 therapy.
The potential clinical benefit of PHP administration to both patients and physicians may be two-fold: PHP may decrease the incidence of dose-limiting hypotension and shock and could, therefore, improve the outcomes of IL-2 anti-tumour therapy.
The phase I study planned by Curacyte is designed to study the safety, tolerability and activity of continuous infusion of PHP in patients receiving high-dose IL-2 therapy.
The study will be open-label and a total of 20 patients will be randomised to either the control or the treatment arm.
It will be conducted at the Huntsman Cancer Institute, University of Utah, USA.
Joseph DeAngelo, chief development officer of Curacyte, stated: "The initiation of the second clinical trial for our lead product represents an important milestone in our development strategy for PHP.
The outcome of this phase I study may help us establish a line extension of PHP in another area of unmet medical need.
Scientifically, the results of this study may corroborate the clinical utility of PHP as a NO scavenger and pave the way for exploring other areas of shock." PHP is a chemically-modified human hemoglobin and represents Curacyte's most advanced product in development. PHP is currently in a phase III pivotal study as a treatment for patients suffering from distributive shock affecting more than 1.2 million patients annually.
The therapeutic utility of PHP is based on several physiological functions of hemoglobin, the most important of which is the ability of hemoglobin to bind and metabolise excess and toxic levels of nitric oxide, the main cause of shock.
