CURACYTE
RECEIVES FDA CLEARANCE FOR CLINICAL TRIAL
OF PHP AS AN ADJUNCT TO IL-2 CANCER THERAPY
Munich,
Germany, July 1st, 2003 Curacyte AG, a Munich-based drug development
company focused on novel treatments of inflammatory diseases, thrombotic
disorders and cancer has announced
today 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-tumor 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 randomized to either the control or the treatment
arm. It will be conducted at the Huntsman Cancer Institute, University of
Utah, Salt Lake City, UT, USA.
Joseph
DeAngelo, Chief Development Officer of Curacyte AG, 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.”
Wolfram
E. Samlowski, M.D., Professor of Oncology Huntsman Cancer Institute,
Director, Cancer Immunotherapy Program who will be the principal
investigator when the Phase I study commences said: "The clinical use
of high dose IL-2 is currently limited to a few specialized centers due to
severe and dose limiting side effects (low blood pressure, vascular leak
syndrome). In my experience, about 1/3 to 1/2 of planned IL-2 doses are
skipped due to toxicity, reducing the chances for successful cancer
response. An agent that blocks these side effects will allow broader and
safer use of IL-2 by oncologists"
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 metabolize
excess and toxic levels of nitric oxide, the main cause of shock.
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Ends -
Notes
Curacyte
– www.curacyte.com
Curacyte
AG was founded in 1999 as a
research-based biopharmaceutical company dedicated to the discovery and
development of innovative and clinically meaningful new medicines. Last
year, 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 has one product in the clinic. This lead product, Pyridoxalated
Hemoglobin Polyoxyethylene (PHP), is in a Phase III pivotal study as a
treatment for patients suffering from distributive shock and there are
several other programs in pre-clinical development.
Curacyte
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 and plasma kallikrein
inhibitors are being evaluated for preventing activation of blood clotting
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 early in
2004. In June of this year, the Company announced that its scientists had
discovered small molecule inhibitors of matriptase, a trypsin-like serine
protease that is believed to play a key role in tumor invasion and
metastasis and that this program would move into pre-clinical development.
Media
enquiries
Sue
Charles, CEO, Northbank Communications, London
Phone:
+44 (0)20 7886 8152 E-mail: s.charles@northbankcommunications.com
Dr
Eileen Paul, Account Manager, Northbank Communications, Munich
Phone:
+49 (0)891895 7845 E-mail: e.paul@northbankcommunications.com
At
the Company
Dr.
Helmut Giersiefen, CEO, Curacyte AG, Munich
Phone:
+49 89 500808 0 Mobile: +49 172 9072885 E-mail:
info@curacyte.com
