BRANFORD, Conn., Nov. 14 /PRNewswire-FirstCall/ -- CuraGen Corporation today announced positive results from its Phase I safety, pharmacokinetic and pharmacodynamic study of CR002, a fully-human monoclonal antibody being evaluated for kidney inflammation, were presented on Saturday, November 12, 2005 in a poster presentation at the American Society of Nephrology’s (ASN) Renal Week 2005, hosted in Philadelphia, PA, November 8 to 13, 2005.
“CR002 is a novel and promising antibody therapeutic, and we are very pleased with the results from this initial Phase I trial. These data fully support further evaluation of CR002 for kidney inflammation where platelet derived growth factor-D (PDGF-D) is believed to play a role in the progression of disease,” stated Timothy M. Shannon, M.D., Executive Vice President of Research and Development and Chief Medical Officer at CuraGen. “We are excited about the data and look forward to identifying a partner who will work to further advance CR002 through clinical development to explore its role in potentially helping patients with kidney inflammation caused by PDGF-D, including IgA nephropathy and diabetic nephropathy.”
Data on 40 healthy volunteers dosed with CR002 were presented in a poster entitled, “A Phase I study of safety, tolerability, pharmacokinetics and pharmacodynamics of CR002, a fully-human monoclonal antibody which neutralizes PDGF-D.” Volunteers were randomized to receive either a single dose of CR002 or placebo via a two hour intravenous infusion. A total of five dose levels were evaluated, ranging from 0.3 mg/kg to 30 mg/kg. Each dose level enrolled six volunteers randomized to receive CR002 and two to receive placebo. Following administration of the study drug, subjects were followed for a total of three months.
CR002 was well tolerated at all doses evaluated and no serious adverse events were reported following exposure. Possibly related adverse events were mild in severity and self- limited. Pharmacokinetic analysis indicated that CR002 exhibited linear exposure across all dose levels with a terminal phase half-life ranging from 20.1 to 34.2 days. Pharmacodynamic studies indicate that CR002 binds to its intended target, PDGF-D, for periods of time in excess of 21 days. The safety and tolerability profile, long half-life and pharmacodynamic properties of CR002 support the future evaluation of CR002 in additional clinical trials as a potential therapeutic for kidney inflammation.
Reprints of the poster presentation, as well as information about CuraGen’s therapeutic pipeline and ongoing clinical trials are available on the Company’s website, http://www.curagen.com, or by emailing info@curagen.com.
Background on CR002 and Kidney Inflammation
CR002 is a fully human monoclonal antibody, generated with the XenoMouse(R) technology from Abgenix, Inc. The CR002 antibody neutralizes PDGF-D, a mediator discovered by CuraGen that stimulates mesangial cell proliferation. Mesangial cell proliferation has been implicated in the pathogenesis of IgA nephropathy, lupus nephritis, and diabetic nephropathy, forms of kidney inflammation that can lead to kidney failure. An effective treatment for kidney inflammation has the potential to delay or prevent kidney failure, and avoid the need for dialysis or kidney transplantation.
About CuraGen
CuraGen Corporation is a biopharmaceutical company dedicated to improving the lives of patients by developing a pipeline of novel protein, antibody, and small molecule therapeutics in the areas of oncology, inflammatory diseases, and diabetes. CuraGen has established broad development alliances with Abgenix, TopoTarget, and Bayer, and its experienced preclinical and clinical teams are advancing the Company’s pipeline of products for unmet medical needs. The Company is headquartered in Branford, CT. For additional information please visit http://www.curagen.com.
Safe Harbor
This press release contains forward-looking statements including statements about our plans to further evaluate CR002 for kidney inflammation; our expectation that we will identify a partner who will work to further advance CR002 through clinical development to explore its role in potentially helping patients with kidney inflammation caused by PDGF-D, including IgA nephropathy and diabetic nephropathy; CR002’s potential as a therapeutic for kidney inflammation; and the potential of an effective treatment for kidney inflammation to delay or prevent kidney failure and avoid the need for dialysis or kidney transplantation. We caution investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: the risk that any one or more of CuraGen’s drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; CuraGen’s history of incurring losses and the uncertainty of achieving profitability; CuraGen’s stage of development as a genomics-based pharmaceutical company; government regulation; patent infringement claims against CuraGen’s products, processes and technologies; the ability to protect CuraGen’s patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. Please refer to CuraGen’s Quarterly Report on Form 10-Q for the period ended September 30, 2005 for a complete description of these risks. CuraGen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.
CuraGen Contact: Glenn Schulman, Pharm.D. gschulman@curagen.com (888) 436-6642
CuraGen Corporation
CONTACT: Glenn Schulman, Pharm.D., CuraGen, 1-888-436-6642, orgschulman@curagen.com
Web site: http://www.curagen.com/
