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2004 DEC 1 - (NewsRx.com & NewsRx.net) -- CuraGen Corp. (CRGN) announced progress with their pipeline of protein, antibody, and small-molecule therapeutics highlighted by the transitioning of CG53135 into phase II for the prevention of oral mucositis (OM) in cancer patients undergoing bone marrow transplantation (BMT).
The company also announced that CR002, a fully human monoclonal antibody, is being developed for the treatment of IgA nephropathy and will begin a phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy male volunteers.
"We are very pleased to transition CG53135 into phase II and bring CR002 into a phase I program. CuraGen has focused its resources on advancing CG53135 for both the prevention and treatment of oral mucositis, CR002 for IgA nephropathy, and PXD101 for solid and hematologic cancers, through clinical development," stated Timothy M. Shannon, MD, executive vice president research and development and chief medical officer. "We are also very excited about CR011, a potential treatment for metastatic melanoma, which we anticipate will enter the clinic during the first half of 2006."
CG53135 is a novel growth factor discovered by CuraGen that promotes both epithelial and mesenchymal cell proliferation in vitro and is active in animal models of OM. Safety, tolerability, and activity results from the phase I program with CG53135 will be presented at the 46th annual meeting of the American Society of Hematology in December. The goal of this phase II clinical trial is to establish, in a randomized, controlled trial, the safety and efficacy of a single dose of CG53135, compared to a placebo, in preventing the development of clinically significant OM in cancer patients undergoing BMT.
The trial will be conducted at ...
Source: HighBeam Research, Company details clinical development plan for CG53135 and CR002.