FDA Grants Fast Track Designation to CG53135, for Prevention and Treatment of Oral Mucositis

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CuraGen Corporation (Nasdaq: CRGN) announced today it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CG53135, a novel protein therapeutic being developed for the prevention and treatment of oral mucositis (OM). Under the FDA granted designation CG53135 will be investigated for the prevention of OM in patients receiving hematopoietic stem cell transplantation (HSCT) following myeloablative chemotherapy with or without total body irradiation (TBI).

“Oral mucositis is a serious and debilitating side effect resulting from the chemotherapy and radiation used in the treatment of cancer.

Patients receiving a bone marrow transplant who develop oral mucositis may experience significant pain which can lead to an inability to eat or drink, and have an increased risk of developing a life-threatening infection,” stated Mary E. Taylor, Vice President of Regulatory Affairs at CuraGen. “As we continue to advance CG53135 through Phase II, we are pleased to have received fast track status and look forward to working closely with the FDA to develop this therapeutic.”

CG53135 is an investigational protein discovered by CuraGen that promotes both epithelial and mesenchymal cell proliferation. Data from the recently completed Phase I program evaluating CG53135 for the prevention of OM in patients receiving high dose chemotherapy followed by hematopoietic stem cell transplantation will be presented on Saturday, December 4th at the 46th Annual Meeting of the American Society of Hematology in San Diego, CA. CG53135 is currently in a Phase II program to evaluate its safety and efficacy for the prevention of OM in patients receiving myeloablative chemotherapy with or without TBI followed by HSCT. An additional Phase I study is being initiated to evaluate the safety and potential efficacy of CG53135 for the treatment of active OM.

Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment of serious or life-threatening diseases where there is an unmet medical need. The Fast Track program enables a company to file an NDA on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which could decrease the typical review period.

Background on Oral Mucositis

Oral mucositis is a side effect experienced by cancer patients undergoing chemotherapy or radiation therapy. The disease is characterized by inflammation and ulceration of the tissue lining the mouth and throat, leading to bleeding, pain, and difficulty eating and drinking. Oral mucositis is sometimes a cause for clinicians to interrupt patients’ cancer treatment regimens, thus limiting the success of therapeutic plans. An effective treatment for oral mucositis has the potential to treat debilitating symptoms, to allow cancer patients to tolerate the appropriate doses of cancer treatment, and to decrease hospitalization time.

SOURCE: CuraGen Corporation

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