CuraGen Corporation has been given Fast Track designation from the US 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 haematopoietic 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, VP 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," Mary added.

CG53135 is an investigational protein discovered by CuraGen that promotes both epithelial and mesenchymal cell proliferation. Data from the recently completed phase I programme evaluating CG53135 for the prevention of OM in patients receiving high dose chemotherapy followed by haematopoietic stem cell transplantation will be presented soon.

CG53135 is currently in a phase II programme 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.

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.