Velafermin Shows Promising Results in Prevention of Chemotherapy Induced Oral mucositis

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Therapy
Velafermin Shows Promising Results in Prevention of Chemotherapy Induced Oral mucositis
By CuraGen Corporation, May 18, 2005 - 9:36:38 AM

CuraGen Corporation today announced that Michael W. Schuster, M.D., Principal Investigator, Professor of Clinical Medicine in the Division of Hematology/Oncology at the Weill Medical College of Cornell University, and Director of Stem Cell Transplantation at NewYork-Presbyterian Hospital/Weill Cornell Medical Center presented the final Phase I results for a single-dose of velafermin (CG53135) for the prevention of oral mucositis (OM) in patients receiving high dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation (AHSCT) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, FL.

The final results from this Phase I study suggest velafermin (CG53135) is well tolerated following intravenous administration with data supporting the Company's ongoing Phase II trial and strategy of investigating a single-dose of velafermin (CG53135) for the prevention of OM.

"Based on our experience with velafermin in Phase I, we are pleased to be taking part in the Phase II trial to evaluate this investigational drug for the prevention of OM," stated Michael W. Schuster, M.D. "Oral mucositis is a severe side effect that frequently occurs as a result of the high-dose chemotherapy administered to patients prior to bone marrow transplantation. Fibroblast growth factors, including velafermin, represent a new class of drugs that show promise for potentially avoiding or ameliorating OM and avoiding complications associated with this condition, such as pain and infection, and improving patients' quality of life."

"As we continue to advance velafermin through Phase II, we are pleased with the progress being made in the program and remain on track to complete this trial during the first half of 2006," stated Timothy M. Shannon, M.D., Executive Vice President of Research and Development and Chief Medical Officer at CuraGen. "In addition to exploring the efficacy of a single-dose of velafermin for the prevention of OM, we are also evaluating the safety of velafermin in a Phase I study for the treatment of active OM, specifically in patients who develop OM as a result of the chemotherapy they receive for the treatment of their cancer."

Data on 30 patients dosed with velafermin (CG53135) were presented in a poster entitled, "Phase I Trial of CG53135-05 (Velafermin) to Prevent Mucositis in Patients Undergoing High-dose Chemotherapy (HDCT) and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)." Primary objectives for the study were the evaluation of safety, tolerability, and pharmacokinetics following a single-dose of velafermin (CG53135). As a secondary objective, the study assessed the development of OM using the WHO OM assessment scale. Patients received a single-dose of 0.03, 0.1, 0.2, or 0.33 mg/kg velafermin (CG53135) administered intravenously one day after infusion of blood stem cells following high-dose chemotherapy.

Of the 30 patients (male = 21, female = 9) presented in this poster, the median age was 55 years (range 25-75) with diagnoses including multiple myeloma (n=16), non-Hodgkin's lymphoma (n=12), acute myelogenous leukemia (n=1) and desmoplasmic round cell tumor (n=1). High-dose chemotherapy conditioning regimens included high-dose melphalan (Mel 200), carboplatin and thiotepa, cyclophosphamide, carmustine, and etoposide, and busulfan and cyclophosphamide. No serious drug-related adverse events were noted following treatment with velafermin (CG53135). Mild to moderate reactions including nausea, vomiting, tachycardia, hypotension, chills, and fever were observed. Following administration of a single-dose of velafermin (CG53135), 22 of 30 patients (73%) did not develop severe grade 3 or 4 OM.

Based on results from Phase I, the 0.03, 0.1 and 0.2 mg/kg single doses of velafermin (CG53135) are currently being evaluated in a randomized, double- blind, placebo-controlled, multi-center Phase II clinical trial for the prevention of OM in approximately 200 patients receiving HDCT followed by AHSCT. This trial is expected to be complete during the first half of 2006.

Background on Velafermin (CG53135) and OM

Velafermin (CG53135), a novel fibroblast growth factor discovered by CuraGen that appears to promote both epithelial and mesenchymal cell proliferation, is currently being investigated for the prevention and treatment of OM, 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. OM is sometimes a cause for clinicians to interrupt patients' cancer treatment regimens, thus limiting the success of therapeutic plans. Velafermin (CG53135) is being investigated for the prevention of OM by being administered to patients before the onset of symptoms in order to decrease the incidence and duration of the disease.

Animal studies suggest that velafermin (CG53135) may also be effective for the treatment of OM when it is administered after the onset of early signs of OM in order to decrease the duration and progression to severe OM. An effective therapy for OM has the potential to treat debilitating symptoms, to allow cancer patients to better tolerate the appropriate doses of cancer treatment, and to decrease hospitalization time.

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