Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under
 investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring
 side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem
 cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy
 of CG53135-05 when administered as a single dose to patients at risk for developing oral
 mucositis.
Inclusion Criteria:

 -  Male or female patients ages > 18 yrs

 -  Patients undergoing high dose chemotherapy with or without radiation therapy treatment
 as conditioning for autologous hematopoietic stem cell transplantation. The
 conditioning regimens include at least one of the following: high dose melphalan (Mel
 200), busulfan, or etoposide, with or without total body irradiation.

 -  Patients with Karnofsky performance scores > or = 70%

 -  Informed consent for participation in study

 Exclusion Criteria:

 -  Patients who weigh < 33 kg

 -  Premenopausal female patients who are pregnant, lactating or are likely to become
 pregnant

 -  Patients with active medical conditions that preclude autologous hematopoietic stem
 cell transplantation

 -  Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis
 B/C

 -  Patients with known hypersensitivity to recombinant protein therapeutics

 -  Patients who have taken CG53135-05, palifermin or other investigational drugs in the
 past 30 days

 -  Patients who have untreated symptomatic dental infection

 -  Patients with a history of sensitivity or allergy to E. coli-derived products

 -  Patients with WHO Grade 3 or 4 oral mucositis (OM)