DUJazz Pharmaceuticals announced that the first patient has been enrolled and dosed in a clinical trial of Erwinaze® (asparaginase Erwinia chrysanthemi) administered intravenously (IV) as an alternative method of administration to treat patients with acute lymphoblastic leukemia (ALL) with hypersensitivity to E. coli-derived asparaginase therapy.
About Acute Lymphoblastic Leukemia (ALL)Acute lymphoblastic leukemia affects approximately 6,000 Americans, 60 percent of whom are children. ALL is the most common form of childhood cancer, with the peak incidence between two and five years of age.
ALL has a 90 percent survival rate with treatment including asparaginase-based regimens, but progresses quickly if left untreated. A majority of asparaginase treatments derive from E. coli; however, approximately 15 to 20 percent of ALL patients develop hypersensitivity to E. coli-derived asparaginase regimens. Erwinaze asparaginase-based therapy plays a critical role for patients with no other treatment options.
The trial is designed to enroll up to 25 ALL patients in the U.S. and Canada who have a documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase and have not completed their full courses of prescribed asparaginase therapy. Preliminary pharmacokinetic data from the trial are expected in the second half of 2013.
"Intravenous administration of Erwinaze may provide meaningful benefit to patients, their caregivers and families by avoiding the need for multiple intramuscular injections," stated Lynda Vrooman, MD, MSc, a pediatric oncologist at Dana-Farber/Children's Hospital Cancer Center and principal investigator of the trial. "Intramuscular injections can be painful and difficult for patients, and this alternative route of administration, if it is shown to be feasible, would be an important advancement in the care of certain ALL patients, many of whom are young children."