Date: 2012-12-03
Type of information:
phase:
Announcement: enrolment of the first patient
Company: Jazz Pharmaceuticals (Ireland)
Product: Erwinaze® (asparaginase Erwinia chrysanthemi)
Action mechanism: This drug consists of L-asparaginase that has been pegylated (coated with polyethylene glycol -PEG). This reduces the rate at which it is cleared from the body. L-asparaginase is an enzyme that breaks down the substance L-asparagine in the blood. L-asparagine is produced by the normal cells in the human body. Certain cancer cells, such as the cancerous cells in acute lymphoblastic leukaemia, cannot make L-asparagine, so they need to take it up from the blood in order to grow. By reducing the levels of L-asparagine in the blood, the cancerous cells are deprived of their supply of L-asparagine and die.
Disease: acute lymphoblastic leukemia with hypersensitivity to E. coli-derived asparaginase therapy.
Therapeutic area: Cancer - Oncology
Country: USA, Canada
Trial details: 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.
Latest
news: Jazz Pharmaceuticals jas 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. Preliminary pharmacokinetic data from the trial are expected in the second half of 2013.
