Jazz Pharmaceuticals has initiated patient dosing in a clinical trial intravenously (IV) administering Erwinaze in acute lymphoblastic leukemia (ALL) patients hypersensitive to asparaginase therapy derived from E. coli.
The trial will assess Erwinaze asparaginase-based therapy that is believed to play a vital role for ALL patients not left with any other treatment options and is expected to reveal preliminary pharmacokinetic data in latter half of 2013.
Trial principal investigator and Dana-Farber/Children's Hospital Cancer Center pediatric oncologist Lynda Vrooman said, "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."
Study will enroll around 25 patients with ALL, recognized with Grade 2 or higher hypersensitivity reaction to E. coli asparaginase and who have not finished the prescribed asparaginase therapy quota, in the US and Canada.
Jazz Pharmaceuticals chief medical officer and research and development executive vice president Jeffrey Tobias said, "This important clinical trial underscores our commitment to those patients with ALL who require treatment with Erwinaze."
