The open-label, dose-escalation trial is designed to assess the safety and maximum-tolerated dose of Oncaspar in combination with Gemzar in patients with these cancers.
Oncaspar was initially approved by the FDA in February 1994 and is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia.
The company has also announced the FDA completed review of its investigational new drug application for the use of recombinant human Mannose-Binding Lectin (rhMBL) for the prevention and treatment of severe infections in patients with multiple myeloma with low levels of MBL undergoing high-dose chemotherapy and hematopoietic stem cell transplantation. Clinical trials are expected to begin enrollment later this year.
“The advancement of these two important oncology programs is a testament to our commitment to both reinvest in our brands and build our pipeline,” said Jeffrey Buchalter, Enzon’s chairman and CEO. “Oncaspar moving into clinical trials in solid tumors also marks an important turning point for the company as we begin to explore broader markets of unmet medical need.”