Enzon plans to start enrollment in trials of Oncaspar as FDA completes review

New York, April 3 - Enzon Pharmaceuticals, Inc. said it plans to start enrolling patients in clinical trials of Oncaspar (pegaspargase) for non-Hodgkin's lymphoma and certain solid tumors following the Food and Drug Administration's completion of its review of the company's Investigational New Drug application.

"We are committed to maximizing Oncaspar's therapeutic potential, by exploring this agent's activity in other cancers such as pancreatic and non-Hodgkin's lymphoma," said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer, in a news release. "Our clinical teams have been working with several key investigators on this program and we expect to begin patient enrollment this summer."

Oncaspar is approved for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment but have developed hypersensitivity to the native forms of L-asparaginase.

Oncaspar is a PEG-enhanced version of the naturally occurring enzyme L-asparaginase, which depletes the amino acid asparagine. Some malignant cells, including many pancreatic and ovarian cell lines, lack asparagine synthetase and therefore may depend on exogenous L-asparagine to survive. This dependence on exogenous L-asparagine may be exploited by treating these malignancies with L-asparaginase. Additionally, preclinical in vivo and in vitro models suggest synergistic activity of pegaspargase with the chemotherapeutic agent gemcitabine.

Enzon is a Bridgewater, N.J., biopharmaceutical company.

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