Enzon Commences Phase II Trial Of PEG-SN38

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 23 Jun 2009 - 7:00 PDT

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Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced that it has opened its first Phase II trial for PEG-SN38 (EZN-2208), its novel proprietary cancer compound. The trial is open at multiple centers throughout the United States for patients diagnosed with metastatic colon cancer.

"We are pleased to have the first PEG-SN38 Phase II trial open in early summer as promised," said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer. "We are encouraged by the safety profile in the Phase I trials and are looking forward to this next phase of development."

Two Phase I studies were conducted evaluating different dosing schedules of PEG-SN38. The dose limiting toxicity was febrile neutropenia. No cumulative toxicity was reported. A recommended Phase II dose was established in April 2009.

"We are very excited to have played a key role in the Phase I testing of this novel cancer compound and are very interested to see its continued development," stated Dr. Anthony Tolcher, a leading principal investigator in the Phase I trials from START (South Texas Accelerated Research Therapeutics) in San Antonio, Texas.

On Tuesday, June 23, 2009 at 2:00 p.m. ET, Enzon will host a conference call with two of its clinical investigators to discuss PEG-SN38. Dr. Anthony Tolcher, who has experience in the Phase I trials, will participate on the call. Additionally, Dr. Richard Goldberg of The University of North Carolina at Chapel Hill, the lead principal investigator in the Phase II trial, will be available to provide their perspective and answer questions on PEG-SN38.

About PEG-SN38

SN38 is the active metabolite of the widely used cancer drug irinotecan (also CPT-11), marketed as Camptosar® in the U.S. Although unmodified SN38 is 1,000 times more potent than CPT-11, it has not been converted into a viable drug candidate because of its insolubility. Using Enzon's proprietary PEGylation technology, the Company developed PEG-SN38 (EZN-2208), which results in a compound with excellent pharmaceutical properties as shown in animal models: increased solubility, higher exposure, and longer half-life than unmodified SN38.

Source
Enzon Pharmaceuticals, Inc.