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Executive Summary

CETUS BEGINNING PEG/IL-2 PHASE I CLINICALS, following FDA approval of the company's IND the week of April 11. "This new [polyethylene glycol/interleukin-2] product . . . has the potential to broaden the use of interleukin-2 through increased antitumor activity, reduced side effects and easier administration," Cetus noted in an April 18 press release. The dose-ranging trial will take place at the University of California, Davis Medical Center in Sacramento under the direction of Frederick Meyers, MD, and is expected to last approximately six months. Cetus said the study will include 20-30 patients with refractory metastatic cancer. Polyethylene glycol can be used to alter the surface structure of proteins, thereby changing where proteins go in the body. As a result, PEG-modified proteins can have longer half lives with less potential for immune responses. Among the advantages of the PEG/IL-2 product over the standard formulation, Cetus noted, are a less frequent dosing regimen and the potential for subcutaneous, and thus self-administration. The Phase I study will examine PEG/IL-2 given in a bolus injection once or twice a week. In studies to date with interleukin-2, the lymphokine has been administered intravenously once or twice daily. The initial PEG technology development work was performed at Rutgers University. Research Corporation Technologies, an arm of Rutgers, is the patent holder. Cetus is developing its PEG/IL-2 product under an exclusive worldwide license. Enzon, a biotech firm whose founders include members of the Rutgers research group, has also licensed the patent for the development of other PEG-modified compounds. Cetus said it has filed patent applications specifically covering the new IL-2 formulation. The biotech firm also reported that animal studies have indicated that PEG/IL-2 may have greater antitumor activity than the standard IL-2 product and be less toxic as well. Cetus has filed for regulatory approval of its Proleukin IL-2 brand in several European countries and is in Phase III clinicals in the U.S.

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