Under a protocol approved by the Canadian Health ProtectionBranch (HPB), Imutec Corp.'s drug Virulizin will be tested in300 patients with pancreatic cancer at sites throughout Canada.The randomized, placebo-controlled, double-blind Phase IIIstudy will evaluate survival time, tumor response,immunological parameters and quality of life in its subjects.
Virulizin, a biological response modifier extracted from bovinereticuloendothelium, has been shown in a Phase II Canadianstudy to increase median survival times in pancreatic cancerpatients from three-and-a half to eight months.
Imutec of Toronto said it hopes to show that the drug not onlyincreases survival time but also improves patients' quality oflife, the company's vice president of business development,Carolyn Armstrong, told BioWorld. Quality of life will bemeasured in terms of pain (amount of pain medication takenby patients, for example), weight fluctuation and otherparameters set by the Eastern Cooperative Oncology Group(ECOG).
The company filed an investigational new drug (IND)application with FDA for a U.S. clinical trial in December,Armstrong said. The agency told the company that it hadquestions about the submission and Imutec is now awaitingthose queries, she added.
Imutec (NASDAQ:IMUTF) has applied for a Phase I/II studythat will be conducted at Rush Presbyterian St. Luke's MedicalCenter in Chicago. -- Karl Thiel
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