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Full Patient Enrollment Achieved in Virulizin Phase 3 Trial
This study compares the efficacy and safety of Virulizin(R) when combined with gemcitabine versus a placebo combined with gemcitabine in patients with locally advanced or metastatic pancreatic cancer. The primary efficacy endpoint is overall survival, while secondary endpoints include progression of symptoms of pain, deterioration of performance status and weight loss. Additionally, the activity of Natural Killer (NK) cells is evaluated throughout the study. The correlation between NK cell activity profiles and clinical outcome will be assessed. Virulizin(R) has been granted fast track status, orphan drug status and a special protocol assessment by the U.S. Food and Drug Administration (FDA) in advanced pancreatic cancer.
According to the study protocol requirement for follow-up, database lock and data analysis, the results of the study are anticipated for late 2005. This clinical study report will be pivotal in the application for marketing approval for Virulizin(R), which is planned for submission to the (FDA) in the first half of 2006.
"This is a significant milestone in the clinical development process of Virulizin(R) and Lorus is encouraged to see that the target has been achieved earlier than originally projected," said Dr. Jim Wright, CEO of Lorus. "This study was designed to examine Virulizin(R) in both the first line setting and also in the second line treatment setting in combination with 5FU."
Virulizin(R) is a novel immunotherapy that stimulates a patient's innate immune system through the activation of macrophages and the infiltration of NK cells into tumors. Evidence of clinical response was demonstrated in Phase II clinical studies of Virulizin(R) as a monotherapy in advanced pancreatic cancer. Median survival compared favorably with single-agent chemotherapy trials, and endpoints of quality of life, pain and performance status were maintained or improved during the first four to eight weeks of treatment. Importantly, in contrast to most standard chemotherapeutic drugs, Virulizin(R) was well tolerated with no significant systemic toxicity.
Preclinical studies have demonstrated that Virulizin(R) activates macrophages and NK cells, produces significant reduction in tumor growth and increases survival across a broad range of animal xenograph models of human carcinoma.
In a gemcitabine-resistant pancreatic tumor model in mice, treatment with Virulizin(R) was associated with a delay in tumor growth and a significant reduction in tumor size compared to controls. Pharmacologic studies in healthy volunteers, as well as from cancer patients, suggest that peripheral blood monocytes, display a significantly enhanced capacity to kill tumor cell targets when stimulated with Virulizin(R).
Source: Lorus Therapeutics Inc.