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news.ProMetic Life Sciences has announced favorable top-line findings from the third cohort in its Phase II trial with PBI-1402, in patients with chemotherapy-induced anemia or CIA.
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Analysis of the compiled data from a total of 18 patients showed an overall statistically significant increase of the mean hematocrit values at weeks four, six and eight, and of the hemoglobin values at week eight. At week eight, p values were 0.02 for hematocrit and hemoglobin. Other PBI-1402 development highlights include the extension of the enrollment for the PBI-1402 CIA trial to include an additional 12 patients receiving the lowest trial dose. Data from these additional patients are expected by June 2008.
In addition, a new Phase II study in patients with anemia resulting from chronic kidney disease has been scheduled. This multi-center study will be placebo controlled and will examine the effect of PBI-1402 on anemia, as well as several other clinical parameters.
Pierre Laurin, president and CEO of ProMetic, said: “We are excited about the prospects for PBI-1402 for the treatment of anemia in oncology since, unlike erythropoietin, PBI-1402 demonstrated some anticancer activity in animal models.”