Lorus Reports Positive Review, Pharmacokinetic Results of Virulizin Trial
Lorus Therapeutics has announced that an independent data safety monitoring board (DSMB) reported that the company's ongoing Phase III registration clinical trial in advanced pancreatic cancer, for its lead anticancer drug Virulizin, can continue without modification to the Phase III study design.
The DSMB arrived at its independent conclusion after reviewing preliminary data from the Phase III clinical trial. The principal objective of the DSMB review was to evaluate the interim safety of the study. The Virulizin Phase III clinical trial completed full enrollment of 436 patients at over 100 clinical sites in North America, South America and Europe in mid-2004 and is expected to conclude in mid-2005.
Additionally, Lorus has learned that the results of the pharmacokinetic drug interaction portion of the Phase III clinical trial revealed no significant adverse interactions between Lorus' product Virulizin and the current standard of care in pancreatic cancer, gemcitabine. This data was also reviewed by an independent body and submitted to the FDA. Virulizin has been granted fast-track status, orphan-drug status and a special protocol assessment by the FDA in advanced pancreatic cancer.
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