Tekmira Pharmaceuticals this week announced that it has received approval from the US Food and Drug Administration to go forward with a new phase I study of its siRNA-based cancer drug TKM-PLK1 in collaboration with the National Cancer Institute.
Tekmira moved the drug, which targets polo-like kinase 1, into phase I testing early this year (GSN 1/6/2011). The company said that the new study, which will be conducted in parallel with the ongoing trial, will provide an “early opportunity to validate the drug's mechanism of action.”
"Patients in this new study, who will have either primary liver cancer or liver metastases, will receive TKM-PLK1 delivered directly into the liver via hepatic artery infusion,” Tekmira Preisdent and CEO Mark Murray said in a statement. “The trial design will allow us to measure tumor delivery, polo-like kinase 1 messenger RNA knockdown, and RNA interference activity in tumor biopsies from all of the patients treated.”
Interim phase I data on TKM-PLK1 is expected before year end.