Tekmira Pharmaceuticals Corporation has announced that they have met all regulatory requirements to initiate a Phase I/II clinical trial of TKM-PLK1 in patients with Hepatocellular Carcinoma (HCC). Tekmira is also conducting a separate Phase I/II clinical trial evaluating TKM-PLK1 in patients with Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC).
"Hepatocellular carcinoma is associated with one of the poorest survival rates in oncology, and clearly new therapies are needed. We are encouraged with the positive data from our GI-NET and ACC clinical studies with TKM-PLK1 and there is sound rational for evaluating this agent in HCC," said Dr. Mark J. Murray, Tekmira's President and CEO.
"We are excited about reaching another important milestone for Tekmira by launching this new clinical trial, and also remain on track to share results from our GI-NET/ACC trial in the second half of this year," added Dr. Murray.
This trial is an open-label, multi-center, Phase I/II dose escalation study in patients with advanced hepatocellular carcinoma. The study is designed to determine the safety, tolerability and clinical benefit of TKM-PLK1. The study will be conducted at sites in North America and Asia.