Tekmira Pharmaceuticals Corporation (TSX:TKM), a leader in RNA interference (RNAi) therapeutics, today announced that its Investigational New Drug (IND) application for TKM-PLK1 has been cleared by the United States Food and Drug Administration (FDA) allowing Tekmira to initiate a Phase 1 human clinical trial.
Dr. Mark J. Murray, Tekmira's President and CEO, said, "We are pleased to have received FDA approval of our IND for TKM-PLK1. With this approval, we remain on track to achieve the company's milestone of initiating a Phase 1 human clinical trial in patients with advanced solid tumors before the end of the year."
TKM-PLK1 is being developed as a treatment for patients with advanced solid tumor cancers who are not well served by current therapy. The Phase 1 clinical trial will be an open label, non-randomized, dose finding study designed to evaluate the safety, tolerability and pharmacokinetics of TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein implicated in tumor cell proliferation and a validated oncology target. Inhibition of PLK1 prevents the tumor cell from completing cell division, resulting in cell cycle arrest and death of the cancer cell. PLK1 has been implicated as a target in a number of significant cancer indications including colorectal, breast, non-small cell lung, and ovarian cancers. These diseases collectively affect over five hundred thousand new patients each year in the United States.
TKM-PLK1 consists of a small interfering RNA (siRNA) designed to silence PLK1 encapsulated in a Tekmira proprietary lipid nanoparticle (LNP) formulation. TKM-PLK1 has been shown in preclinical animal studies to selectively kill cancer cells, while sparing normal cells in healthy tissue. The therapeutic activity of TKM-PLK1 has been demonstrated in preclinical models of liver cancer as well as tumors outside the liver.
TKM-PLK1 is licensed under Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) intellectual property. Additionally, Alnylam has the right to co-develop TKM-PLK1 and retains that right until the start of a TKM-PLK1 Phase 2 clinical trial.