Biopharmaceutical company Tekmira Pharmaceuticals has begun Phase I/II study of its RNAi oncology therapeutic targeting polo-like kinase 1 (PLK1), TKM-PLK1, to treat solid tumours.
The single arm, open label, GI-NET and ACC Phase I/II trial will measure efficacy using RECIST and tumour biomarkers for GI-NET patients, in addition to assessing the safety, tolerability and pharmacokinetics of TKM-PLK1.
Around 20 patients with advanced GI-NET or ACC tumours are expected to be enrolled in the trial, with at least ten GI-NET patients.
The multi-centre study will administer TKM-PLK1 every week with each four-week cycle comprising three once-weekly doses followed by a rest week.
Tekmira president and CEO Dr Mark Mur said the Phase I/II trial with TKM-PLK1 will enrol patients with either advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC).
Mur said: "By focusing on these indications, where we observed drug activity in the Phase I trial, we aim to collect additional data on the efficacy of TKM-PLK1 to guide our future development and regulatory strategy for this promising agent. We expect to have results from this completed trial by mid-2014, and if it issupported by the data, we will commence a pivotal trial in GI-NET in 2014.
"In addition, we anticipate initiating a separate Phase I/II clinical trial with TKM-PLK1, which will enroll patients with Hepatocellular Carcinoma (HCC) in the first half of 2014."
Another Phase I/II trial with TKM-PLK1 to include patients with Hepatocellular Carcinoma (HCC) will also be commenced in the first half of 2014.
The multi-centre, open label, non-randomised, dose escalation study will assess the safety, tolerability and pharmacokinetic profile of TKM-PLK1.
Further, the maximum tolerated dose in HCC patients and the anti-tumour activity of TKM-PLK1 in HCC patients will be measured.
Image: High magnification micrograph of a small intestine neuroendocrine tumour. H&E stain. Photo: courtesy of Nephron.