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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"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.