Tekmira provides update on TKM-PLK1 Phase I/II clinical trial

Tekmira today reported that:

• Enrolment of the target patient numbers in these Phase I/II studies has been completed;
• To date, 55 patients, in the both the Phase I and Phase I/II studies have been treated at doses of >= 0.6 mg/kg, considered to be in the efficacious dose range based on preclinical studies. Of these, 31 patients comprise the target population of GI-NET or ACC patients;
• Nine GI-NET and ACC patients remain actively on treatment, and data collection is ongoing;
• The Company continues to see evidence of anti-tumor activity in some treated subjects, including one ACC patient with an almost complete resolution of their disease;
• Final data from these studies is expected in mid-2015.

"Having completed enrolment in these studies, we will follow these patients to measure the responses observed with TKM-PLK1 in patient groups where there are very few, if any, treatment options," said Dr. Mark J. Murray, Tekmira’s President and CEO.

"We are on track to report complete study results and determine the TKM-PLK1 development path forward next year."

Neuroendocrine tumors (NETs) refer to a group of unusual and complex cancers that affect neuroendocrine cells, with those arising in the gastrointestinal tract referred to as GI-NET.

A Surveillance Epidemiology and End Results (SEER) database analysis demonstrates a dramatic five-fold increase in the incidence of neuroendocrine tumors from 1973 to 2004. Incidence of GI-NET is predicted to continue to rise at a faster rate than other malignant tumors.

Each year an estimated 8,000 people in the United States are diagnosed with a neuroendocrine tumor that starts in the gastrointestinal tract, which includes the stomach, intestine, appendix, colon, or rectum. There is a poor prognosis for advanced metastatic NETs, with survival rates for GI-NET ranging from five to 56 months.

Adrenocortical Carcinoma is a rare cancer that forms in the outer layer of tissue of the adrenal gland (a small organ on top of each kidney that makes steroid hormones, adrenaline, and noradrenaline to control heart rate, blood pressure, and other body functions).

Adult adrenocortical carcinoma tumors are aggressive with a very poor prognosis. Between 60%-70% of patients at the time of diagnosis are found to have stage III or IV disease. These patients have a survival rate of 40%, or less, with a known recurrence rate between 70% and 90%.

As adrenocortical carcinomas are so rare, there has been only limited prospective evaluation of treatment strategies. Very few, if any, universally accepted treatment standards have been identified. (Source:American Cancer Society)

This ongoing TKM-PLK1 Phase I/II clinical trial is currently targeting two indications: GI-NET and ACC. This trial is a multi-center, single arm, open label study designed to measure efficacy using Response Evaluation Criteria in Solid Tumors and tumor biomarkers for GI-NET patients, as well as to evaluate TKM-PLK1’s safety, tolerability and pharmacokinetics.

TKM-PLK1, which employs a unique lipid nanoparticle (LNP) formulation for oncology applications, is administered weekly with each four-week cycle consisting of three once-weekly doses followed by a rest week. Tekmira has achieved its target enrolment for the Phase I/II trials of TKM-PLK1.