Tekmira Pharmaceuticals Corporation Announces Dosing of First Subject in Phase I Hepatitis B Trial
Jan 27 15
Tekmira Pharmaceuticals Corporation dosed the first subject in a Phase I clinical trial of TKM-HBV, a therapeutic agent designed to reduce hepatitis B surface antigen in patients chronically infected with hepatitis B virus, or HBV. The TKM-HBV Phase I clinical trial is a randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV. The study will assess the safety, tolerability and pharmacokinetics of intravenous administration of two formulations of TKM-HBV in healthy adult subjects. For each formulation, there are five planned cohorts for a total of 20 subjects (40 in total for both formulations). Four subjects will be enrolled per cohort with three subjects receiving TKM-HBV, and one receiving placebo. The goal of TKM-HBV is to facilitate hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B. The continued presence of HBsAg in chronic HBV is believed to be responsible for disease pathogenesis and impairing the body's ability to clear the virus. Blocking HBsAg may lead to a functional cure by promoting immune-mediated clearance and control of HBV, potentially through HBsAg seroconversion. TKM-HBV is a novel lipid nanoparticle (LNP) formulated RNAi therapy that uniquely targets three highly conserved regions of the HBV viral genome. Targeting multiple sites on the HBV genome allows for potent reduction of multiple viral antigens, knockdown across a broad range of HBV genotypes, and a decrease in the probability of developing antiviral resistance. Preclinical studies with TKM-HBV have shown reductions of HBsAg and other important viral markers across the most prevalent HBV genotypes, demonstrating that TKM-HBV has the potential to treat patients with chronic HBV.
OnCore Biopharma, Inc., Tekmira Pharmaceuticals Corporation - M&A Call
Jan 12 15
To discuss the merger agreement between Tekmira Pharmaceuticals Corporation and OnCore Biopharma, Inc. to create a new global HBV company focused on developing a curative regimen for hepatitis B patients by combining multiple therapeutic approaches
Tekmira Pharmaceuticals Corporation Provides Update on TKM-PLK1 Phase I/II Study
Dec 31 14
Tekmira Pharmaceuticals Corporation provided a status update on the Phase I/II clinical study in patients with advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) and Adrenocortical Carcinoma (ACC). Tekmira 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. 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. 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%. 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. RNAi therapeutics have the potential to treat a number of human diseases by "silencing" disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi trigger molecules often require delivery technology to be effective as therapeutics. Tekmira believes its LNP technology represents the most advanced and widely adopted delivery technology for the systemic delivery of RNAi triggers. Tekmira's LNP platform is being utilized in multiple clinical trials in various disease areas by Tekmira and its partners. Tekmira's LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates RNAi triggers with high efficiency in uniform lipid nanoparticles that are effective in delivering these therapeutic compounds to disease sites. Tekmira's LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple regulatory agencies for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.