Tekmira Builds Upon Extensive Experience in Anti-Viral Therapeutics by Adding Therapeutics Addressing Hepatitis B and Marburg Virus to Product Pipeline
TKM-ALDH2, an RNAi Therapeutic for Alcohol Use Disorder, Shows Promise of Overcoming Limitations of Existing Treatments, and Provides Partnering Opportunity
Preclinical Research Programs Focus on Rare and Orphan Diseases Including Glycogen Storage Diseases and Rare Forms of Hypertriglyceridemia
"As RNAi technology has come of age, so has Tekmira evolved from a platform company to a product-focused company. We have outlined today a robust, diverse pipeline of therapeutically important and commercially valuable clinical programs advancing to near term inflection points. Specifically, we intend to focus on diseases where the scientific and medical rationale for using RNAi is strong, where our technology can best perform, and where there is high unmet medical need and significant commercial markets," said Dr.
"Our plans announced today significantly add breadth to our existing pipeline, which includes our TKM-PLK1 oncology program already in a Phase I/II clinical trial. Our new TKM-HBV program, along with our work addressing the Marburg virus, benefit from our immense experience in the anti-viral sector and our existing TKM-Ebola program. We are also excited by the strength of the preclinical data around our TKM-ALDH2 program, and we believe this unique RNAi therapeutic could address a significant segment of this market, making it an ideal candidate for partnering and other sources of funding for clinical development. Our research team continues to generate data to support the advancement of our most promising of preclinical targets, especially those where the molecular target is found in the liver, and the disease is rare. We will be in a position to identify another development candidate from these activities in 2014," added Dr. Murray.
Highlights from Corporate Update
Tekmira anticipates the following milestones related to its product pipeline:
•TKM-PLK1: Results from ongoing Phase I/II clinical trial in GI-NET and ACC patients by mid-2014, and if supported by the data, initiate a pivotal trial in GI-NET by the end of 2014. Initiate a Phase I/II clinical trial in Hepatocellular Carcinoma in the first half of 2014.•TKM-Ebola: Phase I clinical trial to be initiated in the first quarter of 2014 with data available in the second half of 2014.•TKM-HBV: Complete preclinical work and file IND in the second half of 2014, in order to advance TKM-HBV into chronically infected HBV patients with Phase 1 data available in 2015.•TKM-ALDH2: Complete preclinical work and file IND in second half of 2014, with Phase I data in healthy volunteers, including proof-of-concept with alcohol challenge available in 2015.•Next Product Candidate: Nominate next product candidate for development in 2014 from broad preclinical research efforts with focused work in rare and orphan diseases, including glycogen storage diseases and rare genetic forms of hypertriglyceridemia.