Jan 11 2011
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today provided the following comment on Alnylam Pharmaceuticals, Inc.'s recently presented data from a Phase 1 human clinical trial for ALN-VSP showing that analysis of human tissue samples demonstrated proof of RNAi in man.
ALN-VSP utilizes Tekmira's LNP technology, the only RNAi delivery technology supporting multiple clinical candidates being advanced by Tekmira and its partners in multiple disease indications.
Dr. Mark J. Murray, Tekmira's President and CEO, said, "Last week, Tekmira's partner Alnylam presented clinical data from patients with advanced solid tumors with liver involvement treated with ALN-VSP, which demonstrated RNAi activity in humans. This was an important accomplishment by Alnylam and an exciting event for Tekmira, as it confirms that our LNP technology enables bona fide RNAi activity in man. Tekmira's LNP technology has been established as the leading RNAi delivery technology based on both the number of product candidates being advanced and the breadth of therapeutic indications it underpins."
"Human proof-of-concept is an important advancement in the field of RNAi drug development. At Tekmira, we intend to build on this momentum in 2011 with clinical data of our own as well as new partnering relationships. We believe the future is extremely promising for the field of RNAi therapeutics and we remain focused on advancing our therapeutic pipeline and supporting our partners, which depend on our LNP technology to advance their own clinical programs."
"Internally, we are accelerating our discovery efforts and expect to be in a position to advance multiple product candidates over the next few years. We will also continue to build upon our leadership position in delivery as we make advancements in LNP potency and tolerability as well as targeting new disease sites," added Dr. Murray.
Tekmira's LNP or lipid nanoparticle delivery technology represents the leading delivery technology in the RNAi field and supports Tekmira's internal product development and pharmaceutical partnering activities. Tekmira has licensed its LNP technology to Alnylam and Merck and has ongoing collaborative relationships with Takeda Pharmaceutical Company Limited, Pfizer, Bristol-Myers Squibb as well as additional undisclosed pharmaceutical and biotechnology companies. Tekmira also has a contract with the U.S. Government's Transformational Medical Technologies (TMT) program worth up to $140 million to advance TKM-Ebola.
Products being advanced utilizing Tekmira's LNP technology include Tekmira's internal product candidates, licensed under Alnylam's intellectual property, as well as Alnylam's systemic product candidates. In December, Tekmira announced that it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target. Earlier in 2010, Tekmira published data in The Lancet demonstrating the ability of TKM-Ebola to completely protect non-human primates from Ebola virus, a highly contagious and lethal human infectious disease. Tekmira expects to file an Investigational New Drug application for TKM-Ebola in the second half of 2011 to initiate a Phase 1 clinical trial. Tekmira is currently evaluating several LNP formulations for use in its TKM-ApoB program before it initiates a Phase 1-2 clinical trial for that product candidate.
Alnylam's product candidates being advanced using Tekmira's technology include ALN-VSP, which is continuing in a Phase 1 clinical trial; ALN-TTR01, which is in a Phase 1 clinical trial as a treatment for transthyretin-mediated amyloidosis; and ALN-PCS, which is expected to enter a Phase 1 clinical trial in 2011 as a treatment for hypercholesterolemia.
Tekmira's LNP technology encapsulates RNA-based drugs with high efficiency through a proprietary manufacturing process that is robust, scalable and highly reproducible. LNP-based products have been reviewed by the United States Food and Drug Administration and European health regulators for use in human clinical trials.
Source: http://www.tekmirapharm.com/