VANCOUVER, British Columbia, March 30, 2011 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, announced today its 2010 audited operating results and provided a corporate update.
- Tekmira 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. The Phase 1 clinical trial, conducted at three medical centers in the United States, is an open label, multi-dose, multi-cycle, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TKM-PLK1 as well as the determination of the maximum tolerated dose in patients with advanced solid tumors. Secondary objectives of the trial will be to measure tumor response as well as the pharmacodynamic effects of TKM-PLK1 in patients providing biopsies.
- Tekmira is developing its TKM-Ebola product under a US$140 million contract awarded by the U.S. Government's Transformational Medical Technologies (TMT) Program. The TMT contract will support the development of TKM-Ebola through to FDA approval. The TKM-Ebola program is well underway in support of an investigational new drug (IND) application to be filed in the second half of 2011. Tekmira's work on the TKM-Ebola program also supports continued lipid nanoparticle (LNP) technology innovations around process development, manufacturing scale-up, and lyophilization.
- Tekmira has made significant advances in LNP formulation development, and there are several alternative LNP formulations with improved characteristics that are currently being evaluated for TKM-ApoB development as well as for other metabolic target indications. Guidance on next steps for TKM-ApoB will be provided once this evaluation has been completed.
- Tekmira's preclinical pipeline continued to expand over the past year with multiple new targets evaluated in the areas of metabolic disease, oncology, and infectious disease. In addition, Tekmira continues to publish key data in high quality, peer reviewed scientific journals, in order to support the expansion of collaborative relationships within the broader RNAi industry.
- Tekmira's LNP technology is enabling the entire clinical-stage systemic RNAi product pipeline of Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY). Under an exclusive manufacturing agreement entered into in January 2009, Alnylam obtains their LNP drug product from Tekmira, including the products ALN-VSP, ALN-TTR and ALN-PCS. In January 2011, Alnylam 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. Subsequent to year-end, Tekmira filed a complaint against Alnylam for misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising. Tekmira has taken appropriate steps to ensure that it can pursue this lawsuit without interruption to its core business activities and intends to fulfill all of its manufacturing obligations to Alnylam.
- Together with collaborators at The University of Texas Medical Branch, Tekmira was awarded a new United States National Institutes of Health (NIH) grant to support research to develop RNAi therapeutics to treat Ebola and Marburg hemorrhagic fever viral infections using Tekmira's LNP technology. The grant, worth US$2.4 million, will support work at Tekmira and the University of Texas Medical Branch at Galveston, Texas.
- This past year, Tekmira announced the expansion of its research collaboration with Bristol-Myers Squibb (BMS). Under the new agreement, BMS will use siRNA molecules formulated by Tekmira in lipid nanoparticles to silence target genes of interest. BMS will conduct the preclinical work to validate the function of certain genes. Tekmira can use the shared preclinical data to develop RNAi therapeutic products against the therapeutic targets of interest. Work is ongoing to provide a pre-determined number of LNP batches over the span of the four-year agreement.
- Tekmira continues to support its other collaborative industry partners with a focus on LNP evaluation, active targeting and combining new nucleic acids payloads with LNP delivery.