Tekmira Pharmaceuticals has declared that the United States Food and Drug Administration (FDA) approved its TKM-Ebola investigational new drug (IND) application, paving the way for the company to start a Phase 1 clinical study.
TKM-Ebola is a systemically injected RNAi therapeutic based on lipid nanoparticle delivery technology of Tekmira Pharmaceuticals to treat Ebola virus fever. According to pre-clinical findings reported in ‘The Lancet’ journal, complete protection obtained from a deadly dosage of Zaire Ebola virus when small interfering RNA (siRNA) systemically delivered through Tekmira's lipid nanoparticle technology to target the Ebola virus.
The President and Chief Executive Officer at Tekmira Pharmaceuticals, Dr. Mark J. Murray stated that the company is excited to get the approval from the FDA for its TKM-Ebola IND, which allows the company to start this product’s Phase 1 clinical trial in the beginning of 2012.
Dr. Murray further said that that the Transformational Medical Technologies (TMT) Program of the US government awarded the $140 million worth contract to develop the product, TKM-Ebola.
Besides developing the TKM-Ebola product, the TMT program has promoted further advancements in Tekmira's lipid nanoparticle technology, enabling lyophilization process development and a 100-time improvement in the lipid nanoparticle production process, while retaining important features of the lipid nanoparticle product. These developments will be helpful during the clinical trial and commercialization stages of TKM-Ebola and other lipid nanoparticle products of Tekmira Pharmaceuticals. The company and its partners are using its lipid nanoparticle platform in several clinical trials.
Source: http://www.tekmirapharm.com