Tekmira Begins Manufacture of RNAi Therapeutic for Ebola

Tekmira Pharmaceuticals Corp. began limited GMP manufacture of a new RNAi therapeutic specifically targeting the Ebola Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa. Supply of the new product will be available in early December 2014 for potential use by various collaborators. The company will provide updates as definitive agreements are established.
 
The FDA previously authorized the company to provide TKM-Ebola for treatment under expanded access protocols to patients with confirmed or suspected Ebola virus infections. While the current supply of TKM-Ebola inventory is limited, Tekmira plans to continue to provide the product under this regulatory framework.
 
To date, several patients have been treated with the product and the data collected will be used for the company’s IND. The company’s IND for TKM-Ebola remains on partial clinical hold with respect to the multiple ascending dosing in healthy subjects, but this is expected to be resolved this quarter.