Tekmira Pharmaceuticals yesterday announced it has commenced limited GMP manufacture of TKM-Ebola, an RNAi therapeutic specifically targeting the Ebola – Guinea virus variant.
Tekmira has completed the design of a modified RNAi therapeutic specifically targeting the Guinea viral variant, now termed Ebola-Guinea, which is the variant responsible for the Ebola epidemic currently prevalent in West Africa.
Supply of this new product is expected to be available in early December 2014 for potential use by various collaborators.
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. The current supply of TKM-Ebola inventory is limited. However, Tekmira intends to continue to provide TKM-Ebola, if requested, to patients with confirmed or suspected Ebola virus infections under this regulatory framework.
“To date, several patients have been treated with the product and data collected will be provided to the FDA under the Company’s Investigational New Drug Application (IND),” stated the Tekmira announcement. “We have established a similar framework with Health Canada for the potential use of TKM-Ebola for patients with confirmed or suspected Ebola virus infections.”
In September, Tekmira joined an international consortium facilitating expedited clinical trials in West Africa for Ebola Virus Disease countermeasures in West Africa.
The Company’s IND for TKM-Ebola remains on partial clinical hold with respect to the multiple ascending dosing in healthy subjects, which the company expects to be resolved this quarter.
TKM-Ebola is backed by a $140M contract with the U.S. Department of Defense Joint Project Manager Medical Countermeasure Systems (JPM-MCS). JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats.
Source: Tekmira press release, adapted.