Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, provides an update on its Ebola program. The Company is reporting it has commenced limited GMP manufacture of a new therapeutic specifically targeting the Ebola – Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa. Supply of this new product will be available in early December, 2014, for potential use by various collaborators. As definitive agreements are established we will provide updates accordingly.
The genomic sequence of the Ebola virus responsible for the current outbreak in West Africa has been determined from several viral isolates. The Company has completed the design of a modified RNAi therapeutic specifically targeting this viral variant, now termed ‘Ebola-Guinea.’ The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.
In September, we announced our active engagement with an International Consortium led by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), the University of Oxford, with representatives from the WHO, the US Centre for Disease Control (CDC), Médecins Sans Frontières (MSF), Institut Pasteur and others, on plans for potential expedited clinical trials in West Africa. The Wellcome Trust has awarded £3.2 million to the International Consortium to fund this initiative. The award includes funds for the manufacture of investigational therapeutics and to establish an operational clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centers in West Africa. In this initiative, RNAi has been prioritized as a possible investigational therapeutic. However the use of our new product has not yet been confirmed.
As stated previously, the FDA 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). 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.
The Company’s IND for TKM-Ebola remains on partial clinical hold with respect to the multiple ascending dosing in healthy subjects. We expect this matter to be resolved this quarter.