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Tekmira Pharmaceuticals Corp (2)
Symbol TKM
Shares Issued 22,281,878
Close 2014-10-21 C$ 20.17
Market Cap C$ 449,425,479
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Tekmira begins making product for Ebola-Guinea variant

2014-10-21 19:56 ET - News Release

Ms. Julie Rezler reports

TEKMIRA PROVIDES PERIODIC UPDATE ON TKM-EBOLA PROGRAM

Tekmira Pharmaceuticals Corp. has provided 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, the company 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, the company announced its active engagement with an international consortium led by the International Severe Acute Respiratory and Emerging Infections Consortium, the University of Oxford, with representatives from the WHO, the U.S. Centre for Disease Control, Medecins Sans Frontieres, Institut Pasteur, and others, on plans for potential expedited clinical trials in West Africa. The Wellcome Trust has awarded 3.2 million pounds to the international consortium to finance 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 treatment centres in West Africa. In this initiative, RNAi has been prioritized as a possible investigational therapeutic. However, the use of its 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. The company has 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. The company expects this matter to be resolved this quarter.

About RNAi and Tekmira's LNP

RNAi therapeutics have the potential to treat a number of human diseases by silencing disease-causing genes. The discoverers of RNAi, a gene-silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for physiology or medicine. RNAi trigger molecules often require delivery technology to be effective as therapeutics. Tekmira believes its LNP technology represents the most advanced and widely adopted delivery technology for the systemic delivery of RNAi triggers. Tekmira's LNP platform is being utilized in multiple clinical trials in various disease areas by Tekmira and its partners. Tekmira's LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates RNAi triggers with high efficiency in uniform lipid nanoparticles that are effective in delivering these therapeutic compounds to disease sites. Tekmira's LNP formulations are manufactured by a proprietary method, which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple regulatory agencies for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.

About joint project manager medical countermeasure systems

This work is being conducted under a $140-million contract with the U.S. Department of Defence joint project manager-medical countermeasure systems. JPM-MCS, a component of the Joint Program Executive Office for Chemical and Biological Defence, 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. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance biodefence response capability.

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