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Published On: Fri, Mar 7th, 2014

FDA grants ‘fast track designation’ to Tekmira to develop Ebola drug

Canadian pharmaceutical company, Tekmira Pharmaceuticals Corporation announced Wednesday that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of TKM-Ebola, an anti-Ebola viral therapeutic.

Ebola virus  Image/CDC

Ebola virus Image/CDC

The FDA’s Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.1

“This is an important milestone for Tekmira and our TKM-Ebola program. Receiving a Fast Track designation from the FDA supports our work to advance the development of this therapeutic as quickly as possible. Our leadership in developing anti-viral therapies has been supported by our collaboration with the U.S. Department of Defense, which is funding the development of TKM-Ebola,” said Dr. Mark J. Murray, Tekmira’s President and CEO.

“In January, we announced that the first subject had been dosed in a Phase I clinical trial evaluating the safety of our TKM-Ebola therapeutic, which utilizes a third-generation LNP formulation. We continue to enroll subjects and remain on track to have data from this trial available in the second half of this year,” added Dr. Murray.

Tekmira’s anti-viral product platform includes RNAi therapeutics addressing chronic Hepatitis B infection and lethal hemorrhagic fever viruses, including Ebola and Marburg.

TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being developed under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.

Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP technology were used to treat previously infected non-human primates, the result was 100 percent protection from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010).

Tekmira’s productive collaboration with the MCS-BDTX was modified and expanded in 2013 to include significant advances in LNP formulation technology since the initiation of the program in 2010.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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