Ebola Therapy Put on Hold by FDA

Ebola

Ebola is a disease that has frightened humankind ever since it was identified in 1976 in Central Africa. Recently a Canadian company produced a drug which had been proven 100 percent effective at killing the virus in non-human primates but has now been put on hold by the FDA until further notice. Ebola virus is not just one virus. After the initial outbreaks in 1976 subsequent research and records show that there are actually 4 variants of the Ebola virus. The most deadly, Zaire Ebola virus (named after the country in which it was first identified), is known for killing 90 percent of its victims and is highly contagious.

Today there is no cure or vaccine that is currently in use and treatment is focused on supporting the patient as their body attempts to fight off the pathogen, or as one expert put it, “tepid sponging” and the promise of a nice burial. However that does not mean that researchers have not been trying to find a way to treat the deadly illness. One such company, Tekmira Pharmaceuticals Corporation, has developed what they believe to be an effective treatment to Zaire Ebola virus. However the Federal Drug Administration (FDA) has refused to approve it without first subjected it to further review, citing worries over whether the treatment could possibly become harmful to patient at high dosages. Dr. Mark Murray, the CEO of Tekmira, pledged to resolve the issue with the FDA and “advance the development of this important therapeutic agent.”

Development of the drug started in 2010, when studies revealed that the unique pharmaceutical compounds used by the company could completely protect both guinea pigs and variety of monkey species from the virus. This breakthrough prompted a hundred million dollar contract with the Department of Defense to use their techniques to create an actual treatment for the Ebola virus. This partnership continued well into 2013, when the contract was expanded to develop more advanced and potent formulas.

Then in March of 2013, the FDA designated the company’s Ebola virus drug development with a “fast track” status, a designation which it awards only to developers of therapies which have shown promise in treating serious conditions which are currently not treatable using conventional or existing methods. Fast track designation also allows for “accelerated approval and priority review” in order to get the drugs out onto the market as fast as possible.

As of now the development of the drug (called TKM-Ebola) is stuck in Phase One of clinical trials and it seems likely that Tekmira will keep it that way until they are permitted to continue. Dr. Murray’s press release seemed hopeful, even hinting that it was the Clinical Hold notice from the FDA that may have been based on a misunderstanding of their procedures rather than a substantive medical or ethical issue. It is doubtful that the FDA will attempt to bury such a promising therapy, especially when there is a possible global pandemic headed their way, not to mention those currently dying from the disease in Africa.

If they are able to pass the FDA’s scrutiny and complete the clinical trials then they have a chance at saving innumerable lives and of course making their investors very happy. Of course, that is only if their drug is as successful at treating Ebola in humans as it is in guinea pigs and chimpanzees. It also assumes that the particular Ebola virus found in West Africa, which has killed a record number of people, is going to be responsive to their drug, which seems to be designed specifically for the most deadly virus, the Zaire Ebola strain. However even if it does nothing to help the suffering masses in West Africa, Tekmira’s drug, if effective, will help to eliminate one humankind’s most formidable microbial foes.

By Andrew Waddell

Sources

Tekmira Corporation
Tekmira
The Lancet
Federal Drug Administration
Center for Disease Control
GMA Network

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