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U.S., Canada Authorities OK Biotech Ebola Treatments

Ebola health care workers

Ebola health care workers in Guinea (European Commission-ECHO/USIAD)

23 September 2014. Tekmira Pharmaceuticals Corp. says the U.S. Food and Drug Administration approved the company providing its experimental therapy for people with suspected or confirmed Ebola infections. The Vancouver, British Columbia biotechnology company says approval of its therapy called TKM-Ebola is part of a larger regulatory framework for the treatments worked out with FDA and Health Canada, its counterpart agency.

Tekmira develops therapies based on small interfering RNA, synthesized molecules that suppress the production of proteins causing disease. RNA is a nucleic acid related to DNA that generates the protein-making instructions from an individual’s genomic code. Small interfering RNA attaches to the RNA signals, called messenger RNA, and blocks the production of the disease-causing proteins.

The company says these small interfering RNA target specific messenger RNA molecules, and can continue working in the body to prevent further production of those disease-causing proteins. To aid this process, Tekmira also developed a lipid nanoparticle delivery system for its interfering RNA that encapsulate the therapeutic molecules in natural nanoscale fats or oils, which allows disease site cells to accumulate and then interact with the cells to release the treatments.

in 2010, Tekmira received a contract from the U.S. Defense department to advance a therapy for an earlier (Zaire) strain of Ebola that the company showed could protect non-human primates from infection. The contract was expanded 3 years later to include improvements in its lipid nanoparticle delivery system allowing for freeze-dried formulations and administrations of the drug with injections under the skin.

In January 2014, Tekmira began an early-stage clinical trial of TKM-Ebola among healthy subjects for safety and chemical activity in the body. In March, FDA approved a fast-track designation for TKM-Ebola that expedites regulatory review of the treatments. The company says FDA is allowing development of TKM-Ebola under its so-called animal rule that permits consideration of marketing approval for therapies based on tests with animals, in cases where human trials are infeasible or unethical.

The new regulatory framework, says Tekmira, comes under FDA’s expanded access program that allows early use of experimental drugs outside of clinical trials, where there are no comparable or satisfactory treatment options. While that authority is usually granted on a case-by-case basis, it can also be extended to smaller groups of people before the safety of the new therapy is established, and to larger groups once the drug’s safety is known.

Tekmira’s CEO Mark Murray says in a company statement TKM-Ebola was given to “a number of patients” and was well tolerated, even with repeated infusions. “However,” Murray adds, “it must be kept in mind that any uses of the product under expanded access, does not constitute controlled clinical trials. These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome.”

The company says as well it is collaborating with a consortium to expedite clinical trials of Ebola treatments in West Africa that includes World Health Organization, University of Oxford, Institut Pasteur, and several non-government organizations. The initiative, announced today, is funded by a £3.2 million ($US 5.2 million) grant from the Wellcome Trust. A group of experts from WHO is evaluating potential Ebola treatment candidates for the trials, including those made by Tekmira.

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Hat tip: FirstWord Pharma

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