Friday, October 24, 2014

The FDA recently halted trials on a potential Ebola treatment

The Ebola virus under a microscope Tyler Hicks / Hulton Archives

Finding money to back an investment in Ebola treatments has been difficult — but not impossible.

A Canadian pharmaceutical company called Tekmira has been at work for the past few years on an Ebola treatment called TKM-Ebola. It has been among the most advanced attempts at a drug that could protect against, and treat, the disease — but was also recently dealt a setback by the Food and Drug Administration.

Diseases like Ebola often have difficulty attracting investment, as pharmaceutical companies rarely see a large payday in tackling a disease that has rare outbreaks and affects a low-income area of the world.

But TKM-Ebola has attracted the interest of the government. The Defense Department awarded it a contract for $140 million in 2010, after the vaccine proved completely effective in treating non-human primates in chimps. The government's interest in vaccinating against Ebola is largely rooted in preventing bioterrorism attacks, where the disease could be used a weapon.

In January, TKM-Ebola began Phase One trials with the Food and Drug Administration, injecting its first patient with the drug on January 14. This is the phase where drug companies test whether a drug is safe — that it doesn't create dangerous complications or side effects — before bigger studies look at whether the drug actually works.

The drug got added to the FDA's "fast track" schedule two months later, in March. That's a designation given to drugs that can help treat conditions without any current therapies. Once a drug receives that designation, its creators are eligible for more frequent meetings with FDA regulators, aimed at speeding up the drug's development.

But more recently the federal government has dealt TKM-Ebola a setback: the FDA halted the treatment's phase one trials at the start of July, requesting that Tekmira provide additional information about how the drug actually works, before the company begins giving trial subjects even larger dosages. That happens in Phase One trials to test how much the human body can handle.

So for the past month now, the TKM-Ebola trial has been on hold as Tekmira pulls together this information. "Our team is working expediently to respond to the FDA," Tekmira chief executive Mark Murray said in a recent statement. "We are mindful of the need for this important therapeutic in situations such as the ongoing Ebola outbreak in West Africa."

TKM-Ebola may not be the only hope: the New York Times reported Sunday that unnamed Ebola vaccine has been added to the FDA's Fast Track, and will be injected into human subjects beginning in September.

Still, both of these treatments are early in the research and development project. After Phase One testing comes Phases Two and Three, which typically involve running trials on hundreds and then thousands of subjects, respectively.

The halting of the Phase One research, Jonathan Gardner at EPVantage writes, not only "represent a setback for research into treating the deadly virus, it also serves to demonstrate how far the sector is from discovering a cure or vaccine."

Correction: An earlier version of this article mistakenly identified TKM-Ebola as a vaccine. While it has been tested as an Ebola treatment, it is not a vaccine.

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