Merck hits a hiccup with its new Ebola vaccine

Ebolavirus under an electron microscope--Courtesy of CDC

Investigators have suspended a Phase I study of NewLink Genetics' ($NLNK) Ebola virus vaccine just weeks after Merck ($MRK) stepped in to license it, citing a safety issue that could delay the pharma giant's plans to quickly ramp up production.

As Reuters reports, researchers at the University of Geneva Hospital have stopped a 59-person trial on rVSV-EBOV after four participants cited joint pain in their hands and feet, halting the safety study a week ahead of schedule. The move is "a measure of precaution," the hospital said, and the patients "are all fine and being monitored regularly by the medical team leading the study."

Now the hospital plans to examine the affected patients to ensure the symptoms were "benign and temporary," according to Reuters, figuring it can resume the study as soon as Jan. 5.

The news sent NewLink's shares down about 8% on Thursday morning over fears that the safety scare could affect the vaccine's future late-stage development. The Geneva study is the first among the handful of Phase I rVSV-EBOV trials underway around the world to disclose an interruption-worthy safety issue, researchers said.

The National Institutes of Health has blueprinted a Phase III trial for rVSV-EBOV to kick off in early 2015, studying NewLink's vaccine alongside one developed by GlaxoSmithKline ($GSK) and the National Institute of Allergy and Infectious Diseases. Merck, which paid an undisclosed amount of money to partner up on NewLink's vaccine, is on hand to develop, manufacture, and distribute rVSV-EBOV if and when it's approved.

Meanwhile, global researchers are rushing to study whether any of the in-development products can help stem the spread of a virus that has killed more than 6,000 people in its latest outbreak. Regulators have fast-tracked treatments from Fujifilm, Mapp Biopharmaceutical and Chimerix ($CMRX) in hopes of finding a cure, while industry titans like Merck, GSK and Johnson & Johnson ($JNJ) lend their weight to the cause.

- here's the hospital's statement (PDF)
- read the story

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