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WHO urges drug companies, regulators to speed Ebola work

Thu, 04th Sep 2014 15:15

* WHO hosts two-day talks on experimental Ebola therapies

* Says eight drugs and two vaccines have shown potential

* Calls for speeding work on developing safe, efficienttreatments

* A few hundred doses of ZMapp may be available by year-end

* Newlink gets FDA nod for clinical trials of Ebola vaccine

By Stephanie Nebehay

GENEVA, Sept 4 (Reuters) - The World Health Organisation(WHO) called on Thursday for pharmaceutical companies andregulatory agencies to work together to accelerate developmentof safe and efficient drugs and vaccines against Ebola.

Ten experimental treatments - eight drugs and "two promisingcandidate vaccines" - have shown potential against the virus butremain under investigation, the WHO said in a documentdistributed at the start of a two-day meeting in Geneva.

They include the antibody drug ZMapp made by U.S.-based MappBiopharmaceutical Inc., which has been given to several Ebolapatients for "compassionate care" but whose clinicaleffectiveness is "still uncertain", it said. "Efforts to scaleup production (of ZMapp) may yield increased supplies ofpotentially a few hundred doses by the end of 2014."

Evidence of the effectiveness of the medicines and vaccinesis "suggestive but not based on solid scientific data fromclinical trials," the WHO said. Existing supplies of allexperimental medicines are extremely limited or exhausted.

The virulent disease, which has killed at least 1,900 peoplein West Africa since March, could affect 20,000 by the time itis contained in the next six to nine months, the WHO has said.

"Accelerating the development of experimental/not approvedEbola Virus Disease therapies and vaccines require a concertedeffort by product developers and regulatory agencies, incooperation with the WHO," the WHO paper said.

Decisions on which products go into accelerated developmentshould be transparent and involve the West African countriesaffected by the epidemic, it said.

"While there is an urgent need for product to be used on acompassionate basis, the ultimate goal should be productapproval so that countries affected by Ebola Virus Disease haveproducts which have been demonstrated safe and effective attheir disposal."

"THE HOPE OF WHAT WE ARE GOING TO HAVE"

Marie-Paule Kieny, WHO assistant director-general who ischairing the closed-door talks attended by more than 150experts, said the meeting would focus on developing the mostpromising drugs in the quickest possible time.

"Developed in terms of getting them to registration anddeveloped in terms of putting them in the treatment centre asmuch as possible in order to make a difference in the lives ofpeople," she said.

The WHO paper said that while supplies of experimental drugsare limited "the prospects of having augmented supplies ofvaccines quickly look slightly better".

Human safety trials are due to begin this week on a vaccinefrom GlaxoSmithKline Plc and later this year on one fromNewLink Genetics Corp. Johnson & Johnson saidon Thursday that clinical trials of its vaccine would commencein early 2015, accelerated from late 2015 or early 2016.

NewLink Genetics Corp NLNK.O said the U.S. Food and DrugAdministration (FDA) allowed the Iowa-based company to starttesting an experimental Ebola vaccine in humans. [ID:nL3N0R53VM}

NewLink founder Charles Link told Reuters on the sidelinesof the Geneva talks on Thursday: "The clinical trials do takesome time. Everybody is trying as hard and furiously as possibleto move those trials forward as rapidly as possible with theregulations, scientific and ethical constraints.

A treatment by Tekmira Pharmaceuticals of Vancouver, Canada,that targets two viral genes to stop the virus from replicating,may be available in limited supplies, the WHO said. "There ispotential for the production of 900 courses by early 2015." (Additional reporting by Antony Paone in Geneva; Editing byDominic Evans)

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