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GSK Ebola vaccine trial seen moving to wider phase in February

Fri, 19th Dec 2014 11:30

GENEVA, Dec 19 (Reuters) - Trials of GlaxoSmithKline's experimental Ebola vaccine are likely to move to asecond phase in February, later than previously suggested, aftera meeting of national regulators said they needed moreinformation.

The World Health Organization, which hosted a meeting ofnational regulatory authorities and ethics committees earlierthis week, said they had thoroughly discussed all aspects of theproposed trials at the two-day meeting.

"Reviewing countries requested additional documentation fromthe manufacturer of the vaccine, GlaxoSmithKline, beforeauthorization of the trials," the WHO said in a statement.

Countries where the trials are planned -- Cameroon, Ghana,Mali, Nigeria and Senegal -- should receive and review theadditional information by the end of January.

"If these steps are completed to the satisfaction of thenational authorities, Phase II trials are likely to begin inFebruary," the statement said.

The GSK vaccine is already undergoing Phase I trials, tocheck its safety in humans, in Switzerland, Britain, Mali andthe United States, and is one of the two leading candidatevaccines for Ebola already undergoing tests.

The other vaccine, from NewLink Genetics is alsostill in Phase I trials. One of its trials, in Geneva, wassuspended earlier this month after some patients complained ofjoint pains.

Johnson & Johnson plans to start clinical trialswith a third vaccine shortly.

WHO officials have said they hope the unprecedentedfast-track trials mean vaccines may be widely available aroundthe middle of 2015, although they also hope the outbreak will beover by then. So far it has killed almost 7,000 people.

There are still many unresolved questions about the use ofexperimental vaccines, including whether subjects will need oneor two injections. (Reporting by Tom Miles; editing by Ben Hirschler and MarkTrevelyan)

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GSK unveils promising results from endometrial cancer trial

(Sharecast News) - GSK unveiled promising outcomes from a phase three trial of 'Jemperli', or dostarlimab, in treating primary advanced or recurrent endometrial cancer on Monday.

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TOP NEWS: Pfizer launches GBP2 billion sale of 8% stake in Haleon

(Alliance News) - Haleon PLC on Monday said Pfizer Inc plans to sell around GBP2 billion in Haleon shares, some of which will be bought back by Haleon.

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GSK says Jemperli combination gets good results for endometrial cancer

(Alliance News) - GSK PLC on Monday said a test of its Jemperli drug in combination with chemotherapy has shown it reduced the risk of death in patients with endometrial cancer by nearly a third.

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GSK reports more encouraging trial results for Blenrep

(Sharecast News) - GSK unveiled encouraging results from its 'DREAMM-8' phase three trial on Thursday, comparing the efficacy of 'Blenrep', or belantamab mafodotin, in combination with pomalidomide plus dexamethasone, or PomDex, against the standard treatment of bortezomib plus PomDex in relapsed or refractory multiple myeloma patients.

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GSK says ViiV's cabotegravir study supports longer HIV dose interval

(Alliance News) - GSK PLC on Tuesday celebrated study results from ViiV Healthcare Ltd, that showed an investigational formulation of cabotegravir can be dosed at four-month intervals.

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GSK's ViiV upbeat on ultra-long-acting HIV treatment study

(Sharecast News) - GSK announced on Tuesday that its specialist GIV joint venture with Pfizer and Shionogi, ViiV Healthcare, had reported encouraging results from its phase one clinical trial of an investigational formulation of cabotegravir, termed cabotegravir ultra long-acting (CAB-ULA).

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TOP NEWS: GSK avoids "protracted litigation" with Zantac settlement

(Alliance News) - GSK PLC on Thursday emphasised its commitment to science, as it reached another settlement in ongoing litigation over alleged links between its heartburn drug and cancer.

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GSK reaches settlement in another Zantac case

(Sharecast News) - GSK announced a confidential settlement with Boyd/Steenvoord, effectively resolving a case filed in California state court over its discontinued heartburn drug Zantac.

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GSK gonorrhoea treatment achieves efficacy endpoint in latest trial

(Alliance News) - GSK PLC on Monday announced positive results from the latest trial of its oral gonorrhoea treatment, showing it to be on par with intramuscular therapies.

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GSK reports positive results from gonorrhoea treatment trial

(Sharecast News) - GSK announced encouraging headline outcomes from its trial of gepotidacin, an oral antibiotic aiming to address uncomplicated urogenital gonorrhoea in adolescents and adults, on Monday.

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GSK reports encouraging results for ViiV's Cabenuva HIV treatment

(Alliance News) - GSK PLC on Wednesday said that its majority-owned company ViiV Healthcare had received positive interim data from ongoing trials of its injectable HIV treatment.

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GSK's ViiV sees success in latest HIV treatment trial

(Sharecast News) - GSK's specialist HIV unit ViiV Healthcare, which it owns in partnership with Pfizer and Shionogi, unveiled promising findings from the 'LATITUDE' phase three trial of its long-acting injectable HIV treatment Cabenuva on Wednesday.

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