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Glaxo (GSK) Publishes Phase III Data on Shingles Vaccine
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GlaxoSmithKline plc (GSK - Free Report) announced that detailed results from a randomized phase III study (ZOE-70) on its experimental shingles vaccine candidate, Shingrix, were published in the New England Journal of Medicine.
The study, from which head-line results were reported in Oct 2015, demonstrated that a two-dose of the vaccine candidate showed 90% efficacy in comparison to placebo in people aged 70 years and above, and that is maintained for at least four years. High efficacy witnessed in the study is in line with that seen in another phase III study (ZOE-50) in people aged 50 years and above, data from which were presented and published last year. A pooled analysis of data from both studies showed that the vaccine demonstrated 91% efficacy against shingles in people aged 70 years and above, when compared to placebo.
Additionally, a pooled analysis of data from the ZOE-70 and ZOE-50 studies demonstrated that the candidate was effective in reducing the risk of subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN) – the most common but severe complication of shingles. Shingrix was seen to be 89% efficacious in preventing PHN in people aged 70 years and above, and 91% efficacious in people aged 50 years and above.
Based on encouraging ZOE-70 and ZOE-50 data, Glaxo plans to seek approval for Shingrix for the prevention of shingles in people aged 50 years and above later this year. Approval of the candidate for the prevention of shingles and the pain associated with it will be a positive both for the eligible patient population as well as for the company.
Meanwhile, additional studies evaluating the potential of Shingrix are currently underway in healthy people aged 50 and above, and in adults with compromised immune systems. Also, the candidate is being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients and HIV-infected people.
These studies are expected to provide additional information regarding the efficacy and safety profile of the candidate along with its potential to stimulate immune responses in other populations and in specific circumstances.
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Glaxo (GSK) Publishes Phase III Data on Shingles Vaccine
GlaxoSmithKline plc (GSK - Free Report) announced that detailed results from a randomized phase III study (ZOE-70) on its experimental shingles vaccine candidate, Shingrix, were published in the New England Journal of Medicine.
The study, from which head-line results were reported in Oct 2015, demonstrated that a two-dose of the vaccine candidate showed 90% efficacy in comparison to placebo in people aged 70 years and above, and that is maintained for at least four years. High efficacy witnessed in the study is in line with that seen in another phase III study (ZOE-50) in people aged 50 years and above, data from which were presented and published last year. A pooled analysis of data from both studies showed that the vaccine demonstrated 91% efficacy against shingles in people aged 70 years and above, when compared to placebo.
Additionally, a pooled analysis of data from the ZOE-70 and ZOE-50 studies demonstrated that the candidate was effective in reducing the risk of subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN) – the most common but severe complication of shingles. Shingrix was seen to be 89% efficacious in preventing PHN in people aged 70 years and above, and 91% efficacious in people aged 50 years and above.
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Based on encouraging ZOE-70 and ZOE-50 data, Glaxo plans to seek approval for Shingrix for the prevention of shingles in people aged 50 years and above later this year. Approval of the candidate for the prevention of shingles and the pain associated with it will be a positive both for the eligible patient population as well as for the company.
Meanwhile, additional studies evaluating the potential of Shingrix are currently underway in healthy people aged 50 and above, and in adults with compromised immune systems. Also, the candidate is being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients and HIV-infected people.
These studies are expected to provide additional information regarding the efficacy and safety profile of the candidate along with its potential to stimulate immune responses in other populations and in specific circumstances.
Glaxo is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector are Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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