Blueprint
FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 27 October 2016
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
27 October, London UK
GSK presents new data for shingles candidate vaccine at IDWeek
scientific conference
-
New studies support flexible dosing
and co-administration with flu vaccine
GSK
today announced new data for its shingles candidate vaccine
ShingrixTM, at the Infectious
Disease Week (IDWeek) scientific conference in New Orleans,
Louisiana, USA. The data examined co-administration of GSK's
candidate vaccine with the flu vaccine; a flexible dosing schedule;
and the vaccine's impact on quality of life.
Summary of new data
●
Using subjects from two multicentre,
multinational studies from the global phase III candidate vaccine
clinical programme, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229),
the vaccine's impact on quality of life was analysed. Due to the
high efficacy across all ages in these two pivotal trials, only a
few subjects in the vaccines arm developed "breakthrough" shingles
after vaccination, as expected. Using an established standard
health survey, those who had developed shingles reported reduced
levels of pain compared to the group that did not receive the
vaccine. The study concluded that in addition to helping prevent
shingles, the candidate vaccine also reduced the severity of
shingles in the few patients who developed the disease after
vaccination.
●
In the phase III clinical trial programme,
adults aged 50 years or over received two doses of the candidate
vaccine two months apart. A new study (ZOSTER-026) of 354 patients
showed that the second dose of the vaccine could be administered
during a window of two to six months following the first dose, with
a similar level of immune response and comparable safety
profile.
●
A study (ZOSTER-004) conducted during the 2013
Northern Hemisphere flu season with adults aged 50 years or over
showed that when the candidate vaccine was given to patients at the
same time as an unadjuvanted seasonal flu vaccine, both vaccines
were well tolerated and the immune response to each vaccine was
similar whether it was administered at the same time or
separately.
Across
the clinical trial programme, the risk of serious adverse events,
potential immune-mediated diseases or deaths observed was similar
in people receiving Shingrix and placebo. The most commonly
reported local adverse reaction was pain at the injection site and
the most frequently reported systemic adverse reaction was fatigue.
The majority of injection site and systemic reactions occurred
within seven days of vaccination, with most lasting 1-3 days, and
generally were mild-to-moderate in intensity.
GSK
included data on flexible dosing and co-administration with
unadjuvanted seasonal flu vaccine in its regulatory file submission
to the United States Food and Drug Administration (FDA) on Monday
24 October 2016. Data will also be part of the licensure
applications in other parts of the world, which are planned later
this year.
Dr Thomas Breuer, Chief Medical Officer GSK Vaccines said:
"Shingles is a common but serious condition that results from the
reactivation of the virus that causes chicken pox. The risk of
getting shingles increases sharply after 50 years of age. GSK's
shingles candidate vaccine has consistently shown high efficacy in
older people in its phase III development programme. This
underscores the potential impact of this novel vaccine candidate to
help prevent shingles, and to help overcome the challenge of
decreasing immunity that comes with age. Today's new data further
support the vaccine candidate's profile in helping to prevent
shingles and improve quality of life, and provide new evidence to
support flexible dosing options."
IDWeek
is the combined annual meeting of the Infectious Diseases Society
of America (IDSA), the Society for Healthcare Epidemiology of
America (SHEA), the HIV Medicine Association (HIVMA), and the
Pediatric Infectious Diseases Society (PIDS). In addition to
presenting data about shingles, GSK will also be presenting
abstracts on improving the prevention of influenza through
vaccination.
About Shingrix
The
candidate vaccine is a non-live, recombinant vaccine to help
prevent herpes zoster and its complications and combines
glycoprotein E, a protein found on the varicella zoster virus (VZV)
that causes shingles, with an adjuvant system, AS01B, which is
intended to enhance the immunological response to the
antigen3.
GSK intends to register the product as
ShingrixTM,
subject to approval by relevant regulatory review bodies. The name
Shingrix is not yet approved for use by regulatory authorities in
any country.
Additional
trials to evaluate the ability of the vaccine candidate to help
prevent shingles are ongoing in older adults aged 50 and older and
in adults with compromised immune systems. These studies will
provide additional information with respect to the efficacy and
safety profile of the candidate vaccine in an immunocompromised
population as well as its ability to stimulate immune
responses in other populations and in specific
circumstances.
About the phase III study programme
Involving
more than 37,000 subjects globally, the phase III programme for
GSK's candidate shingles vaccine evaluates its efficacy, safety and
immunogenicity. In addition to older adults, the candidate vaccine
is being evaluated in immunocompromised patient populations,
including solid and haematological cancer patients, haematopoietic
stem cell and renal transplant recipients and HIV-infected
people.
About the Zoster-026 study
In this
study, two doses of the candidate vaccine were administered two,
six or 12 months apart. Immune response and safety profile after
these alternative dose schedules were compared.
About the Zoster-004 study
In this
study, quadrivalent inactivated seasonal influenza vaccine was
given at the same time as the first dose of the vaccine candidate,
or both vaccines were given sequentially. Immune response and
safety profile were compared.
About shingles
Shingles
typically presents as a painful, itchy rash that develops on one
side of the body, as a result of reactivation of latent chickenpox
virus (varicella zoster virus or VZV). Data from many countries
indicates that more than 90% of adults have been infected with
varicella during childhood. The individual lifetime risk of
developing shingles is approximately one in three for people in the
USA; however, this increases to one in two people aged 85 and over.
A person's risk for shingles increases sharply after 50 years of
age due to a natural age-related decline in immune system function,
or as a consequence of an underlying immunocompromising
condition.4
The
most common complication from shingles is post-herpetic neuralgia,
defined as localised pain of significant intensity persisting at
least 90 days after the appearance of the acute shingles rash.
Other complications of shingles include ophthalmologic,
neurological and cutaneous disease, which can result in severe
disability.5
References
1.
Cunningham et al., N Engl J Med 2016; 375: 1019-32. Efficacy of the
herpes zoster subunit vaccine in adults 70 years of age or
older.
2.
Lal et al., N Engl J Med 2015; 372:2087-2096 Efficacy of an
Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults
3. Shingles (Herpes
Zoster) Clinical Overview. US Centers for Disease Control and
Prevention. Accessed at: http://www.cdc.gov/shingles/hcp/clinical-overview.html
on 6 Sept 2016.
4.
Cohen et al., N Engl J Med 2013;369:255-63 Clinical practice:
Herpes zoster.
5.
The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon® adjuvant licensed from Antigenics LLC, a wholly
owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and
liposomes
GSK - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please
visit www.gsk.com.
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GSK enquiries:
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UK
Media enquiries:
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David
Mawdsley
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+44 (0)
20 8047 5502
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(London)
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Catherine
Hartley
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+44 (0)
20 8047 5502
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(London)
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Melinda
Stubbee
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Gwynne
Oosterbaan
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+1 215
751 7468
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(Philadelphia)
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Analyst/Investor
enquiries:
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Cautionary statement regarding forward-looking statementsGSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
GlaxoSmithKline plc
(Registrant)
Date: October
27, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc