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 the
month of November 2016
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F X
Form
40-F __
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
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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
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule
12g3-2(b): 82-_____________
AstraZeneca
PLC
INDEX
TO EXHIBITS
1. AZ head and neck cancer trials
resume enrolment dated 22nd November 2016
22 November 2016,
07:00
ASTRAZENECA HEAD AND NECK CANCER TRIALS
RESUME NEW PATIENT ENROLMENT AS FDA LIFTS
PARTIAL CLINICAL HOLD
AstraZeneca
today announced that the US FDA has lifted the partial clinical
hold on the enrolment of new patients with head and neck squamous
cell carcinoma (HNSCC) for clinical trials of durvalumab as
monotherapy and in combination with tremelimumab or other potential
medicines.
The Phase III KESTREL trial has already re-opened
for new patient enrolment at some clinical study sites and the
EAGLE trial is expected to resume recruitment shortly, without
amendments to either protocol. AstraZeneca will progressively
resume enrolment for all HNSCC trials across the participating
sites in the US and globally, subject to national health
authority and ethics committee approval where required.
The status of active recruitment will
be reflected on clinicaltrials.gov in the coming days.
The partial clinical hold on new patient enrolment
was communicated on 27 October, after preliminary findings from
ongoing clinical trials related specifically to head and neck
cancer. The FDA lifted the partial clinical hold following a
review of the comprehensive analysis provided by AstraZeneca of
bleeding events that were observed as
part of the routine safety monitoring of the Phase III KESTREL and
EAGLE trials.
Monitoring
of safety signals is an integral part of the development process
for new medicines. Bleeding is a known complication in treatments
of head and neck cancers primarily due to the nature of the
underlying disease, the proximity of tumours to major blood vessels
and use of prior cancer therapies, which may involve surgery and
radiation.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please
visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
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 authorized.
AstraZeneca
PLC
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Date:
22 November 2016
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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