Approval to Initiate Phase2 Pancreatic Cancer Trial in Korea
Released
Released
Announcement PDF
ABN 16 165 160 841
4th Dec 2023
ASX RELEASE
APPROVAL FROM KOREAN REGULATOR TO INITIATE PHASE 2 ACCENT PANCREATIC CANCER TRIAL
IN KOREA
HIGHLIGHTS
•
The Korean Ministry of Food and Drug Safety have approved the Phase 2a ACCENT clinical
trial
•
Amplia is working with the chosen clinical trial sites so that screening and recruitment of
patients for inclusion in the trial begins as quickly as possible
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is
pleased to announce that the Korean Ministry of Food and Drug Safety (MFDS) have approved the
clinical trial to test narmafotinib (AMP945) in combination with gemcitabine and Abraxane®, in
advanced pancreatic cancer patients in Korea.
This approval means that the five preselected clinical trial sites in Korea can be opened shortly to
commence enrolment of patients. Six sites in Australia were opened in November and experience at
these sites with the initial 1B Phase of the ACCENT trial will help optimise the recruitment and
management of patients in this important Phase 2 stage of the trial both in Australia and Korea.
Amplia’s CEO and Managing Director Dr Chris Burns commented: “The approval from the Korean MFDS
comes after many months of hard work from the Amplia team, who have worked closely with the
Korean regulators, to achieve this important approval. The Korean health system and their clinical trial
capability is world class, and recruitment into pancreatic cancer trials has been historically strong. We
look forward to opening our planned sites in Korea and working with the excellent clinical groups, to
further test the impact of our drug narmafotinib in the treatment of advanced pancreatic cancer.”
About the ACCENT Trial
The protocol for the ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the
Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and
Gemcitabine in Pancreatic Cancer Patients’.
The trial is a single-arm open label study conducted in two stages. The Phase 1b stage of the trial,
now complete, determined an optimal dose of AMP945 when dosed in combination with gemcitabine
and Abraxane, in first-line patients with advanced pancreatic cancer.
The Phase 2a, second stage of the trial, is designed to assess efficacy of the triple drug combination
of narmafotinib, gemcitabine and Abraxane. The primary endpoint is Objective Response Rate (ORR)
with secondary endpoints including Progression Free Survival (PFS) and Overall Survival (OS). Safety
and tolerability will continue to be assessed.
More information about the ACCENT trial, including a list of participating sites, can be found via our
website and at ClinicalTrials.gov under the identifier NCT05355298.
The Company will provide further updates as recruitment proceeds.
Level 17, 350 Queen Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
This ASX announcement was approved and authorised for release by the Board of Amplia
Therapeutics.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
About Amplia Therapeutics Limited
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal
Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the
field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic
and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic
pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on Twitter
(@ampliatx), Threads (@ampliatx) and LinkedIn.
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