Delta-Fly Pharma Inc.: Notice of initiation of patients enrollment in Phase III Pivotal comparative clinical trial of DFP-14323
03 July 2024 - 8:00AM
Business Wire
We are excited to share our latest development status.
We are pleased to announce that the enrollment of patients in
the Phase III clinical trial of DFP-14323 in combination with
Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage
III/IV non-small cell lung cancer patients with uncommon EGFR
mutation positive that was approved by the Pharmaceuticals and
Medical Devices Agency (PMDA) in Feb. 2024, has started as of today
in Japan.
This Phase III clinical trial will be conducted at 30 sites with
NSCLC experts in Japan and the superiority of the add-on effect of
DFP-14323 on progression-free survival (PFS) as primary endpoint
will be confirmed.
As DFP-14323 selectively binds to the aminopeptidase N, which is
widely expressed on various cells, as lung cancer and inflammatory
cells, it is expected to be effective in the treatment of patients
with refractory cancer and when the superiority of the add-on
effect can be confirmed in this study, it is expected to provide a
novel cancer immunotherapy that is independent of EGFR mutation
types, uncommon or common mutation.
We will accelerate the progress of the trial by expanding this
Phase III clinical trial outside of Japan to Asian countries with
large numbers of EGFR mutation-positive non-small cell lung cancer
patients, and at the same time, we will promote out-licensing
activities to Asian pharmaceutical companies.
Please find out the innovation for the miserable cancer patients
by Delta-Fly Pharma Inc. (TOKYO: 4598) and contact with us.
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version on businesswire.com: https://www.businesswire.com/news/home/20240702506304/en/
Inquires Dr. Yasundo Yamasaki Director, Business Development
Dept. Delta-Fly Pharma, Inc. Head office: Tokushima 771-0117, Japan
Phone: +81-3-6231-1278 E-mail: yyamasaki1206@delta-flypharma.co.jp
Home page: https://www.delta-flypharma.co.jp/en/