DELTA-FLY-PHARMA
2.2.2024 07:16:29 CET | Business Wire | Press release
We are excited to share our latest development status.
As presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months).
Subsequently, based on these results, we have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in our decision to conduct a Phase III clinical trial (superiority study) 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 based on the PMDA's recommendation.
And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.
This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, we believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical.
Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.
We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.
Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240201128942/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sharjah Advocates More Dominant Role for Women in Technology under 2050 Roadmap24.9.2026 18:38:00 CEST | Press release
As artificial intelligence reshapes global economies, the UAE is placing women at the heart of its global ambitions positioning them not only as participants, but as key contributors to the AI future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924186173/en/ Women leaders and technology experts during a session at the Women in Technology 2026 Forum in Sharjah (Photo: AETOSWire) The message was echoed by Her Highness Sheikha Bodour bint Sultan Al Qasimi, Chairperson of the Sharjah Research, Technology and Innovation Park (SPARK), who urged women to move beyond participation in technology to playing a leading role in shaping the future. Addressing the seventh edition of the Women in Technology 2026 Forum, hosted by SPARK on the theme “The 2050 Mindset,” HH Sheikha Bodour said: “2050 may seem far away, but it is being shaped by the decisions we make, the research we fund and the technologies we develop today. Women must t
MultiBank Group Founder and Chairman Naser Taher Named Financial Leader of the Year at Gulf Business Awards 202624.9.2026 17:39:00 CEST | Press release
Recognition highlights Taher’s leadership in building MultiBank Group into a global financial institution Naser Taher, Founder and Chairman of MultiBank Group, one of the world’s largest financial derivatives institutions, was named Financial Leader of the Year at the Gulf Business Awards 2026. Presented during a ceremony held on 23 September at The Ritz-Carlton JBR, Dubai, the award was part of the Editor’s Choice category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924454616/en/ Naser Taher, Founder and Chairman of MultiBank Group, one of the world’s largest financial derivatives institutions, was named Financial Leader of the Year at the Gulf Business Awards 2026 The recognition comes after Taher lead the expansion of MultiBank Group for more than two decades, from its founding in 2005 to a financial institution serving more than four million clients across 100 countries today. Under his leadership, the Group has b
Multiple Industry Honors Reinforce CSG/Netcracker Leadership in Customer Journey Orchestration and AI Innovation24.9.2026 17:05:00 CEST | Press release
Customer engagement platform recognized for ability to orchestrate connected, AI-driven customer experiences The next phase of customer experience hinges on how well brands turn customer data into relevant communications, real-time action, and responsible, proven AI use. CSG® and Netcracker Technology today announced that CSG has been named a Leader in The Forrester Wave™: Customer Journey Orchestration Platforms, Q3 2026, with the highest possible scores in 19 of 23 Forrester Wave™ criteria. CSG Xponent, a best-in-class customer engagement platform, helps brands land timelier, more relevant communications that drive customer action, secure loyalty, and bolster measurable business results. The Forrester Wave™: Customer Journey Orchestration Platforms states that, “CSG earns superior scores across the core journey intelligence and orchestration capabilities that define this market. Its excellent journey simulation, predictive intelligence, and decisioning capabilities help organizations
VasionⓇ Enhances Global Partner Program to Accelerate AI-Powered Automation24.9.2026 16:05:00 CEST | Press release
A refreshed rewards structure, new Partner Academy, and rebuilt partner portal give partners a clearer path to sell and support agentic print and document workflows. VasionⓇ, the Intelligent Print Automation platform trusted by more than 14,000 organizations worldwide, today unveiled a comprehensive refresh of its Global Partner Program. The program delivers the resources partners expect from Vasion: always-on incentives, structured onboarding, elevated enablement, and a rebuilt portal experience, all engineered to help partners scale, compete, and deliver stronger customer outcomes as agentic AI reshapes how enterprises automate work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924791639/en/ Agentic print and document workflow environments remain an overlooked channel opportunity, as enterprises race toward agentic automation. IDC forecasts that by 2026, 40% of all Global 2000 job roles will involve working with AI ag
The Only AI Crypto Lead Prioritization Solution Built With Law Enforcement, for Law Enforcement: Elliptic Launches Pulse24.9.2026 15:15:00 CEST | Press release
Pulse delivers actionable leads in seconds, no crypto expertise required, enabling decisions in the field Elliptic, the global leader in on-chain risk, today launched Pulse. Pulse puts crypto lead prioritization directly in the hands of every frontline law enforcement and government officer. Crypto now touches every part of law enforcement, from the patrol officer on the street to the detective assigned to investigate the case. Pulse gives each of them a quick, accurate financial summary and a starting point: whether that's a crypto address on a suspect's phone, in a scam ATM victim's receipt, uncovered during a vehicle or pocket search, or found at the scene of an overdose, an arrest, or a seizure. An officer can input anything that looks like a wallet address or transaction hash. Pulse identifies it, reasons over the result, and returns a summary in plain language, enough for the officer to decide on the spot whether the case needs escalation. If a case needs further investigation, o
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom