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
Royal Moroccan Football Federation Acknowledges Decision Rendered by the CAF Appeals Committee18.3.2026 18:49:00 CET | Press release
The Royal Moroccan Football Federation (FRMF) wishes to reiterate that its appeal was never aimed at contesting the sporting merit or performance of the teams involved in this tournament, but solely to ensure the proper enforcement of competition regulations. The federation reaffirms its commitment to respecting the regulations, ensuring the clarity of the competitive framework and maintaining the stability of African football competitions. The Federation also wishes to commend all the nations that participated in this year’s edition of the Africa Cup of Nations (AFCON), which served as a significant moment for African football. The FRMF will issue a more comprehensive official statement in the coming days after a scheduled meeting of its governing bodies. Source: AETOSWire View source version on businesswire.com: https://www.businesswire.com/news/home/20260318763307/en/
SIMCON Unveils World’s First Large Engineering Model for Plastic Injection Moulding18.3.2026 18:05:00 CET | Press release
SIMCON today announced the launch of the Cadmould AI Solver, the world’s first Large Engineering Model for injection moulding. Co-developed with Emmi AI, the new transformer-based architecture delivers simulation results up to 1000 times faster than traditional numerical solvers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318680159/en/ SIMCON’s new Cadmould AI Solver delivers injection molding simulation results in seconds. By removing lengthy computation times, the tool enables engineers to dynamically explore thousands of design and process variations in a single day. Historically, lengthy computation times have acted as a bottleneck, limiting the number of design variations engineers can practically explore during the development process. The Cadmould AI Solver shatters this barrier by providing engineers with instant feedback on filling pattern, pressure, and temperature in seconds. What once required hours per si
Boomi, a 12X Leader, Positioned Highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service18.3.2026 16:30:00 CET | Press release
Boomi™, the data activation company, today announced it has been recognized as a Leader and positioned highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service (iPaaS). This marks the 12th consecutive time Boomi has been named a Leader– the longest recognized vendor in the report’s history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318987091/en/ Boomi, a 12X Leader, Positioned Highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service Boomi attributes its continued industry recognition to its unwavering commitment to innovation, customer success, and ecosystem growth. Over the past year, Boomi has accelerated its investments in integration and automation, APIM, agent management, and data management to help enterprises transform fragmented systems and data into orchestrated processes and governed agentic workflows. Recent i
Laserfiche Announces 2026 Run Smarter® Award Winners18.3.2026 15:17:00 CET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — today announced the winners of the 2026 Laserfiche Run Smarter® Awards. These awards celebrate the visionaries and trailblazers who are redefining the possible, using Laserfiche to break down operational silos and catalyze a new era of enterprise-wide productivity. From a large city reimagining criminal justice to a financial services firm’s innovative use of AI for smarter service delivery: The winners enhance productivity, reimagine processes and improve lives with Laserfiche technology. “The true power of Laserfiche has always been in how it unlocks value — whether that is through delivering actionable intelligence, cost savings, or reclaimed time to put toward innovation,” said Karl Chan, CEO of Laserfiche. “This year’s honorees are at the forefront of information management, with many of them leveraging cloud and AI technology to modernize processes and achieve business transformation.” Congratulations to t
I-Pulse Acquires CSI Technologies to Strengthen U.S. High-Energy Capacitor Manufacturing Capabilities18.3.2026 14:30:00 CET | Press release
I-Pulse Acquires California Capacitor Specialist CSI Technologies to Advance Disruptive Pulsed Power ApplicationsCSI Acquisition Secures Strategic Technologies Central to I-Pulse’s Pulsed Power Roadmap Co-Founder, Chairman, and CEO, Robert Friedland, and Co-Founder and Chief Technology Officer, Laurent Frescaline, of I-Pulse, the world leader in high pulsed power technologies, are pleased to announce the acquisition of CSI Technologies, Inc., the California-based manufacturer of high-energy, high-voltage capacitors serving industrial, medical, and defense applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318099794/en/ The strategic acquisition enhances I-Pulse’s pulsed power development and U.S. manufacturing capabilities, particularly in mining, geothermal energy, mineral exploration, and water resource applications. By integrating CSI Technologies’ proven capacitor design and production expertise, I-Pulse str
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