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
Entrepreneurs Invited to Apply for 2027 SPIE Startup Challenge11.8.2026 20:40:00 CEST | Press release
The competition will bring seven teams head-to-head in pursuit of $10,000 first prize Entrepreneurs around the world are invited to apply for a chance to pitch their optics or photonics technologies or products to a panel of expert judges at the 17th annual SPIE Startup Challenge. SPIE, the international society of optics and photonics, holds the competition at Photonics West every January, with multiple teams walking away with cash prizes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811090450/en/ Coalesenz won first prize for their hand-held, point-of-care coagulation analyzer at the SPIE Startup Challenge at Photonics West in January 2026. More than a simple pitch competition, the SPIE Startup Challenge is an entry point into the community of high-tech business development of new products in healthcare and deep tech, with an audience of experienced photonics innovators and investors. Cash prizes of $10,000, $5,000, a
The Aga Khan Museum Welcomes Prince Aly Muhammad Aga Khan and Saira Bhojani to its Board of Directors11.8.2026 17:30:00 CEST | Press release
The Aga Khan Museum is pleased to announce the appointment of Prince Aly Muhammad Aga Khan and Saira Bhojani to its Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811597825/en/ Prince Aly Muhammad Aga Khan, board member, Aga Khan Museum Prince Aly Muhammad Aga Khan joins the Board with a deep commitment to arts and culture. He brings an international outlook shaped by working with the Aga Khan Foundation and Aga Khan Music Programme. Committed to advancing pluralism and cultural dialogue, Prince Aly brings a fresh perspective that will help guide the Museum as it continues to evolve, engage new audiences, and expand its impact both in Canada and internationally. Prince Aly is the son of His Late Highness Prince Karim Aga Khan IV and brother of His Highness Prince Rahim Aga Khan V. Joining him on the Board is Saira Bhojani, Partner at Torys LLP and one of Canada's leading tax lawyers. Ms. Bhojani is wid
Mouser Explores the Future of Quantum Computing and Its Potential to Transform Engineering11.8.2026 16:48:00 CEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, A Quantum Leap in Computer Processing. This installment explores the emerging field of quantum computing and examines how the principles of quantum mechanics could unlock new computational capabilities for solving problems that remain difficult for conventional computing architectures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811222432/en/ Explore how quantum computing could help engineers address problems too complex for traditional systems. Unlike traditional computers, quantum computers leverage quantum-mechanical phenomena, such as superposition, entanglement, and interference, to perform calculations in fundamentally different ways. While today's quantum systems still face challe
Rehlko Expands Power Plus™ Connected-Services Capabilities, Enhancing Value Across Installed Base11.8.2026 15:15:00 CEST | Press release
Rehlko Power Plus™Delivers 24/7 Remote Monitoring, Advanced Diagnostics, and Fleet-Wide Asset Visibility to Critical Power Systems Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced the expanded capabilities of Rehlko Power Plus™ industrial remote monitoring. The cloud-based platform is designed to help customers reduce downtime, improve backup power reliability, and proactively manage critical power assets through real-time monitoring, alerts, diagnostics, and reporting. Rehlko Power Plus represents a meaningful expansion of Rehlko’s aftermarket capabilities and reinforces the company's strategy to deepen customer engagement across the asset lifecycle while growing its higher-value aftermarket business. As backup power systems become increasingly critical to business continuity, organizations need more than periodic inspections and reactive maintenance. Rehlko Pow
Boomi Ranked #1 Overall Leader in the 2026 ISG Buyers Guide™ for Application Integration11.8.2026 15:00:00 CEST | Press release
Boomi earns top rankings across Product Experience, Capability, Platform, Customer Experience in 2026 ISG Buyers Guide™ for Application Integration Boomi, the data activation company for AI, today announced it has been ranked the #1 overall software provider in ISG Buyers Guides™ for Application Integration 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811102868/en/ Boomi Ranked #1 Overall Leader in the 2026 ISG Buyers Guide™ for Application Integration In the report published by ISG Software Research, a division of ISG (Information Services Group), Boomi was placed within ISG's highest quadrant classification, Exemplary. ISG's report states that “Boomi was designated a Leader Overall and in every category,” a distinction no other provider assessed achieved. Capability, Platform and Customer Experience Leader The ISG Buyers Guide™ looks at how well software providers deliver for their customers, evaluating both the
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