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
MSCI Announces the Results of the MSCI 2026 Market Classification Review23.6.2026 23:42:00 CEST | Press release
MSCI released the results of the MSCI 2026 Market Classification Review. Key takeaways from this year's review include: Reclassification of Bulgaria from Standalone to Frontier Market status Assessment of shareholder transparency and coordinated trading concerns in the Indonesian and Turkish equity markets, acknowledging the announced steps undertaken by both markets to address these matters and noting the continued potential for future consultations on the appropriate treatment of these markets if credible progress is not observed Acknowledgement of the removal of floor prices in Bangladesh, with a caution that any reintroduction could prompt a consultation on reclassification from Frontier to Standalone Market status Ongoing monitoring of the implementation of measures aimed at improving the accessibility of the Korean equity market for international institutional investors Reminder on the reclassification of Greece from Emerging to Developed Market status at the May 2027 Index Revie
Elliptic Intelligence Used by the FBI in Action Against Huione, the $134 Billion Criminal Marketplace and Money Laundering Operation23.6.2026 23:28:00 CEST | Press release
Elliptic, the global leader in digital asset decisioning, today announced that its intelligence was used by the Federal Bureau of Investigation in today's action against the operators of Huione Group. The Justice Department announced the seizure of a cloud computing account used by subsidiaries of the Huione Group, a Cambodia-based corporate conglomerate. First exposed by Elliptic in July 2024, Huione Guarantee was a Telegram-based marketplace serving online fraudsters across Southeast Asia. Merchants sold money laundering services, stolen personal data, websites and other goods and services necessary to perpetrate so-called “pig-butchering” scams and other online fraud., By the time Huione was forced offline, it had received more than $31 billion in cryptoasset transactions, making it the largest illicit online marketplace ever recorded, more than 25 times larger than Silk Road and AlphaBay combined. Huione Group’s payments arm, Huione Pay, was also implicated in the laundering of pro
Rockwell Automation Site Named a World Economic Forum Global Lighthouse23.6.2026 23:13:00 CEST | Press release
Recognition highlights advanced manufacturing capabilities at Rockwell’s Singapore facility and the company’s role in scaling AI-driven transformation Rockwell Automation, Inc. (NYSE: ROK), the world’s largest company dedicated to industrial automation and digital transformation, today announced its Singapore manufacturing facility has been named a member of the Global Lighthouse Network by the World Economic Forum (WEF). The designation recognizes this facility for applying advanced technologies at scale to deliver measurable improvements in productivity, quality and workforce enablement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623794856/en/ Rockwell Automation Site Named a World Economic Forum Global Lighthouse Rockwell’s Singapore site was recognized with distinction in the productivity category, reflecting its transformation into a highly flexible, data-driven operation. By deploying more than 50 digital and AI
NIKE, Inc. Announces Planned CFO Transition23.6.2026 22:17:00 CEST | Press release
David M. Denton named incoming Chief Financial Officer NIKE, Inc. (NYSE:NKE) today announced that David M. Denton will join the company as Executive Vice President and Chief Financial Officer, effective August 17. Matthew Friend will step down as Executive Vice President and Chief Financial Officer at that time and remain with the company through September 4 to support an orderly transition. Friend will participate in the company’s fourth quarter fiscal 2026 earnings call on June 30, as planned. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623328558/en/ David M. Denton | Incoming Executive Vice President & Chief Financial Officer, NIKE, Inc. Denton will lead Nike’s global finance organization, partnering with President and Chief Executive Officer Elliott Hill and the Senior Leadership Team to support disciplined execution, capital allocation, and long-term value creation. “Dave is a proven public-company CFO who knows h
Grid Dynamics Hosted XT26, Convening Capital Markets Technology Leaders on the Volatility of AI in Financial Services23.6.2026 22:05:00 CEST | Press release
Key Takeaways: Grid Dynamics hosted XT26, an invite-only forum focused on the volatility of AI in financial services. XT26 attendees and speakers included over 250 senior technology leaders from global financial institutions such as Bank of America, Citi, HSBC, UBS, JP Morgan, Morgan Stanley, and others. Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, hosted XT26. The invite-only conference convened over 250 senior technology leaders from banking, hedge funds, and capital markets at Tower Hill, London. Now in its 10th year, the XT conference series has grown into one of financial services engineering's most respected peer forums in London, built on a single premise: pure thought leadership grounded in real-world experience, with no sales pitches, and no vendor presentations. Just practitioners who are actually doing the work. This press release features multimedia. View the full release here: https://www.businessw
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