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
Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release
New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit
AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release
Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co
Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation6.8.2026 15:00:00 CEST | Press release
Omani conglomerate gains greater control over its IT roadmap, avoids migration pressure and funds AI and growth initiatives Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced that Khimji Ramdas Group, one of Oman’s largest privately held conglomerates, has selected Rimini Support™ for SAP, a move that has helped the organization reduce costs, reinvest savings in AI innovation and maintain its highly customized SAP ECC 6 environment with zero downtime. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806244148/en/ Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation “Staying on SAP ECC is a strategic decision for us,” said Prashant Kumar, CTO, Khimji Ramdas Group. “We went to an industry analyst to ask what options
Naser Taher, Chairman and Founder of MultiBank Group, Honored by H.H. Sheikh Nahyan bin Mubarak Al Nahyan with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence6.8.2026 14:53:00 CEST | Press release
The recognition honors Naser Taher and MultiBank Group for its revolutionary advances in regulated digital assets, blockchain, and real-world asset tokenization Naser Taher, Chairman and Founder of MultiBank Group, has been honored with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence at the 9th Golden Excellence Awards 2026. The award was presented by H.H. Sheikh Nahyan bin Mubarak Al Nahyan, UAE Cabinet Member and Minister of Tolerance & Coexistence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806828617/en/ Naser Taher, Chairman and Founder of MultiBank Group, Honored by H.H. Sheikh Nahyan bin Mubarak Al Nahyan with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence. The recognition reflects MultiBank Group’s continued expansion into regulated digital assets through mb.io, the Group’s VARA-regulated cryptocurrency exchange. Through mb.io, clients can acces
Mary Kay’s Pink Changing Lives® Program Turns Purpose Into Measurable Impact for Women Around the World6.8.2026 14:05:00 CEST | Press release
More than 4 million women have benefited through nonprofit organizations supported by the program since its launch. Mary Kay Inc., a global advocate for women’s empowerment, proudly reaffirms its commitment to enriching women’s lives worldwide through its signature Pink Changing Lives® Program – a multi-faceted global initiative that blends purpose-driven giving with cause-marketing to create meaningful, measurable impact across communities. Since 1996, the program has provided over $230 million in monetary and product donations to nonprofit organizations empowering women, transforming women’s health and safety, and protecting our natural resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806671194/en/ Mary Kay China supports the Hope for Pearl Program, providing financial assistance to girls from economically disadvantaged areas to receive a life-changing education, opening doors to new possibilities and bright fu
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