Followers | 145 |
Posts | 27581 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Monday, May 13, 2024 12:23:39 PM
https://finance.yahoo.com/news/fite-75-oncologists-coordinators-europe-110000599.html
Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the current pivotal Phase 3 clinical study
RAMAT GAN, Israel, May 13, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces that it held a conference for 75 oncologists and coordinators who are conducting the pivotal Phase 3 advanced liver cancer study, to accelerate patient enrolment.
The participants have been presented with the drug chemical and biological profile and the study protocol as well as study procedures. Dr. Lencioni, a key opinion leader in radiology of liver tumors, Department of Radiology, Pisa University School of Medicine Italy, educated the oncologists on the way to measure tumor lesion size prior and post namodenoson treatment. The difference in tumor growth or regression defines progression free survival (PFS) and the objective response rate (ORR) to the drug, serving as part of the study objectives. US experts presented to the participants the electronic data entry of the patients’ data during the trial.
"The conference was very successful and we are very pleased with the enthusiasm of the participants with respect to the drug characteristics. They are looking forward to complete patient enrolment and conclude the data of this very promising anti-cancer drug," said Dr. Pnina Fishman, Can-Fite CSO and Executive Chairperson.
Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase 3 clinical study which is now enrolling patients is Israel, Europe and the US. The study is designed to perform an interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been effective.
Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.
According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
Recent CANF News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/29/2024 11:05:26 AM
- Independent Scientists Published a Review Article Demonstrating That Can-Fite Drugs Have Therapeutic Effects on Heart Diseases • Business Wire • 05/29/2024 11:00:00 AM
- Can-Fite to Participate in Partnering Meetings at Bio International Convention 2024 • Business Wire • 05/27/2024 11:00:00 AM
- Join Can-Fite’s Exclusive Live Investor Webinar and Q&A Session on June 6 • Business Wire • 05/23/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/22/2024 08:15:19 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/13/2024 11:03:28 AM
- Can-Fite: 75 Oncologists and Coordinators from Europe US and Israel Participated in a Conference Aimed at Accelerating Patient Enrolment for the Pivotal Phase 3 Advanced Liver Cancer Study • Business Wire • 05/13/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/09/2024 11:03:03 AM
- Can-Fite: FDA Grants IND Clearance for Namodenoson to Treat MASH Patients in a Phase IIb Study • Business Wire • 05/09/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/06/2024 11:11:47 AM
- Can-Fite Received Notice of Allowance from the European Patent Office for the Treatment of Erectile Dysfunction with CF602 • Business Wire • 05/06/2024 11:00:00 AM
- Long-term Complete Response to Can-Fite's Namodenoson in Patient with Advanced Liver Cancer: Article Published in a Leading Scientific Journal • Business Wire • 04/25/2024 11:00:00 AM
- Can-Fite: Scientific Article Published by KOL Presents Namodenoson as a Promising Drug Candidate to Treat Advanced Liver Cancer and MASH • Business Wire • 04/15/2024 11:00:00 AM
- Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients • Business Wire • 04/03/2024 11:00:00 AM
- Can-Fite Reports 2023 Financial Results and Clinical Update • Business Wire • 03/28/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/11/2024 11:27:14 AM
- Namodenoson Treatment for Pancreatic and Liver Cancer: Data will be Discussed in Out-licensing and Distribution Partnering Meetings at Bio Europe Conference • Business Wire • 03/11/2024 11:00:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/28/2024 12:06:42 PM
- Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada • Business Wire • 02/28/2024 12:00:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:32:17 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/30/2024 12:24:02 PM
- Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication • Business Wire • 01/30/2024 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/29/2024 12:05:47 PM
- Can-Fite: Top Scientific Journal Published Positive Data from the COMFORT-1 Phase III Psoriasis Study • Business Wire • 01/29/2024 12:00:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/08/2024 05:15:13 AM
North Bay Resources Reports Assays up to >25% Mg, 0.1% Ni, 0.1% Cu, 0.01% Co, 0.3 ppm Pt at Tulameen Platinum Project, British Columbia • NBRI • May 29, 2024 9:03 AM
One World Products, Inc. Issues Shareholder Update • OWPC • May 29, 2024 8:20 AM
Green Leaf Innovations, Inc. Engages Olayinka Oyebola & Co for Two-Year Audit • GRLF • May 28, 2024 8:30 AM
HealthLynked Introduces AI-Powered Chat Function to Enhance Healthcare Accessibility • HLYK • May 28, 2024 8:00 AM
Avant Technologies Engages Wired4Tech to Evaluate the Performance of Next Generation AI Server Technology • AVAI • May 23, 2024 8:00 AM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM