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Wednesday, April 21, 2021 4:30:55 AM
https://finance.yahoo.com/news/fite-starts-preclinical-studies-required-151839953.html
Can-Fite BioPharma (NYSE: CANF) has initiated a series of preclinical studies required by regulators to support potential marketing registration filings for its drug candidates Piclidenoson and Namodenoson in the U.S. and Europe.
As part of marketing applications in the U.S. and Europe, both regulators require specific preclinical data to be submitted along with the pivotal Phase 3 data.
Piclidenoson is now being evaluated in the COMFORT Phase 3 clinical study designed to establish Piclidenoson's superiority compared to placebo and non-inferiority compared to Amgen, Inc's (NASDAQ: AMGN) Otezla (Apremilast) for moderate-to-severe plaque psoriasis.
A Phase 3 study of Namodenoson in the treatment of hepatocellular cancer (HCC) is expected to commence in the fourth quarter of this year.
Recent CANF News
- 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
- Form F-3/A - Registration statement by foreign private issuers: [Amend] • Edgar (US Regulatory) • 12/28/2023 09:16:08 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/20/2023 12:09:12 PM
- The Anti-Obesity Effect of Can-Fite’s Namodenoson: Molecular Mechanism of Action in Pre-clinical and Human Studies • Business Wire • 12/20/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/18/2023 12:07:51 PM
- Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan • Business Wire • 12/18/2023 12:00:00 PM
- Form F-3 - Registration statement by foreign private issuers • Edgar (US Regulatory) • 12/12/2023 09:15:49 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/04/2023 12:05:03 PM
- Can-Fite’s Namodenoson for the Treatment of Pancreatic Cancer Patients: Progress in Clinical Development • Business Wire • 12/04/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/30/2023 12:05:42 PM
- Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update • Business Wire • 11/30/2023 12:00:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 11/22/2023 09:20:47 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/22/2023 09:15:30 PM
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