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Can-Fite to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Very Positive)
Tags
Rhea-AI Summary
Can-Fite BioPharma (NYSE American: CANF) announced plans to hold virtual investor meetings at the J.P. Morgan Healthcare Conference. The company reported a complete response to Namodenoson for hepatocellular carcinoma (HCC) in its Phase II study. In Q1 2022, patient enrollment for a pivotal Phase III trial for HCC is expected to commence, supported by the FDA and EMA’s approval of the study design. Namodenoson has Orphan Drug Designation in the U.S. and Europe, with Fast Track Status in the U.S.
These developments position Can-Fite favorably in the competitive biopharma landscape.
Positive
Complete response to Namodenoson in Phase II study for HCC.
Anticipated enrollment in pivotal Phase III trial for HCC in Q1 2022.
FDA and EMA approval for the Phase III study design.
Namodenoson has Orphan Drug Designation in the U.S. and Europe.
Fast Track Status for Namodenoson in the U.S.
Negative
None.
PETACH TIKVA, Israel--(BUSINESS WIRE)--
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, announced today that it will hold one-on-one virtual investor meetings during the J.P. Morgan Healthcare Conference.
The Company recently reported a complete response to Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, in its Open Label Extension program of its concluded Phase II study. This follows publication in October 2021 of an article featuring positive Phase IIa NASH study data of Namodenoson in Alimentary Pharmacology & Therapeutics (AP&T), a peer reviewed scientific journal focused on gastroenterology and hepatology. According to AP&T, the article was the top electronic download in the month of November of articles published in AP&T.
In the first quarter of 2022, Can-Fite expects to commence patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed with the design of the 471-patient study. Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel.
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.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
