Multiple countries are approving Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) ’s Namodenoson for compassionate use in patients with advanced liver cancer.
These countries, including Romania and Israel, seem to have acknowledged Namodenoson’s high efficacy and good safety record with anti-inflammatory and anti-cancer effects — in line with Phase II and Phase III studies conducted by the company.
Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR).
According to Can-Fite, the drug has a potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation and in a Phase IIa NASH study.
Interestingly, Namodenoson is not the only drug in the company’s pipeline that seems to be grabbing a lot of attention. Can-Fite is also conducting studies for Piclidenoson for treating psoriasis and CF602 for treating erectile dysfunction.
Can-Fite seems to have carved a niche for itself as an advanced clinical-stage drug development company with a platform technology designed to address multi-billion-dollar markets in the treatment of cancer, liver, and inflammatory disease.
Multiple Shots On Goal
The company’s lead drug candidate, Piclidenoson, recently reported topline results in a Phase III trial for psoriasis.
Namodenoson is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, is open for enrollment.
The drug 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.
Can-Fite says Namodenoson has shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma.
The company’s third drug candidate, CF602, reports suggest, has also shown efficacy in treating erectile dysfunction. These drugs, according to Can-Fite, have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.
Late-Stage Clinical Development Pipeline
The company’s late-stage clinical pipeline seems to be ticking all the right boxes. For example, Can-Fite recently reported that if the Phase III pivotal (registration) study for liver cancer meets its primary endpoint, then Namodenoson can be approved to treat it.
The Phase III pivotal (registration) study for psoriasis, it added, is now being prepared based on successful results from the most recent Phase III study of Piclidenoson, which showed the drug is safe and effective.
Lastly, the Phase IIb NASH study is now enrolling and treating patients, following a successful Phase IIa study.
Clearance Of Cancer In Patients Treated With Namodenoson?
On October 25, the company reported that a patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite’s prior Phase II study.
The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for five years under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.
This case report demonstrates that treatment with Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.
Current Out-Licensing Deals
Can-Fite has out-licensed its drugs to companies such as Cipher Pharmaceuticals Inc. (TSE: CPH) (Canada), China Medical System Holdings (HKG: 0867) (China), Kyongbo Pharmaceutical Co Ltd. (KRX: 214390) (South Korea), Gebro Pharma (Spain, Austria, and Switzerland), and Ewopharma (Central Eastern Europe).
The company has already received $20 million in upfront and milestone payments and expects $130 million in revenues based on regulatory and sales milestones.
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 recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. 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.
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Forward-Looking StatementsThis press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are "forward looking statements". 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. 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 known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, 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 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; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the "Risk Factors" section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 24, 2022 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
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