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Multiple countriesare approving Can-Fite BioPharma Ltd. (NYSE American: CANF)(TASE: CFBI) ’s Namodenoson for compassionate use in patients withadvanced liver cancer.
These countries, including Romania and Israel, seem to have acknowledged Namodenoson’s high efficacyand good safety record with anti-inflammatory and anti-cancer effects— in line with Phase II and Phase III studies conducted by thecompany.
Namodenoson is an oral small molecule drug generically known asCl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’-N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosinereceptor (A3AR) .
According to Can-Fite, the drug has a potent anti-cancereffect, particularly against hepatocellular carcinoma, andanti-inflammatory activity demonstrated in pre-clinical animal modelsof 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 alsoconducting studies for Piclidenoson for treating psoriasis and CF602for treating erectile dysfunction.
Can-Fite seems to have carved a niche for itself asan advanced clinical-stage drug development company with a platformtechnology designed to address multi-billion-dollar markets in thetreatment of cancer, liver, and inflammatory disease.
MultipleShots On Goal
Thecompany’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-alcoholicsteatohepatitis (NASH), and Phase III trial for hepatocellularcarcinoma (HCC), the most common form of liver cancer, is open forenrollment.
Thedrug has been granted Orphan Drug Designation in the U.S. and Europe and Fast TrackDesignation as a second-line treatment for HCC by the U.S. Food and Drug Administration.
Can-Fite saysNamodenoson has shown proof of concept to potentially treat othercancers, including colon, prostate, and melanoma.
The company’s thirddrug candidate, CF602, reports suggest, has also shown efficacy intreating erectile dysfunction. These drugs, according to Can-Fite,have an excellent safety profile with experience in over 1,500patients in clinical studies to date.
Late-Stage ClinicalDevelopment Pipeline
The company’s late-stage clinical pipeline seems to beticking all the right boxes. For example, Can-Fite recently reportedthat if the Phase III pivotal (registration) study for liver cancermeets its primary endpoint, then Namodenoson can be approved to treatit.
The Phase IIIpivotal (registration) study for psoriasis, it added, is now beingprepared based on successful results from the most recent Phase IIIstudy of Piclidenoson, which showed the drug is safe andeffective.
Lastly,the Phase IIb NASH study is now enrolling and treating patients,following a successful Phase IIa study.
Clearance Of Cancer InPatients 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 hepaticdysfunction Child-Pugh B (CPB7), participated in Can-Fite’s priorPhase II study.
The patient was in the Namodenoson arm of the Phase II studyand continued treatment with Namodenoson for five years under an OpenLabel Extension Program. Treatment is ongoing under a CompassionateUse Program established in Romania in August of 2022.
This case reportdemonstrates that treatment with Namodenoson can lead to a completeand durable response in patients with HCC and CPB7.
CurrentOut-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) (SouthKorea), Gebro Pharma (Spain, Austria, and Switzerland), and Ewopharma(Central Eastern Europe).
The company has already received $20 million in upfront andmilestone payments and expects $130 million in revenues based onregulatory and sales milestones.
About Can-Fite BioPharmaLtd.Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is anadvanced clinical stage drug development Company with a platformtechnology that is designed to address multi-billion dollar markets inthe treatment of cancer, liver, and inflammatory disease. TheCompany's lead drug candidate, Piclidenoson recently reportedtopline results in a Phase III trial for psoriasis. Can-Fite'sliver drug, Namodenoson, is being evaluated in a Phase IIb trial forthe treatment of non-alcoholic steatohepatitis (NASH), and enrollmentis expected to commence in a Phase III trial for hepatocellularcarcinoma (HCC), the most common form of liver cancer. Namodenoson hasbeen granted Orphan Drug Designation in the U.S. and Europe and FastTrack Designation as a second line treatment for HCC by the U.S. Foodand Drug Administration. Namodenoson has also shown proof of conceptto potentially treat other cancers including colon, prostate, andmelanoma. CF602, the Company's third drug candidate, has shownefficacy in the treatment of erectile dysfunction. These drugs have anexcellent safety profile with experience in over 1,500 patients inclinical studies to date. For more information please visit:www.can-fite.com.
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Forward-Looking StatementsThis press release maycontain forward-looking statements, about Can-Fite’s expectations,beliefs or intentions regarding, among other things, its productdevelopment efforts, business, financial condition, results ofoperations, strategies or prospects. All statements in thiscommunication, other than those relating to historical facts, are"forward looking statements". Forward-looking statements canbe identified by the use of forward-looking words such as"believe," "expect," "intend," "plan,""may," "should" or "anticipate" or theirnegatives or other variations of these words or other comparable wordsor by the fact that these statements do not relate strictly tohistorical or current matters. Forward-looking statements relate toanticipated or expected events, activities, trends or results as ofthe date they are made. Because forward-looking statements relate tomatters that have not yet occurred, these statements are inherentlysubject to known and unknown risks, uncertainties and other factorsthat may cause Can-Fite’s actual results, performance orachievements to be materially different from any future results,performance or achievements expressed or implied by theforward-looking statements. Important factors that could cause actualresults, performance or achievements to differ materially from thoseanticipated in these forward-looking statements include, among otherthings, our history of losses and needs for additional capital to fundour operations and our inability to obtain additional capital onacceptable terms, or at all; uncertainties of cash flows and inabilityto meet working capital needs; the initiation, timing, progress andresults of our preclinical studies, clinical trials and other productcandidate development efforts; our ability to advance our productcandidates into clinical trials or to successfully complete ourpreclinical studies or clinical trials; our receipt of regulatoryapprovals for our product candidates, and the timing of otherregulatory filings and approvals; the clinical development,commercialization and market acceptance of our product candidates; ourability to establish and maintain strategic partnerships and othercorporate collaborations; the implementation of our business model andstrategic plans for our business and product candidates; the scope ofprotection we are able to establish and maintain for intellectualproperty rights covering our product candidates and our ability tooperate our business without infringing the intellectual propertyrights of others; competitive companies, technologies and ourindustry; risks related to the COVID-19 pandemic and the Russianinvasion of Ukraine; risks related to not satisfying the continuedlisting requirements of NYSE American; and statements as to the impactof the political and security situation in Israel on our business.More information on these risks, uncertainties and other factors isincluded from time to time in the "Risk Factors" section ofCan-Fite’s Annual Report on Form 20-F filed with the SEC on March24, 2022 and other public reports filed with the SEC and in itsperiodic filings with the TASE. Existing and prospective investors arecautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. Can-Fiteundertakes no obligation to publicly update or review anyforward-looking statement, whether as a result of new information,future developments or otherwise, except as may be required by anyapplicable securities laws.
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