Can Fite BioPharma Ltd

Petah Tikva, Israel

Can Fite BioPharma Ltd

Petah Tikva, Israel

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"We look forward to a positive response from Health Canada to our CTA so that we may begin enrolling patients in Canada for our upcoming Phase III study. Having recently received Institutional Review Board (IRB) approvals in Israel for our rheumatoid arthritis trial, we are ready to expand into clinical sites in Canada and Europe," said Can-Fite CEO Dr. Pnina Fishman. "New therapies are needed for people who face the tremendously debilitating symptoms of rheumatoid arthritis," said Robert Tessarolo, President and CEO of Cipher Pharmaceuticals. "We are looking forward to a positive outcome from the Piclidenoson Phase III clinical program to help manage this chronic disease." Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases including rheumatoid arthritis and psoriasis, both set to commence Phase III. Can-Fite BioPharma Ltd. (NYSE MKT: 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 autoimmune-inflammatory indications, oncology and liver diseases as well as sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is headed into Phase III trials for two indications, rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug Namodenoson is in a Phase II trial for patients with liver cancer and is slated to enter another Phase II for the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to 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 hepatocellular carcinoma 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 in preclinical studies These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com. Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America.  For more information, visit www.cipherpharma.com. This press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, market risks and uncertainties and Can-Fite's ability to satisfy all the conditions to the closing of the proposed offering, 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, including, but not limited to, the factors summarized 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/can-fite-files-clinical-trial-application-in-canada-for-piclidenoson-ahead-of-upcoming-acrobat-rheumatoid-arthritis-phase-iii-study-300458161.html


Patent
Can Fite Biopharma Ltd. | Date: 2010-05-06

The present invention provides a method for treating dry eye condition in an individual comprising administrating to said individual an amount of A_(3 )adenosine receptor (A_(3)AR) agonist, the amount being effective to ameliorate symptoms of dry eye in the individual. In accordance with one embodiment, the dry eye condition is manifested by one or more opthalmologic clinical symptoms selected from foreign body sensation, burning, itching, irritation, redness, eye pain, blurred vision, degraded vision and excessive tearing. A preferred A_(3)RAg in accordance with the invention is N^(6)-(3-iodobenzyl)-adenosine-5-N-methyluronamide (IB-MECA).


The present invention is based on the clinical finding that twice daily administrations of 2 mg of 1-[N^(6)-(3-iodobenzyl)-adenin-9-yl]--D-ribofuronamide (IB-MECA) (total daily administration of 4 mg) to subjects having moderate to severe psoriasis, was significantly more effective in treatment of the psoriatic plaques than treatment of psoriasis at two administration doses of 1 mg or 4 mg (total daily doses of 2 or 8 mg, respectively). Thus, the present invention provides a pharmaceutical composition for the treatment of psoriasis comprising as the active ingredient IB-MECA in an amount suitable for a total daily dose administration of about 4 mg. In one preferred embodiment IB-MECA is administered twice a day to a subject in need of psoriasis treatment, the pharmaceutical composition comprising an administration dose of 2 mg.


Patent
Can Fite Biopharma Ltd. | Date: 2013-08-22

Inflammatory state in a subject is assayed by determining the level of expression of A_(3 )adenosine receptor (A_(3)AR) in white blood cells (WBC), e.g. circulating WBCs, from the subject. A high level of expression of A_(3)AR is indicative of an inflammatory state in the subject. This assay can be used for determining whether a patient known to have an inflammatory state should be treated with an A_(3)AR agonist to reduce the inflammatory state. The patient will be so treated only if the level of A_(3)AR in the WBC of the subject is above a predefined threshold, which is about twice the level of A_(3)AR in WBC of healthy subjects. The inflammatory state may particularly be rheumatoid arthritis or uveitis.


Patent
Can Fite Biopharma Ltd. | Date: 2010-06-21

Inflammatory state in a subject is assayed by determining the level of expression of A_(3 )adenosine receptor (A_(3)AR) in white blood cells (WBC), e.g. circulating WBCs, from the subject. A high level of expression of A_(3)AR is indicative of an inflammatory state in the subject. This assay can be used for determining the severity of inflammation in a subject and monitoring the efficacy of anti-inflammatory treatment. Also, the level of expression may be used for selecting patients to receive an anti-inflammatory treatment that comprises an A_(3)AR agonist.


Patent
Can Fite Biopharma Ltd. | Date: 2013-01-23

The present disclosure concerns the A_(3 )adenosine receptor agonist, 2-Chloro-N^(6)-(3-iodobenzyl)-adenosine-5-N-methyluronamide (Cl-IB-MECA) in an amount of at least about 10 mg/day, for use in treatment of hepatocellular carcinoma (HCC). The present invention also provides Cl-IB-MECA for use in maintenance of liver function in a subject having a chronic liver disease, such as cirrhosis. The liver function is considered as maintained if level of at least one physiological parameter indicative of liver function is essentially constant between two or more time points, i.e. the difference between the two time points does not exceed a medically acceptable tolerance.


Patent
Can Fite Biopharma Ltd. | Date: 2010-05-16

The present disclosure provides the use of an A3R agonist, such as IB-MECA, for reducing in a subject, preferably, human subject, intra ocular pressure (IOP). Similarly, the invention provides a pharmaceutical composition and a method for reducing IOP in a subject making use of the A_(3)R agonist.


Patent
Can Fite Biopharma Ltd. | Date: 2013-08-08

The present disclosure provides an A_(3 )adenosine receptor (A_(3)AR) ligand for the treatment of sexual dysfunction. In some embodiments the A_(3)AR ligand is selected from an A_(3)AR agonist and A_(3)AR allosteric enhancer. The present disclosure also provides a method a method and pharmaceutical composition for treating a sexual dysfunction, the method comprises administering to a subject having the sexual dysfunction an amount of an A_(3 )adenosine receptor (A_(3)AR) ligand. In some embodiments, the A_(3)AR ligand is an A_(3)AR agonist and more specifically, IB-MECA.


Patent
Can Fite Biopharma Ltd. | Date: 2014-08-21

The present application provides methods and compositions for inducing hepatocyte proliferation and liver regeneration, the latter being mainly dependent on hepatocyte proliferation even if all the other cell types divide to reconstitute the organ specific-lobular-architecture. The methods and compositions provided herein make use of an A_(3)AR agonist. A preferred A_(3)AR agonist disclosed herein is Cl-IB-MECA.


Patent
Can Fite Biopharma Ltd. | Date: 2016-05-20

Provided is an A_(3 )adenosine receptor agonist (A_(3)AR agonist) for the preparation of a pharmaceutical composition for the treatment of a mammal subject having osteoarthritis (OA), as well as to a method for the treatment of OA in a mammal subject, the method includes administering to said subject in need of said treatment an amount of A_(3)AR agonist, the amount being effective to treat or prevent the development of OA. Preferred but not exclusive A_(3)AR agonists in accordance with the present subject matter are IB-MECA and Cl-IB-MECA. The A_(3)AR agonist may be administered in combination with another drug, such as Methotrexate (MTX). Also provided are pharmaceutical compositions for treatment of osteoarthritis including an amount of an A_(3)AR agonist.

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