Favorable safety profile is a substantial benefit in the treatment of chronic diseases that require long-term dosing
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it is submitting its annual Drug Safety Update Reports (DSUR) for both Piclidenoson and Namodenoson to the governing health regulatory agencies where its drug candidates are currently treating patients. Submission of the DSUR is an annual requirement for investigational-stage new drugs under development in territories which subscribe to the International Council for Harmonization guidelines, including the U.S. Food and Drug Administration and the European Medicines Agency. The DSUR includes updates on drug safety information such as adverse events, suspected unexpected serious adverse reactions, and other indicators of potential risk. Can-Fites reports being filed this year extend the growing body of documentation showing both Piclidenoson and Namodenoson have favorable safety profiles and risk-benefit ratios in more than 1,500 patients.
Dr. Michael Silverman, M.D., Can-Fites Medical Director, commented, "We welcome the opportunity to compile our cumulative data on a regular basis, as afforded by the DSUR process. As in years past, these snapshots of our safety data continue to confirm that both of our A3AR drugs in development are well-tolerated. We are pleased that there are no emerging safety concerns that could put patients at risk or impede our efforts to develop new drugs to meet unmet patient needs. These latest data are particularly robust, as we have achieved over 50% enrollment in both of our Phase III studies for Piclidenoson, as well as having completed two Phase II trials for Namodenoson."
Piclidenoson is currently in two Phase III studies, one for the treatment of moderate-to-severe psoriasis to establish superiority versus placebo and non-inferiority versus Otezla with over 50% of the planned 407 patients already enrolled; and another for the treatment of moderate-to-severe rheumatoid arthritis in newly diagnosed patients to establish non-inferiority to MTX, the standard of care, with over 50% of the planned 500 patients enrolled, and an interim analysis is planned. Namodenoson has completed a 78-patient Phase II study in liver cancer, and Can-Fite is currently preparing for a Phase III trial in this indication. Namodenoson has also recently completed enrollment in a 60 patient Phase II study in the treatment of NASH, with topline results expected later this month.
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, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II 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: http://www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fites 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-Fites 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-Fites actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fites 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 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-Fites 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200303005502/en/
Contacts
Can-Fite BioPharmaMotti Farbsteininfo@canfite.com +972-3-9241114
Originally posted here:
- Why Jews With Psoriasis Might Think Twice About Seeking Treatment in Jordan - December 20th, 2013 [December 20th, 2013]
- Skin conditions leave emotional scars - December 20th, 2013 [December 20th, 2013]
- Psoriasis Free Forever Review | How This Program Helps People Treat The Root Causes Of Their Psoriasis Symptoms ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis | University of Maryland Medical Center - December 20th, 2013 [December 20th, 2013]
- Psoriasis Treatment, Symptoms, Pictures, Types, Prognosis ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis - National Library of Medicine - PubMed Health - December 20th, 2013 [December 20th, 2013]
- Psoriasis: MedlinePlus - U.S. National Library of Medicine - December 20th, 2013 [December 20th, 2013]
- Psoriasis - Wikipedia, the free encyclopedia - December 20th, 2013 [December 20th, 2013]
- Psoriasis Symptoms, Treatment, Causes, Medication Information ... - December 21st, 2013 [December 21st, 2013]
- Psoriasis Free For Life Review - Watch This Before You Buy - Video - December 21st, 2013 [December 21st, 2013]
- Natural Psoriasis Relief in Seattle, Washington - Video - December 21st, 2013 [December 21st, 2013]
- PSORIASIS VULGARIS - Video - December 21st, 2013 [December 21st, 2013]
- Top 5 Powerful Home Remedies For Psoriasis - Video - December 21st, 2013 [December 21st, 2013]
- Psoriasis feedback after hijama - Video - December 21st, 2013 [December 21st, 2013]
- 9 Home Remedies For Scalp Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- Manga - Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- How to treat psoriasis | In Good Shape - Interview - Video - December 22nd, 2013 [December 22nd, 2013]
- Best Scalp Psoriasis Treatment - Video - December 22nd, 2013 [December 22nd, 2013]
- Sandoz begins Phase III clinical trial for biosimilar adalimumab - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis - Wikipedia, la enciclopedia libre - December 23rd, 2013 [December 23rd, 2013]
- What Is Psoriasis? - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis Treatment Medical Course - Video - December 23rd, 2013 [December 23rd, 2013]
- Healing Psoriasis Hypnosis Session - Video - December 23rd, 2013 [December 23rd, 2013]
- Natural Farm cure for Skin Problems like Psoriasis - Video - December 26th, 2013 [December 26th, 2013]
- Psoriasis - 100% Natural Treatment Shivax® - December 27th, 2013 [December 27th, 2013]
- Psoriasis Symptoms, Causes, Treatment - What is psoriasis ... - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P3 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P2 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P1 - Video - December 28th, 2013 [December 28th, 2013]
- Can Acupuncture treat psoriasis and other scalp disorders? - Video - December 28th, 2013 [December 28th, 2013]
- Psoriasis - Wikipédia - December 31st, 2013 [December 31st, 2013]
- Psoriatic nails - Wikipedia, the free encyclopedia - December 31st, 2013 [December 31st, 2013]
- How to Cure Psoriasis - Psoriasis Symptoms, Treatment, Causes, Medication Information - Video - December 31st, 2013 [December 31st, 2013]
- Psoriasis Chronicles - Dealing with Depression, Anxiety and Anger - Video - January 2nd, 2014 [January 2nd, 2014]
- How to Prevent Psoriasis Flare-Ups - January 4th, 2014 [January 4th, 2014]
- Psoriasis Treatment | Health Plus | Studio N - Video - January 4th, 2014 [January 4th, 2014]
- Ayurvedic Remedy for Psoriasis - By Panditha Elchuri - Video - January 4th, 2014 [January 4th, 2014]
- Silica Gel For Psoriasis / Neurodermatitis - Video - January 4th, 2014 [January 4th, 2014]
- comment traiter son psoriasis détail oubliés - Video - January 4th, 2014 [January 4th, 2014]
- Psoriasis tends to relapse after stopping Methotrexate, shown in a case at Life Force - Video - January 4th, 2014 [January 4th, 2014]
- hiking nevada Health and Wellness Enthusiast Dawn Talks About Managing Plaque Psoriasis hiking watch - Video - January 5th, 2014 [January 5th, 2014]
- Guttate psoriasis - Wikipedia, the free encyclopedia - January 7th, 2014 [January 7th, 2014]
- Biofeedback May Help Control Stress-Related Diseases - January 8th, 2014 [January 8th, 2014]
- Psoriasis can be managed with proper treatment - January 10th, 2014 [January 10th, 2014]
- CNN anchor: How I fight psoriasis - January 10th, 2014 [January 10th, 2014]
- Psoriasis - My Home Remedies - January 10th, 2014 [January 10th, 2014]
- Psoriasis: MedlinePlus en español - January 10th, 2014 [January 10th, 2014]
- Psoriatic arthritis - Wikipedia, the free encyclopedia - January 10th, 2014 [January 10th, 2014]
- CNN anchor Zain Verjee: How I fight psoriasis - January 11th, 2014 [January 11th, 2014]
- Testimonio psoriasis - Video - January 14th, 2014 [January 14th, 2014]
- Heroin addict with severe Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- biospray for Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Psoriasis - Psoriasis Free For Life - Video - January 15th, 2014 [January 15th, 2014]
- 8 Cure For Scalp Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Learn about plaque psoriasis, guttate psoriasis, inverse ... - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Symptoms, Triggers, and Causes of Psoriasis on WebMD - January 16th, 2014 [January 16th, 2014]
- Psoriasis Causes, Symptoms, Treatments, Home Remedies - January 16th, 2014 [January 16th, 2014]
- Psoriasis Treatment - Dermasis Psoriasis Cream - My Honest Review - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Psoriasis Speaks Couple Looking At Rings In Jewelery Store Emotional - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Humira Psoriasis Medication Salon Clearer Skin is Possible - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis Symptoms, Causes and Treatment Pictures Slideshow - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Medscape Reference - January 19th, 2014 [January 19th, 2014]
- 5 Home Remedies For Scalp Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Ikonsulta Mo: Medical Advise on Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Patient Recruitment: Television Campaign for Severe Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Patient Recruitment: Television Campaign for resistant, summertime Mild to Moderate Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Dr stephen ferguson ND PhD chronic fatigue psoriasis cured - Video - January 23rd, 2014 [January 23rd, 2014]
- Noir Naturals Age of Innocence (Unscented) Goat's Milk Lotion for Psoriasis Relief - Video - January 23rd, 2014 [January 23rd, 2014]
- New biologic drugs offer relief for psoriasis sufferers - January 24th, 2014 [January 24th, 2014]
- Psoriasis traitement appliquer le lait pour le corps ISO UREA MD Vidéo La Roche Posay INFO PSO - Video - January 24th, 2014 [January 24th, 2014]
- Psoriasis - Video - January 24th, 2014 [January 24th, 2014]
- Coping with psoriasis - Video - January 26th, 2014 [January 26th, 2014]
- Exfoliative Dermatitis/Psoriasis Vulgaris with Psoriatic Arthritis with English Subtitles - Video - January 26th, 2014 [January 26th, 2014]
- Psoriasis skin care routine 2014 - Video - January 27th, 2014 [January 27th, 2014]
- How to treat psoriasis effectively - By Franziska Ringpfeil, Board Certified Dermatologist - Video - January 28th, 2014 [January 28th, 2014]
- My Psoriasis 411: Apple Cider Vinegar Tutorial for Scalp Treatment - Video - January 29th, 2014 [January 29th, 2014]
- 12 Best and Worst Foods for Psoriasis - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en radio Tagoror - Video - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en Canarias Hoy - Video - January 31st, 2014 [January 31st, 2014]
- Psoriasis Natural Treatment that Workswww savevid com - Video - January 31st, 2014 [January 31st, 2014]