Full Press Release Details
Positive Results from Osteoarthritis Clinical
Reported by Can-Fite's Partner Vetbiolix
The canine osteoarthritis market is projected
to reach $3 billion by 2028
Ramat Gan, Israel, June 28, 2024 -- Can-Fite BioPharma
Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address
oncological and inflammatory diseases, today announced that its veterinary partner Vetbiolix reported positive results in an osteoarthritis
multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite's veterinary commercialization partner which is
covering all costs associated with veterinary clinical development, concluded successfully the study interim analysis.
After Piclidenoson proved efficacious, Vetbiolix
can exercise the option to enter into a full in license agreement with Can-Fite and be obligated to pay Can-Fite upfront and milestone
payments, in addition to royalties on sales upon regulatory approval.
The study looked at the effect of 90 days treatment
with Piclidenoson at 100 g/kg and 500 g/kg twice daily orally in dog patients with osteoarthritis. The primary objective was the
Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog's mobility. The secondary
objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and
(ii) pain assessment by the veterinarian. The study reached the primary and secondary end points with a dose and time dependent inhibitory
effect of piclidenoson on LOAD and VAS and NRS, demonstrating significant improvement in clinical status and decrease in pain in the 500
The canine osteoarthritis market is projected
to reach $3 billion by 2028.
There is a clear need in the market for a safe
and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs
(NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug
(DMOAD) that targets the progression of the disease.
"We are very much encouraged by the positive
results in the osteoarthritis dog clinical study and hope Piclidenoson can be used as an efficacious drug with this unmet clinical indication,"
stated Can-Fite CSO Dr. Pnina Fishman. "This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the
market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with
the team at Vetbiolix."
Piclidenoson is a novel, first-in-class, A3 adenosine
receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase
III clinical study in psoriasis. The drug's mechanism of action entails inhibition of the inflammatory cytokines interleukin 17
and 23 (IL-17 and IL-23) and the induction of apoptosis of patients' skin cell keratinocytes involved with the disease pathogenicity.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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 and is expected to commence a pivotal
Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of Metabolic
Dysfunction-associated Steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning
a Phase IIa study in pancreatic 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 1,600 patients in clinical studies
to date. For more information please visit: www.can-fite.com.
VETBIOLIX develops innovative products for the
treatment and prevention of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules
in-licensed (exclusive and worldwide license) from Human Biotech worldwide which will answer to veterinary unmet medical needs
in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; Adenosin-A3 agonist) and gut motility disorders
(VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests on (i) clinical
proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical
studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical
For more information please visit: https://www.vetbiolix.com
Contact: matthieu.dubruque@vetbiolix.com
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