Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan
- Positive response from the FDA on the Pediatric Study Plan for Piclidenoson
- High market need for a safe and efficacious drug for children with psoriasis
- Inclusion of children in Phase 3 studies broadens future market launch potential
- None.
- FDA encouraged the Company to accelerate enrollment of adolescent patients due to Piclidenoson’s good safety profile
- There is an unmet need for safe, convenient, and effective drugs to treat chronic plaque psoriasis in children
PETACH TIKVA,
The plan has been submitted to allow enrollment of children with psoriasis to Can-Fite’s upcoming Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis.
There is a high market need for a safe and efficacious drug for the treatment of children who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market, however all have safety issues and are not satisfactory regarding efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease.
Can-Fite believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of children who endure the physical and emotional burden of this challenging disease.
“We believe Piclidenoson’s oral formulation with its excellent safety profile, combined with its progressive effectiveness over time make it ideally suited for the chronic treatment of psoriasis in adults and children alike,” stated Can-Fite VP Drug Development, Dr. William Kerns.
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 steatotic liver disease (SLD), 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
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Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Source: Can-Fite BioPharma Ltd.
FAQ
What is the purpose of the Pediatric Study Plan for Piclidenoson?
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