Can-Fite Received FDA Positive Response to Psoriasis Pediatric Plan
18 Diciembre 2023 - 6:00AM
Business Wire
- 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
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncological and inflammatory diseases,
today announced that it received a positive response from the U.S.
Food and Drug Administration (FDA) on the Pediatric Study Plan for
the treatment of children suffering from psoriasis with
Piclidenoson.
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 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.canfite.com.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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