Can-Fite Submitted to FDA a Pediatric Plan to Allow Registration of Piclidenoson for the Treatment of Adolescents with Psoriasis
18 Agosto 2023 - 6:00AM
Business Wire
- FDA encouraged the Company to enroll 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 the adolescents
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncology, inflammatory, and liver
diseases, today announced that it submitted a pediatric study plan
to the U.S. Food and Drug Administration (FDA) for the treatment of
adolescents suffering from psoriasis with Piclidenoson.
The plan has been submitted to allow enrollment of adolescents
with psoriasis to Can-Fite’s upcoming two 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 adolescents who suffer from psoriasis. There are a
couple of small molecule or biological drugs on the market in use
for adolescents with psoriasis, all have safety issues and are not
satisfactory regarding the 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 adolescent patients 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 adolescents who
endure the physical and emotional burden of this challenging
disease.
“Based on the FDA’s recommendation to enroll adolescents into
the upcoming Phase 3 psoriasis trials, we believe Piclidenoson’s
oral formulation with an excellent safety record, combined with its
progressive effectiveness over time, make it ideally suited for the
chronic treatment of psoriasis in adults and adolescents alike,”
stated Can-Fite CEO & CFO Motti Farbstein.
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 anti-inflammatory drug Piclidenoson reported topline
results in a Phase 3 trial for psoriasis and is expected to
commence a pivotal Phase 3 program. Can-Fite's cancer and liver
drug, Namodenoson, is being evaluated in a Phase 2b trial for the
treatment of non-alcoholic steatohepatitis (NASH), enrollment is
expected to commence in a Phase 3 trial for hepatocellular
carcinoma (HCC), and the Company is planning a Phase 2a 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 1,500 patients
in clinical studies to date. For more information please visit:
www.can-fite.com.
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More information on these risks, uncertainties and other factors is
included from time to time in the “Risk Factors” section of
Can-Fite’s Annual Report on Form 20-F filed with the SEC on March
30, 2023 and other public reports filed with the SEC and in its
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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