Can-Fite Receives U.S. FDA’s Go Ahead for Piclidenoson Psoriasis Registration Plan
29 Junho 2023 - 8:00AM
Business Wire
- FDA encouraged the Company to enroll adolescent patients due
to the strong safety profile of the drug demonstrated over the
development history and prior clinical studies
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 received feedback and advice from
the U.S. Food and Drug Administration (FDA) with respect to
non-clinical and clinical development and registration plans for
Piclidenoson for the treatment of patients with moderate to severe
plaque psoriasis.
The FDA had a positive view of the non-clinical studies
conducted by the Company and the accumulated safety data that the
Company submitted to the agency as part of the registration
plan.
The FDA provided advice on the randomized, double-blind,
placebo-controlled Phase 3 clinical trial protocol with
Piclidenoson that is aimed at demonstrating clinical safety and
efficacy for the treatment of patients with moderate to severe
plaque psoriasis. The FDA requested two Phase 3 safety and efficacy
studies and also encouraged the Company to enroll adolescent
patients due to the strong safety profile of the drug demonstrated
over the development history and prior clinical studies. To
harmonize the requests of the European Medicines Agency (EMA) and
the FDA, Can-Fite plans to conduct two Phase 3 studies in parallel,
including adolescent patients.
Can-Fite believes the inclusion of adolescent patients in one or
both of the Phase 3 studies significantly broadens the 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.
There are limited treatment options available for adolescent
patients in the U.S. Otezla is not approved for use in adolescents,
and existing oral options include steroids and off-label use of
retinoids (acitretin) and methotrexate, both of which carry
significant safety and tolerability issues for teenagers. The
Company believes that Piclidenoson represents a promising oral
option for this underserved population.
Upon positive conclusion of the Phase 3 program, the Company
plans to submit a New Drug Application (NDA) to the U.S. FDA and
Marketing Authorization Plan (MAA) to the EMA.
“We are delighted to share the positive feedback that we
received from the U.S. FDA and we believe that Piclidenoson’s oral
dosage and excellent safety record, combined with its progressive
effectiveness over time, make it ideally suited for the chronic
treatment of psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.
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.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite’s expectations, beliefs or intentions regarding, among
other things, its product development efforts, business, financial
condition, results of operations, strategies or prospects. All
statements in this communication, other than those relating to
historical facts, are “forward looking statements”. 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.
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 known and
unknown risks, uncertainties and other factors that may cause
Can-Fite’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Important factors that could cause actual results,
performance or achievements to differ materially from those
anticipated in these forward-looking statements include, among
other things, 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; risks
related to the COVID-19 pandemic and the Russian invasion of
Ukraine; risks related to not satisfying the continued listing
requirements of NYSE American; and statements as to the impact of
the political and security situation in Israel on our business.
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
periodic filings with the TASE. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Can-Fite
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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