MedPath

Piclidenoson

Generic Name
Piclidenoson
Drug Type
Small Molecule
Chemical Formula
C18H19IN6O4
CAS Number
152918-18-8
Unique Ingredient Identifier
30679UMI0N
Background

CF 101 (known generically as IB-MECA) is an anti-inflammatory drug for rheumatoid arthritis patients. Its novel mechanism of action relies on antagonism of adenoside A3 receptors.

CF101 is supplied as an oral drug and has an excellent safety profile. It is also being considered for the treatment of other autoimmune-inflammatory disorders, such as Crohn's disease, psorasis and dry eye syndrome.

Indication

Investigated for use/treatment in cancer/tumors (unspecified), eye disorders/infections, psoriasis and psoriatic disorders, and rheumatoid arthritis.

Can-Fite BioPharma has reported that by targeting the adenosine A3-receptor, CF101 may also be used to treat Crohn's disease, a serious gastrointestinal disorder.

Can-Fite BioPharma Secures $3 Million in Funding to Advance Clinical Trials for Oncology and Inflammatory Disease Treatments

• Can-Fite BioPharma has secured $3 million through a registered direct offering of 2.5 million American Depositary Shares priced at $1.20 per ADS, with the transaction expected to close by April 15, 2025. • The biotech company plans to allocate the proceeds toward advancing its pipeline of small-molecule drugs, including Piclidenoson for psoriasis, Namodenoson for liver cancer and MASH, and CF602 for erectile dysfunction. • Namodenoson has received Orphan Drug Designation in both the U.S. and Europe, as well as Fast Track Designation from the FDA as a second-line treatment for hepatocellular carcinoma.

Can-Fite Launches FDA & EMA-Approved Phase 3 Trial for Oral Psoriasis Drug Piclidenoson

• Can-Fite BioPharma has initiated a pivotal Phase 3 clinical trial for Piclidenoson, an oral drug targeting moderate to severe plaque psoriasis, with protocols approved by both FDA and EMA regulatory authorities. • The randomized, double-blind study will evaluate 3mg twice-daily oral dosing, measuring efficacy through PASI 75 scores and Static Physician's Global Assessment at Week 16, with patient enrollment beginning in Europe before expanding to North America. • Piclidenoson works by inhibiting inflammatory cytokines IL-17 and IL-23 while inducing apoptosis in affected skin cells, positioning it as a potential key player in the psoriasis market projected to reach $30 billion by 2030.

Can-Fite Advances Piclidenoson to Phase II Trial for Rare Lowe Syndrome with No Current Treatments

• Can-Fite BioPharma has completed the design of a Phase II clinical trial for Piclidenoson in Lowe Syndrome, a rare genetic disease affecting approximately 1 in 500,000 people with no approved treatments. • The open-label study will enroll five patients who will receive 3mg of Piclidenoson twice daily for 12 months, with the primary endpoint measuring improvements in renal uptake. • The development follows successful preclinical research by Dr. Antonella De Matteis, who found Piclidenoson significantly decreased urinary protein loss in Lowe Syndrome models after testing thousands of compounds.

Namodenoson Shows Promise in Treating Decompensated Liver Cirrhosis: Patient's Remarkable Recovery in Compassionate Use Program

• A patient with decompensated liver cirrhosis demonstrated significant clinical improvement after 20 months of Namodenoson treatment, including resolution of moderate ascites and no further variceal bleeding episodes. • Can-Fite BioPharma's Namodenoson emerges as a potential breakthrough for decompensated cirrhosis patients, addressing a critical gap in treatment options beyond liver transplantation. • The development holds significant promise for the estimated 10.6 million people globally affected by decompensated cirrhosis, targeting a U.S. market projected to reach $15 billion by 2030.

Can-Fite's Namodenoson Shows Liver Protection and Anti-Cancer Activity in HCC

• Can-Fite BioPharma's Namodenoson demonstrates liver-protective effects alongside its anti-cancer activity in hepatocellular carcinoma (HCC). • A Phase 3 trial is underway for Namodenoson in advanced liver cancer, with promising results including one patient cancer-free for over 8 years. • The drug's unique mechanism involves adiponectin, offering potential cardio- and neuro-protective benefits in addition to liver protection. • Namodenoson's liver-protective properties differentiate it from other HCC treatments that can induce liver toxicity, according to Can-Fite.

Can-Fite BioPharma Advances Clinical Trials for Psoriasis, HCC, and NASH

• Can-Fite BioPharma focuses on orally bioavailable small molecule therapeutics for cancer, liver, and inflammatory diseases. • Piclidenoson is in Phase III clinical trials for psoriasis, showing promise in treating this chronic skin condition. • Namodenoson is progressing through Phase III trials for hepatocellular carcinoma (HCC) and Phase IIb for non-alcoholic steatohepatitis (NASH). • The company's A3 adenosine receptor (A3AR) targeted platform offers innovative solutions with improved patient compliance via oral administration.

Piclidenoson Shows Positive Results in Canine Osteoarthritis Clinical Study

• Vetbiolix reported positive results from a multicenter clinical study of Piclidenoson in dogs with osteoarthritis, showing significant improvement in clinical status. • The study met its primary endpoint, the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, and secondary endpoints, including pain assessment by pet parents. • Vetbiolix exercised its option for a full in-license agreement with Can-Fite, projecting $325M in income to Can-Fite over the next 10 years upon regulatory approval. • Piclidenoson, an A3 adenosine receptor agonist, demonstrated a dose and time-dependent inhibitory effect on LOAD and VAS scores in treated dogs.

Namodenoson Receives FDA Orphan Drug Designation for Pancreatic Cancer

• Namodenoson, a drug developed by Can-Fite BioPharma, has been granted Orphan Drug Designation by the FDA for pancreatic cancer treatment. • The designation offers Can-Fite potential market exclusivity for seven years post-approval, along with regulatory advantages and tax credits. • A phase 2 study is planned to assess the safety, clinical activity, and pharmacokinetics of namodenoson in patients with advanced pancreatic cancer. • Preclinical studies indicate that namodenoson inhibits pancreatic cancer cell growth and modulates key signaling pathways, supporting its continued evaluation.
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