Can-Fite BioPharma Ltd. American Depositary Shares, each representing three hundred (300) Ordinary Shares - CANF STOCK NEWS

Can-Fite BioPharma, a biotechnology firm focused on oncological and inflammatory diseases, has submitted an application to the FDA for Orphan Drug Designation for Namodenoson, aimed at treating pancreatic carcinoma. An orphan drug designation provides benefits including seven-year marketing exclusivity, tax credits, fee waivers, and grant eligibility. Can-Fite plans to initiate a Phase IIa multicenter open-label trial to assess Namodenoson's safety, clinical activity, and pharmacokinetics in patients with advanced pancreatic adenocarcinoma. The trial will involve approximately 20 patients receiving oral Namodenoson 25 mg twice daily over 28-day cycles. Key metrics will include safety profile, Objective Response Rate (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). Namodenoson has already been granted Orphan Drug Status for advanced liver cancer by the FDA and EMA.

Can-Fite BioPharma announced an improvement in a patient with decompensated liver cirrhosis treated with Namodenoson at Soroka Medical Center, Israel. The drug candidate, currently in Phase III for advanced liver cancer and Phase IIb for MASH, showed positive effects in liver function tests. The patient, a 63-year-old female, had been treated for a year with Namodenoson, showing no decompensation events and improved liver indices. The global market for liver cirrhosis treatment is estimated to reach $29.2 billion by 2031, highlighting a strong demand for effective treatments.

Can-Fite BioPharma (NYSE American: CANF) announced positive results from a clinical study in dogs with osteoarthritis conducted by its partner Vetbiolix. The study found that Piclidenoson significantly improved clinical status and reduced pain in canine patients. The study, which utilized a 90-day treatment period with doses of 100 μg/kg and 500 μg/kg administered twice daily, met both primary and secondary objectives. The primary objective was assessed using the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, while secondary objectives included pain assessments through Visual Analog Scale (VAS) and Numerical Rating Score (NRS). The 500 μg/kg dose showed the most significant improvement. Vetbiolix may now enter a full in-license agreement with Can-Fite, including upfront and milestone payments, as well as royalties upon regulatory approval. The canine osteoarthritis market is projected to reach $3 billion by 2028.

Can-Fite BioPharma (NYSE American: CANF) has announced breakthrough findings regarding Namodenoson, a drug demonstrating significant anti-cancer and protective effects in the liver. These effects are attributed to the signaling protein adiponectin, which has key roles in anti-inflammatory, anti-cancer, metabolic, and insulin resistance regulation. Namodenoson has been shown to increase adiponectin production in both pre-clinical studies and human trials. The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology in China, from September 12-14, 2024. Namodenoson is currently being evaluated in a Phase III study for advanced liver cancer and a Phase IIb study for MASH.

Can-Fite BioPharma (NYSE American: CANF) announced IRB approval from Rabin Medical Center for a Phase IIa study on Namodenoson for pancreatic cancer treatment. The open-label trial will enroll around 20 patients whose disease has advanced despite first-line treatment. The study will evaluate safety and clinical activity, with patients receiving 25 mg of Namodenoson twice daily. Previous studies showed promising results, encouraging this new trial. The study protocol CF102-222PC has been submitted to the Ministry of Health. Key endpoints include safety, Objective Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS).

Can-Fite BioPharma has provided an update on the pivotal Phase 3 study for Namodenoson, its lead drug candidate for advanced liver cancer. The study involves 31 medical centers across Europe, Israel, and the US, with Namodenoson holding Orphan Drug and Fast Track status from the FDA.

The compassionate use program is ongoing in Israel and Romania. Previous Phase 2 results showed that Namodenoson prolonged survival and improved quality of life in patients, with some achieving long-term complete responses.

The Phase 3 LIVERATION trial will enroll 450 patients with advanced liver cancer and Child Pugh B7 cirrhosis, comparing Namodenoson to a placebo. The trial's primary endpoint is overall survival, with interim analysis by an Independent Data Monitoring Committee after 50% enrollment.

Liver cancer causes over 700,000 deaths annually, with the HCC treatment market projected to reach $3.8 billion by 2027.

Can-Fite BioPharma announced that the International Journal of Molecular Sciences published a review highlighting the positive effects of its drugs, piclidenoson and namodenoson, on heart diseases. The review, based on over 50 publications, showed that these drugs improved outcomes in pre-clinical studies, such as reducing infarct size and protecting against ischemic injury. Dr. Pnina Fishman noted the drugs' cardio-protective potential and their good safety profile observed in over 1600 patients. Can-Fite is also advancing clinical studies in psoriasis, liver cancer, MASH, and pancreatic cancer.

Can-Fite BioPharma announced that its VP of Business Development, Dr. Sari Fishman, will engage in 23 partnering meetings at the Bio International Convention 2024 in San Diego from June 3-6. These meetings aim to explore potential collaborations with biotech and pharma companies. Can-Fite has existing out-licensing and distribution agreements with seven pharma companies across North America, Europe, and Asia. The company is currently developing two small molecule drugs: Piclidenoson for psoriasis (Phase 3) and Namodenoson for advanced liver cancer (Phase 3), pancreatic cancer (Phase 2a), and NASH (Phase 2b).

Can-Fite BioPharma (NYSE American: CANF; TASE: CANF), a biotechnology firm focused on small molecule drugs for oncological and inflammatory diseases, invites investors to a webinar on June 6, 2024, at 4:15 p.m. ET.

Hosted by RedChip Companies, the event will feature CEO Motti Farbstein and Executive Chairperson/Chief Scientific Officer Pnina Fishman, PhD. They will discuss the company's current development pipeline and upcoming milestones.

Investors can register for the free webinar and pre-submit questions at the provided link.