Can-Fite: Pancreatic Carcinoma Phase IIa Clinical Study with Namodenoson Received Regulatory Authorization from the Israeli Ministry of Health

Rhea-AI Summary

Can-Fite BioPharma (NYSE American: CANF) has received approval from the Israeli Ministry of Health to conduct a Phase IIa clinical trial for Namodenoson in treating pancreatic carcinoma. The multicenter, open-label trial will enroll approximately 20 evaluable patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. Patients will receive 25 mg of oral Namodenoson twice daily in 28-day cycles.

The study aims to establish safety and clinical efficacy. Primary objectives include characterizing Namodenoson's safety profile, while secondary objectives involve evaluating clinical activity through metrics such as Objective Response Rate, Progression-Free Survival, and Overall Survival. The trial will be conducted at the Rabin Medical Center in Israel and UT Southwestern Medical Center in the US.

Positive

• Regulatory approval received from Israeli Ministry of Health for Phase IIa trial
• Potential new treatment for advanced pancreatic carcinoma
• Multicenter trial involving both Israeli and US medical centers
• Previous efficacy shown in advanced liver cancer studies

Negative

• Small sample size of only 20 evaluable patients
• Open-label trial design may introduce bias
• to patients who have progressed on at least 1st-line therapy

Oncology Researcher

The approval for a Phase IIa trial of Namodenoson in pancreatic cancer is a significant step for Can-Fite BioPharma. Pancreatic cancer is notoriously difficult to treat, with a 5-year survival rate of only about 10%. The pre-clinical data showing an "impressive anti-cancer effect" is promising, but investors should note that many drugs fail in the transition from pre-clinical to clinical studies.

The trial's design, focusing on patients who have progressed after first-line therapy, targets a critical unmet need. The primary endpoint of safety is appropriate for a Phase IIa study, while the secondary endpoints will provide important efficacy signals. The involvement of key opinion leaders adds credibility, but the small sample size of 20 patients means results should be interpreted cautiously.

Financial Analyst

This news represents a moderate positive for Can-Fite BioPharma (NYSE American: CANF). Advancing to Phase IIa in pancreatic cancer expands the company's oncology pipeline, potentially diversifying revenue streams if successful. However, investors should consider that:

• Phase IIa trials have a success rate of about 30%
• Development costs will increase as the trial progresses
• The timeline to potential commercialization is still lengthy

The market reaction may be tempered due to the early stage and small scale of the trial. Long-term value will depend on future data readouts and the company's ability to fund continued development.

Biotech Industry Expert

Can-Fite's approach with Namodenoson is intriguing. The drug's oral administration could offer a significant advantage in patient compliance and quality of life compared to traditional chemotherapies. The focus on the A3 adenosine receptor pathway is a novel approach in pancreatic cancer treatment.

However, investors should note that:

• The competitive landscape in pancreatic cancer is intensifying
• Large pharma companies have more resources for late-stage development
• Regulatory hurdles for approval in pancreatic cancer are high due to improvements in outcomes over decades

Can-Fite's success will hinge on demonstrating clear efficacy signals in this Phase IIa trial to attract potential partners or additional funding for larger studies.

Study will aim to establish safety and clinical efficacy

PETACH TIKVA, Israel, Sept. 16, 2024 (GLOBE NEWSWIRE) -- 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 approval from the Israeli Ministry of Health (MoH) to conduct Phase IIa clinical trial with orally-administered Namodenoson in the treatment of pancreatic carcinoma.

“We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of namodenoson and definitive molecular mechanism of action against pancreatic carcinoma,” stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. “We are very keen to initiate the study in this devastating disease and are pleased with the regulatory approval of the Israeli MOH. We do hope that as we have shown efficacy in patients with advanced liver cancer studies, we will be able to demonstrate safety and efficacy in the pancreatic cancer patient population.”

The Phase IIa is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients will receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study will be conducted by Dr. Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

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. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of NASH a Phase III 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.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 any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; 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 28, 2024 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.

Contact

Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114

FAQ

What is the purpose of Can-Fite's Phase IIa trial for Namodenoson (CANF)?

The Phase IIa trial aims to establish the safety profile and evaluate the clinical efficacy of Namodenoson in treating advanced pancreatic carcinoma patients who have progressed on at least 1st-line therapy.

What is the dosage and administration method for Namodenoson in Can-Fite's pancreatic cancer trial (CANF)?

Patients will receive 25 mg of oral Namodenoson twice daily in consecutive 28-day cycles.

Where will Can-Fite's Phase IIa pancreatic cancer trial for Namodenoson (CANF) be conducted?

The trial will be conducted at the Institute of Oncology, Rabin Medical Center in Israel and at UT Southwestern Medical Center in the US.

What are the primary and secondary objectives of Can-Fite's Namodenoson trial for pancreatic cancer (CANF)?

The primary objective is to characterize Namodenoson's safety profile. Secondary objectives include evaluating clinical activity through metrics like Objective Response Rate, Progression-Free Survival, and Overall Survival.