Can-Fite: 75 Oncologists and Coordinators from Europe US and Israel Participated in a Conference Aimed at Accelerating Patient Enrolment for the Pivotal Phase 3 Advanced Liver Cancer Study

Rhea-AI Summary

Can-Fite BioPharma held a conference for 75 oncologists and coordinators to accelerate patient enrollment for the pivotal Phase 3 advanced liver cancer study. The study aims to evaluate Namodenoson as a 2nd or 3rd line treatment for CPB7 patients with HCC. The drug has Orphan Drug status and Fast Track Status with the FDA for HCC treatment. The market for HCC treatments is projected to reach $6.1 billion by 2027.

Positive

• The company successfully organized a conference to educate oncologists and coordinators conducting the Phase 3 advanced liver cancer study, demonstrating strong commitment to patient enrollment.

• Can-Fite has received agreement from both the U.S. FDA and EMA for the pivotal Phase 3 clinical study, showcasing regulatory support for their potentially promising anti-cancer drug Namodenoson.

• Namodenoson has Orphan Drug status and Fast Track Status with the FDA for HCC treatment, highlighting the drug's potential for expedited development and approval.

• The market for HCC treatments is estimated to reach $6.1 billion by 2027, indicating a lucrative opportunity for Can-Fite to address the unmet medical needs in liver cancer treatment.

Negative

• The aggressive nature of HCC with poor survival rates poses challenges for the successful development of effective treatments, emphasizing the critical need for innovative therapies like Namodenoson.

• While the conference was successful, the ultimate success of the Phase 3 clinical study and the approval of Namodenoson remain uncertain factors that could impact Can-Fite's future performance and investor confidence.

Insights

Medical Research Analyst

Recent developments in Can-Fite's Phase 3 clinical trial for advanced liver cancer could be influential for investors eyeing the biotechnology sector, specifically in the oncology sub-domain. The company's efforts to accelerate patient enrollment through a targeted conference highlights the critical phase of the study, aiming to expedite the trial's progress. Progression Free Survival (PFS) and Objective Response Rate (ORR) are key metrics in oncology trials, indicating the treatment's efficacy in halting disease progression and reducing tumor size, respectively. Swift enrollment can lead to faster interim analysis, potentially shortening the time to market for namodenoson if results are positive and regulatory approval is achieved. As an orphan drug with Fast Track Status, namodenoson has certain advantages, such as additional support from the FDA and potential for expedited review. This could be favorable in achieving market penetration, especially in a space with high unmet medical need like Hepatocellular Carcinoma (HCC). Considering the projected market growth for HCC treatments, positive trial outcomes could position Can-Fite to capitalize on a significant commercial opportunity. However, investors should be aware that clinical trials carry inherent risks and a single negative study result or regulatory setback could impact the company's valuation.

Financial Analyst

From a financial perspective, the strategic move by Can-Fite BioPharma to enhance patient enrollment can be seen as a step to mitigate the high cash burn typically associated with late-stage clinical trials. Fast-tracking the trial process might lead to earlier-than-expected clinical readouts, which potentially could attract partnership opportunities or additional funding. The company's stock performance may see volatility around major clinical milestones and positive interim analysis could result in significant upside potential. Investors should note that orphan drug designation and Fast Track status often lead to premium pricing power upon successful drug launch, which can substantially affect revenue projections. However, the need for capital to reach commercialization and the risk of dilution from potential future financings are important considerations. Shareholders should monitor enrollment milestones, interim results and regulatory communications closely as they can indicate the trial's trajectory and the company's financial health.

Market Research Analyst

The patient enrollment initiative by Can-Fite must also be understood through the lens of market dynamics. The liver cancer treatment market has a high barrier to entry, but equally high potential rewards due to the seriousness of the condition and the limited effective treatments currently available. With liver cancer being the sixth most common cancer and the fourth leading cause of cancer death worldwide, the demand for novel treatments is palpable. The global market size for HCC treatments is expected to grow and Can-Fite's namodenoson could gain a substantial market share if proven effective. Investors should consider the competitive landscape and be aware of parallel developments in other HCC treatments, as these could affect namodenoson's market potential post-approval. A comprehensive analysis should include potential competition, pricing strategies and market penetration scenarios.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the current pivotal Phase 3 clinical study

RAMAT GAN, Israel--(BUSINESS WIRE)-- 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 announces that it held a conference for 75 oncologists and coordinators who are conducting the pivotal Phase 3 advanced liver cancer study, to accelerate patient enrolment.

The participants have been presented with the drug chemical and biological profile and the study protocol as well as study procedures. Dr. Lencioni, a key opinion leader in radiology of liver tumors, Department of Radiology, Pisa University School of Medicine Italy, educated the oncologists on the way to measure tumor lesion size prior and post namodenoson treatment. The difference in tumor growth or regression defines progression free survival (PFS) and the objective response rate (ORR) to the drug, serving as part of the study objectives. US experts presented to the participants the electronic data entry of the patients’ data during the trial.

"The conference was very successful and we are very pleased with the enthusiasm of the participants with respect to the drug characteristics. They are looking forward to complete patient enrolment and conclude the data of this very promising anti-cancer drug," said Dr. Pnina Fishman, Can-Fite CSO and Executive Chairperson.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase 3 clinical study which is now enrolling patients is Israel, Europe and the US. The study is designed to perform an interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been effective.

Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.

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 and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal 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: https://www.canfite.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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240513153232/en/

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

Source: Can-Fite BioPharma Ltd.

FAQ

What is Can-Fite's drug being evaluated in the Phase 3 advanced liver cancer study?

Namodenoson is the drug being evaluated as a potential 2nd or 3rd line treatment for CPB7 patients with liver cancer in the Phase 3 study.

What regulatory approvals has Can-Fite received for the clinical study?

Can-Fite has received agreement from both the U.S. FDA and EMA for the pivotal Phase 3 clinical study.

What is the market projection for HCC treatments by 2027?

The market for HCC treatments is estimated to reach $6.1 billion by 2027 for the G8 countries.

Who educated the oncologists at the conference on tumor lesion measurement?

Dr. Lencioni, a key opinion leader in radiology of liver tumors from Pisa University School of Medicine Italy, educated the oncologists on tumor lesion measurement.

What is the objective of the Phase 3 advanced liver cancer study?

The study aims to evaluate Namodenoson's effectiveness as a treatment option for CPB7 patients where other therapies have not been effective.