Can-Fite Updates on its Advanced Liver Cancer Pivotal Phase 3 Study
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.
- Namodenoson has Orphan Drug and Fast Track status from the FDA.
- 31 recruiting medical centers across Europe, Israel, and the US.
- Compassionate use program ongoing in Israel and Romania.
- Phase 2 study showed prolonged survival and improved quality of life.
- One patient had a long-term complete response of over 7 years.
- Projected HCC treatment market to reach $3.8 billion by 2027.
- The Phase 3 trial involves a high-risk population with Child Pugh B7 cirrhosis.
- The double-blind, placebo-controlled trial design may delay results.
- Interim analysis to occur only after 50% enrollment, slowing potential adjustments.
- No current data from the Phase 3 study available to investors.
Insights
Namodenoson's progression to a Phase 3 pivotal study for treating advanced liver cancer (HCC) is a significant milestone. The drug has shown promising results in earlier trials, including extended survival and cases of tumor clearance. This is notable because HCC, especially in advanced stages like Child Pugh B, has limited treatment options and poor survival rates. FDA's Orphan Drug and Fast Track status are important as they offer regulatory advantages including market exclusivity and expedited review processes, accelerating the drug's potential approval and availability. From a clinical perspective, these designations underscore the unmet medical need and the potential impact of Namodenoson if it proves effective in larger trials.
Furthermore, the compassionate use programs indicate that the drug is already providing benefits to patients beyond clinical trials, adding real-world evidence to its potential efficacy. This drug could fill a important gap in HCC treatment, particularly for those with advanced hepatic dysfunction.
The initiation of the Phase 3 trial and Orphan Drug status for Namodenoson bring several financial implications. Firstly, Fast Track status can accelerate the approval process, reducing time to market, which is financially advantageous. The exclusivity granted by Orphan Drug status can protect against competition, potentially leading to higher revenues if the drug is approved. The liver cancer market, projected to reach
Investors should note the scale of the Phase 3 trial, with 450 participants, indicative of a significant investment in R&D. However, the success of previous phases and the compassionate use cases suggest a strong case for continuation. Interim analysis after treating 50% of patients will be a pivotal moment, offering early insights that could affect stock performance.
The market for HCC treatments is expanding due to the high incidence and mortality rates associated with liver cancer. The projected market value of
Fast Track and Orphan Drug status not only speed up the drug's pathway to market but also signal strong potential from a regulatory and market access perspective. These designations can also enhance the drug’s marketability and attract partnerships or acquisitions, further benefiting Can-Fite's financial health.
Namodenoson granted Orphan Drug and Fast track status from the FDA
RAMAT GAN,
In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.
Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. 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. The market for HCC treatments is estimated by Delveinsight to reach
The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after
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 Metabolic Dysfunction-associated Steatohepatitis (MASH), 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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20240605024229/en/
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Source: Can-Fite BioPharma Ltd.
FAQ
What is Namodenoson?
What is the current status of Namodenoson's Phase 3 study?
What special designations does Namodenoson have from the FDA?
How many patients will be enrolled in the LIVERATION trial?
What are the primary efficacy endpoints of the Phase 3 trial for Namodenoson?
What were the results of the previous Phase 2 study of Namodenoson?
What market size is projected for HCC treatments by 2027?
