Can-Fite Received IRB Approval for the Treatment of Pancreatic Cancer with Namodenoson in a Phase IIa Study
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).
- IRB approval for Phase IIa study of Namodenoson in pancreatic cancer.
- Study will be conducted at Rabin Medical Center, a leading institution.
- Promising pre-clinical and Phase II data in pancreatic and liver cancer.
- Namodenoson to be evaluated for safety and clinical activity in advanced pancreatic adenocarcinoma.
- Approximately 20 patients to be enrolled, ensuring focused and detailed study.
- Endorsement from esteemed bodies like AACR and publications in Biomolecules.
- The study is in early Phase IIa, indicating a long road ahead before potential market approval.
- to 20 patients, which might not provide comprehensive data.
- Patients included are those whose disease has progressed despite first-line therapy, indicating a high-risk group.
Insights
The approval of the Institutional Review Board (IRB) for the Phase IIa study of Namodenoson in treating advanced pancreatic cancer is noteworthy. Pancreatic adenocarcinoma is notoriously aggressive and often resistant to treatment, making any potential new therapy significant. Namodenoson has shown efficacy in preclinical models through the Wnt/β-catenin signaling pathway, which is an important molecular target in cancer therapy. If this trial demonstrates safety and clinical efficacy, it could potentially offer a new line of treatment for patients who have exhausted other options. However, it's worth noting that this is an early phase study, so the results, while promising, are preliminary and will require further validation in larger, more comprehensive trials.
The Phase IIa study for Namodenoson involves evaluating critical parameters such as Objective Response Rate (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR) and Overall Survival (OS). These metrics are standard in oncology trials and essential for assessing the drug's efficacy. Furthermore, the open-label design of this study allows for a detailed observation of the drug’s effects and side effects. However, it's important to emphasize that with only 20 evaluable patients, the sample size is rather small. This limits the generalizability of the results, necessitating further studies with larger cohorts to confirm these findings. Investors should view this as a positive step but be aware of the cautious optimism given the early stage.
The initiation of a Phase IIa clinical trial for Namodenoson can have important financial implications for Can-Fite BioPharma Ltd. Early-phase clinical trials are typically viewed as high-risk, high-reward scenarios. Positive results could substantially increase the company's valuation and attract partnerships or funding for further development. However, investors should also be aware of the considerable costs and time associated with bringing a new drug to market. Additionally, the biotech sector is highly volatile and stock prices can be significantly influenced by clinical trial outcomes. Therefore, while the IRB approval is a promising development, it’s important to consider the broader financial landscape and the inherent risks involved in the biotech industry.
Namodenoson showed efficacy in pre-clinical models via a definitive molecular mechanism of action
PETACH TIKVA,
“This Phase IIa study is designed as an open-label one, enabling us to assess the safety and potential efficacy of Namodenoson in pancreatic cancer patients whose disease has progressed despite first-line treatment. Our positive Namodenoson data in pancreatic carcinoma experimental models together with the positive data in the Phase II advanced liver cancer study, with a patient showing overall survival of >7 years, encouraged us to initiate the current Phase IIa study,” stated Can-Fite’s Medical Director Dr. Michael Silverman.
The protocol of the clinical study is CF102-222PC entitled: “A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma,” ClinicalTrials.gov Identifier: NCT06387342.
The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this 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. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center,
Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways."
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/20240610723784/en/
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Source: Can-Fite BioPharma Ltd.
FAQ
What recent approval did Can-Fite BioPharma receive for Namodenoson?
What is the study identifier for Can-Fite's Phase IIa trial?
What are the primary objectives of Can-Fite's Phase IIa Namodenoson study?
How many patients will be enrolled in Can-Fite's Phase IIa pancreatic cancer study?
Where will Can-Fite's Phase IIa Namodenoson study be conducted?
What dosages of Namodenoson will be administered in the Phase IIa study?
What are the key endpoints for Can-Fite's Namodenoson study?
What previous data encouraged Can-Fite to initiate the Phase IIa study?
