Shares of Can-Fite Biopharma Ltd ADR (NYSE American: CANF) surged 65% on Wednesday after the company disclosed positive findings from a Phase 2a trial of Namodenoson in advanced pancreatic cancer patients.
The open-label study, which enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies, met its primary safety endpoint and demonstrated survival results the company described as durable.
Study design and exposure
Twenty patients were treated in the trial. Of those, 14 received Namodenoson as third-line therapy, five as second-line therapy and one as a fourth-line treatment. Can-Fite reported that Namodenoson was well tolerated and that the safety profile observed was consistent with previous trials.
Updated survival findings
In an updated analysis focusing on eight evaluable third-line patients who survived at least two months after beginning treatment, median overall survival exceeded five months. Within that subgroup, 62.5% of patients survived five months or longer, and 37.5% survived seven months or longer. At the time of the data cutoff, two of those patients remained alive.
For the five patients treated in the second-line setting, one patient continued to be alive more than 18 months after starting Namodenoson therapy, which the company identified as the longest survivor in the study.
Investigator perspective
"Pancreatic cancer remains one of the most difficult malignancies to treat, particularly after failure of standard therapies. The results of Namodenoson monotherapy are impressive and the favorable safety profile together with the prolonged survival observed in a subgroup of patients, suggest biological activity worthy of further investigation. Based on these findings and the growing preclinical evidence demonstrating enhancement of chemotherapy activity, I believe the next logical step is evaluation of Namodenoson in combination with chemotherapy."
The comment was attributed to Prof. Salomon Stemmer, who is leading the Phase 2a study at the Davidoff Institute of Oncology, Rabin Medical Center, Israel.
Next steps
Can-Fite said it plans to advance Namodenoson into a Phase 2b trial that will evaluate the agent in combination with chemotherapy. The decision to move into a combination study is grounded in the Phase 2a findings and preclinical data the company cited showing Namodenoson can enhance the anti-tumor activity of chemotherapeutic agents in pancreatic cancer models.
Market reaction
The stock move reflected investor response to the clinical update and the companys stated development plans. The trial details reported by Can-Fite include the small, open-label structure and the specific survival outcomes in the subsets described above.