AIM ImmunoTech has dosed the first patient in Phase 2 of its Phase 1b/2 clinical trial, DURIPANC, evaluating Ampligen (rintatolimod) combined with AstraZeneca’s Imfinzi (durvalumab) for late-stage pancreatic cancer. Several participants from Phase 1 who received the highest dose of Ampligen will continue into Phase 2. The open-label, single-center study, conducted at Erasmus Medical Center in the Netherlands, anticipates enrolling up to 25 patients in this phase.
This advancement is particularly important for pancreatic cancer patients, as the disease often presents late, leaving few effective treatment options. Combining Ampligen, a TLR3 agonist, with Imfinzi, a PD-L1 checkpoint inhibitor, offers a novel approach to potentially stimulate a stronger immune response against the cancer. Steady enrollment is anticipated, a significant aspect in a disease where patient recruitment for trials can be challenging. This allows for more efficient data collection and potentially faster progress toward a new therapeutic strategy.
The DURIPANC trial is an investigator-initiated study exploring the combination of these two drugs. Phase 2 will involve up to 25 patients and follows a Phase 1 portion that explored dosage levels of Ampligen. The inclusion of patients from the highest dose cohort of Phase 1 provides valuable continuity and data for evaluating the treatment’s efficacy and safety profile at this dose level.
The initiation of Phase 2 of the DURIPANC trial represents a crucial step forward in developing a potential new treatment approach for late-stage pancreatic cancer. Positive results from this phase could lead to larger trials and bring hope to patients facing this aggressive disease. The combination therapy’s progress may stimulate further research into combined immunotherapeutic strategies for challenging cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
