Stamford reports positive Phase 2 results of SP-002 with vismodegib in Basal Cell Carcinoma patients

On January 17, 2025, Stamford released promising outcomes from its ASN-002-003 multi-lesional clinical trial, officially registered as NCT 04416516 with Protocol No ASN-002-003. This trial assessed the effectiveness of SP-002, a gene therapy using an Adenovirus-5 replication deficient vector that encodes human Interferon, combined with the Hedgehog Pathway Inhibitor vismodegib. The study targeted participants who had multiple basal cell carcinomas (BCCs).

The results from this Phase 2 study have been encouraging. They underscore both the safety and the effectiveness of the gene therapy for individuals dealing with multiple nodular and superficial BCCs. A significant finding is the introduction of histopathologic criteria that can identify responsive patients during the screening process, which can be employed for patient selection. These criteria were initially identified in an earlier clinical study, ASN-002-001, and their successful replication in the ASN-002-003 study strengthens their validity.

Dr. Clement Leong, the CEO of Stamford Pharmaceuticals, expressed enthusiasm about the study's findings. He noted that these results open the door to developing a practical treatment option for patients suffering from nodular BCC. This development addresses a critical need for non-surgical treatments, especially for patients who have BCCs located in challenging areas, known as the H-zone, or for those who are not suitable candidates for surgical procedures.

The press release from Stamford highlights the potential of a four-week combined treatment using SP-002 and vismodegib for individuals with multi-lesional basal cell carcinoma. This approach could offer a significant alternative to current therapies, providing patients with a less invasive option while maintaining effectiveness in treating the condition. The research not only confirms the safety of this combined therapy but also sets the stage for future advancements in the non-surgical treatment of BCC.