The company has announced that the first patient has been enrolled in the fimaChem RELEASE study with registration intent in inoperable bile duct cancer patients.
The pivotal RELEASE study has the potential of accelerated/conditional marketing approval as a first-line treatment given the rare disease status and high unmet medical need in this patient population, which currently are left without any approved effective treatment options, states the company in its press release.
“Bile duct cancer is a devastating disease with a very clear need of better treatment methods. fimaChem represents a novel local treatment approach for inoperable perihilar bile duct cancer patients and the efficacy data from Phase I are encouraging when compared to standard treatment options. It will be exciting to explore fimaChem’s performance in a randomised setting and I look forward to working with my fellow investigators on this pivotal study,” says Prof. Dr. med. Jörg Trojan, coordinating investigator for the study in Europe.
“We appreciate our investigators’ dedication to patients who are underserved with currently available treatment options and the formal kick-off of recruitment in the RELEASE study represents a major milestone for PCI Biotech. The company is now fully focused on execution of the pivotal phase and we are eager to see the benefits we believe fimaChem can provide to the patients in need of better local treatment options,” says Per Walday, CEO of PCI Biotech.
Photo of Per Walday: PCI Biotech