Russian pharmaceutical company Biocad has launched a Phase I clinical trial of BCD-225, a drug candidate for the treatment of bladder cancer, the company told GxP News. The primary objective is to evaluate safety and determine the recommended therapeutic dose of the immunotherapeutic agent.
The study will also assess the drug’s pharmacokinetic, pharmacodynamic and immunological characteristics, and gather preliminary efficacy data when used in combination with BCG. The approach is expected to enhance local anti-tumor immune response in patients with high-risk non-muscle invasive bladder cancer who face a significant risk of recurrence or disease progression, the company said.
Developing combination immunotherapeutic approaches could help boost the efficacy of standard therapy and potentially reduce the need for radical surgical interventions in the future, the company added.
The BCD-225 trial will be conducted at research centers across multiple Russian cities, including Barnaul, Nizhny Novgorod, Moscow, Krasnoyarsk, Omsk, St. Petersburg, Volzhsky, Ivanovo, Ufa and Novosibirsk.
Bladder cancer is among the most common oncological diseases. Globally, it ranks as the seventh most prevalent malignancy in men and the seventeenth in women. Approximately 75% of patients present with non-muscle invasive disease at initial diagnosis. Standard treatment in such cases involves tumor removal via transurethral resection followed by intravesical immunotherapy with BCG vaccine, which may be administered for one to three years depending on recurrence risk.
In 2022, the Ministry of Health authorized the company to conduct clinical trials of a therapy for spinal muscular atrophy, which is currently in Phase I-II trials.
