Oncolys BioPharma Inc. [4588.T]
TOKYO, Jun 03 (Pulse News Wire) – Oncolys BioPharma Inc. (4588.T) submitted a clinical trial application to PMDA for its tumor-dissolving virus OBP-301, targeting lower rectal cancer and anal cancer patients undergoing preoperative chemoradiotherapy.
The Phase 1b/2a pilot study aims to evaluate the efficacy and safety of combining OBP-301 with chemotherapy. The trial plans to assess local tumor shrinkage effects post-treatment. Lower rectal cancer and anal cancer often require stoma creation during surgery, leading to quality-of-life issues such as bowel management challenges.
Oncolys BioPharma intends to develop OBP-301 specifically for these conditions, aiming to commence patient enrollment by December 2026. The impact on the fiscal year ending December 2026 is expected to be minor. Additionally, the company remains on track to launch sales of OBP-301 for esophageal cancer treatment in the same period, following regulatory approval and pricing inclusion.
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