One of the leading Russian R&D companies, developing breakthrough genetically engineered medicines for the treatment of severe and socially significant diseases, has ordered OCT to prepare a clinical trial design for its novel monoclonal antibody which is to be registered and marketed in Russia.
The novel mAb has been tested and registered in numerous Asian countries. This drug should be investigated within a Phase III clinical study which is double-blind, placebo-controlled, and aimed at local registration in Russia. 60 patients with Head and Neck Squamous Cell Carcinomas (HNSCC) are planned to be enrolled at six sites within one year and then followed up within 5 years. Total study duration is expected to be 6.5 years. The investigational product or placebo will be administered in parallel with a postoperative adjuvant chemo-radiotherapy (CTRT).
This will be the third leading Russian biotechnology company, which OCT is working with, from the field of nanomedicine. They develop recombinant proteins, monoclonal antibodies, and cell products, manufacture and sell their medicines in Russia.
OCT will be happy to provide strategic consulting to all potentially interested partners in terms of clinical research and registration of biological products in Russia, CIS, and CEE. Our medical writers have excellent experience in preparing clinical study protocols, investigators’ brochures, informed consent forms, case report forms, patient questionnaires, and other documents. OCT has gained substantial experience in conducting Phase I-III trials of biological drugs, for example: Avastin biosimilar, Erbitux biosimilar, human lgG monoclonal antibody, G-CSF, etc. We will be glad to express our vision on the way of development of your products. In case of your curiosity, please contact our Business Development team. OCT’s medical writing services are available as an integral part of a full drug development program, a Phase I-IV clinical trial or as a stand-alone service.