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OCT Clinical, one of the leading Eastern European CROs, has been contracted by Mabscale Biotech to run a clinical trial of a breast cancer treatment in Russia. Mabscale is a biopharmaceutical company engaged in development and production of drugs (biosimilars) based on monoclonal antibodies and other recombinant proteins. Mabscale is a biotech spin-off of Ozon Pharmaceuticals, one of the key players in the Russian pharmaceuticals market.
This is a multicenter, randomized, double-blind, comparative study of the efficacy and tolerability of investigational drug within neoadjuvant and adjuvant therapies.
596 women over 18 years of age with HER2-positive breast cancer are planned to be randomized into the study. OCT Clinical will be conducting the study at more than 25 clinical sites in Russia. The planned therapy period is 17 months. Currently, the project is at the start-up stage, with qualified research site selection underway. The approval of additional sites and the initiation of the first ones are expected shortly.
Irina Petrova, Director of Clinical Operations, OCT Clinical: “We are delighted to have the opportunity to support the first major oncology study by Mabscale. Research in this therapeutic area accounts for over a third of our oncology projects. We appreciate the Sponsor’s trust and we are confident that our in-depth expertise and understanding of the industry will allow us to implement the project efficiently and within the specified timelines."
Natalia Titova, Director General, Mabscale: “The experience of OCT Clinical allowed us to delegate to them all activities related to study design, documentation, provision of regulatory support and high-quality project management. Thanks to our joint efforts and the results of the study, cancer patients will have the opportunity to receive effective treatment.”
The OCT team is responsible for the full range of services within this study. Turnkey projects make up a significant part of the company's portfolio. For more information on OCT’s CRO services, visit www.oct-clinicaltrials.com/services.