RA Approval for Breast Cancer Study Received

Global Clinical Trials is managing a Phase I clinical study in Breast Cancer. The project has recently been approved by the Russian Ministry of Health. This is the first drug created based on the modified oncogenic virus. Pre-clinical studies have shown that the Investigational Product is successful at eliminating cancer cells. The scientists have reason to believe it can also identify and target metastases. The drug has been developed by the Institute of Chemical Biology and Fundamental Medicine SB RAS, State Research Center of Virology and Biotechnology VECTOR in partnership with Oncostar, LLC.

During the clinical trial, it is planned to evaluate the safety, tolerability, and pharmacokinetics of the drug in patients with recurrent and/or refractory metastatic breast cancer.

GCT is providing full-service management of the project, including regulatory support, clinical site monitoring and management and the drug logistics.

β€œIt is great excitement for us as a team to work on the break-through therapy aimed at fighting the most common type of cancer,” – said Dr. Eugene Selivra, GCT CEO.

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GCT is a CRO experienced in performing clinical research in the USA, Europe, Russia and India.

We are a full-service clinical development provider, offering feasibility analysis, regulatory submission, site selection, project management, monitoring, data management, logistics, and more.

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