Cancers of the breast, lung, colon, prostate and ovary remain a highly significant cause of morbidity and mortality worldwide. One potentially promising avenue for the development of new anti-cancer agents is stimulating the immune system to specifically recognise and eradicate targeted cancer cells.
The MUC-1 Study is a single-site, First-in-Human clinical trial in oncology which aims to assess the safety and benefit of the MUC-1 vector vaccine in patients with epithelial cancers and to identify a tolerable, immunologically active dose level. This unique MUC-1 vector vaccine is provided by MicroVAX, LLC, a biotechnology company located in Manassas, Virginia, USA, the study was conducted at National Cancer Center, Singapore. SCRI was invited by the PI and MicroVAX to participate in this First-in-Human trial as the Study Sponsor.
As Study Sponsor, SCRI is responsible for ensuring sufficient resources to initiate, manage and deliver the research as proposed. SCRI also worked with the PI and MicroVAX to develop the study protocol and to prepare the site for the study initiation.
SCRI provided oversight of safety monitoring, quality control and quality assurance throughout the study to ensure the data collected was accurate and of quality standard. SCRI also provided CRO management via close supervision to ensure that overall conduct of the study was in compliance with the approved study protocol, regulatory requirements and good clinical practice.
As Sponsor, SCRI proactively identified potential study risks and provided mitigation actions. Moreover, SCRI ensured that any protocol deviations were reported promptly to the Ethics and Regulatory authorities with appropriate corrective and preventive actions. SCRI also undertook regulatory submissions to the Health Sciences Authority, obtained regulatory approvals, acted as the IP importer to ensure the appropriate delivery and storage conditions for the IP on site.
With able support from SCRI, the study has been successfully completed, data has been analysed and the results are promising. The manuscript is under preparation for the publication.