Researchers at the University of Alabama at Birmingham (UAB) have signed on to lead a clinical study to evaluate the safety and activity of a radiolabeled, humanized monoclonal antibody from Navidea Biopharmaceuticals’ RIGS™ Monoclonal Antibody Targeting technology. The study will evaluate up to 20 patients with colorectal cancer (CRC) by administering the RIGS tumor-specific radiolabeled, CH2 domain-deleted, anti-TAG-72 Mab-targeting agent and assessing by SPECT/CT imaging for the presence of liver metastasis.

“The detection of metastasis of colorectal cancer to the liver has had less than acceptable sensitivity and low specificity using traditional CT. There is the need to find better modalities to evaluate the liver at the time of the initial diagnosis of CRC,” commented Andres Forero, M.D., one of the principle investigators on the study. “We are looking forward to working with Navidea to evaluate this tumor-specific imaging agent that may benefit surgeons in effectively locating cancerous tissues leading to better patient outcomes.”

The study is to be funded in part through the company’s SBIR grant from the National Cancer Institute announced in 2012. The SBIR grant has the potential for grant money up to a total of $1.5M over three years if fully funded. The first-year Phase I funding of $315,000 focused on completing preclinical bridging activities using the CH2 domain-deleted, anti-TAG-72 mAb and preparing a standardized clinical trial protocol. Phase II funding of up to $1.2M will be used in support the clinical study and is contingent upon meeting certain Phase I success criteria, including Institutional Review Board approval of the clinical trial protocol.

RIGS (radio-immuno-guided surgery) is a monoclonal antibody targeting technology that includes an investigational, tumor-specific, radiolabeled humanized monoclonal antibody (CH2 Domain-Deleted, Anti-TAG-72). According to the company, the RIGS agent may enable more effective detection and surgical intervention of colorectal cancers, and potentially other cancers. By binding specifically to the target TAG-72 cancer antigen, the RIGS agent accumulates within affected tissue and is then detected by imaging or a gamma probe.

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