Navidea Biopharmaceuticals will collaborate with the University of Alabama at Birmingham (UAB) on a clinical study that will assess the safety and activity of a radiolabeled, humanized monoclonal antibody from its RIGS (radio-immuno-guided surgery) monoclonal antibody targeting technology.
The study will enroll approximately 20 patients with colorectal cancer. Patients will be administered with RIGS tumor-specific radiolabeled, CH2 domain-deleted, anti-TAG-72 Mab-targeting agent and will be assessed for the presence of liver metastasis by SPECT/CT imaging.
Navidea Biopharmaceuticals will partly fund the study through its Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), National Institutes of Health (NIH) announced in 2012.
The SBIR grant has the potential for grant money approximately a total of $1.5m over three years if fully funded.
The first-year Phase I funding of $315,000 is focused on completing preclinical bridging activities using the CH2 domain-deleted, anti-TAG-72 Mab and preparing a standardized clinical trial protocol. This funding has already been approved.
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.
Initiation of the clinical study is also contingent upon completing certain antibody stability and quality tests currently in process.
Navidea Biopharmaceuticals senior vice president and chief scientific officer Dr Frederick Cope noted the company is excited to work with UAB as its re-initiates human clinical trials with its RIGS agent.
"We are also pleased with the current and potential future support of the NCI/NIH grant funding as we advance development efforts in this important technology," Dr Cope added.
RIGS monoclonal antibody targeting technology includes an investigational, tumor-specific, radiolabeled humanized monoclonal antibody (CH2 domain-deleted, anti-TAG-72).
RIGS monoclonal antibody targeting technology may be useful prior to, during, or after surgery for identifying cancerous tissue that is undetectable by traditional diagnostic and intraoperative techniques.
The RIGS agent may enable effective detection and surgical intervention of colorectal cancers, and potentially other cancers, leading to improved patient management and survival.
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.
The tumor-associated glycoprotein TAG-72 is expressed on the surface of a wide range of carcinomas and prompted the development of antibodies to TAG-72 for investigation in the diagnosis and treatment of carcinomas
TAG-72 is a target for detection of the spread of colorectal cancer to the liver.
