CryoLife Inc's, subsidiary, Aurazyme Pharmaceuticals Inc, announced that in pre- clinical animal trials AZ-CINN-310 demonstrated accelerated destruction of breast cancer tumor cells at the site of activation with a single low dose of paclitaxel when AZ-CINN 310 was light activated. AZ-CINN 310 links paclitaxel, a drug used in chemotherapy, to Herceptin, an antibody that targets HER-2 antigens that are above normal in certain breast cancer patients. The study involved the implantation and growth of human breast cancer cells in mice.

The pre-clinical studies were performed by Dr. Mark Pegram at UCLA's Jonsson Comprehensive Cancer Center and were funded in part by a grant provided by the National Cancer Institute of the National Institutes of Health to Aurazyme. "Seven days after treatment, AZ-CINN 310 demonstrated extensive tumor cell kill, with few viable tumor cells, in mice with a single paclitaxel dose that was less than 5% of the estimated normal paclitaxel dose and had no observed toxicity," stated Dr. Mark Pegram, associate professor UCLA.

AZ-CINN 310 utilizes a novel linker technology that combines a monoclonal antibody and a chemotherapeutic drug that is intended to destroy tumors. Aurazyme's proprietary technology is designed to release the drug after the antibody is attached to the tumor site through light activation, ultrasound, or normal hydrolysis. Two of the groups of mice in the study received AZ-CINN 310. In one of these groups the AZ-CINN 310 was light activated, in the second the AZ-CINN 310 activation was by normal hydrolysis. The group which received AZ-CINN 310 and was subjected to light activation demonstrated visible evidence of tumor necrosis two days after treatment. Histology samples taken from mice in that group two days after the activation treatment showed a central necrotic core, an extensive zone of dying tumor cells, and viable cells in the tumor periphery. At seven days, samples taken from both groups of mice showed extensive tumor kill, with few viable tumor cells. The study is ongoing.

"While these AZ-CINN 310 preliminary results are encouraging, we are in the early stages of development. In addition to linking to antibodies, there are a wide range of other potential targeting agents such as hormones, cytokines, and enzymes that we plan to investigate with our linker technology," said Aurazyme's Vice President and Chief Operating Officer, Kirby Black.