CryoLife(R) Announces Results of Aurazyme(R)'S Pre-Clinical Animal Trials of AZ-CINN 310 to Treat Breast Cancer

September 9, 2003 at 11:15 AM EDT

ATLANTA, Sept. 9 /PRNewswire-FirstCall/ -- CryoLife, Inc.'s (NYSE: CRY), subsidiary, Aurazyme Pharmaceuticals, Inc., announced today 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, PhD.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiovascular and vascular surgeries throughout the United States and Canada. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels, and is CE marked in the European Community and approved in Canada for use in soft tissue repair, and approved in Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) Vascular Graft, which is CE marked for distribution within the European Community.

Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur as and when expected, if at all, and, together with the Company business, are subject to various risks and uncertainties. Such risks and uncertainties include that the preliminary results involved only a small number of test mice, future pre-clinical or clinical results or other research and development efforts related to AZ-CINN 310 may prove less encouraging than current results or show AZ-CINN 310 to cause side effects not observed in the current pre-clinical trials, AZ-CINN 310 research may require resources that the Company does not have available for that purpose, and AZ-CINN 310 may not be effective with additional targeting agents.

For additional information about the company, visit CryoLife's web site: http://www.cryolife.com

SOURCE  CryoLife, Inc.
CONTACT:  Joseph T. Schepers, Vice President, Corporate Communications of
CryoLife, Inc., +1-770-419-3355