Curis Begins Phase I Clinical Study With Vascugel in Coronary Artery Disease
Curis, Inc. (NASDAQ: CRIS) today announced the initiation of a Phase I clinical trial in the U.S. with Vascugel, a cellular transplant product, in patients undergoing coronary artery bypass graft (CABG) surgery.
Vascugel is being developed to prevent complications related to cardiovascular surgical procedures and maintain long-lasting blood flow and tissue perfusion. The conditions leading to such complications include thrombosis (blockage of the blood vessel due to the formation of blood clots) and restenosis (the re-blockage of the blood vessel after surgery due to uncontrolled smooth muscle cell growth).
“CABG patients are the first population being tested for Vascugel, and we expect to evaluate additional patient populations as we move this exciting product forward,” said Doros Platika, M.D., president and chief executive officer of Curis, Inc. “There are over 1.5 million revascularization procedures each year with a market opportunity of approximately $1.5 billion.”
“We are very enthusiastic about the potential of this technology to reduce anastomotic complications following coronary bypass procedures,” said Dr. David Adams who is the principal investigator currently enrolling patients at the Brigham and Women’s Hospital in Boston, Massachusetts. Additional hospitals are being explored as clinical sites for this trial.
“Vascugel is designed to restore the normal control function of endothelial cells after vascular injury, such as that experienced in surgery, by delivering multiple agents required to prevent thrombosis and restenosis,” said Andrew C. G. Uprichard, M.D., F.R.C.P., chief operating officer of Curis, Inc. Although surgical procedures to correct these conditions are generally successful on a short-term basis, approximately 10 to 15 percent of these procedures fail within months, requiring additional intervention with further risk.
“An innovative, cell-based product such as Vascugel, which is thought to be capable of delivering multiple biochemical agents in a physiologically regulated fashion, represents a significant potential therapeutic option in connection with coronary surgery,” said Dr. Uprichard. “Furthermore, because the cells used in Vascugel are allogeneic, that is, derived from an individual other than the patient, the manufacturing process is simplified and the product can be used in many patients, making it cost-effective.”
Vascugel is a biodegradable implant containing human endothelial cells which, in this trial, will be wrapped at the junction (anastomosis) of the bypassed and grafted coronary blood vessels at the time of CABG procedures. The technology of wrapping endothelial cells around the outside of a blood vessel is unique and was originally conceived in Dr. Elazer Edelman’s laboratory at the Massachusetts Institute of Technology. Endothelial cells normally line the interior of the artery and are essential in controlling the proliferation of the underlying smooth muscle cells in the wall of the artery. Additional preclinical development studies performed at Curis were funded in part by an award from the National Institute of Standards and Technology.
Vascugel is believed to provide multiple biochemicals that are normally secreted by endothelial cells in response to vessel injury. These biochemicals, which include heparan sulfate proteoglycan (HSPG) and prostacyclin, are believed to control the overgrowth of smooth muscle cells lining the inside of the blood vessel and to prevent the formation of blood clots.
Curis, Inc. is developing products based on technologies in the emerging field of regenerative medicine. The Company is combining insights gained through the study of developmental biology with high-throughput screening capabilities, proteins, cells and biocompatible materials to facilitate the development of new regenerative medicine therapies. For more information, please visit the Curis web site at http://www.curis.com.
The statements in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, regulatory approval and commercialization, the impact of competitive products, patents, patent litigation, product liability, third party reimbursement, and other risks and uncertainties associated with the biotechnology industry. For additional factors that could cause actual results to differ materially, please refer to the risk factors section of Curis’ Registration Statement filed on Form S-1 with the Securities and Exchange Commission and dated December 20, 2000 and Quarterly Report on Form 10-Q/A filed with the Securities and Exchange Commission on December 6, 2000.
