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Hemocellular Therapeutics establishes licensing agreement with UNC, ECU

CHAPEL HILL -- Hemocellular Therapeutics, expected to produce the first platelet-based therapeutic available to doctors for the immediate treatment of active bleeding, has established an exclusive licensing agreement with the University of North Carolina at Chapel Hill and East Carolina University, company officials recently announced.

The agreement recognizes key technology developed by researchers at the two universities as central to the N.C. companyís planned creation of lyophilized, or "freeze-dried," human platelets Ė the component of blood primarily responsible for initiation of coagulation. As a part of the exclusive license agreement, both universities received equity in Hemocellular and will share in royalties on the eventual sale of products.

Hemocellularís freeze-dried platelets are the result of a decade of research supported by initial private funding of $10 million.

The companyís scientific founders, Dr. Arthur P. Bode of ECU and Dr. Thomas H. Fischer of UNC, have led the research efforts. Bode, who received his doctorate in experimental pathology from UNC, has served as ECUís scientific director of clinical coagulation programs for 15 years. Fischer is scientific director of UNCís Francis Owen Research Laboratory, where researchers discovered the molecular cell membrane cross-linking technology crucial to Hemocellularís product development, said Richard A. Basile, chief executive officer of the company, and the initial extensive series of trials have taken place at that lab.

"The Francis Owen lab has a worldwide reputation in the field of coagulation therapeutics. We are extremely fortunate to have researchers affiliated with this lab informing our efforts to bring this technology to health-care settings as rapidly and responsibly as possible," he said.

Basile added that the licensing agreement is key in advancing platelet development to the next stage: human clinical trials. No other functional hemostatic agent is known to be in this stage of development, he said, and the need for such an agent to be developed is critical, particularly in acute-care settings. Human trials could start as early as 18 months from now, he added.

The U.S. Centers for Disease Control and Prevention has reported more than 4 million admissions to non-federal hospitals nationwide in 1999 where active bleeding was the primary or secondary diagnosis. In addition, tens of thousands of deaths are estimated to occur nationwide each year due to issues related to bleeding.

"We see tremendous implications for this technology," said Basile. "Our primary focus, ultimately, is to bring doctors and other health-care professionals a new tool in dealing with the very serious medical challenges associated with clinical bleeding. We also see this as a means to strengthen our nationís biodefense efforts."

The current standard of care, liquid-stored platelets, does not provide immediate responsiveness after reinfusion, is vulnerable to viral or bacterial infection and can be stored for only five days.

The technology licensed to Hemocellular modifies human platelets to be a hemostatic agent that has a long shelf life, is safe and sterile, and provides immediate response to platelet-related bleeding.

"Carolinaís partnership with Hemocellular represents a best-case model of how promising research discoveries can ultimately translate into solutions to some of our nationís most critical challenges," said Mark Crowell, associate vice chancellor for economic development and director of technology development at UNC.

"Our state benefits tremendously, as well, with research and the company based in North Carolina, and the possibility of hundreds of new jobs when this product prepares to enter the marketplace."

From 1997 through 2002, UNC spawned 22 new spin-off companies based on faculty research. Fifteen launched in 2001-2002, more than twice as many in the four prior years. Examples of commercialization include therapeutic agents for Parkinsonís disease, technologies for drug delivery to treat cancer, contrast media for medical imaging, industrial applications for carbon nanotubes, and gene therapy treatment for diseases like muscular dystrophy.

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