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Case spins out Arteriocyte, first stem cell company

Case Western Reserve University has completed a technology license agreement with Arteriocyte, Inc., an early-stage company developing proprietary stem cell based therapies to grow new blood vessels for patients with a variety of vascular diseases.

The university has also invested $250,000 in Arteriocyte through its Case Technology Ventures (CTV) fund.

Arteriocyte was founded by Mary Laughlin and Vincent Pompili, members of the Case School of Medicine faculty and clinicians at University Hospitals of Cleveland (UHC), with the assistance of Case's Technology Transfer Office. The company is based on technologies developed by the founders and Steven Haynesworth, associate dean of the College of Arts and Sciences at Case.

Enrollment for a Phase 1 safety trial in humans is expected to begin later this year at UHC.

The company is the first spin-out of the new Center for Stem Cell and Regenerative Medicine, a collaboration among Case, UHC and the Cleveland Clinic Foundation. The center received $19 million in state funding last year.

"We are pleased to have launched Arteriocyte based on Case/UHC technology," said Don Brown, chief executive officer of Arteriocyte. "The market for the treatment of vascular diseases is enormous and growing and we hope to one day offer a standardized, off-the-shelf injectable cocktail of stem cells as an option for heart surgeons and interventional cardiologists attempting to restore or enhance blood flow to the heart.

"Given the two institutions' prominence in the use of non-embryonic stem cells for vascular therapies, it was a natural fit for us," added Brown, a former executive of Viacell and Schering-Plough.

The Arteriocyte technology consists of a method for combining multiple stem cell types in a unique way and the steps for infusing damaged tissues with them so new blood vessels will grow. This technology offers distinct advantages over other methods that attempt to grow new blood vessels to replace damaged ones, and has the potential to augment conventional therapies such as artery bypass grafting and angioplasty.

Other approaches have used single blood cell types or crude, multiple cell type preparations without achieving the necessary level of blood vessel formation needed in the target tissue. The unique combination of blood cell types has shown encouraging results in yet unpublished animal studies.

Blocked or damaged blood vessels are a major cause of illness and death around the world. Atherosclerosis, for example, can lead to congestive heart failure and heart attacks. More than 10 percent of the U.S. population over the age of 65 is diagnosed with congestive heart failure each year.

Existing therapies include drugs, gene therapy, and vascular interventions for relief of arterial obstructions. In 2003, approximately 750,000 coronary artery bypass graft (CABG) surgeries were performed worldwide and approximately 1.8 million balloon angioplasty procedures were performed. While these interventional therapies are now the standard of care, there are still a significant number of people for whom these methods do not work, or who have blockage throughout their bodies.

"Arteriocyte's technology is at the cutting-edge of non-embryonic stem cell-based therapies," said Michael Haag, senior licensing manager in Case's Technology Transfer office. "It represents a unique approach to the use of stem cells to treat a wide variety of conditions."

Arteriocyte will initially target patients for whom the current treatments are marginally effective, such as diabetic patients who have higher rates of restenosis (re-closing of the arteries) and bypass graft failure. This at-risk population includes 30 percent of the approximately $26 billion US market for angioplasty and CABG procedures. Importantly, the novel Arteriocyte therapy is expected to improve outcomes and thereby provide significant cost reduction over a patient's lifetime for significant segments beyond the initial target population.

Stanton Gerson, director of the Center for Stem Cell and Regenerative Medicine said, "Arteriocyte represents an important milestone for Cleveland. This innovative technology will use stem cells initially to regenerate diseased blood vessels of the heart. In time, other targets will include peripheral vascular disease that disables people with diabetes and sickle cell anemia, and other stem cell therapeutics of all kinds. The Center promised the citizens of Ohio that it would develop new technology and commercialize it. Arteriocyte represents the first installment on that promise."

The company's first investor, with $250,000, is Case Technology Ventures (CTV), the University's pre-seed funding source. Arteriocyte follows Interventional Imaging, Inc., as CTV's second portfolio company.

"Arteriocyte represents the ideal investment candidate for CTV. It brings together a unique combination of cutting-edge Case technology, world-class researchers, and an excellent management team in a manner that positions it for great success," said Nick Frollini, CTV managing director.

Arteriocyte was the 2004 BioScience track winner of the third annual CASE Business Launch Competition in May. The competition, sponsored by Case's Institute for the Integration of Management and Engineering is designed to further advance entrepreneurial activity in the biotechnology sector.

The company is working with BioEnterprise, the bioscience business development organization founded by Case, UHC, and the Cleveland Clinic Foundation. BioEnterprise will continue to provide management guidance, strategic alliance support, and clinical and regulatory advice, in addition to hosting Arteriocyte in its office space.

"Arteriocyte has all the components of an ideal university-launched startup world-class researchers, exciting technology, a large, growing market, and a solid team," said Joseph Jankowski, assistant vice president for biomedical sciences at Case. "The launch of this company represents the end product of a strong collaboration between multiple departments and programs at Case, University Hospitals and B ioEnterprise. We are excited that the company may become a major player in this important field."

 

About Case Western Reserve University

Case is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case is distinguished by its strengths in education, research, service, and experiential learning. Located in Cleveland, Case offers nationally recognized programs in the Arts and Sciences, Dental Medicine, Engineering, Law, Management, Medicine, Nursing, and Social Work. http://www.case.edu.