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Juventas Therapeutics, Inc. Enrolling Phase I Clinical Trial of JVS-100 for Patients with Heart Failure


4/5/2010 8:49:40 AM

CLEVELAND, April 5 /PRNewswire/ -- Juventas Therapeutics, a privately held, clinical-stage regenerative medicine company announced it has started enrolling patients in a Phase I clinical trial for JVS-100 to evaluate safety and efficacy in the treatment of patients with Class III heart failure. JVS-100 encodes Stromal Cell-derived Factor-1 (SDF-1) and has been shown in pre-clinical studies to significantly increase cardiac function by promoting cell survival and increasing new blood vessel formation in the damaged organ. Specifically, the company completed studies in heart failure pig models demonstrating that JVS-100 treated pigs showed statistically significant improvements in key indicators of cardiac function and remodeling including reductions in left ventricular end systolic volume. Douglas Losordo, M.D., the Director of the Feinberg Cardiovascular Research Institute at Northwestern University serves as the Principal Investigator for the 16 person first-in-man, open-label, dose-escalation study. Also serving as Investigators are Drs. Farrell Mendelsohn, Director, Center for Therapeutic Angiogenesis Interventional & Regenerative Cardiovascular Medicine and Warren Sherman, the Director, Stem Cell Research and Regenerative Medicine for the Center for Interventional Vascular Therapies at Columbia University Medical Center.

"The initiation of this clinical trial builds upon years of work in our laboratory demonstrating that SDF-1 is a key molecular factor that attempts to repair damaged tissue through the local recruitment of stem cells," said Marc Penn, M.D., Ph.D., Director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics in the Heart and Vascular Institute at the Cleveland Clinic and Chief Scientific Officer for Juventas Therapeutics. "Humans have evolved in such a way that our natural SDF-1 expression is too short-lived for us to see any benefit; however, by delivering JVS-100, we prolong SDF-1 expression or re-introduce it at a time remote from injury for a period of time sufficient to promote significant tissue repair."

"It is exciting to see the molecular mechanisms of stem cell-based tissue repair that we and many others have worked to define starting to move forward as potential therapies. JVS-100 provides an attractive candidate to provide regenerative therapy to our patients," said Dr. Losordo.

The company's lead product, JVS-100 encodes Stromal-cell Derived Factor 1 (SDF-1). JVS-100 has been shown to protect and repair tissue following organ-damage in a broad range of pre-clinical disease models. Their first clinical target will be treatment of patients with advanced heart failure. The company has demonstrated that JVS-100 therapy has the potential to improve cardiac function following a heart attack by recruiting the body's own stem cells to the damaged region, the prevention of cardiac cell death and promotion of new blood vessel growth in the heart. In addition to heart failure, Juventas is developing JVS-100 into a platform therapy with active development programs in peripheral vascular disease and wound healing.

Juventas Therapeutics




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