Juventas Therapeutics commences enrollment in Phase I trial of JVS-100 for treatment of Class III heart failure

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.

"Juventas is excited to have initiated this Phase I heart failure trial and honored to be working with a top-tier group of interventional cardiologists," said Rahul Aras, Ph.D., President and Chief Executive Officer for Juventas Therapeutics.  "The trial is an important milestone and represents the first of several clinical opportunities for our company.  By activating the SDF-1 repair pathway, which is well-conserved in most end-organ systems including the heart, brain, kidney, dermis, vasculature and nervous system, JVS-100 provides the opportunity for one product to impact a broad range of clinical indications."

"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."

Regenerative medicine is an emerging therapeutic field focused on the repair, replacement, or regeneration of cells, tissues, or organs to restore impaired function resulting from any cause, including congenital defects, disease, and trauma.  Several companies are investigating clinical products that often involve extracting a person's own stem cells and re-delivering them to the damaged organ.  While cell-based therapies are showing clinical promise, extracting, processing and re-delivering these cells in a cost-effective and timely fashion is predicted to be a major challenge for the field.  JVS-100 has the potential to provide therapeutic benefits associated with regenerative medicine without the complexity of having to deliver stem cells to the patient.

"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.

SOURCE Juventas Therapeutics


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