Developing first-in-class cardiovascular biopharmaceuticals that target natural repair pathways.

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(Juventas Therapeutics, Inc. is formerly known as AcelleRX Therapeutics, Inc.)

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

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.

"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.

About Juventas Therapeutics

Juventas Therapeutics, headquartered in Cleveland, OH, is a privately-held biotechnology company developing a pipeline of regenerative therapies to treat life–threatening diseases. Founded in 2007 with an exclusive license from the Cleveland Clinic, Juventas has secured nearly $10 million in venture capital and grant funding since inception. Investors include Triathlon Medical Venture Partners, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received non-dilutive grant support through the Ohio Third Frontier-funded Global Cardiovascular Innovation Center and Center for Stem Cell & Regenerative Medicine to advance development platforms for heart failure and peripheral vascular disease, respectively.

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.

SOURCE Juventas Therapeutics