SironRX completes enrollment in Cohort 1 to study JVS-100 for wound healing, scar prevention

Therapeutic Rallies Body's Stem Cells for Natural Tissue Repair

SironRX Therapeutics Inc. (SironRX), a privately-held, clinical-stage biotechnology company developing novel regenerative therapies to prevent scarring and promote dermal wound repair, is pleased to report that it has completed enrollment of patients in Cohort 1 of its placebo-controlled, randomized, dose escalation double-blind clinical study evaluating the safety and efficacy of JVS-100 to reduce scar formation and improve wound healing in patients receiving surgical sternotomy incisions. Cohort 2 is actively being enrolled.

JVS-100, the Company's lead product, encodes Stromal cell-Derived Factor 1 (SDF-1). SDF-1 is an important natural chemokine that repairs damaged tissue through recruitment of circulating stem cells to the site of injury, prevents ongoing cell death and restores localized blood flow. This regenerative therapy has demonstrated the ability to reduce scarring and accelerate dermal wound healing after delivery to damaged skin in multiple preclinical investigations.

Patients in Cohort 1 were enrolled at University of Utah Hospital, Montefiore Medical Center and Summa Health Systems. Several additional centers are joining the trial for enrollment in Cohorts 2 and 3.

Dr. Amit Patel, Director of Cardiovascular Regenerative Medicine and Associate Professor of Surgery at the University of Utah, treated the first patient in the trial. "Current wound healing treatments are focused largely on ensuring the incision site retains a certain set of environmental conditions to aid healing. This treatment is different in that it is aimed directly at triggering the body's own repair mechanism," states Dr. Patel. "So rather than only impacting one element of the repair process, this therapy is enhancing the entire set of pathways. There are no other therapies existing today that do this."

"We are excited and hopeful that the use of SDF-1, a novel regenerative medicine therapy, will promote faster wound healing and reduce scarring in our heart surgery patients," said Dr. Robert Michler , Surgeon-in-Chief, Samuel I. Belkin Chair, Professor and Chairman, Department of Surgery and Professor and Chairman, Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center/ Albert Einstein College of Medicine New York. "The applications for this therapy could be widespread, ranging from cosmetically improved wounds to healing hearts damaged by heart attacks."

"The clinical development of JVS-100 highlights the benefits and clinical translatability of defining the molecular mechanisms associated with stem cell- based tissue repair. Our bench and clinical work to date demonstrate that SDF-1, which is produced by JVS-100, is clearly central in the biology of tissue repair throughout the body," said Dr. Marc Penn , founder of SironRX and the Director of Research, Summa Cardiovascular Institute, Summa Health System and Professor of Medicine and Integrative Medical Sciences at Northeast Ohio Medical University.

"SironRX is committed to developing novel therapies that reduce scar formation and accelerate wound healing, both of which represent important unmet medical needs," states Dr. Evan Facher , President & CEO of SironRX. "Advancing to the next phase of this clinical trial with top-tier clinical centers is an important milestone for the Company, its investors and partners. We are excited about the current study and also by the significant opportunity that extends well beyond it in the large dermal scar prevention and wound healing market."