Company Overview of Juventas Therapeutics, Inc.
Juventas Therapeutics, Inc. discovers and develops biopharmaceutical therapies for regenerative medicine. It offers Stromal Derived Factor-1, a therapy that improves cardiac function, as well as enables to protect and repair tissues following organ–damage in pre–clinical disease models. The company also develops biopharmaceuticals that activate the natural repair process that occurs after an injury. In addition, it provides therapies for wound healing and peripheral vascular diseases. Juventas Therapeutics, Inc. was formerly known as AcelleRX Therapeutics, Inc. and changed its name to Juventas Therapeutics, Inc. in April 2009. The company was founded in 2007 and is based in Cleveland, Ohio.
10265 Carnegie Avenue
Cleveland, OH 44106-2130
Founded in 2007
Key Executives for Juventas Therapeutics, Inc.
Vice President of Business Development
Director of Product Development
Compensation as of Fiscal Year 2013.
Juventas Therapeutics, Inc. Key Developments
Juventas Therapeutics Initiates First Clinical Trial for Retrograde Infusion of Gene Therapy to Patients with Heart Failure
Dec 9 13
Juventas Therapeutics announced that the company has initiated enrollment of RETRO-HF, a Phase I/II clinical trial that will assess the safety and efficacy of JVS-100 administered by retrograde infusion to patients with symptomatic heart failure. The 12-person open-label, dose-escalation Phase I component will evaluate safety of performing retrograde infusion of JVS-100 dosed at 30 mg or 45 mg. It will be immediately followed by a 60-patient randomized, double-blinded, placebo-controlled Phase II component in which patients will receive JVS-100 at 30 mg or 45 mg or a placebo infusion. Enrollment is underway and Dr. Amit Patel, Director of Cardiovascular Regenerative Medicine at University of Utah, successfully dosed the first patient. JVS-100, the Company's lead product, is a non-viral gene therapy that encodes stromal cell-derived factor 1 (SDF-1). It has been shown to promote tissue repair through recruitment of a patient's own stem cells to the damaged organ. Juventas recently completed enrollment of two Phase II trials. The 93-patient STOP-HF trial will measure safety and efficacy of JVS-100 administered by endo-myocardial injection to patients with symptomatic heart failure and the 48-patient STOP-CLI trial will measure safety and efficacy for JVS-100 in patients with critical limb ischemia. Retrograde infusion is a minimally invasive technique in which a catheter is inserted through the venous system into a patient's coronary sinus. A balloon is then inflated in order to temporarily block blood flow out of the heart so that the gene therapy can be infused directly into the heart. The technique employs commonly used balloons and catheters that are already approved for delivery of non-biologic agents to the heart. The RETRO-HF trial will enroll patients with symptomatic ischemic heart failure. Heart failure affects nearly six million Americans, with an estimated cost to the company's healthcare system in excess of $37 million. The patients targeted for treatment with JVS-100 have typically progressed to a stage where their options are limited to a heart transplant or assist device.
Juventas Therapeutics, Inc. Presents at 2013 Therapeutic Area Partnerships Conference, Nov-19-2013 04:00 PM
Nov 15 13
Juventas Therapeutics, Inc. Presents at 2013 Therapeutic Area Partnerships Conference, Nov-19-2013 04:00 PM. Venue: One Avenue De Lafayette, Boston, MA 02111, United States.
Juventas Therapeutics Completes Enrollment of Phase II STOP-HF Study of JVS-100 in Patients with Symptomatic Heart Failure
Oct 28 13
Juventas Therapeutics announced that the company has completed enrollment of the STOP-HF trial. STOP-HF is a double-blinded, placebo-controlled, multi-center trial of its non-viral DNA plasmid therapy JVS-100 for patients with symptomatic heart failure. A total of 93 patients have been enrolled in this trial at 16 academic and community hospitals throughout the United States. Patients enrolled in STOP-HF had a prior history of a heart attack and years later developed symptomatic heart failure as defined by an ejection fraction less than 40% and poor quality of life and exercise tolerance as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHQ) and six minute walk distance (6MWD), respectively. Patients were randomized to placebo or treatment with two different doses of JVS-100. Therapy was directly delivered to the heart via endo-ventricular injection using the BioCardia Helical Infusion Catheter(TM). In addition to safety, data for several efficacy endpoints is being collected at four months and one-year post-treatment including heart failure related hospitalizations, major adverse cardiac events, and changes in 6MWD, MLWHQ scores, and ejection fraction. Earlier 2013, Juventas Therapeutics completed enrollment of STOP-CLI, a Phase IIa first-in-human, double-blinded, placebo-controlled, dose-escalation trial of JVS-100 for patients with Rutherford class 4 or 5 critical limb ischemia (CLI). The 48-person trial enrolled CLI patients considered poor candidates for revascularization at four centers in the United States and two centers in India. The primary endpoint for the trial will be safety with efficacy data collected on several key endpoints including amputation rates, Rutherford class, wound closure, and pain management.
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October 31, 2013