Navigation Links
Juventas Therapeutics completes enrollment of Phase II STOP-HF study of JVS-100 in patients with symptomatic heart failure
Date:10/28/2013

CLEVELAND, Oct. 28, 2013 /PRNewswire-USNewswire/ -- Juventas Therapeutics, a privately-held clinical-stage company developing novel therapies for treatment of cardiovascular disease, announced today 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.

(Logo: http://photos.prnewswire.com/prnh/20131028/DC04442LOGO)

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 percent 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 CatheterTM.  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.

"The patients studied in this trial, on average, have experienced their most recent heart attack nearly a decade prior to treatment and their heart failure symptoms have progressed to a point that their health and ability to perform the activities of daily living are significantly deteriorating despite receiving optimal medical management," states Marc Penn M.D., Ph.D., Chief Medical Officer for Juventas and Director of Research, Summa Cardiovascular Institute at Summa Health Systems. "The goal of STOP-HF is to further define the safety and clinical benefits of JVS-100 in heart failure patients who are already receiving the current standard of care."

Earlier this year, 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.

"Completing enrollment of STOP-CLI and STOP-HF are significant milestones for the company this year," states Rahul Aras, Ph.D., President and CEO for Juventas Therapeutics.  "To date, more than 120 patients have received JVS-100 therapy and we are building a strong safety profile.  Next year is an important year for Juventas, with efficacy data results targeted from both Phase II studies and additional trials scheduled to enroll.  We are excited to transition JVS-100 into late stage clinical trials and commercialization."

About Juventas Therapeutics

Juventas Therapeutics, headquartered in Cleveland, Ohio, is a privately-held clinical-stage biotechnology company developing therapies for cardiovascular disease. Founded in 2007 with an exclusive license from the Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to mid-stage clinical trials for treatment of heart failure and critical limb ischemia.  Investors include New Science Ventures, Triathlon Medical Venture Partners, Takeda Ventures, Early Stage Partners, Fletcher Spaght Ventures, Venture Investors, Reservoir Venture Partners, The Cleveland Clinic, Glengary, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received support through the Ohio Third Frontier funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center, and Center for Stem Cell and Regenerative Medicine.

About JVS-100

The company's lead product, JVS-100 encodes Stromal–cell Derived Factor 1 (SDF–1).  JVS-100 is a non-viral DNA plasmid that has been shown to protect and repair tissue following organ–injury in a broad range of pre–clinical disease models. The first clinical targets will be treatment of patients with advanced symptomatic heart failure and critical limb ischemia. The company has demonstrated in pre-clinical models that JVS-100 therapy has the potential to repair tissue-damage following ischemic injury 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 also developing JVS-100 for additional indications including acute myocardial infarction, chronic angina, and muscle regeneration.

Contact:

Juventas Therapeutics, Inc.
Joseph Barone
Email: jbarone@juventasinc.com
Telephone: 216 273 4000
Website: www.juventasinc.com


'/>"/>
SOURCE Juventas Therapeutics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sorrento Therapeutics Announces Pricing of Public Offering of 4,150,000 Shares of Common Stock and Listing on NASDAQ
2. ISSYS Inc. will showcase its Titan Wireless Implantable Hemodynamic Monitor and its clinical study summary at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference (Booth 1638) in San Francisco (October 29 to 31, 2013)
3. Aratana Therapeutics Adds to Commercial Leadership Team
4. Mirati Therapeutics Prices Public Offering Of Common Stock
5. Shareholder Alert: Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Repros Therapeutics, Inc.
6. Cell Therapeutics to Report Third Quarter Financial Results after Market on October 30, 2013
7. Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Osiris Therapeutics, Inc.
8. 3-V Biosciences Presents Positive Data for Novel FASN Inhibitor at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
9. Aratana Therapeutics names Wendy Yarno to its Board of Directors
10. PTC Therapeutics to Showcase Breadth of Pipeline at Upcoming R&D Day
11. Cornerstone Therapeutics Inc. Stockholders Seeking More Money Regarding the Proposed Buyout by Chiesi Farmaceutici S.P.A. Encouraged to Contact Lawyers at Deans & Lyons
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)...   Acsis , a leading provider of supply ... research and advisory firm IDC has named it a ... Pharmaceutical Track and Trace Software 2016 Vendor Assessment (doc ... of the capabilities and business strategies of 10 vendors ... Logo - http://photos.prnewswire.com/prnh/20160427/360791LOGO ...
(Date:4/28/2016)... 2016 New market research ... a report that provides an overview of the ... by identifying new targets and MOAs to produce ... discussed in this H1 2016 Osteoarthritis Pipeline report ... Inc., Abiogen Pharma S.p.A., Ablynx NV, Achelios Therapeutics, ...
(Date:4/27/2016)... 2016   ... sur le trimestre, soutenu par une croissance de ... Croissance de +16% des ventes aux hôpitaux et ... Technologies (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), inventeur de ... son chiffre d,affaires pour le premier trimestre clos ...
Breaking Medicine Technology:
(Date:5/2/2016)... ... May 02, 2016 , ... ... announced a new Specialty Pharmacy Patient Satisfaction Award that will recognize specialty pharmacies ... quarterly results from Zitter Health Insights’ Specialty Pharmacy Patient Satisfaction Survey compiled throughout ...
(Date:5/2/2016)... ... May 02, 2016 , ... Visceral fat, also known as ... kidneys, liver and pancreas. If not properly addressed, visceral fat can lead to ... Medicine, Medical Oncology and Palliative Care, warns against the dangers of visceral fat. ...
(Date:5/2/2016)... (PRWEB) , ... May 02, ... ... researchers report that many commonly used prescription medications, including anxiolytics, painkillers, antidepressants ... mitigate these risks, Novus Medical Detox Center —a leading Florida-based drug ...
(Date:5/2/2016)... , ... May 02, 2016 , ... Pregnancy Awareness Month ... trying to conceive. , “If you are ready to have a baby, ... “My book, HealthChequesTM: Journal Babies is your Personal Conception & Pregnancy Organizer, written ...
(Date:5/2/2016)... , ... May 02, 2016 , ... ... and urgent care facilities designed to automate and improve the rapid diagnosis, triage ... it is demonstrating their platform, application, and mobile experience for the first time ...
Breaking Medicine News(10 mins):