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TMCNet:  Phase II STOP-HF Trial Shows Excellent Safety Profile, Supports Efficacy for Juventas JVS-100 as Delivered by BioCardia® Helix™ Transendocardial Delivery System

[May 19, 2014]

Phase II STOP-HF Trial Shows Excellent Safety Profile, Supports Efficacy for Juventas JVS-100 as Delivered by BioCardia® Helix™ Transendocardial Delivery System

SAN CARLOS, Calif. --(Business Wire)--

BioCardia®, Inc., a leader in cardiovascular regenerative medicine, today announced the presentation by Juventas Therapeutics of their positive four-month results for their STOP-HF Trial.

STOP-HF is a double-blinded, placebo-controlled, multi-center trial of its non-viral DNA plasmid therapy JVS-100 delivered by BioCardia's Helix™ Transendocardial Delivery System (known as Helical Infusion System/HIS in the trial) in patients with symptomatic heart failure. A total of 93 patients were enrolled in this trial at 16 academic and community hospitals in 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 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. 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. Clinical results from the STOP-HF trial to date are detailed in the Juventas press release.


In the trial, the Helix system performed well, with no instances of treatment emergent mortality, myocardial infarction, aortic dissection, arterial spasm or stroke, all major adverse events believed to have occurred in other clinical trials using other transendocardial and intracoronary biotherapeutic delivery platforms.

"BioCardia congratulates the Juventas team and the talented clinical investigators on the performance of a rigorous clinical program, and we are honored that Juventas selected the Helix system for use in its STOP-HF trial," said BioCardia Chief Executive Officer Peter Altman. "The Helix system's growing safety experience adds value to therapeutic development programs, enhancing the probability of both technical and commercial success for biotherapeutic cardiovascular regenerative medicine products."

About the Helix Transendocardial Biotherapeutic Delivery System

The Helix system is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The system's unique performance advantages include crossing the aortic valve over a wire to prevent damage; enhanced navigation using the company's steerable Morph® guiding catheter; a helical needle which screws into the myocardium for stable delivery; and the use of contrast at the base of the needle to confirm tissue engagement. The system requires no external capital equipment.

The BioCardia Helix system has received CE Mark and is commercially available in the European Union. The system is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale in the U.S.

About BioCardia®

BioCardia, Inc., headquartered in San Carlos, CA (News - Alert) is a privately held company developing regenerative biologic therapies to treat cardiovascular disease. The Company's current products include the Helix™ Transendocardial Delivery System and the Morph® steerable guide and sheath catheter portfolio. BioCardia partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.


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