Date: 2015-03-05
Type of information: Initiation of patient enrollment
phase: 2
Announcement: initiation of patient enrollment
Company: Capricor Therapeutics (USA - CA)
Product: cenderitide
Action
mechanism: peptide. Cenderitide belongs to a class of drugs called natriuretic peptides. Preclinical and clinical data have shown that the natriuretic peptide class can act on multiple disease processes that play a role in negative outcomes associated with heart failure. Cenderitide is designed as an outpatient therapy to be delivered continuously using a validated subcutaneous infusion pump for up to 90 days (the \"post-acute\" period) following a hospital admission for ADHF. Cenderitide was designed by scientists at the Mayo Clinic to be the only dual natriuretic peptide receptor agonist.
Disease: chronic heart failure
Therapeutic area: Cardiovascular diseases
Country: USA
Trial
details: The study is assessing the safety and tolerability, pharmacokinetics, and pharmacodynamics of open-label, continuous, stepwise, dose increasing, subcutaneous infusion of cenderitide via the insulet drug delivery system in subjects with stable, chronic heart failure
Planned enrollment is approximately twelve subjects with stable chronic heart failure. Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug Delivery System. Planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.(NCT02359227)
Latest
news: * On March 5, 2015, Capricor Therapeutics, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, announced that it is currently enrolling a Phase II clinical trial with cenderitide, a dual receptor natriuretic peptide agonist that has previously been used in approximately 270 patients including those suffering from acute decompensated heart failure. Capricor\'s current trial is a dose ranging study that is intended to evaluate the safety and feasibility of delivering the drug via a subcutaneous drug delivery patch pump. Capricor intends to address the large market for outpatient and ambulatory heart failure treatment including those patients with recent acute heart failure admissions as well as other potential indications. The present trial will enroll up to 14 patients with stable, chronic heart failure. Currently, the first two cohorts of patients have completed dosing with the remaining subjects expected to be treated over the next month. Patients will receive up to eight consecutive days of Cenderitide through subcutaneous infusion using Insulet\'s drug delivery system based on the OmniPod® technology. This trial will assess the safety and tolerability, pharmacokinetics profiles, and pharmacodynamic response to increasing dose levels of open-label Cenderitide administered in a stepwise fashion with each patient getting the entire range of doses. Cenderitide\'s treatment goal and target indication is to provide a novel and effective therapeutic option for the outpatient treatment of heart failure thereby addressing a critical unmet need and one of the largest potential markets in medicine.
