Cytori Therapeutics, Inc. Receives Approval from FDA to Initiate U.S. Cardiac Cell Therapy Trial
January 30, 2012 at 08:00 am
Share
Cytori Therapeutics, Inc. received an Investigational Device Exemption (IDE) approval from the U.S. FDA to begin the ATHENA trial. ATHENA will investigate the use of the Celution(R) System, an innovative medical device to prepare adipose-derived stem and regenerative cells (ADRCs) to treat a form of coronary heart disease, chronic myocardial ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011. ATHENA is a multi-center, randomized, double blind, placebo controlled, pilot trial to investigate the use of autologous, clinical-grade ADRCs, processed at the point-of-care with Cytori's proprietary Celution(R) System. The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options. It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months. Previously, Cytori reported six and 18-month trial data from PRECISE, a European clinical trial for this same indication showing improvement in mVO2. In Europe, Cytori has applied to expand its Celution(R) System CE Mark to include no-option CMI claims based on data from the PRECISE trial. Cytori is also enrolling ADVANCE, a European pivotal trial investigating the Celution(R) System for acute myocardial infarction (heart attacks). In the U.S., it is estimated that 120,000 to 250,000 patients are diagnosed each year with chronic myocardial ischemia, a subset of the approximate 5.8 million patients who currently have some form of heart failure. CMI patients typically have undergone multiple revascularization procedures that have not improved their condition and are at a stage where they have few therapeutic options remaining.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company. The Company is developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers. The Company combines image-guided local beta radiation and targeted drug delivery approaches. The Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). Its radiotherapeutic candidate, rhenium (186Re) obisbemeda, is designed specifically for CNS cancers including GBM, LM, and pediatric brain cancers (PBC). The Companyâs Rhenium (186Re) obisbemeda, a novel injectable radiotherapy designed to deliver targeted, high dose radiation directly into GBM tumors. Its radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM), is designed to treat many solid organ cancers.