Cesca Therapeutics Inc. Announces FDA Approval of IDE Supplement for Phase III Clinical Trial
January 05, 2017 at 06:00 am EST
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Cesca Therapeutics Inc. announced that the company received approval from the U.S. Food and Drug Administration (FDA) for significant revisions to the Company’s pivotal study for treatment of Critical Limb Ischemia (CLI). The CLI clinical trial is designed to demonstrate the safety and efficacy of the Company’s point-of-care SurgWerks™ system for the treatment of CLI patients with limited or no treatment options. The study was first approved by FDA in June 2015, but was not initiated at that time pending funding. The changes approved by the FDA are intended to increase patient enrollment by expanding the patient pool from Rutherford Category 5 patients only, to also include Rutherford Category 4 patients, or patients with a less severe form of the disease. In addition, the study population has been expanded to include patients who are poor candidates for either surgery or endovascular therapies, as opposed to only those patients with no viable treatment options. Finally, the FDA accepted to change the control arm from a placebo, which was both invasive and carried measureable safety risk, to a much less risky sham procedure. Although the primary endpoint remains Amputation Free Survival (AFS), a standard in all current CLI drug and biologic trials, the FDA recognized the need to increase the available patient population in order to properly power the clinical trial. Compared to the initial study design, the sample size was increased from 224 to 362 patients, which in turn allowed the superiority margin to be reduced from 20% to 13%. Other improvements to the study include a reduction in study-related testing, improved statistical methods, and streamlined study oversight, all of which are intended to reduce costs and improve patient recruitment and investigator participation.
ThermoGenesis Holdings, Inc. develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics. The Company provides the AutoXpress and BioArchive platforms for automated clinical bio-banking, the PXP platform for point-of-care cell-based therapies and X-Series products for cell processing services. Its product lines include Clinical Bio-Banking Applications, Point-of-Care Applications and Cell Processing. Its Clinical Bio-Banking Applications include AXP II Automated Cell Separation System and BioArchive Automated Cryopreservation System. Its Point-of-Care Applications include PXP Point-of-Care System, and PXP-1000 System. Its Cell Processing includes X-Series Products for general laboratory use: X-Lab for cell isolation, X-Wash System for cell washing and reformulation, and X-Mini for high efficiency small scale cell purification. The Company markets and sells its medical device products through independent distributors.