RANCHO CORDOVA, Calif., May 13, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced it has submitted its amendment to the investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for a U.S. pivotal multicenter study of the Company's SurgWerks™-CLI and VXP System (SurgWerks-CLI) for treating advanced stages of no-option lower limb critical limb ischemia. The amendment outlines the Company's responses to the FDA's deficiencies in the original pivotal application. The amendment includes considerable data specific to assessing the SurgWerks-CLI and VXP System autologous cellular output and new methods in assessing the rapid device output in the operating room. The Company also notes that it has filed additional intellectual property as a result of this new work.
"This proposed pivotal trial is an important step toward the development of an autologous cell-based treatment for no-option critical limb ischemia patients. The novel approach developed and outlined to the FDA combines the best of the consistency of manufactured cell therapies with the safety of autologous cells. Essentially, we have now taken the cell manufacturing plant with its quality department and miniaturized it to be completed in the operating room in 90-120 minutes," commented Ken Harris, Cesca's President and head of clinical development.
The CLIRST III study will be a randomized controlled trial evaluating the efficacy of the SurgWerks-CLI and VXP System in CLI patients with non-healing foot ulcers who have no further surgical options except a major amputation versus a blinded placebo control of the same population. The primary endpoint is major amputation free survival at 12 months following enrollment and there will be an interim analysis for futility or repowering (adding more subjects) if necessary. The study will be conducted at up to 60 centers in the U.S. under Dr. Richard Powell, M.D., Chief of Vascular Surgery at Dartmouth-Hitchock Medical Center and Professor of Surgery and Radiology at Dartmouth School of Medicine. Currently, the Company has nearly 40 sites in the pipeline and is using its in-house clinical research organization to properly qualify the sites to specifications of the trial.
CLI, the most severe and deadly form of peripheral arterial disease, currently affects up to 2 million people in the U.S., many of whom are in a later stage of disease progression. By 2020, the prevalence of CLI in the U.S. is forecasted to grow to as much as 3.5 million people. In the U.S., it is estimated that there are approximately 280 amputations per million people per year and that 25% of all patients who undergo amputation below the knee will fail rehabilitation and require chronic institutional care or professional assistance at home. Consequently, the median cost of managing a patient after amputation is estimated to be two-three times that of successful limb salvage. Beyond the physical disability and financial cost, there is a significant emotional toll on the patient and the patient's caregiver/family as well; psychological testing of patients with CLI shows quality of life indices similar to patients with terminal malignancy. Thus there is an absolute critical need to develop novel strategies to promote limb salvage or limb amputation delay in patients with late stage CLI with no further options for conventional revascularization. Based on this prevalence data in the U.S. as well as similar data for European and Asian regions, the annual economic cost of CLI related amputations is estimated at $25 billion. It is in this therapeutic arena that Cesca expects to make a significant difference in the lives of patients with this debilitating disease.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.Cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. We are a leader in developing and manufacturing automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
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SURGWERKS™ Platform with VXP System, proprietary stem cell therapy point-of-care device kits and cell processing systems for treating vascular and orthopedic indications that integrate the following indication specific systems:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- CellWerks™ Platform, a proprietary stem cell laboratory kit for processing target cells used in the treatments of oncological and hematological disorders.
- AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood.
- The MarrowXpress Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the MNCs.
- The Res-Q™ 60 (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 35 countries for cryopreserving and archiving cord blood stem cell units for transplant.
Forward Looking Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.