RANCHO CORDOVA, Calif., Nov. 20, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company developing proprietary devices and methods for cardiovascular, orthopedic and hematological/oncological procedures, today announced it has submitted an investigational device exemption ("IDE") application to the U.S. Food and Drug Administration ("FDA") for a 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 IDE application is the result of two prior positive pilot and feasibility studies conducted in Italy and India, respectively, and collaborative pre-IDE feedback from the U.S. FDA.
"This application marks a significant milestone in the emergence of Cesca Therapeutics as a leading late-stage regenerative medicine development company," said Ken Harris, President and Clinical Program Leader at Cesca Therapeutics. "The pivotal trial application milestone is the culmination of nearly six years of focus on cardiovascular clinical trials and device engineering specifically designed to verify that a patient's own bone marrow stem cells can positively impact a debilitating and potentially fatal disease," he continued.
The CLIRST III study, as proposed in the IDE application, is a double blinded randomized controlled trial to evaluate the safety and efficacy of the SURGWERKS-CLI and VXP System in CLI patients with non-healing foot ulcers who have no further surgical options, and will be compared against a placebo control of the same population. The primary endpoint is major amputation free survival at 12 months following enrollment. The study will be conducted in approximately 60 sites with up to 3 sites in India.
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 up to 3.5 million people. It is estimated by the Sage Group that approximately 70,000 amputations are completed each year in the U.S., and, according to MacKenzie et al at Johns Hopkins, 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 almost 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 absolutely critical need to develop novel strategies to promote limb salvage or delay limb amputation in patients with late stage CLI who have 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 Company believes this potential therapy represents at least a $2 billion addressable annual market. Cesca expects to make a significant difference in the lives of patients with this debilitating disease.
Dr. Richard Powell, M.D., Chief for Vascular Surgery at Dartmouth-Hitchcock Medical Center, Professor of Surgery and Radiology at Dartmouth Medical School in New Hampshire and chair/national principle investigator of the study, commented that no-option CLI patients will now have a potential treatment to salvage their limb and positively impact their quality of life.
Cesca Therapeutics' SURGWERKS platform utilizes a patient's own bone marrow stem cells which are collected, prepared and delivered into the targeted damaged tissue in a single 90 minute average intra-operative procedure. The Company has a development pipeline of therapies, in addition to this late stage peripheral vascular indication, that includes acute myocardial infarction, ischemic stroke, bone marrow transplant, avascular necrosis, and non-union fractures.
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
- CellWerksTM 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.