RANCHO CORDOVA, Calif., Nov. 9, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that Dr. Richard Powell, MD is presenting Cesca's feasibility data on critical limb ischemia (CLI) at the American Heart Association-Scientific Sessions Conference in Orlando, Florida. The data presented will summarize results from two cardiovascular clinical studies, which enrolled no-option CLI patients (high risk for near term amputation) and used Cesca's patented point-of-care technology (SurgWerksTM) to prepare autologous bone marrow derived stem cells for lower extremity transplant. CLI is a late phase form of peripheral artery disease (PAD), which is often associated with diabetes, and can result in severe non-healing ulcers and potential loss of limb due to the lack of blood circulation. While medications and surgical options are available to advanced cases of the disease, approximately 70,000 patients undergo major amputations and an additional 135,000 minor amputations each year in the U.S. alone. In June, Cesca received FDA IDE approval for its CLIRST III pivotal CLI trial (see www.clinicaltrials.gov, NCT02538978).
Dr. Richard Powell, Chief of Vascular Surgery for Dartmouth-Hitchcock Medical Center, is the Lead Principal Investigator for Cesca's CLIRST III trial. "CLI and resulting amputation rates continue to be a major unmet medical need globally and new solutions, like Cesca's SurgWerks technology, have the potential to relieve debilitating pain, improve quality of life and extend the lives of countless patients. This trial does a better job of directing cells into the affected limb through optimized cell delivery needles. I'm encouraged by the SurgWerks technology and the data from Cesca's preliminary studies, and look forward to the initiation of this pivotal trial," said Dr. Powell.
Dalip Sethi, Ph.D., Senior Clinical Scientist at Cesca Therapeutics commented, "Dr. Powell's experience in CLI clinical trials, particularly those in regenerative medicine, has provided invaluable insight that we anticipate will have a positive impact on our upcoming study. The results Dr. Powell is presenting were included in our submission to the U.S. FDA which resulted in approval to conduct the CLIRST III trial. We are excited by the prospect of starting this final stage in our path towards commercialization and ultimately making this technology available to patients."
Christy Hansen, DNP, MSN, RN-CCRC, Clinical Trial Field Operations Manager for the CLIRST III trial, added, "The CLIRST III trial differs from previous trials in that it provides rapid point-of-care technology, minimizes treatment variability and streamlines the experience of treating CLI patients. Our inclusion/exclusion criteria have been developed to facilitate enrollment rates of Rutherford Category 5 patients while optimizing the length of follow-up needed to analyze treatment efficacy."
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. The Company is a leader in the development and manufacture of 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™; proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
- The AutoXpress® (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
- The MarrowXpress™ (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
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The BioArchive® System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of 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, including our ability to initiate and prosecute the pivotal CLIRST III trial, our ability to obtain efficacy consistent with prior CLI studies, continued FDA approval, Medicare reimbursement approval, timing of the Company's future submission of IDE, PMA and/or Medicare reimbursement applications, or amendments to such applications, and outcomes from such submissions. Further, clinical trial outcomes are not predictable, and results may vary from the Company's expectations, including the start of any such clinical trials, patient follow up issues, and costs associated with such trials. Further description of other 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. Contact: Cesca Therapeutics Inc. http://www.cescatherapeutics.com. Cesca may, at its discretion, choose to publish on-going interim notifications, requests for further information as received from the FDA, Medicare or equivalent foreign agencies, but as a general policy only makes announcements regarding material or significant information, such as filing of applications, approvals, initiation of studies, and conclusions.