RANCHO CORDOVA, Calif., July 8, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today that it recently participated in a pre-submission IDE (Investigational Device Exemption) teleconference with the Food and Drug Administration's ("FDA") Center for Biologics Evaluation and Research to discuss the Company's proposed pivotal clinical trial design for the treatment of Critical Limb Ischemia ("CLI") using its CLIRST (Critical Limb Ischemia Rapid Stem cell Therapy) treatment protocol delivered via the Company's proprietary SURGWERKS-CLI kit.
"We are quite pleased with the feedback we received from the FDA regarding our proposed trial design and our conclusion that our SurgWerks-CLI kit as outlined in our pre-submission is properly designated a Class III product that follows an IDE-PMA regulatory pathway," said Matthew Plavan, Chief Executive Officer of Cesca Therapeutics. "Good trial design and critical analysis of pivotal trial endpoints leads to better clinical outcomes. With that in mind, we believe our call with the FDA bodes well on our upcoming IDE submission," continued Plavan.
CLIRST is Cesca's proprietary method and bedside platform technology utilizing a patient's own bone marrow stem cells and is in the clinical development stage. Cesca's intended goal in its planned pivotal trial is to demonstrate prevention or delay in major limb amputation in Rutherford 5 patients, as compared to the standard of care. This therapy is targeted as an alternative to major limb amputation having a current cost of care in the US of approximately $15 billion.
The SURGWERKS™-CLI therapy kit contains optimized stem cell harvesting, selection, and delivery disposables and can be completed on a patient in less than 60 minutes in the operating room with mild sedation. Unlike other cell therapies under development, SURGWERKS™-CLI patient cells never leave the operating room, meet the FDA definition for "minimally manipulated" cells, and are delivered to the patient in a single procedure.
The Company sponsored a Phase Ib clinical trial for CLIRST which demonstrated safety and early efficacy results treating no-option patients suffering from CLI. The Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia (NCT01472289) was a single center, unblinded, single arm study in 17 patients with late-stage CLI. The original study results were announced in January 2014. The trial achieved both its primary safety endpoint and secondary efficacy endpoints at an average of 26 months having no serious adverse events determined to be related to the therapy, and achieving >82% in the protocol amputation free survival rates, and statistically significant improvement in pain reduction, 6-minute walking distance, open wound healing and, vasculogenesis over the 12 month follow-up period in the treated leg.
Critical limb ischemia afflicts an estimated 2 million people combined in the United States, European Union and Indian sub-continent, and results in approximately 500,000 amputations each year. The overall prevalence and incidence in the United States increases with age and diabetes status and five year mortality rates post limb amputation reaches nearly 50%.
The Company expects to submit an IDE application for its U.S. based CLI pivotal clinical trial with the FDA in October of 2014 and to fund its trial with a portion of the proceeds received from its recently completed equity financing of $11.3 million.
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, proprietary stem cell therapy point-of-care kit 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 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
Forward-Looking Statement
This press release contains forward-looking statements. Such forward-looking statements include but are not limited to that Cesca Therapeutics Inc. will be able to close it proposed offering of Units. These statements and Cesca Therapeutics' business involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking 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.