RANCHO CORDOVA, Calif., May 20, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that it has received Institutional Ethics Committee (IEC) approval to initiate the SurgWerks-AMI and VXP System (patent pending) phase II clinical trial. This multi-site IEC approval paves the way for the safety and preliminary 6 month efficacy study of 40 patients having suffered an ST- Elevated Myocardial Infarction (STEMI) resulting in a Left Ventricle Ejection Fraction (LVEF) ≤ 40% at least 72 hours after a primary Acute Myocardial Infarction (AMI). The study will be a 1:1 randomized, open label, active controlled, multi-center device Phase II (feasibility) trial.
The study follows a successful 24 month single patient pilot trial of a primary STEMI 43 year old male who had an LVEF of 35% on admission to the emergency department, was unresponsive to reperfusion and pharmaceutical therapies and underwent treatment with Cesca's AMIRST I therapy six days after the primary heart attack. As reported in the case report publication in 2013, at the 24 month follow-up the patient had a normal LVEF of 60.3%, suffered no complications, and was doing remarkably well.
This new clinical trial, titled "AMIRST II", will test the company's point-of-care medical device treatment on a larger patient population for safety and efficacy. Essentially, individuals who suffer a primary heart attack and are adequately reperfused by stenting or clot busting drugs but fail to recover with a healthy heart pumping action will be candidates for this experimental therapy. The procedure takes 90 minutes, involves a single trip to the heart cath lab, and uses a specially optimized system of devices for aspirating bone marrow, preparing the cell formulation with the bedside "smart-vision" based VXP System, and injecting the cells through the coronary artery with a specialized cell therapy catheter.
"We are pleased to take the next step in the development of the SurgWerks-AMI and VXP System technology specific to this patient population who have a poor prognosis without regenerative medicine. We estimate that more than 30,000 patients would fit our stringent inclusion criteria in the U.S. alone, and that such a therapy will have an annual global market between $750M to $1B. Our patent pending method, and patented devices bring a scaled down version of the biopharmaceutical plant directly into real-time bedside medicine, empowering the interventional cardiologist to ensure the cells are fresh, safe, viable and potent," commented Ken Harris, President of Cesca.
The company will conduct this Phase II study in India, and if meeting the safety endpoints, will plan for pivotal efficacy trials in the U.S., E.U., and India in late 2017. Under the new Indian clinical trial authorization procedure, a three-step approval process is followed. First, a nationally recognized and registered Institutional Ethics Committee must review and approve the trial, followed by an Expert Advisory Committee, which will make final recommendations to a Technical Review Committee (TRC) of the Central Drugs Standard Control Organization. The TRC will have the final decision in granting approval for the trial. This entire process is expected to take up to six additional months, and will be spearheaded by the company's clinical and regulatory departments with support by the National Principle Investigator, Dr. Ashok Seth, M.D., F.R.C.P., Chairman of Cardiovascular Medicine at Fortis Healthcare.
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 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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The 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 components:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- The CellWerksTM Platform, a proprietary stem cell laboratory kit for processing target cells used in the treatments of oncological and hematological disorders.
- The 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.