RANCHO CORDOVA, Calif., April 10, 2015 (GLOBE NEWSWIRE) — Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced a corporate update on Cesca’s clinical trial program in CLI and AMI.
Critical Limb Ischemia
As previously announced in early January, the Company received a letter from the U.S. Food and Drug Administration (“FDA”) responding to the Company’s submittal of its Investigational Device Exemption (“IDE”) application for a pivotal phase three clinical trial for the treatment of no-option patients with CLI. In its letter, the FDA requested additional information on characterization of the output of the SurgWerks(TM) – CLI kit and VXP System, a plan for testing device output for conformity to pre-defined intra-operative release criteria prior to administration, modifications to the management of potential adverse events and a strengthening of the language in the risk clauses in the informed consent document.
The Company determined that in order to meet the FDA’s request for additional data it would process and evaluate a number of fresh donor bone marrow samples through each individual step of the SurgWerks-CLI kit and VXP cell automation system. This process included careful characterization after bone marrow aspiration, cellular concentration and simulated delivery through the SurgWerks intramuscular needles. As requested by the FDA, the Company is also adding rapid screening procedures for device cell output and sterility to ensure consistent quality in the operating room.
Ken Harris, Cesca’s President and the leader of the Company’s clinical programs stated, “we will shortly be concluding this additional testing to confirm that our proprietary devices and methods produce a highly consistent cell output as previously demonstrated in our earlier feasibility studies.” “We expect to submit an amended application to the FDA in the next several weeks upon conclusion of our remaining cell characterization and sterility tests,” continued Mr. Harris.
The proposed Critical Limb Ischemia Rapid Stem Cell Therapy (“CLIRST III”) study is anticipated to be a randomized double blinded placebo controlled trial to evaluate the safety and efficacy of the SurgWerks-CLI and VXP System in treating CLI patients with non-healing foot ulcers who have no further surgical/interventional options other than amputation under current standard of care guidelines. Clinical outcomes will be compared against a placebo control of the same patient population. The primary endpoint will be major amputation free survival at 12 months following enrollment and the study will be conducted across approximately 60 sites.
CLI is the most severe form of Peripheral Arterial Disease (“PAD”), affecting over two million patients in the United States. It is frequently associated with chronic foot and leg ulcers, leading to approximately two hundred thousand amputations per year. A diagnosis of CLI statistically results in a 25% mortality rate, and a 25% amputation rate, within one year.
Acute Myocardial Infarction
In addition to CLI, the Company has also developed an autologous cell therapy using its SurgWerks-AMI and VXP System to treat patients who have suffered an ST Elevated Myocardial Infarction (“STEMI”). In March 2015, Cesca submitted its application to the Internal Review Board (“IRB”) of Fortis Healthcare, India, to conduct a phase two feasibility study treating STEMI patients who have a poorly responding ventricle fraction 72 hours after reperfusion. Upon approval from the IRB, the Company expects to submit its phase two feasibility application to the Drug Controller General of India (“DCGI”) for approval to conduct its AMI trial in India. The Company anticipates the DCGI to take approximately six months to complete its review of the Company’s clinical protocols and trial design.
The Acute Myocardial Rapid Stem Cell Therapy (“AMIRST II”) study is anticipated to be a randomized active control multi-center phase two feasibility study including approximately 40 patients with a 1:1 randomization. The primary endpoint for safety will be major adverse cardiovascular events (“MACE”) and the secondary endpoint for efficacy will be left ventricular ejection fraction (“LVEF”) changes.
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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:
SurgWerks(TM); 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
CellWerks(TM); a proprietary stem cell laboratory kit for the processing of target cells used in the treatment of oncological and hematological disorders.
The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
The MarrowXpress(R) (MXP); a derivative product of the AXP and its accompanying disposable bag set, for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood (RBC’s and plasma) from bone marrow (stem cells) to a user defined volume in 30 minutes while retaining over 90% of mononuclear cells (MNCs).
The Res-Q(TM) 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(R) 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 FDA approval, timing of the Company’s submission of IDE 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.
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