CESCA Management Provides Regulatory Update on Its Proposed U.S. Pivotal
Critical Limb Ischemia Clinical Trial
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,"
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
*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 processing and selection
*CellWerks^TM Platform, a proprietary stem cell laboratory kit for
processing target cells used in the treatments of oncological and
*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.
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.
CONTACT: Cesca Therapeutics Inc.
Contact: Investor Relations
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