Cesca Announces FDA Approval of IDE Supplement for Phase III Clinical Trial
January 05 2017 - 6:00AM
Cesca Therapeutics Inc. (NASDAQ:KOOL), a market leader in automated
cellular processing and point-of-care autologous cell-based
therapies, announced today that the Company received approval from
the U.S. Food and Drug Administration (FDA) for significant
revisions to the Company’s pivotal study for treatment of Critical
Limb Ischemia (CLI). The CLI clinical trial is designed to
demonstrate the safety and efficacy of the Company’s point-of-care
SurgWerks™ system for the treatment of CLI patients with limited or
no treatment options. The study was first approved by FDA in June
2015, but was not initiated at that time pending funding.
The changes approved by the FDA are intended to
increase patient enrollment by expanding the patient pool from
Rutherford Category 5 patients only, to also include Rutherford
Category 4 patients, or patients with a less severe form of the
disease. In addition, the study population has been expanded
to include patients who are poor candidates for either surgery or
endovascular therapies, as opposed to only those patients with no
viable treatment options. Finally, the FDA accepted to change the
control arm from a placebo, which was both invasive and carried
measureable safety risk, to a much less risky sham procedure.
Although the primary endpoint remains Amputation
Free Survival (AFS), a standard in all current CLI drug and
biologic trials, the FDA recognized the need to increase the
available patient population in order to properly power the
clinical trial. Compared to the initial study design, the
sample size was increased from 224 to 362 patients, which in turn
allowed the superiority margin to be reduced from 20% to 13%.
We believe that the reduced superiority margin is both achievable
and clinically relevant. Due to the increased patient pool, it is
expected that enrollment rates will be better than previous CLI
clinical trials.
Other improvements to the study include a
reduction in study-related testing, improved statistical methods,
and streamlined study oversight, all of which are intended to
reduce costs and improve patient recruitment and investigator
participation.
“We are pleased the FDA approved our IDE
supplement. The changes, especially expanding the patient
population and the improved statistical methods, allow us to strike
an important balance between patient enrollment rates, superiority
margin, cost and time”, said Dr. Xiaochun “Chris” Xu, Cesca’s
Interim CEO. “With this compelling trial design we look
forward to finding strategic partners to help develop and
commercialize the SurgWerks™ CLI system. We remain committed to
advancing our innovative point-of-care platforms and devices and
making Cesca the leading solution provider in the broader cell
therapy and healthcare space.”
About Cesca Therapeutics
Inc.Cesca Therapeutics Inc. (www.cescatherapeutics.com) is
engaged in the research, development, and commercialization of
cellular therapies and delivery systems 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 therapeutics. These include:
- The SurgWerks™ System (in development) - a
proprietary system comprised of the SurgWerks Processing Platform,
including devices and analytics, and indication-specific SurgWerks
Procedure Kits for use in regenerative stem cell therapy at the
point-of-care for vascular and orthopedic diseases.
- The CellWerks™ System (in development) - a
proprietary cell processing system with associated analytics for
intra-laboratory preparation of adult stem cells from bone marrow
or blood.
- The AutoXpress® System (AXP®) - a proprietary
automated device and companion sterile disposable for concentrating
hematopoietic stem cells from cord blood.
- The MarrowXpress™ System
(MXP™) - a derivative product of the AXP and its accompanying
sterile disposable for the isolation and concentration of
hematopoietic stem cells from bone marrow.
- The BioArchive® System - an automated
cryogenic device used by cord blood banks for the cryopreservation
and storage of cord blood stem cell concentrate for future
use.
- Manual bag sets for use in the processing and
cryogenic storage of cord blood.
Forward-Looking StatementThe
statements contained herein may include statements of future
expectations and other forward-looking statements that are based on
management’s current views, beliefs 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. These statements
include those concerning the effect of the changes approved by the
FDA as they relate to patient enrollment, safety risk, efficacy,
cost and achievability and those concerning the ability of the
Company to finding strategic partners for development and
commercialization. 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.
Company Contact: Cesca Therapeutics Inc.
ir@cescatherapeutics.com
Investor Contact: The Ruth Group
Lee Roth / Tram Bui
646-536-7012 / 7035
lroth@theruthgroup.com / tbui@theruthgroup.com
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