Cesca Submits IDE Supplement for CLI Pivotal Trial
December 05 2016 - 6:00AM
Cesca Therapeutics Inc. (NASDAQ:KOOL), a market leader in automated
cellular processing and point-of-care autologous cell-based
therapeutics, today announced that on November 21, 2016 the Company
has submitted an Investigational Device Exemption (IDE) Supplement
to the U.S. Food and Drug Administration (FDA) for its previously
approved pivotal trial. The study is designed to demonstrate the
safety and effectiveness of the Company’s point-of-care, SurgWerks™
system, in the treatment of late stage, “no-option” and
“poor-option”, CLI patients. The Company expects the FDA to submit
its response to the IDE supplement within 30 days from submission.
“This IDE supplement is the result of extensive
review of current literature, as well as discussions with
independent advisors, key opinion leaders and the FDA. After
taking everything into consideration, from scientific to clinical
to reimbursement, we believe that amputation free survival, a hard
clinical end-point, gives us the best chance for a successful
pivotal CLI trial outcome, pre-marketing approval (PMA), and path
to commercialization,” said Dr. Xiaochun “Chris” Xu, Cesca’s
Interim Chief Executive Officer. “We remain dedicated to the
development of safe and effective point-of-care autologous cell
therapies, with CLI being just one of Cesca’s many opportunities in
the space. We have several other vascular and orthopedic
cellular therapies in our pipeline and are committed to opening up
multiple clinical avenues to unlock the immense value and drive the
success of the Company.”
Designed to demonstrate the safety and efficacy
of the Company’s point-of-care SurgWerks™ system, the revised Phase
III trial design will focus on the difference in AFS measured over
12 months between a treatment arm and a sham control arm. The
general design of the study will include 1:1 randomization with a
12 month follow-up program. The estimated sample size needed to
successfully demonstrate safety and a statistically powered
efficacy result is 362 patients (181 patients in the treatment arm
and in the sham control arm, factoring in an estimated dropout rate
of 10%).
The supplement also details changes to the
protocol designed to improve patient enrollment. These include
expanding the cohort to include both “no option” and “poor option”
Rutherford Category 4 and 5 CLI patients, using a sham control arm
vs placebo, restricting severe diabetic R5 subjects, and
stream-lining follow-up procedures.
The trial also includes clinically significant
secondary endpoints, such as wound healing and improvement in rest
pain, designed to show quality-of-life improvements, which are
relevant to receiving reimbursement approval from The Centers for
Medicare and Medicaid Services (CMS).
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, including
statements concerning Cesca Therapeutics’ ability to demonstrate
safety and efficacy of its CLI therapy from its clinical study, the
timing of the FDA’s response to the IDE supplement, the ability to
successfully develop any particular therapy, and the receipt of any
related reimbursement approval, all of which 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.
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
Cesca Therapeutics (NASDAQ:KOOL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cesca Therapeutics (NASDAQ:KOOL)
Historical Stock Chart
From Sep 2023 to Sep 2024