Cardium Completes Initial Patient Evaluation Period For MATRIX Phase 2b Excellarate Clinical Study
Gumbo
Excellarate Clinical Study
Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Aug 2009 - 1:00 PDT
Cardium Therapeutics (NYSE Amex: CXM) announced that all patients enrolled
in the Company's MATRIX clinical study have now completed their initial
12-week evaluation period and that it plans to provide detailed safety and
efficacy data in late September 2009.
The Phase 2b MATRIX clinical trial is a prospective, randomized,
double-blind, placebo-controlled study of Excellarate(TM) for the potential
treatment of chronic diabetic foot ulcers. The clinical study is designed to
evaluate safety and key efficacy measures including complete wound closure,
time to complete wound closure, absolute and percent change in ulcer area,
and wound healing trajectories at various time points, as well as a wide
range of other safety and comparative healing metrics which will be used to
develop a Phase 3 clinical study. In addition, following the initial 12-week
efficacy evaluation period, patients whose wounds have successfully closed
are now being followed for three months to further evaluate wound healing
durability.
"With the data set now complete for the initial 12-week evaluation period,
we look forward to completion of the formal statistical review and analysis
and, as previously reported, we expect to announce safety and efficacy data
around the end of September," stated Christopher J. Reinhard, Chairman and
Chief Executive Officer of Cardium Therapeutics. "During the course of this
landmark gene therapy trial, we have observed some remarkable healing
responses, based on a one or two physician-administered treatment protocol,
instead of current therapies which require multiple treatments by physicians
or patients either on a daily or weekly basis for up to 20 weeks. We look
forward to reviewing the MATRIX study's complete data set."
Observational Safety and Efficacy Insights
Based on a continuing review of safety information, the Excellarate product
candidate appears to be both safe and well-tolerated, with no serious
adverse events attributed to use of the study product.
With respect to efficacy, while the study remains blinded until all key data
are collected and fully analyzed, the Company and investigators are
encouraged by several observations related to wound healing in the enrolled
patient population. First, a number of study investigators have observed
very rapid reductions in ulcer area after initial treatment (whereas the
ulcers had not substantially reduced in size during a prior 2-week run-in
period that was used to screen all patients entering the study). These
findings are similar to what had been observed in the Phase 1/2 study.
In addition, the current blinded pooled data set, which includes patients
that received the Excellarate product candidate or standardized therapy
(placebo or standard of care) is also encouraging. In particular, based on a
comparative review of multiple, well documented protein-based wound healing
studies, three key efficacy measures: Wound Closure Incidence (percent of
patients achieving complete closure over time), Wound Closure Efficiency
(percent reduction in wound size), and Wound Closure Rate (wound closure
trajectories over time), all appear to be occurring at rates higher than
would be expected for patients receiving only standardized therapy.
If substantial differences in these key efficacy measures are confirmed in
the final unblinded data set, we would expect the data to form the basis for
a Phase 3 study designed to further demonstrate the safety and effectiveness
of Excellarate for the potential treatment of patients with non-healing
diabetic ulcers. In addition, as discussed recently, we believe that the
Gene Activated Matrix (GAM) technology used for Excellarate has the
potential to be applied to other types of wound and tissue repair settings,
including not only the potential treatment of other soft tissue injuries
such as pressure ulcers, but also hard tissue injuries such as those
associated with bone fractures and other orthopedic applications.
Innovative Advanced Care DNA-Based Therapy
Excellarate is an advanced care DNA-based biologic product candidate that is
being developed to provide physicians and patients with a potentially
simpler and easy to use treatment as compared to current therapies. Based on
the positive data from the Phase 1/2 study, the Company believes that the
Excellarate topical gel provides a unique opportunity to: (1) improve
patient compliance, based on a one- or two-treatment regimen, and (2)
enhance acceptance by the medical community due to improved ease of use (as
a pre-filled syringe, requiring only standard refrigeration and a 15-18
month shelf life), when compared to other treatment options. With this
targeted registration profile, Cardium believes that Excellarate offers the
unique potential to become an important new therapeutic class that, in
certain cases, may supplant the use of current healing agents and medical
devices, and, in other cases, may be used in concert with other agents and
current therapies in certain wounds and under various medical conditions
within an expanding spectrum of advanced wound care solutions.
About Excellarate and New Formulation Advancements
Excellarate is a collagen-based topical gel employing TRC's Gene Activated
Matrix(TM) that is designed to locally stimulate the release of
platelet-derived growth factor-B protein (PDGF-B), an important key in the
human body's wound healing process. Sustained, localized micro-release of
PDGF-B by a patient's own cells directly at the wound site is believed to
stimulate angiogenesis and granulation tissue formation through the
recruitment and proliferation of cells such as monocytes, fibroblasts and
endothelial cells. These cell types are critical for the effective
stimulation of a variety of wound healing processes.
The Excellarate product candidate is designed to require only one or two
physician-administered treatments, in contrast to most diabetic wound
healing agents or devices in use that require repeated administrations over
a long term (weeks to months). Based on recently announced advancements,
Excellarate will be re-formulated as an easy-to-use single syringe that is
pre-mixed and ready to be applied to patients' wounds. The reformulation
will allow Excellarate to be maintained in a physician's office using a
standard refrigerator (at a temperature of about 4 C) and is expected to
have a shelf life of 15-18 months.
Orthobiologics Initiative
Cardium recently announced its plans to develop a DNA-based orthobiologics
product portfolio based on research and development that will initially
focus on non-union bone fractures for medically-compromised patients, and
spinal fusions for patients with degenerative disc disease. Orthobiologics
is a rapidly growing segment of the orthopedics market and represents
biologically-active products designed to enhance musculo-skeletal repair and
regeneration. The initial orthobiologics focus will be on the development of
Osteorate(TM), a DNA-based non-surgical injectable bone graft gel to repair
bone fractures and regenerate tissue in certain medically-compromised
patient populations. Osteorate will be based on a reformulation of Cardium's
DNA-based Excellarate wound healing product candidate, which is designed to
stimulate localized and sustained cellular production of platelet-derived
growth factor-B (PDGF-B) protein, as a treatment for patients with
non-healing diabetic foot ulcers. The Gene Activated Matrix technology
allows for a broad spectrum of formulations which would include, but not be
limited to, collagen, demineralized bone matrices, allograft and synthetic
graft materials.
About Cardium
Cardium is focused on the acquisition and strategic development of new and
innovative bio-medical product opportunities and businesses that have the
potential to address significant unmet medical needs and definable pathways
to commercialization, partnering and other economic monetizations. Cardium's
investment portfolio includes the Tissue Repair Company and Cardium
Biologics, medical technology companies primarily focused on the development
of innovative therapeutic products for wound healing, bone repair, and
cardiovascular indications. In May 2009, Cardium announced completion of the
enrollment for the Matrix Phase 2b clinical study to evaluate the
Excellarate product candidate as a treatment for patients with non-healing
diabetic ulcers. In July 2009, Cardium completed the sale of its InnerCool
Therapies medical device business to Royal Philips Electronics, the first
asset monetization from the Company's biomedical investment portfolio.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this
press release are forward looking and reflect numerous assumptions and
involve a variety of risks and uncertainties, many of which are beyond our
control and may cause actual results to differ materially from stated
expectations. For example, there can be no assurance that the MATRIX study
or other human clinical trials can be conducted and completed in an
efficient and successful manner, that product formulation enhancements will
be successful or will effectively simplify or expand the use of product
candidates or technologies, that the GAM technology can be successfully
broadened or applied to additional wound healing or tissue repair
opportunities, that Excellarate or our other candidates will prove to be
sufficiently safe and effective, that results or trends observed in one
clinical study or procedure will be reproduced in subsequent studies or
procedures, that clinical studies even if successful will lead to product
advancement or partnering, that our products or product candidates will not
be unfavorably compared to competitive products that may be regarded as
safer, more effective, easier to use or less expensive, that FDA or other
regulatory clearances or other certifications, or other commercialization
efforts will be successful or will effectively enhance our businesses or
their market value, that our products or product candidates will prove to be
sufficiently safe and effective after introduction into a broader patient
population, or that third parties on whom we depend will perform as
anticipated.
Actual results may also differ substantially from those described in or
contemplated by this press release due to risks and uncertainties that exist
in our operations and business environment, including, without limitation,
risks and uncertainties that are inherent in the development of complex
biologics and in the conduct of human clinical trials, including the timing,
costs and outcomes of such trials, our ability to obtain necessary funding,
regulatory approvals and expected qualifications, our dependence upon
proprietary technology, our history of operating losses and accumulated
deficits, our reliance on collaborative relationships and critical
personnel, and current and future competition, as well as other risks
described from time to time in filings we make with the Securities and
Exchange Commission. We undertake no obligation to release publicly the
results of any revisions to these forward-looking statements to reflect
events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics(TM) and Generx((R)) are trademarks of Cardium
Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellarate(TM) and
Osteorate(TM) are trademarks of Tissue Repair Company.
Other trademarks are the property of their respective owners.
Source: Cardium Therapeutics
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