SAN DIEGO, Jan. 27, 2015 /PRNewswire/ -- Taxus Cardium
Pharmaceuticals Group (Symbol: CRXM) today announced a presentation
at the 2015 Phacilitate Annual Cell & Gene Therapy Forum in
Washington, DC. The review and
clinical update, entitled "Progress in Angiogenic Gene Therapy for
Coronary Artery Disease" was presented by the Company's Chief
Scientific Officer, Gabor M. Rubanyi, M.D., Ph.D.
Dr. Rubanyi outlined the current scientific knowledge about the
mechanistic basis of adaptive coronary collateral growth, the
biological processes that are targeted by therapeutic angiogenesis
discoveries and teachings based on Company-sponsored pre-clinical
and clinical research, and provided an update on the Generx
microvascular gene therapy Phase 3 international clinical
study. He reported that only about 20%-30% of patients with
coronary artery disease have well developed coronary collateral
networks, and independent clinical studies have confirmed that well
established collateral networks can reduce myocardial ischemia,
infarct size following a heart attack, and cardiovascular
mortality. Dr. Rubanyi further noted that the Company has
identified a range of patients with cardiac conditions and
syndromes, experiencing persistent myocardial-driven angina due to
cardiac microvascular insufficiency, who may also benefit from the
Generx microvascular therapy product candidate, despite the
etiology of their disease. The presentation is available for
viewing at
http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.
Generx Product Candidate
The Generx®, alferminogene tadenovec [Ad5FGF-4] Phase 3
product candidate, is a first in class, single-dose, disease
altering therapeutic, specifically targeted for the cardiac
micro-vasculature, that is designed to leverage cardiac plasticity
to endogenously initiate the formation of new biologic coronary
structures of patients with cardiac microvascular insufficiency
(CMI) and coronary artery disease. This process is believed to
increase the level of micro-vascularity, to enhance cardiac
perfusion, and improve cardiac performance, as measured by exercise
tolerance and the occurrence and severity of myocardial
ischemia-driven angina. The Generx microvascular therapy is
designed to easily fit within the current practice of medicine, as
a single-dose treatment, which is administered by an interventional
cardiologist using standard cardiac catheters during an
approximately one-hour, out-patient, angiogram-like procedure,
which is conducted in a hospital or medical center.
The Company's proprietary Generx angiogenic gene therapy
technology platform is being developed for treatment of specific
subgroup patient populations with coronary artery disease, as well
as for patients with orphan medical indications, all of which have
myocardial ischemia due to CMI and experience persistent
symptomatic angina pectoris despite maximum doses of currently
available medications, and who are not optimal candidates for
surgical and percutaneous interventions. These subgroups
include patients who have been diagnosed with (1) progressive
coronary artery disease and who have reached clinically defined
stages in their disease cycle; (2) "female pattern" angina; (3)
Cardiac Syndrome X; and (4) certain orphan medical indications
including variant anginas like Prinzmetal's angina.
The Science & Biology of Ad5FGF-4
The Generx [Ad5FGF-4] angiogenic gene therapy product candidates
are comprised of three key elements that include (1) a myocardial
delivery vector; (2) a therapeutic transgene and (3) proprietary
methods of gene therapy. The Generx [Ad5FGF-4] product candidate is
a gene therapy construct that utilizes an adenovirus serotype 5
delivery vector that is replication-deficient, non-integrating and
drives short-term transient expression of the Fibroblast Growth
Factor-4 (FGF-4) transgene. Generx is designed to stimulate
the body's natural healing response to ischemic coronary artery
disease by promoting microvascular angiogenesis and arteriogenesis,
and enhancing cardiac perfusion. Adenovirus is the most
studied and well-characterized, gene therapy delivery vector, and
has cGMP manufacturing and testing standards established by the
FDA. When administered by an interventional cardiologist into the
coronary arteries under transient ischemic conditions through the
use of a standard balloon catheter, Generx distributes into the
heart's microvascular pathways and transfects heart cells by
binding to cell surface coxsackievirus-adenovirus receptors (CAR).
CAR receptors are found throughout the heart, and the binding of
Generx to CAR receptors is enhanced by the induction of transient
ischemia and the use of agents like nitroglycerin to boost cell
permeability during administration.
The transfected heart cells then express and release FGF-4
protein, which promotes the growth of new blood vessels that
increase blood flow to ischemic heart tissue. In addition,
the Generx FGF-4 transgene has been modified to include a signal
peptide, which allows its effective secretion from cells that
express the protein (such as cardiac myocytes). The Company's
preclinical studies showed that therapeutic efficacy is
significantly increased by the presence of such a signal sequence
in the growth factor DNA construct. This finding is explained by
the fact that FGF-4 acts in a paracrine manner (i.e. it is released
from target cells and acts on neighboring cells to stimulate new
vessel formation in the heart).
Company-sponsored pre-clinical research has demonstrated
localized FGF-4 protein expression in the heart following Generx
administration, and shown that pre-existing antibodies to the
adenovector have no significant impact on treatment effect. Recent
Company-sponsored research studies have also shown that FGF is a
key angiogenic regulatory protein that stimulates the release and
action of other angiogenic factors, including vascular endothelial
growth factors (VEGF), platelet-derived growth factors (PDGF), and
hepatocyte growth factor (HGF), to orchestrate and promote the
growth of cardiac microvasculature (a functional collateral
network) in ischemic cardiac tissue. Research indicates that the
Generx angiogenic gene therapy product candidate has the capacity
to enlarge pre-existing collateral arterioles (arteriogenesis) and
to form new capillary vessels (angiogenesis) when driven by cardiac
hemodynamic-impairment and ischemic stimulus.
Generx® ASPIRE Phase 3 Clinical Update
The ASPIRE study is a 100-patient, randomized and controlled
multi-center study currently enrolling patients at up to eight
leading international cardiology centers. The ASPIRE study is
designed to further evaluate the safety and effectiveness of
Cardium's Generx DNA-based angiogenic product candidate, which has
already been tested in clinical studies involving 650 patients at
more than one hundred medical centers in the U.S., Europe and elsewhere. The efficacy of
Generx is being quantitatively assessed using rest and stress SPECT
(Single-Photon Emission Computed Tomography) myocardial imaging to
measure improvements in microvascular cardiac perfusion following a
one-time, non-surgical, catheter-based administration of
Generx. The Cedars-Sinai Medical Center Nuclear Cardiology
Core Laboratory in Los Angeles,
California, is the central core lab for the study and is
responsible for the analysis of SPECT myocardial imaging data
electronically transmitted from the international medical centers
participating in the ASPIRE study.
In June 2014, the Company
announced data from an interim analysis from the current
International Clinical Study. The interim analysis from the ASPIRE
study showed that the Generx product candidate, together with
Cardium's new catheter-based delivery protocol, appears to be safe
and well tolerated. In addition, statistically significant
improvement in myocardial perfusion was identified by the efficacy
endpoint of SPECT imaging. The SPECT studies were evaluated by the
Los Angeles-based Nuclear
Cardiology Core Laboratory at Cedars-Sinai Medical Center, the
study's central analytical core lab. At eight weeks, Generx
treatment resulted in a 24% improvement in RPDS, a statistically
significant response compared to the control group (p=0.01, n=11).
The observed improvement in RPDS with Generx in the ASPIRE trial is
consistent with RPDS improvement previously reported in the Generx
AGENT Phase 2 clinical study (n=52) [Grines et al., J Am Coll
Cardiol. 2003; 42:1339-47]. Improvement in RPDS was observed in 77%
of patients in the AGENT-2 study, and 86% of the patients from the
interim ASPIRE data analysis, giving a pooled response rate of 79%.
Furthermore, the improvements in RPDS reported in both the ASPIRE
and AGENT clinical studies are similar in magnitude to large vessel
revascularization procedures, either bypass surgery or angioplasty
(PCI), involving the right coronary artery (RCA), the left anterior
descending artery (LAD) and the left circumflex artery (LCx), as
reported in patients undergoing these procedures [Berman et al., J
Nucl Cardiol. 2001; 8:428-37].
In addition, since the International Clinical Study and the
AGENT-2 perfusion studies were intentionally designed using the
same primary quantitative functional efficacy endpoint of RPDS at
the same 8 week interval after a single Generx administration, and
both studies were independently statistically significant, Cardium
has conducted a pooled analysis of the SPECT results. This
additional data analysis of the interim ASPIRE data with the AGENT
Phase 2 study data shows that patients treated with Generx have a
25% improvement in RPDS that is also statistically significant
compared to the pooled control groups (p=0.005, n=63).
Taxus Cardium Pharmaceuticals Group
Taxus Cardium Pharmaceuticals Group Inc. is a holding company
that operates Cardium Therapeutics, a development stage advanced
regenerative therapeutics company focused on the late-stage
clinical and commercial development of regenerative medicine
therapeutics that includes: (1) Angoinetics, a business unit
focused on the clinical and commercialization of
Generx®, an interventional cardiology, angiogenic gene
therapy product candidate designed for the potential treatment of
patients with cardiac microvascular insufficiency and myocardial
ischemia due to advanced coronary artery disease; and (2)
Activation Therapeutics, a business unit focused on the
commercialization of Excellagen®, an FDA-cleared
flowable dermal matrix designed as a professional-use advanced
wound care product for the treatment of chronic non-healing
diabetic foot, venous and pressure ulcers, which also has
additional potential tissue regeneration applications based on stem
cells and other biologics (www.excellagen.com). In November 2014, the Company reported the formation
of Angionetics and Activation Therapeutics to facilitate the
independent monetization of Generx and Excellagen. For more
information about Taxus Cardium, visit the Company's website
www.cardiumthx.com.
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 expectations. For example, there can be no
assurance that results or trends observed in one clinical study or
procedure will be reproduced in subsequent studies or in actual
use; that new clinical studies will be successful or will lead to
approvals or clearances from health regulatory authorities, or that
approvals in one jurisdiction will help to support studies or
approvals elsewhere; that the company can attract suitable
commercialization partners for our products or that we or partners
can successfully commercialize them; that our product 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 or blocked by third party proprietary rights or
other means; that the products and product candidates referred to
in this report or in our other reports will be successfully
commercialized and their use reimbursed, or will enhance our market
value; that new product opportunities or commercialization efforts
will be successfully established; that third parties on whom we
depend will perform as anticipated; that we can raise sufficient
capital from partnering, monetization or other fundraising
transactions to maintain our stock exchange listing or adequately
fund ongoing operations; or that we will not be adversely affected
by these or other risks and uncertainties that could impact our
operations, business or other matters, as described in more detail
in our filings 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 2015 Taxus Cardium Pharmaceuticals
Group Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit
www.cardiumthx.com.
Cardium
Therapeutics®,
Generx®, Cardionovo®,
Tissue Repair™, Excellagen®, Excellarate™,
Genedexa™, and LifeAgain™, are trademarks of Cardium Therapeutics,
Inc., Tissue Repair Company or LifeAgain Insurance Solutions Inc.
Other trademarks belong to their respective owners.
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