SAN DIEGO, May 11, 2015 /PRNewswire/ -- Angionetics Inc., a
majority-owned subsidiary of Taxus Cardium Pharmaceuticals Group
Inc. (Trading Symbol: CRXM), announced today that it will be a
featured presenter at the 4th Annual 2015 Marcum MicroCap
Conference on Wednesday, May 27, 2015
in New York City at the Grand
Hyatt Hotel. The Company's presentation, which will be made by the
CEO of Angionetics, Chris Reinhard,
will cover recent business and Generx® clinical development
activities. A copy of the presentation is now available on
the Angionetics website (www.angionetics.com). The annual Marcum
MicroCap Conference is a signature showcase focused on introducing
investors to superior, undiscovered companies with market
capitalizations under $500
million.
About Angionetics Inc.
The newly-formed Angionetics Inc., which is a majority-owned
subsidiary of Taxus Cardium Pharmaceuticals Group, is an
angiogenesis gene therapy company focused on the development and
commercialization of novel DNA-based therapeutics that are designed
to promote the heart's innate natural capacity to modulate the
formation and growth of cardiac microvascular circulation to
enhance blood flow (perfusion) in patients with a variety of
ischemia-driven disease conditions and refractory angina and
myocardial ischemia due to cardiac microvascular insufficiency
(CMI), and other cardiovascular disease conditions.
On April 13, 2015,
Angionetics reported that it entered into an agreement to sell a
15% stock equity interest for an aggregate purchase price of
$3,000,000, payable in three tranches
to be completed by May 30,
2015. The agreement contemplates that this initial funding is
a bridge equity investment to a separate larger financing to be
conducted by Angionetics Inc. including a potential registration
and public offering of securities. The proceeds from this
Angionetics equity investment will be used to advance the
international and United States Phase 3 clinical studies of Generx,
for working capital, and transactional expenses to facilitate
current plans to advance Angionetics forward as an independent
company with direct access to capital markets and strategic
partnerships.
In addition, on April 7, 2015,
Taxus Cardium and Angionetics announced an exclusive territorial
license agreement with Dr. Reddy's Laboratories covering the
co-development, marketing and sales of Generx in certain
international markets including the Russian Federation and the Commonwealth of
Independent States. Positive safety and efficacy findings from the
Company's Generx international Phase 3, Russia-based ASPIRE study were announced at
the Annual 2014 Biotechnology Industry Organization Conference
following completion of a protocol-specified interim data
analysis. Dr. Reddy's Laboratories operates across the
globe. Major markets include the
United States, India and
Russia.
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
microvasculature, that is designed to leverage cardiac plasticity
to stimulate and augment the formation of new coronary structures
in 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 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 endothelial 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 further indicates
that the Generx angiogenic gene therapy product candidate has the
capacity to enlarge pre-existing collateral arterioles
(arteriogenesis) and to stimulate the formation of 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 enrolling patients at 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. At eight weeks, Generx treatment
resulted in a 24% improvement in Reversible Perfusion Defect Size
(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
U.S.-based FDA-cleared 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 manages and operates the following investments: (1)
Angionetics, a majority-owned business unit focused on the clinical
development and commercialization of Generx®, an
interventional cardiology, angiogenic gene therapy Phase 3 product
candidate designed for the potential treatment of patients with
cardiac microvascular insufficiency and myocardial ischemia due to
advanced coronary artery disease (www.angionetics.com); (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; (3) LifeAgain, an advanced medical data
analytics (ADAPT®)technology platform focused on developing new and
innovative products for the life insurance and healthcare sectors
(www.lifeagain.com); and (4) Healthy Brands Collective, a
functional food and nutraceutical company which acquired Taxus
Cardium's To Go Brands® business (www.healthybrandsco.com). 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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SOURCE Taxus Cardium (CRXM)
