Cardium Announces Patent Award For Rights To Cardiovascular Gene
Therapy For The Treatment Of Heart Disease
SAN DIEGO, Nov. 19, 2012 /PRNewswire/ -- Cardium
Therapeutics (NYSE MKT: CXM) today announced a winning patent
decision in Europe and successful
resolution of a long-standing competition between Cardium and its
licensor the University of California, and Boston Scientific Corporation
(NYSE: BSX) and its licensor Arch Development, over rights to key
methods for the application of cardiovascular gene therapy to the
treatment of coronary heart disease, as is employed in Cardium's
Generx® gene therapy candidate currently in late-stage
clinical studies. Following a decision by the European Patent
Office, Cardium's patent portfolio now includes allowed and issued
patents covering its gene therapy approach both in Europe and in the
United States, with competing patent applications licensed
and pursued by Boston Scientific having been successfully overcome
in both Europe and the U.S.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
The competing patent applications licensed by Boston Scientific
Corporation had been filed by Dr. Jeffrey
Leiden et al., currently President & CEO of Vertex
Pharmaceuticals, and had been the subject of opposition proceedings
in Europe and interference
proceedings in the United States,
both of which were ultimately resolved in favor of Cardium.
Following resolution of the opposition proceedings and further
examination of Cardium's case, the European Patent Office has now
approved Cardium's patent application for grant in Europe. Three corresponding U.S. Patents that
had been challenged by Boston Scientific Corporation (in decisions
that were appealed to the United
States Court of Appeals for the Federal Circuit), have been
affirmed in Cardium's favor.
Cardium has additional patents and patent applications directed
to its methods of cardiovascular gene therapy in the U.S.,
Europe, Russia and elsewhere, and the company recently
filed new patent applications directed to certain improved
techniques for the treatment of heart disease that are currently
the subject of a Phase 3 registration trial based in Moscow, which is designed to generate
additional safety and effectiveness data for the Russian Federation and other jurisdictions.
Generx® (alferminogene tadenovec) is intended to
stimulate the growth of collateral blood vessels to effectively
bypass coronary artery atherosclerotic blockages without the need
for surgical procedures or angioplasty and stents; and its safety
and effectiveness have been the subject of clinical studies
involving more than 650 patients in the U.S., Europe and elsewhere. Generx has been assigned
the trade name Cardionovo™ for planned commercialization in the
Russian Federation. Cardium
believes that its Generx clinical database represents the largest
and most complete gene therapy dossier – and is directed to a major
medical indication that is a leading cause of death throughout the
developed world.
"The resolution of these important reviews of our gene therapy
patents, and the consistent decisions in our favor including
rulings by the U.S. courts of appeal, underscore the value of our
patent portfolio, which we believe reflects a breakthrough approach
to the treatment of coronary heart disease," said
Dr. Tyler M. Dylan-Hyde, Chief Business Officer and
General Counsel of Cardium Therapeutics.
Recently-published findings demonstrate that Cardium's
innovative technique employing transient cardiac ischemia can be
used to dramatically enhance gene delivery and transfection
efficiency after one-time intracoronary administration of
adenovector in mammalian hearts. Two consecutive but brief periods
of coronary artery occlusion combined with co-administration of
nitroglycerin increased both adenovector presence (measured by PCR)
and transgene expression (assessed by luciferase activity) by over
two orders of magnitude (>100 fold) in the heart, as compared to
prior intracoronary artery delivery methods.
The research results published in Human Gene Therapy
Methods extend those findings and demonstrate that Cardium's
new technique for adenovector gene delivery in the heart can be
used to dramatically boost adenovector delivery. By enhancing
uptake even in patients with less severe forms of disease and
ischemia, it would be expected to reduce response variability and
allow for the potential treatment of patients with a broader range
of associated coronary artery disease. The new treatment protocols
for Cardium's recently-initiated ASPIRE clinical study have been
developed to use this improved knowledge about induced transient
ischemia techniques to enhance the non-surgical, catheter-based
delivery of Generx to the heart.
Cardium has also been actively advancing its Generx product
candidate's engineering and process technology in preparation for
commercialization. The Company successfully
transferred a refined, improved and fully-validated manufacturing
process to SAFC®, the custom manufacturing and services
business unit of Sigma-Aldrich Corporation (NASDAQ: SIAL), a top
global specialty chemicals and biologics supplier, located in
Carlsbad, California. As a
result of the rigorous technical transfer process, important
process improvements were achieved enabling much higher
manufacturing process yields. Generx's long-term product
stability has been established at a minimum of six years making it
possible to manufacture product in large, cost effective batch
sizes. The dose preparation process for Generx has been
simplified through the integration of a fully-validated,
closed-system drug transfer process incorporating the use of
PhaSeal® System passive safety technology to streamline
and simplify the cath-lab preparation and eliminating the need to
prepare Generx in a sterile, biological safety hood. The
Company has also developed a new and unique, fully-validated
bio-activity release assay to measure and evaluate the
pro-angiogenic potency of each newly manufactured batch of
Generx.
The European Commission's recent approval of uniQure's
Glybera® (alipogene tiparvovec) – the first gene therapy
approval by a major health regulatory authority – is considered to
represent a significant milestone and validation for the gene
therapy industry.
About Generx and the ASPIRE Study
Generx (Ad5FGF-4) is a disease-modifying regenerative medicine
biologic that is being developed to offer a one-time, non-surgical
option for the treatment of myocardial ischemia in patients with
stable angina due to coronary artery disease, who might otherwise
require surgical and mechanical interventions, such as coronary
artery by-pass surgery or balloon angioplasty and stents.
Similar to surgical/mechanical revascularization approaches, the
goal of Cardium's Generx product candidate is to improve blood flow
to the heart muscle – but to do so non-surgically, following a
single administration from a standard balloon angioplasty
catheter. The video "Cardium Generx Cardio-Chant" provides an
overview Generx and can be viewed at
http://www.youtube.com/watch?v=pjUndFhJkjM.
In March 2012, Cardium reported on
the ASPIRE Phase 3 registration study to evaluate the therapeutic
effects of its lead product candidate Generx in patients with
myocardial ischemia due to coronary artery disease. The ASPIRE
study, a 100-patient, randomized and controlled multi-center study
to be conducted at up to eight leading cardiology centers in the
Russian Federation, 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 will be quantitatively assessed using rest and stress SPECT
(Single-Photon Emission Computed Tomography) myocardial imaging to
sensitively measure improvements in microvascular cardiac perfusion
following a one-time, non-surgical, catheter-based administration
of Generx. A recent article, "Cardium's Heart Disease Gene
Therapy Advancing with New Discoveries", outlining the history of
the Generx clinical development program is available at
http://sandiegobiotechnology.com/topics/4705/cardiums-heart-disease-gene-therapy-moving-toward-commercialization/.
About
Cardium
Cardium is an asset-based health sciences and regenerative
medicine company focused on the acquisition and strategic
development of innovative products and businesses with the
potential to address significant unmet medical needs and having
definable pathways to commercialization, partnering or other
economic monetizations. Cardium's current portfolio includes the
Tissue Repair Company, Cardium Biologics, and the Company's
newly-acquired To Go Brands® healthy nutraceutical
supplement business. The Company's lead commercial product
Excellagen® topical gel for wound care management has
received FDA clearance for marketing and sale in the United
States. Cardium's lead clinical development product candidate
Generx® is a DNA-based angiogenic biologic intended for
the treatment of patients with myocardial ischemia due to coronary
artery disease. To Go Brands
develops, markets and sells dietary supplements through established
regional and national retailers. In addition, consistent with
its capital-efficient business model, Cardium continues to actively
evaluate new technologies and business opportunities. News from
Cardium is located at 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 stated expectations. For example,
there can be no assurance that our intellectual property will be
effectively enforceable or that rights to commercialize our
products will not be challenged by others; that enhancements in the
uptake of adenovectors can be successfully applied to improve the
uptake, applicability or therapeutic effects of Generx in human
patients; that Generx can be successfully advanced in clinical
studies outside of the U.S.; that results or trends observed in one
clinical study or procedure will be reproduced in subsequent
studies or procedures, or that clinical studies even if successful
will lead to product advancement or partnering; that improvements
in the formulation or use of Generx will be commercially
practicable, or that Generx could be successfully advanced as a
therapeutic in developing markets or that the results of studies in
such markets could be used to advance or broaden the regulatory or
commercialization activities of Generx in the U.S. or other
markets; that the ASPIRE clinical study will be successful or will
lead to approval of Generx by the Russian Health Authority for
marketing and sales in Russia or
lead to approvals in other countries of the Commonwealth of
Independent States; that additional clinical evidence regarding the
safety and effectiveness of Generx that might be obtained in
Russia would be useful for
optimizing and broadening commercial development pathways in other
industrialized countries; 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 2012 Cardium Therapeutics, Inc. All rights
reserved.
For Terms of Use Privacy Policy, please
visit www.cardiumthx.com.
Cardium Therapeutics®,
Generx®, Cardionovo™, Tissue Repair™, Gene
Activated Matrix™, GAM™, Excellagen®,
Excellarate™, Osteorate™, MedPodium®,
Appexium®, Linée®,
Alena®, Cerex®, D-Sorb™,
Neo-Energy®, Neo-Carb Bloc®,
Neo-Chill™, and Nutra-Apps® are
trademarks of Cardium Therapeutics, Inc. or Tissue Repair
Company.
To Go Brands®, Acai
Natural Energy Boost™, Green Tea Energy Fusion™, Trim
Energy®, Healthy Belly®,
Smoothie Complete®, High
Octane®, VitaRocks®, Trim Green Coffee
Bean™ and Glucoberry™ are trademarks of To Go Brands,
Inc.
(Other trademarks belong to their respective
owners)
SOURCE Cardium Therapeutics