Cardium Announces Patent Award For Rights To Cardiovascular Gene Therapy For The Treatment Of Heart Disease

 Cardium Announces Patent Award For Rights To Cardiovascular Gene Therapy For
                        The Treatment Of Heart Disease

Resolves Long-standing Competition with Boston Scientific Corporation Over
Rights to Cardiovascular Gene Therapy in the U.S. and Europe

PR Newswire

SAN DIEGO, Nov. 19, 2012

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.TylerM.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

Website: http://www.cardiumthx.com
Contact: Bonnie Ortega, Vice President - Corporate Communications, Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
 
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