Lpath Granted Key European Patent Related to iSONEP Drug Program

Wed Dec 5, 2012 8:31am EST

* Reuters is not responsible for the content in this press release.

  SAN DIEGO, CA, Dec 05 (Marketwire) -- 
Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive
lipid-targeted therapeutics, received official notification from European
Patent Office (EPO) that the company has been issued a key patent
covering monoclonal antibodies against sphingosine-1-phosphate (S1P),
including sonepcizumab(TM). S1P is a bioactive lipid that has been
validated as a target in multiple disease states.

    This newly granted patent, European patent No. 1 948 234, claims, among
other things, humanized monoclonal antibodies directed against S1P for
use in treating a wide range of ocular conditions, including age-related
macular degeneration (AMD), diabetic retinopathy and others.

    "This key patent provides exclusivity in Europe for our lead S1P program
in wet AMD in which dysfunctional angiogenesis, inflammation and scarring
contribute to disease progression," said Roger Sabbadini, Lpath's vice
president, founder, and inventor of the granted patent. "It also provides
us exclusivity in our pursuit of other ocular disorders where we believe
dysfunctional levels of S1P may be involved in pathogenesis of disease." 

    ASONEP(TM) and iSONEP(TM) are different formulations of sonepcizumab, a
first-in-class therapeutic antibody against S1P developed by Lpath's
ImmuneY2(TM) drug-discovery engine. Antibodies developed via this
discovery engine are designed to target bioactive signaling lipids, such
as S1P, that are involved in the proliferation and spread of cancer, AMD,
inflammatory and auto-immune disorders, and many other diseases.

    Lpath recently completed two early-stage clinical trials using the two
anti-S1P antibody formulations: iSONEP was evaluated in a Phase 1 trial
in wet-AMD subjects, and ASONEP was evaluated in a Phase 1 trial in
cancer subjects.

    Lpath has initiated a Phase 2 clinical trial for iSONEP, called Nexus,
which is evaluating the anti-S1P antibody's safety and efficacy in
wet-AMD patients. Lpath entered into an agreement with Pfizer (NYSE: PFE)
in 2010 that provides Pfizer an exclusive option for a worldwide license
to develop and commercialize iSONEP. 

    Lpath is also independently pursuing an ASONEP Phase 2 trial in renal
cell carcinoma and will open this trial soon. 

    Lpath was also recently granted a Russian patent (2009120052) and a U.S.
patent (8,222,373) with composition and methods claims relating to
sonepcizumab.

    About Lpath's Patent Portfolio
 Over the course of the company's
development, Lpath has achieved a broad and deep intellectual property
position in the bioactive-lipid area. The company's comprehensive patent
portfolio now includes 33 issued patents (including nine international)
and 109 patent applications (including 82 international). These patents
primarily relate to the use of reagents and methods designed to interfere
with the actions of bioactive lipids involved in human disease. Lpath's
intellectual property portfolio includes coverage of compositions of
matter that specifically bind to sphingolipids and sphingolipid
metabolites. These compositions, including antibodies, could be used in
the diagnosis and treatment of various diseases and disorders, including
cardiovascular and cerebrovascular disease, cancer, inflammation,
autoimmune disorders, ocular disease, and angiogenesis. 

    Lpath has also obtained issued patent claims on sphingolipid targets
(e.g., receptors and signaling sphingolipids) and methods for using such
targets in drug-discovery screening efforts. 

    The company believes that its patent portfolio provides broad and
commercially significant coverage of antibodies, receptors, enzymes, and
other moieties that bind to a lysolipid (or a sphingolipid metabolite)
for diagnostic, therapeutic, or screening purposes.

    About Lpath
 San Diego-based Lpath, Inc., a therapeutic antibody company,
is the category leader in lipid-targeted therapeutics, an emerging field
of medicine that targets bioactive signaling lipids for treating a wide
range of human disease. Lpath's ImmuneY2(TM) drug-discovery engine has
the unique ability to generate therapeutic antibodies that bind to and
inhibit bioactive lipids that contribute to disease. The company has
developed three drug candidates: iSONEP(TM) is currently in a Phase 2
trial for wet AMD; ASONEP(TM) will soon begin a Phase 2 trial in Renal
Cell Carcinoma patients; and Lpathomab is a preclinical drug candidate
that holds promise in neuropathic pain, neurotrauma, and other diseases.
For more information, visit www.Lpath.com.

    About Forward-Looking Statements
 The Company cautions you that the
statements included in this press release that are not a description of
historical facts are forward-looking statements. These include statements
regarding: the protection against competition afforded by issued patents;
the eventual commercial viability of the Company's drug programs; and the
Company's ability to complete additional discovery and development
activities for drug candidates utilizing its proprietary ImmuneY2 drug
discovery process. Actual results may differ materially from those set
forth in this press release due to the risks and uncertainties inherent
in the Company's business, including, without limitation: the outcome of
the final analyses of the data from the Phase 1 clinical trial may vary
from the Company's initial conclusions; the results of any future
clinical trials for iSONEP or ASONEP may not be favorable and the Company
may never receive regulatory approval for iSONEP or ASONEP or any of its
drug candidates; and the Company's may not be able to secure the funds
necessary to support its clinical trial and product development plans.
More detailed information about the Company and the risk factors that may
affect the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission, including
its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q
filed with the SEC. Such documents may be read free of charge on the
SEC's web site at www.sec.gov. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement and the Company undertakes no
obligation to revise or update this press release to reflect events or
circumstances after the date hereof. This caution is made under the safe
harbor provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995.

    

Lpath, Inc.
Scott R. Pancoast
President & CEO
(858) 926-3200
spancoast@Lpath.com

Lpath Investor Relations
Liolios Group, Inc. 
(949) 574-3860
lptn@liolios.com 
Ron Both: ron@liolios.com 
Geoffrey Plank: geoffrey@liolios.com

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