Lpath Initiates Dosing in First Proof-of-Concept Trial of Anti-Cancer Drug,
ASONEP Trial to Study Effects of Lpath's Anti-S1P Antibody in Subjects With
Renal Cell Carcinoma
SAN DIEGO, May 23, 2013 (GLOBE NEWSWIRE) -- Lpath, Inc. (Nasdaq:LPTN), the
industry leader in bioactive lipid-targeted therapeutics,has initiated dosing
in a Phase 2a single-arm trial where ASONEP™ is being investigated as a
treatment for renal cell carcinoma (RCC) in subjects that have failed the
standard of care treatment with FDA-approved agents that block VEGF signaling
(e.g. Sutent®/sunitinib maleate) and the mTOR pathway (e.g.
Sumanta Pal, M.D., from City of Hope, Duarte, California, dosed the first
ASONEP is a humanized antibody that binds to and neutralizes
sphingosine-1-phosphate (S1P). S1P is a bioactive lipid that has been
validated as a drug target in multiple sclerosis and that has been shown to
contribute to progression of several cancer types.
Many scientific publications have concluded that S1P is a tumorigenic and
angiogenic bioactive lipid that cancer cells use to escape therapy. In
collaboration with Rupal Bhatt, M.D., of Beth Israel Deaconess Medical Center,
Lpath has demonstrated that levels of S1P are upregulated in blood of subjects
with RCC. Moreover, Dr. Bhatt has demonstrated efficacy of Lpath's anti-S1P
antibodies in treating mice with human RCC tumors after they had failed
treatment with Sutent.
This current proof-of-concept Phase 2 trial follows the successful completion
of the ASONEP Phase 1 safety study. The Phase 1 study, conducted in subjects
with solid tumors, showed that ASONEP was well tolerated across all doses,
including the highest dose of 24 mg/kg.In addition, of the 21 subjects that
completed the initial four treatments in the Phase 1 study over a 5-week
period, 11 showed stable disease at the end of five weeks; eight had stable
disease at two months, six had stable disease at three months and two were
stable for longer than 12 months.
According to Datamonitor, there are currently about 225,000 new cases of renal
cell cancer worldwide each year, a figure that is projected to approach
300,000 by the year 2020.
The Phase 1 and Phase 2a clinical trials of ASONEP are partially funded by a
$3.0 million grant from the National Cancer Institute (NCI) under its Small
Business Innovation Research (SBIR) Program.
ASONEP, and its sister drug iSONEP™, are different formulations of
sonepcizumab, a first-in-class therapeutic antibody against S1P developed
using Lpath's ImmuneY2™ drug-discovery engine. Antibodies developed via this
discovery engine are designed to target bioactive signaling lipids, such as
S1P, that are involved in cancer, age-related macular degeneration (AMD),
inflammatory and auto-immune disorders, and other diseases.
Lpath is also conducting a clinical trial called Nexus, which is a four-arm,
double-blind Phase 2 study where iSONEP is being evaluated for safety and
efficacy in wet-AMD subjects. 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. As part of that agreement, Lpath
has granted to Pfizer a time-limited right of first refusal for ASONEP.
San Diego-based Lpath, Inc., a therapeutic antibody company, is the category
leader in lipid-targeted therapeutics. The company's ImmuneY2™ drug-discovery
engine has the unique ability to generate monoclonal antibodies that bind to
and inhibit bioactive lipids that contribute to disease. The Company is
developing three drug candidates: iSONEP™ is being studied in a Phase 2 trial
in wet AMD subjects; ASONEP™ is being studied in a Phase 2 trial in renal cell
carcinoma subjects; and Lpathomab is a preclinical drug candidate that holds
promise in pain, neurotrauma, and other diseases. For more information, visit
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 Phase 1
clinical trial may not be predictive of the results from the ongoing Phase 2
trial; 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 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.
CONTACT: Lpath, Inc.
Scott R. Pancoast
President & CEO
Lpath Investor Relations
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