MARKET WIRE
The strength of recent pre-clinical data has
given Lpath, Inc. (OTCBB: LPTN) a broader vision for its lead drug
candidate, sonepcizumab, in the ophthalmic arena. As recognized category
leader in therapeutic agents against bioactive lipids, Lpath now considers
sonepcizumab as a potential treatment for a broad range of ocular diseases
that extend well beyond "wet" Age-related Macular Degeneration (AMD).
Results of Lpath's ocular discovery program suggest that sonepcizumab may
be a valuable therapeutic in the treatment of diabetic retinopathy, dry
AMD, uveitis, and scar formation that results in the failure of a
significant percentage of glaucoma-related surgery.
Lpath previously announced that sonepcizumab (the humanized version of
Sphingomab(TM)) mitigated almost completely the choroidal
neovascularization (CNV) formation in mice with laser-induced choroidal
damage, which mimics the pathologic angiogenesis (new blood-vessel
formation) experienced by patients with the wet form of AMD. As a result,
the company is planning to file an IND ("investigational new drug")
application with the FDA in 2008 for use of sonepcizumab in wet AMD
patients.
Recent studies suggest, however, that sonepcizumab is much more than a
potent inhibitor of pathologic ocular angiogenesis. Other beneficial
therapeutic effects of sonepcizumab in ocular applications include:
-- Anti-permeability: In a recent animal model of AMD whereby the
Bruch's membrane was ruptured via laser, sonepcizumab strongly inhibited
vascular leakage.
-- Anti-fibrosis (reduced collagen scar formation): In recent studies,
Lpath first demonstrated that S1P (the bioactive lipid that sonepcizumab
binds to and inhibits) promotes collagen deposition (scarring) in numerous
ocular cell types and, moreover, that S1P strongly promotes the subretinal
fibrosis that is associated with AMD. Consequently, the company examined
the effects of sonepcizumab on subretinal fibrosis following laser rupture
of Bruch's membrane and showed the drug candidate significantly attenuated
collagen deposition within the CNV lesion area, resulting in a greater than
three-fold decrease at the 28-day time-point. It is important to note that
none of the currently available treatments for wet AMD strategies
demonstrates an ability to inhibit subretinal fibrosis.
-- Anti-inflammatory (reduced macrophage infiltration): Lpath recently
conducted models of ischemic retinopathy characterized by abnormal blood-
vessel growth and demonstrated that sonepcizumab resulted in not only a
marked inhibition of pathologic retinal angiogenesis but also a dramatic
anti-inflammatory effect, as evidenced by a reduction in macrophage
recruitment of over 80%.
This combination of mechanisms of action is potent and provides Lpath with
a wide range of opportunities in the ophthalmology arena, as follows:
-- Lpath is now positioned extremely well in wet AMD: The three
additional modes of action described above confirm the ability of
sonepcizumab to mitigate multiple etiologies of wet AMD and suggest that
sonepcizumab may have significant therapeutic advantages over singly
targeted methods of treatment, such as anti-VEGF compounds.
-- Lpath may be first-to-market with a solution to decrease the failure
rates of glaucoma filtration surgery: Almost one-third of trabeculectomy
and valve implantation surgeries fail due to scarring that forms at the
point of intervention. With its anti-fibrotic mechanism, sonepcizumab could
be used before, during, and/or after surgery to prevent such scarring. This
is currently an unmet need in ophthalmology.
-- Sonepcizumab's profound ability to inhibit the recruitment of
macrophages may make it a valuable therapeutic agent for the treatment of
dry AMD: The incidence of dry AMD is nearly nine times that of wet AMD,
and yet there is no treatment available beyond vitamin and mineral
supplements.
-- Sonepcizumab might have distinct competitive advantages in diabetic
retinopathy: Inflammation appears to play a key role in the pathogenesis
of diabetic retinopathy. Given sonepcizumab's best-in-class anti-
inflammatory results, Lpath hopes to offer therapeutic promise to patients
with diabetic retinopathy where there is currently no treatment available.
"This is exciting and novel research in the ophthalmology arena," said
Glenn L. Stoller, M.D., head of Lpath's ocular therapies division, "as the
presence and the effects of bioactive lipids in the eye was a complete
unknown until just recently."
Added Scott R. Pancoast, Lpath's president and CEO, "Sonepcizumab has shown
to be, at least in animal models, its own combination therapy. This has
created a broad spectrum of opportunity and positions Lpath extremely well
to be a leader in ophthalmology."
Sonepcizumab is a monoclonal antibody against S1P, an innovative target in
cancer and in retinal pathology. It was the first monoclonal antibody ever
developed against any lysolipid, an extremely important subcategory of
lipids.
About Lpath:
Lpath, Inc., headquartered in San Diego, California, is the category leader
in lipidomics-based therapeutics, an emerging field of medical science
whereby bioactive signaling lipids are targeted for treating important
human diseases. ASONEP(TM) (the systemic formulation of sonepcizumab) is an
antibody against S1P that holds promise for the treatment of cancer and
other diseases. A second product candidate, iSONEP(TM) (the ocular
formulation of sonepcizumab), has demonstrated superior results in various
preclinical AMD and retinopathy models. Lpath's third product candidate,
Lpathomab(TM), is an antibody against LPA, a key bioactive lipid that has
been long recognized as a valid disease target. The company's unique
ability to generate novel antibodies against bioactive lipids is based on
its ImmuneY2(TM) drug-discovery engine, which the company is using to add
to its pipeline. For more information, visit www.Lpath.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 required clinical
trials will be successful, necessary regulatory approvals will be obtained,
or the proposed treatments will prove to be safe or effective. 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, our limited experience in the development of therapeutic drugs,
our dependence upon proprietary technology, our history of operating losses
and accumulated deficits, our reliance on research grants, current and
future competition, and other risks described from time to time 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.