Positive phase-1 clinical trial results for ISONEP in AMD
MyVisionTest
clinical trial of iSONEP, an anti-sphingosine-1-phosphate monoclonal
antibody, in neovascular age-related macular degeneration (AMD)
patients.
iSONEP met its primary endpoint of being well tolerated in all 15
patients at dose-levels ranging from 0.2 mg. to 1.8 mg. per
intravitreal injection (three patients per dose level). No
drug-related serious adverse events were reported in any of the
patients.
iSONEP also succeeded in meeting a key secondary endpoint in that a
positive biological effect was observed in an encouraging number of
patients.
iSONEP is the ocular formulation of a monoclonal antibody that targets
sphingosine-1-phosphate (S1P), a bioactive lipid that is dysregulated
in cancer and other disorders of inappropriate angiogenesis and
inflammation. S1P promotes angiogenesis, inflammation, cell survival,
and cell proliferation, all of which have been implicated in AMD.
The most significant benefit observed was a regression in choroidal
neovascularization (CNV). Of the seven patients that had a baseline
lesion that was considered "large," four experienced a reduction
exceeding 5 mm2 and three experienced a reduction of greater than 75%
-- all with a single dose of iSONEP. This type of clinical benefit is
not seen with anti-VEGF therapy. Even with repeated Lucentis dosing,
the total physical size of CNV lesion does not show much reduction.
Another distinctive benefit was the resolution of retinal pigmented
epithelium (RPE) detachment. Of two patients that were diagnosed with
RPE detachment in the Phase 1 trial, both experienced complete or
near-complete resolution of the condition -- again, with only a single
dose of iSONEP.
A key observation was that all of the patients with occult-type CNV
exhibited a strong positive biological effect during the 30-45 days
following a single injection of iSONEP. This correlation has
significant implications for Lpath's Phase II study design.
The fact that these biological effects are non-overlapping vis-a-vis
those of Lucentis and Avastin is significant. Lucentis and Avastin
target the protein VEGF, a promoter of permeable and leaky blood
vessels, and appear to exert most of their beneficial effect via an
anti-permeability action that results in resolution of intra and
sub-retinal edema. However, the actual CNV lesion does not typically
regress.
In contrast, iSONEP has been shown in various animal models of disease
not only to reduce blood-vessel growth and leakiness, but to
significantly mitigate ocular fibrosis and to substantially reduce
inflammation in the eye. As such, iSONEP has the potential to be an
effective wet-AMD treatment that may offer significant advantages over
exclusively anti-VEGF approaches. It may also act synergistically with
them as a combination therapy to address the complex processes and
multiple steps that ultimately lead to vision loss for wet AMD
patients.
Scott Pancoast, Lpath's president and chief executive officer, said:
"We are very encouraged by the results of our Phase 1 trial with
iSONEP, as the drug was extremely well-tolerated and showed the type
of biological activity that we were hoping to see. We now have strong
justification for further investigation of iSONEP's efficacy in one or
more Phase 2 clinical trials."
Medical News Today
http://www.medicalnewstoday.com/articles/166897.php
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