From PR
-reported positive summary results of its single-dose Phase 1 clinical trial of iSONEP(TM) in wet-AMD patients.

-iSONEP met its primary endpoint of being well tolerated in all 15 patients

-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.

-Most of these positive effects appear to be largely independent of the effects seen when wet-AMD patients undergo treatment with Lucentis or with off-label use of Avastin, the predominant market leaders!!!!!!!!!

-The most significant benefit observed was a regression in choroidal neovascularization (CNV), which is the underlying cause of the disease

-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 typical, as the published data (Heier JS et al. Ophthalmology. 2006;113:642e1-642.e4) suggest that, 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, a potentially serious condition that is often a part of the pathology of wet AMD...Neither Lucentis nor Avastin typically produce this type of clinical benefit with a single dose!

-Lucentis and Avastin target the protein VEGF, a validated 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!

-...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!!!

-We now have strong justification for further investigation of iSONEP's efficacy in one or more Phase 2 clinical trials.