Nexus Trial to Study Effects of Anti-S1P Monoclonal Antibody in Wet-AMD Patients
SAN DIEGO, CA-, USA I October 3, 2012 I Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has initiated the dosing of iSONEP™ in its Nexus Phase 2 study, with several wet-AMD patients treated since September 21, 2012.
In the double-blind, multi-site trial, Lpath plans to dose 160 subjects who have not responded completely to a VEGF inhibitor (either Lucentis® or Avastin®). These subjects will be randomized into four arms: (1) VEGF inhibitor alone; (2) combination of a VEGF inhibitor and iSONEP (lower dose); (3) combination of a VEGF inhibitor and iSONEP (higher dose); and (4) iSONEP alone (higher dose).
Endpoints to be studied include changes in best corrected visual acuity (BCVA), retinal thickness, and lesion size. The Nexus trial will also investigate iSONEP’s ability to flatten Pigmented Epithelial Detachments (PEDs), a complication of wet AMD that does not respond well to anti-VEGF treatments.
"We are seeing strong enrollment momentum in our Nexus study," said Scott Pancoast, Lpath’s president and chief executive officer. "Our Nexus study seeks to determine how iSONEP can best be used to benefit wet-AMD patients. Whether as first-line single agent, as first-line in combination with anti-VEGF therapies, or as second-line, a drug that can provide additive benefits in the treatment of wet AMD would have a significant market potential."
In the Phase 1 trial, where subjects with wet AMD received a single injection of iSONEP, a positive biological effect was observed in most patients, almost all of whom had failed to respond to treatment with Lucentis and/or Avastin. One such positive effect was a significant reduction (30%+) in the size of the choroidal neovascular lesion in many of the subjects, all of whom were not responding well to treatment with the VEGF inhibitors at the time they were enrolled in the study. Significant reduction in lesion size with a single injection is not typically observed with VEGF inhibition.
One of these subjects experienced a 100% reduction in lesion size as of Day 45. This subject did not have to be re-injected with the "standard of care" (i.e., with Lucentis or Avastin) for the entire 12-month monitoring period following the iSONEP injection.
Another subject who had undergone 16 prior treatments of Lucentis and Avastin without much response was administered the highest dose of iSONEP studied (1.8 mg.). This subject experienced not only a 100% reduction in lesion size by Day 15, but also a complete elimination of retinal swelling. Like the other subject, this subject also did not have to be re-injected with Lucentis or Avastin for the entire 12-month monitoring period following the iSONEP treatment.
These extended times to re-treatment suggest that any benefit derived from iSONEP may be durable, a particularly important attribute in this market.
Lpath hypothesizes that such distinctive benefits are due to powerful anti-angiogenic, anti-inflammatory, and anti-fibrotic mechanisms of action of iSONEP, which binds to and neutralizes the bioactive lipid, S1P. In various animal models of disease, iSONEP was shown to substantially reduce inflammation and angiogenesis in the eye (Campochiaro et al., Journal of Cellular Physiology, January 2009) and significantly mitigate ocular fibrosis (Grant et al., Experimental Eye Research, March 2009).
Lpath entered into an agreement with Pfizer Inc. (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. Lpath and Pfizer have collaborated extensively on design and goals of the Nexus Phase 2 study.
About Lpath
San Diego-based Lpath, Inc. (OTCQB: LPTN), a therapeutic antibody company, is the category leader in bioactive lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2™ 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, two of which — iSONEP™ for wet AMD and ASONEP™ for cancer — have completed Phase 1 clinical trials. The third candidate is an anti-LPA antibody that holds promise in neuropathic pain, neurotrauma and other disease conditions. For more information, visit www.Lpath.com.
SOURCE: Lpath
Post Views: 45
Nexus Trial to Study Effects of Anti-S1P Monoclonal Antibody in Wet-AMD Patients
SAN DIEGO, CA-, USA I October 3, 2012 I Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has initiated the dosing of iSONEP™ in its Nexus Phase 2 study, with several wet-AMD patients treated since September 21, 2012.
In the double-blind, multi-site trial, Lpath plans to dose 160 subjects who have not responded completely to a VEGF inhibitor (either Lucentis® or Avastin®). These subjects will be randomized into four arms: (1) VEGF inhibitor alone; (2) combination of a VEGF inhibitor and iSONEP (lower dose); (3) combination of a VEGF inhibitor and iSONEP (higher dose); and (4) iSONEP alone (higher dose).
Endpoints to be studied include changes in best corrected visual acuity (BCVA), retinal thickness, and lesion size. The Nexus trial will also investigate iSONEP’s ability to flatten Pigmented Epithelial Detachments (PEDs), a complication of wet AMD that does not respond well to anti-VEGF treatments.
"We are seeing strong enrollment momentum in our Nexus study," said Scott Pancoast, Lpath’s president and chief executive officer. "Our Nexus study seeks to determine how iSONEP can best be used to benefit wet-AMD patients. Whether as first-line single agent, as first-line in combination with anti-VEGF therapies, or as second-line, a drug that can provide additive benefits in the treatment of wet AMD would have a significant market potential."
In the Phase 1 trial, where subjects with wet AMD received a single injection of iSONEP, a positive biological effect was observed in most patients, almost all of whom had failed to respond to treatment with Lucentis and/or Avastin. One such positive effect was a significant reduction (30%+) in the size of the choroidal neovascular lesion in many of the subjects, all of whom were not responding well to treatment with the VEGF inhibitors at the time they were enrolled in the study. Significant reduction in lesion size with a single injection is not typically observed with VEGF inhibition.
One of these subjects experienced a 100% reduction in lesion size as of Day 45. This subject did not have to be re-injected with the "standard of care" (i.e., with Lucentis or Avastin) for the entire 12-month monitoring period following the iSONEP injection.
Another subject who had undergone 16 prior treatments of Lucentis and Avastin without much response was administered the highest dose of iSONEP studied (1.8 mg.). This subject experienced not only a 100% reduction in lesion size by Day 15, but also a complete elimination of retinal swelling. Like the other subject, this subject also did not have to be re-injected with Lucentis or Avastin for the entire 12-month monitoring period following the iSONEP treatment.
These extended times to re-treatment suggest that any benefit derived from iSONEP may be durable, a particularly important attribute in this market.
Lpath hypothesizes that such distinctive benefits are due to powerful anti-angiogenic, anti-inflammatory, and anti-fibrotic mechanisms of action of iSONEP, which binds to and neutralizes the bioactive lipid, S1P. In various animal models of disease, iSONEP was shown to substantially reduce inflammation and angiogenesis in the eye (Campochiaro et al., Journal of Cellular Physiology, January 2009) and significantly mitigate ocular fibrosis (Grant et al., Experimental Eye Research, March 2009).
Lpath entered into an agreement with Pfizer Inc. (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. Lpath and Pfizer have collaborated extensively on design and goals of the Nexus Phase 2 study.
About Lpath
San Diego-based Lpath, Inc. (OTCQB: LPTN), a therapeutic antibody company, is the category leader in bioactive lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2™ 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, two of which — iSONEP™ for wet AMD and ASONEP™ for cancer — have completed Phase 1 clinical trials. The third candidate is an anti-LPA antibody that holds promise in neuropathic pain, neurotrauma and other disease conditions. For more information, visit www.Lpath.com.
SOURCE: Lpath
Post Views: 45
