No Drug-Related Adverse Events Reported at Any Dose Level; Encouraging Efficacy Signals Seen
SAN DIEGO, CA, USA | August 18, 2009 | Lpath, Inc. (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, has completed the enrollment and dosing of 15 wet AMD patients in a multi-center, open label, single-arm Phase 1 study of iSONEP administered as a single intravitreal injection to the study eye.
The drug was well tolerated in all 15 patients, and there were no drug-related serious adverse events reported at any of the five dose levels (0.2 mg/eye to 1.8 mg/eye).
In addition, several patients showed a reduction in retinal thickness and regression of lesion size, the two primary efficacy-related endpoints in a single-dose Phase 1 trial. All of these patients had received prior treatments that included at least two doses of Lucentis(R) and/or Avastin(R), the two leading treatment options for wet AMD patients, but were not responding well to these treatments, implying that their lesions were challenging from a treatment perspective.
The company is expected to release a complete analysis of efficacy when all the data is available later this quarter.
Scott Pancoast, Lpath’s president and chief executive officer, stated, "The excellent safety record from our Phase 1 study, combined with the efficacy signal from several of the patients, warrants further investigation of the safety and efficacy of iSONEP in one or more Phase 2 trials."
About Lpath
San Diego-based Lpath, Inc. is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2(TM) drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is currently advancing three drug candidates, two of which — ASONEP(TM) for cancer and iSONEP(TM) for AMD — are in late-Phase 1 clinical trials. For ASONEP, Lpath has joined with international drug giant Merck-Serono under a worldwide exclusive license and development partnership. For more information, go to www.Lpath.com.
Trademarks are the property of their respective owners.
SOURCE: Lpath, Inc.
Post Views: 72
No Drug-Related Adverse Events Reported at Any Dose Level; Encouraging Efficacy Signals Seen
SAN DIEGO, CA, USA | August 18, 2009 | Lpath, Inc. (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, has completed the enrollment and dosing of 15 wet AMD patients in a multi-center, open label, single-arm Phase 1 study of iSONEP administered as a single intravitreal injection to the study eye.
The drug was well tolerated in all 15 patients, and there were no drug-related serious adverse events reported at any of the five dose levels (0.2 mg/eye to 1.8 mg/eye).
In addition, several patients showed a reduction in retinal thickness and regression of lesion size, the two primary efficacy-related endpoints in a single-dose Phase 1 trial. All of these patients had received prior treatments that included at least two doses of Lucentis(R) and/or Avastin(R), the two leading treatment options for wet AMD patients, but were not responding well to these treatments, implying that their lesions were challenging from a treatment perspective.
The company is expected to release a complete analysis of efficacy when all the data is available later this quarter.
Scott Pancoast, Lpath’s president and chief executive officer, stated, "The excellent safety record from our Phase 1 study, combined with the efficacy signal from several of the patients, warrants further investigation of the safety and efficacy of iSONEP in one or more Phase 2 trials."
About Lpath
San Diego-based Lpath, Inc. is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2(TM) drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company is currently advancing three drug candidates, two of which — ASONEP(TM) for cancer and iSONEP(TM) for AMD — are in late-Phase 1 clinical trials. For ASONEP, Lpath has joined with international drug giant Merck-Serono under a worldwide exclusive license and development partnership. For more information, go to www.Lpath.com.
Trademarks are the property of their respective owners.
SOURCE: Lpath, Inc.
Post Views: 72
