SAN DIEGO, Aug. 20 /PRNewswire-FirstCall/ -- Lpath, Inc. (OTC Bulletin Board: LPTN), the category leader in therapeutic agents against bioactive lipids, reported that a standard panel of safety tests was recently completed with the humanized version of Sphingomab(TM), and the findings indicate no safety concern for systemic dosing of the antibody to humans.
Sphingomab, generated by Lpath's proprietary ImmuneY2(TM) platform technology, is a monoclonal antibody against the bioactive lipid S1P (sphingosine-1-phosphate). S1P has been well validated as a stimulator of angiogenesis (new blood-vessel growth), a process that has been strongly implicated in the pathology of both cancer and AMD.
The safety tests included cardiovascular studies in Cynomolgus monkeys as well as tests to evaluate the potential of the antibody to elicit the release of cytokines or an Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) reaction. The cardiovascular study included evaluation of the effect of humanized Sphingomab treatment on blood pressure, heart rate, and respiratory rate. The cardiovascular, cytokine release, and ADCC tests with humanized Sphingomab were all negative at doses or concentrations well above those expected to be needed in man to provide an anti-angiogenic action.
The panel of tests also included a pivotal multiple-dosing 28-day study in Cynomolgus monkeys. This study featured intravenous administration of humanized Sphingomab at doses as great as 100 mg/kg every three days for 28 days (10 total doses). Parameters monitored during this study included mortality, body weight, organ weight, clinical observations, ophthalmology, clinical pathology (hematology, clinical chemistry, coagulation, and urinalysis), and immune-phenotyping, both pre-treatment and on day 28 in all animals, and after one, two, three, and four weeks of recovery in a large sub- group of the animals.
No animal deaths occurred during the study. There were also no
|SOURCE Lpath, Inc.|
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