Lpath's lead product candidate, Sphingomab, is a humanized monoclonal antibody against a validated cancer target, sphingosine-1-phosphate ("S1P"), and has demonstrated compelling results in preclinical studies against multiple forms of cancers, against age-related macular degeneration ("AMD"), and against heart failure. Sphingomab works by cutting off the blood supply that tumors need to thrive. Drugs that function by this mechanism are said to be anti-angiogenic. While Sphingomab is potently anti-angiogenic, it also has other mechanisms of action that may make it a superior competitor to other successful anti-angiogenic cancer and AMD treatments that have recently been commercialized. We plan to begin testing Sphingomab as a treatment for cancer and AMD in human clinical trials beginning in late 2007 or early 2008.
Lpath's second product candidate, Lpathomab, is a monoclonal antibody against lysophosphatidic acid ("LPA"), a key bioactive lipid that has long been recognized as a significant promoter of cancer-cell growth and metastasis in a broad range of tumor types and as a significant contributor to neuropathic pain. We have demonstrated in vitro efficacy in various cancer studies and plan to conduct in vivo efficacy studies in various tumor models in 2007.
We believe we are the only company to have developed functional monoclonal antibodies against bioactive lipids such as S1P and LPA. These unique antibodies were produced using our ImmuneY2 technology, a series of proprietary processes developed by the company. We are currently applying the ImmuneY2 process to other lipid-signaling agents that are validated targets for disease treatment, thereby creating a potential pipeline of monoclonal antibody-based drug candidates.
Lpath has a broad and deep intellectual-property position in the bioactive-lipid area, with over 28 issued or pending patents in the United States, with comparable intellectual-property coverage in major foreign countries. Most of these patents were developed in-house based on Lpath's pioneering research on bioactive lipid signaling. The company's research partners to date include the M.D. Anderson Cancer Center, Johns Hopkins University, the University of Florida College of Medicine, and San Diego State University.
