Lpath, Inc., has received official notification from the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO) that Lpath was issued two key patents related to ASONEP™, one of the company's two lead drug candidates that will be studied in Phase II trials through next year.
ASONEP is a therapeutic antibody developed by Lpath's ImmuneY2™ drug-discovery engine designed to target bioactive signaling lipids involved in the proliferation and spread of cancer and in other diseases.
The new U.S. patent No. 7,862,812 claims methods of decreasing an immune response and treating diseases or conditions characterized by an aberrant, excessive, or undesired immune response using an antibody that inhibits a sphingolipid or sphingolipid metabolite, such as S1P.
The European patent No. 98923666.6 claims methods for early detection of heart disease, including compositions for antibodies and diagnostic kits that measure sphingolipids in blood and tissues.
Dr. Laurel Bernstein, executive director of intellectual property for Lpath, commented: "By issuing these patents, the USPTO and EPO have further validated the novelty and utility of Lpath's use of S1P-neutralizing monoclonal antibodies for the diagnosis and treatment of multiple and diverse diseases."
These awards follow two other U.S. patents granted to Lpath in November: U.S. patent No. 7,829,674, which covered claims for composition of matter of anti-S1P antibody that is differentially formulated as ASONEP and iSONEP™; and U.S. patent No. 7,169,390, which covers uses of anti-S1P antibodies in the treatment of cancer.
Lpath recently completed two early-stage clinical trials using the anti-S1P antibody: iSONEP was evaluated in a Phase I trial in wet-AMD subjects; and ASONEP was evaluated in a Phase I trial in cancer subjects.
Lpath is about to initiate two iSONEP Phase II trials, one in patients with RPE Detachment (PED), for which there is no approved drug, and another in wet-AMD patients without PED. Lpath entered into an agreement with Pfizer (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP. Lpath is also independently pursing two ASONEP Phase II trials in two distinct cancer indications.
According to Roger Sabbadini, Lpath's chief scientific officer and main inventor of the issued patents: "Lpath now has patent protection not only on our drug candidates, iSONEP and ASONEP, but also on the methods of use in the treatment of several ocular diseases, as well as cancer, cardiac, autoimmune, and inflammatory disorders. The strength of Lpath's patent portfolio is key to the successful commercialization of both iSONEP and ASONEP."