Lpath, Inc. the industry leader in lipidomics-based therapeutics, has received official notification from the US 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 unique therapeutic antibody developed by Lpath's ImmuneY2 drug-discovery engine designed to target bioactive signalling lipids involved in the proliferation and spread of cancer and in other diseases.

The new US 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 US patents granted to Lpath in November: US 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 US 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 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.”

Lpath has achieved a broad and deep intellectual-property position in the bioactive-lipid area. The company's comprehensive patent portfolio now includes 20 issued patents (including four international) and 105 patent applications (including 70 international). These patents primarily concern the use of reagents and methods designed to interfere with the actions of bioactive lipids involved in human disease.

Lpath's intellectual-property portfolio includes compositions of matter that specifically bind to sphingolipids and sphingolipid metabolites. These agents, including antibodies, could be used in the diagnosis and treatment of various diseases and disorders, including cardiovascular and cerebrovascular disease, cancer, inflammation, autoimmune disorders, ocular disease, and angiogenesis.

Lpath has also obtained issued claims on sphingolipid targets (e.g., receptors and signaling sphingolipids) and methods for using such targets in drug-discovery screening efforts.

The company believes its patent estate provides broad, commercially significant coverage of antibodies, receptors, enzymes, or other moieties that bind to a lysolipid (or a sphingolipid metabolite) for diagnostic, therapeutic, or screening purposes.

Lpath a therapeutic antibody company, is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signalling lipids for treating a wide range of human disease.