EntreMed Inc, a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases received a notice of allowance from the US Patent and Trademark Office (PTO) for a patent application claiming composition of matter for purified 2-methoxyestradiol (2ME2). 2ME2 is currently in clinical trials for cancer (Panzem capsules and Panzem NCD), as well as in preclinical development for rheumatoid arthritis.
According to an EntreMed release, the composition of matter claims in the patent application cover a pharmaceutical composition comprising 2ME2 that is substantially free of steroid contaminants having a purity of greater than 99.5% as determined by high pressure liquid chromatography (HPLC) methods. Additional claims cover methods for obtaining purified 2ME2 by synthetic techniques and by liquid-solid chromatographic (LSC) purification techniques. The patent covering high-purity 2ME2 resulted from discoveries by EntreMed scientists.
2ME2 is a novel anticancer agent, which is in clinical development as part of a next generation of antimitotic cancer drugs that bind to tubulin and work through multiple cellular pathways. 2ME2 can attack tumours on multiple fronts directly by disrupting microtubules (an intracellular matrix necessary for the rapid division of cancer cells), by inducing programmed cell death (apoptosis) and by blocking blood vessels that feed tumours (angiogenesis inhibition).
Potential therapeutic uses of 2ME2 in oncology and other diseases may require a high level of purity in order to achieve their maximum benefits. Preparations of 2ME2 that are either less than 99% pure or contain undesirable steroid contaminants do not have properties that would allow development in cancer or inflammatory diseases.
The claims in the allowed patent application strengthen the intellectual property protection for 2ME2 to include highly purified compositions and will extend the patent life for 2ME2 to 2020. Prior patents granted EntreMed intellectual property protection for 2ME2 and derivatives of 2ME2 in oncology and a broad range of non-oncology indications, including inflammatory disorders, immune disorders, and rheumatoid arthritis, adds the release.
James S. Burns, president and chief executive officer, commented, “The composition of matter claims for 2ME2 will provide substantial added patent protection for our lead clinical candidate. The composition claims of our original patent application were not allowed by the PTO, but the decision was reversed on appeal by the Board of Patent Appeals and Interferences. We have now clearly demonstrated that high-purity 2ME2 is a novel composition and can be produced to 99.5% purity through synthetic or purification methods, decreasing the potential for undesirable side effects.”
Burns further added, “Our goal is to continue strengthening EntreMed’s intellectual property for its key product candidates, to strengthen its position in next generation antiproliferative and angiogenesis inhibitors for the treatment of cancer, and to expand the range of indications for our lead multimechanism drug candidates.”
EntreMed Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation.