ROCKVILLE, Md., Dec. 7 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the issuance of a notice of allowance from the U.S. Patent & Trademark Office (PTO) of a patent application claiming composition of matter for purified 2-methoxyestradiol (2ME2). 2ME2 is currently in clinical trials for cancer (Panzem(R) Capsules and Panzem(R) NCD), as well as in preclinical development for rheumatoid arthritis.
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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 tumors 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 tumors (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.
James S. Burns, President & 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.”
Mr. Burns further commented, “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.”
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2), the Company’s lead drug candidate, is currently in clinical trials for cancer, as well as in preclinical development for non-oncology indications. EntreMed’s goal is to develop and commercialize new compounds based on the Company’s expertise in angiogenesis, cell cycle regulation and inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company’s website at http://www.entremed.com and in various filings with the Securities and Exchange Commission.
Forward Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under “Risk Factors,” including risks relating to the need for additional capital and the uncertainty of additional funding; the early-stage products under development; uncertainties relating to clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company’s proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
CONTACT: Ginny Dunn, Associate Director, Corporate Communications & Investor Relations of EntreMed, Inc., +1-240-864-2643.
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CONTACT: Ginny Dunn, Associate Director, Corporate Communications &Investor Relations of EntreMed, Inc., +1-240-864-2643
Web site: http://www.entremed.com/
