(Copyright (c) 2002, PR Newswire)
ROCKVILLE, Md., Dec. 10 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a biopharmaceutical leader in angiogenesis research and product development, has released additional preclinical data demonstrating the increased activity of the Company's thalidomide analog ENMD 0995, when compared to thalidomide and other thalidomide analogs, in preclinical and animal models of multiple myeloma, a form of blood cancer. In these preclinical studies, presented at the American Society of Hematology's Annual Meeting, ENMD 0995 also exhibited less toxicity and greater activity against other tumor types, including lung carcinoma and glioblastoma, an aggressive variety of brain cancer.
ENMD 0995 and the original thalidomide molecule, a drug now used widely on an investigational basis for the treatment of multiple myeloma, are separate and structurally distinct molecules. ENMD 0995, EntreMed's latest drug candidate, entered Phase I clinical trials in November and was granted Orphan Drug designation from the Food and Drug Administration for the treatment of patients with multiple myeloma. EntreMed holds exclusive worldwide rights to ENMD 0995 through a license agreement with Children's Hospital, Boston. ENMD 0995 is protected by U.S. Patent No. 5,712,291, which was filed on June 6, 1995 and issued on June 27, 1998 with priority claims to an original patent application filed by Children's Hospital on March 1, 1993.
Dr. John Holaday, EntreMed Chairman and Chief Scientific Officer, commented, "These persuasive findings support EntreMed's decision to move ENMD 0995 into the clinic. Our in-house scientific team continues to compile preclinical data that suggests this drug candidate is superior to thalidomide and other thalidomide analogs." ENMD 0995 is the S(-) enantiomer 3-amino thalidomide. Three-amino thalidomide has two mirror-image forms known as the S(-) enantiomer and the R(+) enantiomer. EntreMed scientists demonstrated in a number of animal models that the S(-) enantiomer form is more active than either the R(+) enantiomer form or the R,S mixture (racemate).
Referring to recent legal actions taken by Celgene Corporation regarding ENMD 0995 patent protection, EntreMed President and Chief Operating Officer Neil Campbell said, "EntreMed is committed to the continued clinical development of ENMD 0995 and will not be deterred by our competitor's unfounded legal maneuvers. ENMD 0995 and Panzem(TM) are the lead drug candidates in EntreMed's small molecule programs and the Company's focus moving forward into 2003."
EntreMed Associate Director for Discovery Research and lead author, Dr. Anthony Treston, presented the ENMD 0995 data at the Annual Meeting of the American Society of Hematology in Philadelphia. Dr. Treston's poster, "Preclinical Evaluation of a Thalidomide Analog with Activity Against Multiple Myeloma and Solid Tumors -- ENMD 0995 (S-(-)-3-(3-amino-phthalidmido)- glutarimide)" is available at http://www.entremed.com.
On November 19, ENMD 0995 became the center of an intellectual property dispute when Celgene Corporation filed a lawsuit to block the imminent issuance of ENMD 0995 patent applications, as licensed to EntreMed. Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (PTO) James E. Rogan and EntreMed were named as co-defendants in the case. On November 21, EntreMed filed a motion to dismiss that lawsuit and has requested an immediate oral hearing of the motion to dismiss. On December 2, Celgene submitted a brief in opposition to EntreMed's motion to dismiss. EntreMed filed its own lawsuit regarding the ENMD 0995 dispute on November 21, asking that the Court declare three of Celgene's patents invalid, find that Celgene has violated U.S. antitrust laws, and award EntreMed unspecified civil and punitive damages. On December 2, Celgene filed its answer and counterclaims, denying allegations contained in EntreMed's original complaint. All public court documents related to the ENMD 0995 lawsuits are available at http://www.entremed.com .
About ENMD 0995
ENMD 0995 is a small molecule analog of thalidomide with improved angiogenesis inhibitor activity that in animal models has shown no evidence of the toxic side effects as reported for the thalidomide molecule. ENMD 0995 is the S(-) enantiomer 3-amino thalidomide. Three-amino thalidomide has two mirror-image forms known as the S(-) enantiomer and the R(+) enantiomer. EntreMed scientists demonstrated in a number of animal models that the S(-) enantiomer form is more active than both the R(+) enantiomer form and the R,S mixture (racemate). Based on those data, EntreMed moved the S(-) enantiomer -- designated as ENMD 0995 -- to the clinic. EntreMed scientists first identified that ENMD 0995 has not only angiogenesis-inhibitory activity, but also B-cell specific anti-proliferative activity. Therefore, ENMD 0995 may be an ideal candidate for the treatment of B-cell tumors such as multiple myeloma and some lymphomas, as well as some solid tumors.
EntreMed, Inc., The Angiogenesis Company(TM), is a clinical-stage biopharmaceutical company developing angiogenesis therapeutics that inhibit abnormal blood vessel growth associated with over 80 diseases such as cancer, blindness and atherosclerosis. Unlike other angiogenesis compounds, EntreMed's product candidates target disease-associated endothelial cells only and do not disrupt normal biological processes. As a result, our drug candidates have shown a strong safety profile with neither toxicity nor clinically significant side effects reported to date. EntreMed has three Phase II clinical drug candidates in oncology trials where doctors have reported some patients with tumor regression and disease stabilization. The Company also has a rich pipeline, consisting primarily of small molecules and peptides, under development and in preclinical studies. For further information, visit EntreMed's web site at http://www.entremed.com .
Forward Looking Statements
This release contains, and other statements that EntreMed may make may contain, 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 typically identified by words or phrases such as "believe," "feel," "expect," "anticipate," "intend," "outlook," "estimate," "target," "assume," "goal," "objective," "plan," "remain," "seek," "trend," and variations of such words and similar expressions, or future or conditional verbs such as "will," "would," "should," "could," "might," "can," "may," or similar expressions. 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 EntreMed assumes no duty to update forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in EntreMed's Securities and Exchange Commission filings under "Risk Factors," including risks relating to EntreMed's need for additional capital and the uncertainty of additional funding, the early stage of products under development; uncertainties relating to clinical trials; 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).