Entremed (ENMD)

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EntreMed Reports on Anticancer Progress at Angiogenesis Symposium
Reports Cover Panzem(R) NCD, 2ME2 Analogs and FGF-2 Cancer Vaccine
2/14/2005 8:01:00 AM  - PR Newswire



ROCKVILLE, Md., Feb 14, 2005 /PRNewswire-FirstCall via COMTEX/ --

EntreMed, Inc.(Nasdaq: ENMD), a clinical-stage pharmaceutical company developingtherapeutics for the treatment of cancer and inflammatory diseases, todayannounced the presentation of research results during the 7th InternationalSymposium on Anti-Angiogenic Agents, which concluded yesterday in San Diego,California. The Symposium focused on recent advances in the understanding ofprinciples that drive tumor angiogenesis and the development of new therapiesthat inhibit angiogenesis in cancer.

(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )

EntreMed scientists presented posters on three of its oncology programsincluding: 1) Panzem(R) NCD (2-methoxyestradiol or 2ME2), the Company's leadproduct candidate, which is currently in clinical trials for cancer; 2) secondgeneration analogs of 2ME2 with improved in vivo antitumor activity; and 3)its FGF-2 cancer vaccine, which inhibited growth in vivo of primary tumors andmetastases.Findings from in vitro and in vivo studies of Panzem(R) NCD demonstratedthat antitumor activity is maximized by maintaining threshold concentrationsof 2ME2 for defined periods. PK/PD relationships from these studies providedthe basis for selecting the formulation and dosing regimen for Panzem(R) NCD.2ME2 is a novel anticancer agent, which is part of a next generation ofantimitotic cancer drugs that bind to tubulin and work through multiplecellular pathways combining both antiangiogenic and antitumor activity bytargeting disease cells directly and the blood vessels that nourish them.In January 2005, the Company announced commencement of two Phase 1bstudies using Panzem(R) NCD in patients with advanced cancer. The newformulation and dosing schedule of Panzem(R) NCD is intended to maintainplasma levels within the therapeutic range of maximum anticancer activitydemonstrated in preclinical models.Results from preclinical studies of the lead second generation oral 2ME2analog, ENMD-1198, were also presented. ENMD-1198 demonstrated improvedantitumor and antiangiogenic activities in in vitro and in vivo preclinicalmodels, including microtubule destabilization, enhanced inhibition of HIF-1alpha protein, inhibition of the pro-angiogenic protein VEGF, and significantantitumor activity following oral administration. HIF-1 alpha is over-expressed in more than 70% of human cancers and their metastases, includingbreast, prostate, head and neck, brain, and lung cancers. ENMD-1198,discovered by EntreMed scientists and owned exclusively by the Company, isbeing characterized further in IND-directed studies.A third presentation highlighted the Company's cancer vaccine candidate,ENMD-0996. The vaccine, which produces cellular and humoral immune responsesto FGF-2, demonstrated both antiangiogenic activity and tumor inhibition inpreclinical models. Data from spontaneous pulmonary metastatic disease modelsshowed that therapeutic intervention with ENMD-0996 significantly increasedsurvival time, and demonstrated a 93% inhibition of surface lung metastases inother models. Preclinical studies to define further therapeutic effects ofENMD-0996 are currently underway.Carolyn F. Sidor, MD, EntreMed Vice President & Chief Medical Officer,commented on the presentations, "Our oncology programs continue to demonstrateencouraging results. We are not only making clinical progress with Panzem(R)NCD, we now have a lead 2ME2 analog product candidate in IND-directedtoxicology studies, and our FGF-2 cancer vaccine program continues to definethe range of activity of this unique potential drug candidate. IND-directedstudies have commenced for ENMD-1198, and we anticipate filing an IND for thiscompound in 2005."To view the poster presentations, visit the Therapeutic Pathways sectionof the Company's web site at http://www.entremed.com

About EntreMedEntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical companydeveloping therapeutic candidates primarily for the treatment of cancer andinflammation. Panzem(R) (2-Methoxyestradiol or 2ME2), the Company's lead drugcandidate, is currently in clinical trials for advanced cancer, as well as inpreclinical development for indications outside of oncology. EntreMed's goalis to develop and commercialize new compounds based on the Company's expertisein angiogenesis, cell cycle regulation and inflammation -- processes vital tothe treatment of cancer and other diseases. The Company's expertise has alsoled to the discovery of new molecules, including analogs of 2ME2, peptides oftissue factor pathway inhibitor (TFPI), and inhibitors of fibroblast growthfactor-2 (FGF-2) and proteinase activated receptor-2 (PAR-2). EntreMed isdeveloping these potential drug candidates for either in-house advancement orexternal partnering. Additional information about EntreMed is available onthe Company's website at http://www.entremed.com and in various filings withthe Securities and Exchange Commission. Panzem(R) NCD is in clinical trialsand has not been approved by the Food and Drug Administration.

Forward Looking StatementsThis release contains, and other statements that EntreMed may make maycontain, forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act with respect to the outlook for expectationsfor future financial or business performance, strategies, expectations andgoals. Forward-looking statements are typically identified by words orphrases such as "believe," "feel," "expect," "anticipate," "intend,""outlook," "estimate," "target," "assume," "goal," "objective," "plan,""remain," "seek," "trend," and variations of such words and similarexpressions, or future or conditional verbs such as "will," "would," "should,""could," "might," "can," "may," or similar expressions. Forward-lookingstatements are subject to numerous assumptions, risks and uncertainties, whichchange over time. Forward-looking statements speak only as of the date theyare made, and EntreMed assumes no duty to update forward-looking statements.Actual results could differ materially from those currently anticipated due toa number of factors, including those set forth in EntreMed's Securities andExchange Commission filings under "Risk Factors," including risks relating toEntreMed's need for additional capital and the uncertainty of additionalfunding; the early-stage products under development; uncertainties relating toclinical trials; our success in the further clinical development of Panzem(R)NCD, dependence on third parties; future capital needs; and risks relating tothe commercialization, if any, of the Company's proposed products (such asmarketing, safety, regulatory, patent, product liability, supply, competitionand other risks).CONTACT: Ginny Dunn, Associate Director of Corporate Communications &Investor Relations of EntreMed, Inc., [phone].SOURCE EntreMed, Inc.Ginny Dunn, Associate Director of Corporate Communications & Investor Relationsof EntreMed, Inc., [phone]http://www.prnewswire.com