EntreMed Reports on Anticancer Progress at Angiogenesis Symposium
Reports Cover PanzemÂ® NCD, 2ME2 Analogs and FGF-2 Cancer Vaccine
February 14, 2005
ROCKVILLE, MD, Feb. 14—EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of research results during the 7th International Symposium on Anti-Angiogenic Agents, which concluded yesterday in San Diego, California. The Symposium focused on recent advances in the understanding of principles that drive tumor angiogenesis and the development of new therapies that inhibit angiogenesis in cancer.
EntreMed scientists presented posters on three of its oncology programs including: 1) PanzemÂ® NCD (2-methoxyestradiol or 2ME2), the Company’s lead product candidate, which is currently in clinical trials for cancer; 2) second generation analogs of 2ME2 with improved in vivo antitumor activity; and 3) its FGF-2 cancer vaccine, which inhibited growth in vivo of primary tumors and metastases.
Findings from in vitro and in vivo studies of PanzemÂ® NCD demonstrated that antitumor activity is maximized by maintaining threshold concentrations of 2ME2 for defined periods. PK/PD relationships from these studies provided the basis for selecting the formulation and dosing regimen for PanzemÂ® NCD. 2ME2 is a novel anticancer agent, which is part of a next generation of antimitotic cancer drugs that bind to tubulin and work through multiple cellular pathways combining both antiangiogenic and antitumor activity by targeting disease cells directly and the blood vessels that nourish them.
In January 2005, the Company announced commencement of two Phase 1b studies using PanzemÂ® NCD in patients with advanced cancer. The new formulation and dosing schedule of PanzemÂ® NCD is intended to maintain plasma levels within the therapeutic range of maximum anticancer activity demonstrated in preclinical models.
Results from preclinical studies of the lead second generation oral 2ME2 analog, ENMD-1198, were also presented. ENMD-1198 demonstrated improved antitumor and antiangiogenic activities in in vitro and in vivo preclinical models, including microtubule destabilization, enhanced inhibition of HIF-1 alpha protein, inhibition of the pro-angiogenic protein VEGF, and significant antitumor activity following oral administration. HIF-1 alpha is over- expressed in more than 70% of human cancers and their metastases, including breast, prostate, head and neck, brain, and lung cancers. ENMD-1198, discovered by EntreMed scientists and owned exclusively by the Company, is being 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 responses to FGF-2, demonstrated both antiangiogenic activity and tumor inhibition in preclinical models. Data from spontaneous pulmonary metastatic disease models showed that therapeutic intervention with ENMD-0996 significantly increased survival time, and demonstrated a 93% inhibition of surface lung metastases in other models. Preclinical studies to define further therapeutic effects of ENMD-0996 are currently underway.
Carolyn F. Sidor, MD, EntreMed Vice President & Chief Medical Officer, commented on the presentations, “Our oncology programs continue to demonstrate encouraging results. We are not only making clinical progress with PanzemÂ® NCD, we now have a lead 2ME2 analog product candidate in IND-directed toxicology studies, and our FGF-2 cancer vaccine program continues to define the range of activity of this unique potential drug candidate. IND-directed studies have commenced for ENMD-1198, and we anticipate filing an IND for this compound in 2005.”
To view the poster presentations, visit the Therapeutic Pathways section of the Company’s web site at http://www.entremed.com
EntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. PanzemÂ® (2-Methoxyestradiol or 2ME2), the Company’s lead drug candidate, is currently in clinical trials for advanced cancer, as well as in preclinical development for indications outside of oncology. 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. The Company’s expertise has also led to the discovery of new molecules, including analogs of 2ME2, peptides of tissue factor pathway inhibitor (TFPI), and inhibitors of fibroblast growth factor-2 (FGF-2) and proteinase activated receptor-2 (PAR-2). EntreMed is developing these potential drug candidates for either in-house advancement or external partnering. 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. PanzemÂ® NCD is in clinical trials and has not been approved by the Food and Drug Administration.
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 products under development; uncertainties relating to clinical trials; our success in the further clinical development of PanzemÂ® NCD, 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).
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