Healthcare Industry News: NSCLC
News Release - March 13, 2008
EntreMed Announces 2008 Corporate and Clinical Program PrioritiesROCKVILLE, Md., March 13 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced its 2008 corporate and clinical program priorities. Formal remarks regarding corporate objectives, as well as plans for current and future clinical development milestones were delivered this morning by EntreMed President and CEO, James S. Burns, during the Company's year-end 2007 update call.
EntreMed reiterated its strategy of investing behind multiple clinical- stage oncology product candidates. In 2008, EntreMed plans to focus in three principal objectives.
-- Concentrate resources on fewer programs that provide a more direct path forward to product registration and ultimately to the market;
-- Conserve cash by funding essential priority program activities and deferring new program initiatives; and
-- Expand partnering activities across multiple clinical programs.
EntreMed also announced that the Company has reprioritized its development pipeline to focus investment on three of its oncology programs, specifically: MKC-1, ENMD-1198, and ENMD-2076.
-- MKC-1 is a novel, orally-active cell cycle inhibitor with broad-acting antitumor activity, including tumor growth inhibition or regression in multiple preclinical models. MKC-1 has been shown to inhibit the PI3K Akt-mTOR signaling pathway, which occurs through inhibition of the mTOR/rictor branch of the pathway. MKC-1 was discovered and initially developed by Roche; EntreMed has an exclusive worldwide license to develop and commercialize the drug.
-- MKC-1 is currently in multiple Phase 1 and Phase 2 clinical trials, including metastatic breast cancer (MBC), non-small cell lung cancer (NSCLC), hematological cancers, ovarian and endometrial cancer, and pancreatic cancer. Milestones for MKC-1 in 2008 include reporting results for the single agent MKC-1 MBC study (2Q08); presentation of interim data for MKC-1/Alimta combination study in NSCLC (2Q08); presentation of Phase 1 data for MKC-1 in hematological cancers (2H08); initiation of a Phase 1 MKC-1 continuous dosing study (2Q08); and presentation of interim data for a Phase 2 study in pancreatic cancer (4Q08).
-- ENMD-1198 is a potent, orally-active, antimitotic agent discovered at EntreMed that causes cell cycle arrest and apoptosis in tumor cells. ENMD-1198 has shown pronounced antitumor activity and survival increases in multiple preclinical models, including a substantial decrease in tumor cell proliferation and angiogenesis in a breast cancer model; synergistic effects in combination with vincristine that prolonged survival in preclinical leukemia models; and a three-fold increase in survival compared to standard-of-care Cisplatin in a preclinical NSCLC model.
-- A Phase 1b dose-escalation clinical trial is currently underway to evaluate ENMD-1198 in patients with refractory solid tumors. Completion of the study is expected around mid-2008 with a further trial expected in the second half of 2008. ENMD-1198 milestones for 2008 include completion of Phase 1b enrollment (2Q/3Q08); initiation of an expanded Phase 1 or Phase 2 trial (3Q/4Q08); and the reporting of data for the Phase 1b clinical trial (4Q08).
-- ENMD-2076 is an oral selective kinase inhibitor with a unique kinase profile, including antiproliferative activity and inhibition of angiogenesis. ENMD-2076 has demonstrated potent antitumor activity as a single agent in multiple preclinical models, including tumor regression in breast, colon, and leukemia models without cardiovascular effects. ENMD-2076 is a unique-in-class compound that inhibits both Aurora A and growth factor receptors critical to angiogenesis.
-- EntreMed's IND has been accepted by the FDA and a Phase 1 study in solid tumors is expected to enroll patients in early 2Q08. EntreMed has been selected for an oral presentation on ENMD-2076 during the American Association for Cancer Research's "Drugs on the Horizon" symposium to be held during the AACR annual meeting in April. ENMD-2076 milestones for 2008 include initiating a Phase 1 trial in solid tumors (1Q08); initiating a Phase 1 trial in hematological tumors (3Q08/4Q08); and entering into a development alliance (2H08/1H09).
-- EntreMed plans to discontinue development of 2ME2 (PanzemŽ NCD) for oncology. Modest antitumor activity has been shown across most of the clinical studies, yet there is not a clear development path that would narrow the indications for larger randomized studies. Additional trial costs, the high doses required for use in oncology, and manufacturing/process development expenditures would together require the commitment of a disproportionate amount of resources and limit clinical development efforts on the remainder of the pipeline. Patients still on clinical oncology trials, however, will continue to receive PanzemŽ NCD.
-- EntreMed plans to move 2ME2 forward in rheumatoid arthritis based on the knowledge gained from the oncology development effort and favorable preclinical research results showing that 2ME2 has disease modifying or "DMARD" activity, The FDA has accepted EntreMed's IND for 2ME2 in RA, which included an extensive human safety dossier in 300 patients from the oncology studies. PanzemŽ for RA represents a safe, orally administered, small molecule alternative to current biologicals and a potential "first-in-class" cross-over opportunity from oncology. The Company plans to initiate a normal volunteer clinical trial in 2008 and seek a development partner to manage larger multi-arm Phase 2 and Phase 3 studies.
EntreMed President & CEO, James S. Burns, commented, "We are concentrating our resources on fewer programs that we believe have greater potential for product registration and ultimately commercialization. We have three promising oncology programs to pursue in 2008: MKC-1 in multiple Phase 1 and 2 trials, ENMD-1198 that we expect to enter into Phase 2 before year end, and ENMD-2076 that will begin a Phase 1b clinical trial shortly, together with our initial clinical trial for PanzemŽ in a potentially larger RA market."
Mr. Burns further commented, "Our goal in 2008 is to continue moving ahead on priority programs while maintaining our cash expenditures at approximately the same level as in 2007. As part of our financial plan, we are also focusing increased attention on partnering one or more of our programs in order to fund and advance our programs into later stages of development. We will, however, continue to selectively seek opportunities such as individual products or companies that could favorably impact the quality of our pipeline, allow us to de-risk the Company, and enhance shareholder value."
A digital recording of the Company's will be available approximately two hours after the completion of the conference and will be accessible for 60 days. To access the recording, dial 800-642-1687 (U.S. or Canada) or 706-645- 9291 (internationally) and enter the digital pin number 37155333. An audio replay will also be available approximately two hours after the conference and can be accessed through the Company's website at http://www.entremed.com. EntreMed's fourth quarter update call was held today at 10:00 a.m. ET. A digital recording will be available approximately two hours after completion of the conference and will be accessible for 60 days. To access the recording, dial 800-642-1687 (U.S. or Canada) or 706-645-9291 (internationally) and enter the digital pin number 37155333. In addition, an audio replay will also be available on the Company's website at http://www.entremed.com approximately one hour after the conclusion of the live conference.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an oral cell-cycle regulator with activity against the mTOR pathway. ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. The Company has approved IND applications for PanzemŽ in rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, for cancer. 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 web site at 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 (including the timing of royalty revenues and future R&D expenditures), 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; variations in actual sales of ThalomidŽ, risks associated with the Company's product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and 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).
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