NEOPHARM Presents Updated Development Projections for its Drug Candidates at Annual Shareholder Meeting.WAUKEGAN, Ill. -- NEOPHARM, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :NEOL) presented its updated development projections for its drug candidates pipeline at its Annual Shareholder Meeting. A copy of the Company's presentation can be found in its most recent 8-K filing. "After a comprehensive review of the Company's pipeline, we have identified several opportunities in which we will be able to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. the intellectual property NEOPHARM has created to date. As such, we have made initial projections regarding the clinical development cycle of many of our drug candidates," commented Laurence Birch, President and Chief Executive Officer of NEOPHARM. "Additionally, we have successfully completed the restructuring initiative we announced in April 2007. Based on our efforts, we were able to significantly reduce NEOPHARM's cash consumption rate to approximately $5 million, before external clinical costs and certain legacy costs Legacy costs is a term formed by analogy with the computer industry's legacy systems. Legacy costs are those incured by an organization in prior years under different leadership or when the entity's priorities and resources were different. , and retain key technical positions that will support development activities in order to achieve the Company's next meaningful inflection point Inflection Point An event that changes the way we think and act. -Andy Grove, Founder of Intel. Notes: For example, the fall of the Berlin Wall was an inflection point in global politics and the commercialization of the Internet was an inflection point in technology. ." Mr. Birch continued, "Based on our review of the pipeline, coupled with the progress we have made in reducing our cash consumption rate, we believe that the current available cash balance of $25 million, as of June 30, 2007, is sufficient to fund several of our drug candidates through Phase I and Phase II completion. Going forward, we will continue to identify new out-license and partnership opportunities, as well as drive R&D activities to bring the current pipeline to fruition." NeoLipid([R]) Platform NEOPHARM currently plans to initiate a Phase II trial for its LEP-ETU drug candidate in early 2008. This drug candidate is being tested for the treatment of breast cancer. The Company also plans to explore initiating patient enrollment for a new Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of LE-SN38 in mid-to-late 2008, for the treatment of triple negative breast cancer It is now commonly understood that breast cancer is not one form of cancer, but many different "subtypes" of cancer.[1] [2] These subtypes of breast cancer are generally diagnosed based upon the presence, or lack of, three "receptors" known to fuel most breast cancers: . Preclinical work continues on NEOPHARM's LE-DT formulation. Following the completion of this work in late 2007, the Company expects to thereafter be able to promptly file an IND. Assuming all regulatory requirements are met, NEOPHARM hopes to initiate a Phase I trial for this drug candidate in early 2008. The Company plans to complete reformulation of LE-rafAON, a compound being tested for its effectiveness in treating pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. , in late 2007. Additionally, NEOPHARM plans to amend its IND by the end of this year, followed closely by the patient enrollment for its Phase I trial. Cintredekin Besudotox (IL13-PE38QQR) NEOPHARM announced in June 2007, the exclusive licensing agreement with the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) for the use of Cintredekin Besudotox for the treatment of Pulmonary Fibrosis Pulmonary Fibrosis Definition Pulmonary fibrosis is scarring in the lungs. Description Pulmonary fibrosis develops when the alveoli, tiny air sacs that transfer oxygen to the blood, become damaged and inflamed. and Asthma. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the estimates of the National Foundation of Pulmonary Fibrosis, approximately 40,000 Americans die each year of this deadly disease. Pre-clinical studies performed at the NIH, FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. , appear to be promising, as they provided preliminary evidence of the reversal of the disease and its scarring in the animal models of IPF (Itanium Processor Family) See Itanium. when Cintredekin Besudotox is administered as a nebulized product. Based on this initial research, the Company believes that an important opportunity may exist for IL-13 for the treatment of Pulmonary Fibrosis and Asthma. As such, NEOPHARM expects to initiate a Phase I clinical trail in mid-2008. The Company continues to explore partnership opportunities and new drug delivery technologies for IL-13 for indication of recurrent GBM GBM 1 Glioblastoma multiforme, see there 2. Glomerular basement membrane . Currently Projected Trial Completion Dates [TABLE OMITTED] About NEOPHARM, Inc. NEOPHARM, Inc., based in Waukegan, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. Additional information, including ongoing clinical trials, can be obtained by visiting NEOPHARM's Web site at www.neopharm.com. Forward Looking Statements - This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "projects," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development programs, including, but not limited to projections regarding the initiation and completion of clinical trials involving the Company's drug candidates, projections regarding cash used in operations, costs associated with termination benefits, projected cost savings, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, difficulties or delays that may arise in the initiation and completion of clinical development, testing, regulatory approval, production, and marketing of the Company's drug and non-drug compounds, including, but not limited to, the Company's NeoLipid([R]) Platform drug candidates as well as Cintredekin Besudotox, with a reduced work force, the Company's possible need in the future to make reductions in funding of certain of its clinical development projects in order to conserve its cash resources, the ability of the Company to procure additional future sources of financing, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the calendar year ended December 31, 2006 and in its Quarterly Reports on Form 10-Q Form 10-Q See 10-Q. for the quarters ended March 31, 2007 and June 30, 2007. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results. |
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