NeoPharm Announces PRECISE Trial Update.
--No Impact Expected On PRECISE Trial From September 30th BrainLAB AG Patent Infringement Ruling
--Patient Enrollment at 255 as of end of September
--Company Reconfirms Expected 2005 Enrollment Completion
NeoPharm, Inc. (Nasdaq:NEOL) today announced that it expects no impact on the Company's pivotal Phase III PRECISE Trial as a result of a jury decision in a long-standing patent dispute between Medtronic, Inc. and BrainLAB AG. BrainLAB supplies study support services to the Company in connection with PRECISE. NeoPharm has received assurances from BrainLAB AG representatives that this decision will not impact BrainLAB's ability to continue to provide study support services surrounding assessment of catheter planning and placement for PRECISE. None of the Company's cintredekin besudotox study protocols have a stipulation that requires any specific surgical navigation system for catheter planning and placement, such decisions being left entirely to the discretion of each study site.
In addition, the Company also released today the number of patients enrolled in PRECISE. As of September 30, 2005, 255 patients have been enrolled, including a total of 45 patients enrolled in the third quarter of 2005. The evacuation of the coastal areas of Texas brought on by Hurricane Rita had a negative impact on late September enrollment. Patients scheduled to be enrolled at M. D. Anderson Cancer Center in Houston, Texas, were shifted into October due to the hurricane. These patients, as well as patients identified by other trial sites, have been targeted for October enrollment. Assuming the company continues to enroll an average of 15 patients per month, the third quarter 2005 average, PRECISE trial enrollment will be completed by December 31, 2005.
PRECISE, an acronym for Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, is a randomized, controlled Phase III clinical trial. It is designed to compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with patients receiving GLIADEL(R) Wafer in the treatment of first recurrent GBM following surgical tumor resection (removal). Patients are randomized so that 200 patients receive cintredekin besudotox via Convection Enhanced Delivery (CED) using catheters placed following the resection, and 100 patients receive GLIADEL(R) Wafer placed at the time of resection. Enrollment in PRECISE, www.precisetrial.com, is expected to be completed in the fourth quarter of 2005.
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Forest, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. The Company has a portfolio of cancer compounds in various stages of development. Additional information can be obtained by visiting NeoPharm's Website at www.neophrm.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," "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 program, including, but not limited to the PRECISE trial and other clinical studies involving cintredekin besudotox, future patient enrollment in the Company's PRECISE trial, business partners providing services in the Company's PRECISE trial, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, obtaining regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, cintredekin besudotox, uncertainty regarding the availability of third party production capacity, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug and non-drug compounds, including, but not limited to, cintredekin besudotox, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products, including, but not limited to, cintredekin besudotox, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, cintredekin besudotox, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its annual reports on Form 10-K and quarterly reports on Forms 10-Q. 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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|Date:||Oct 3, 2005|
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