NeoPharm, Inc. (Nasdaq:NEOL):
-- Enrollment in PRECISE Trial Surpasses 250 Patients
-- Reconfirms Projected Enrollment Completion By Year-End 2005
-- Project Support Activities Progress for Potential BLA
Submission in 2006
-- Updated Phase I/II Survival Data Continues to be Positive
NeoPharm, Inc. (Nasdaq:NEOL) today announced that its pivotal Phase III PRECISE trial for its lead drug product candidate cintredekin besudotox randomized its 250th patient earlier in the month of September, and reconfirmed its year-end 2005 enrollment completion target for the study.
"We are highly-focused on completing enrollment in our PRECISE trial and continuing our preparations for a possible Biologic License Application (BLA) submission in 2006," said Ronald G. Eidell, NeoPharm's President and Chief Executive Officer. "We recently received the FDA's approval of our Special Protocol Assessment amendment covering our interim efficacy analysis for the PRECISE Trial, which could potentially lead to submitting a BLA at an earlier point in time than would otherwise be the case. We also recently amended our agreement with Diosynth Biotechnology, a business unit of Akzo Nobel, to provide us with validation and conformance lot manufacturing for cintredekin besudotox, which will be necessary in support of any potential application for approval."
The Company also announced updated Phase I/II survival data, originally presented in May 2005 by Dr. Sandeep Kunwar at the World Federation of Neuro-Oncology (WFNO) in Edinburgh, Scotland (Poster Presentation - "Peritumoral Convection Enhanced Delivery of IL13-PE38QQR - Results of Multicenter Phase I Studies in Recurrent High Grade Glioma") which included results from three clinical studies in which peritumoral Convection Enhanced Delivery (CED) of cintredekin besudotox following tumor resection was evaluated.
The updated overall survival data, which was current as of July 18, 2005, for the 45 patients with confirmed recurrent GBM in the three studies who received peritumoral infusion of cintredekin besudotox continue to have a median of 44 weeks after a single treatment. Ten patients are still being monitored for survival; the length of follow-up for these 10 patients ranges from 48 to 215 weeks, with a median of 98 weeks.
As previously reported, optimal catheter positioning (defined in footnote 1 below) for CED appears to improve survival, with a median survival of almost 52 weeks for the 26 patients in the Phase I/II studies who were determined to have received optimal catheter positioning.
GBM Patients Treated With cintredekin besudotox Via Peritumoral CED
Overall Median Survival by Catheter Positioning Score
Data as of July 18, 2005
Median Lower CI(a) Upper CI(a)
------ ----------- -----------
Overall (n=45) 44.0 36.1 55.6
(1) Optimal Catheter Placement
(n=26) 51.7 36.1 78.0
(1) Sub-Optimal Catheter
Placement (n=19) 39.3 29 51.9
(1) = Catheter positioning is assessed via an objective scoring
system based on catheter depth from brain surfaces, including
any intervening brain structures along the catheter
trajectory, as well as proximity to the tumor resection
(a) = 95% Confidence Interval
"The survival data has further matured and remained positive since March 31, 2005, the data point which was used for Dr. Kunwar's WFNO poster presentation on May 6, 2005," continued Eidell. "These Phase I/II data are encouraging, and continue to support the assumptions we used in planning the PRECISE Trial."
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 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, 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 suppliers, uncertainty as to the ability to consistently attain optimal catheter positioning, 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.
CONTACT: NeoPharm, Inc.
Paul Arndt, 847-295-8678 x 215
SOURCE: NeoPharm, Inc.