NeoPharm Investigators Present Results of IL13-PE38QQR Multicenter Phase I Clinical Studies at the World Federation of Neuro-Oncology -- Prolonged Overall Median Patient Survival Observed
Posted on: 05/07/2005
NeoPharm Investigators Present Results of IL13-PE38QQR Multicenter Phase I Clinical Studies at the World Federation of Neuro-Oncology; -- Prolonged Overall Median Patient Survival Observed
May 06, 2005 09:00 AM US Eastern Timezone
LAKE FOREST, Ill.--(BUSINESS WIRE)--May 6, 2005--NeoPharm (Nasdaq:NEOL) today announced that updated combined data from three Phase I studies of cintredekin besudotox ("IL13-PE38QQR") in brain cancer patients were presented at the Second Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO), held in conjunction with the Sixth Meeting of the European Association for Neuro-Oncology (EANO) in Edinburgh, Scotland, from May 5-8, 2005. The poster, entitled "Peritumoral Convection-Enhanced Delivery of IL13-PE38QQR (IL13PE): Results of Multicenter Phase I Studies in Recurrent High Grade Glioma (HGG)" was presented by Sandeep Kunwar, MD, of the University of California-San Francisco, and Principal Investigator of the Company's PRECISE trial, on May 6, as part of a poster and poster discussion session.
The combined data presented by Dr. Kunwar included results from 51 patients from three clinical studies in which peritumoral Convection Enhanced Delivery (CED) of cintredekin besudotox following tumor resection was evaluated. The overall median survival for the 45 patients in the three studies who received peritumoral infusion of cintredekin besudotox is 44 weeks. Six patients from the studies remain progression free, with a survival range of 39+ to 190+ weeks (median 89+ weeks) after a single treatment. In addition, optimal catheter placement (defined in footnote 1 below) appears to further improve median survival.
Median Lower CI(a) Upper CI(a)
Overall (n=45) 44.0 36.1 52.4
Placement (n=26) 51.7 36.1 78.0
Placement (n=19) 39.3 29.0 51.9
(1) = Catheter placement is an objective score 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 cavity.
(a) = 95% Confidence Interval
"The observed overall median survival for the 45 patients in these studies who received peritumoral infusion of cintredekin besudotox is 44 weeks, in contrast to the 28 weeks observed with currently approved treatment options. I believe that the overall median survival data for these 45 patients continue to support the planning assumptions used for the Company's pivotal Phase III PRECISE trial," said Dr. Kunwar.
Of the 51 patients who were treated in the three studies, 45 had histologically confirmed recurrent resectable GBM (Cohort 1, n=39, Cohort 2, n=3, Cohort 3, n=3). Four patients were diagnosed with anaplastic astrocytoma and two were diagnosed with anaplastic oligoastrocytoma, and were not included in the median survival calculations. The studies included in the poster were:
1. IL13PEI-002 - Dose regimen and catheter placement
2. IL13PEI-103R02 - Peritumoral infusion with deferred catheter
3. IL13PEI-105 - CED imaging assessment with 123-I-Human Serum
Albumin tracer + IL13PE38QQR (n=6)
These studies include the patient population study data previously presented at the American Association of Neurological Surgeons ("AANS") annual meeting in April 2005, and an additional nine patients from the two additional study cohorts mentioned above.
Patient follow-up continues for survival. The findings of the studies were used to develop the treatment regimen and catheter placement guidelines for the ongoing Phase III PRECISE trial (www.precisetrial.com), which include:
-- A 0.5ug/mL peritumoral infusion of cintredekin besudotox via CED for 96 hours
-- Deferring catheter placement 2-4 days after tumor resection which increases optimal catheter placement accuracy from 53% intra-operative to 83% post-resection.
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 clinical trials including cintredekin besudotox, future patient survival in and the Company's ongoing Phase I studies and 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, directly or through independent distributors, 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.
Paul Arndt, 847-295-8678 x 215
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