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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: zeta1961 who wrote (14286)	11/22/2004 5:50:59 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 52153

OT, brain cancer or GBM. I think that this data are for real. Press Release Source: NeoPharm, Inc. New and Updated IL13-PE38QQR Phase I/II Data Presented at the 9th Annual Meeting of the Society for Neuro-Oncology Monday November 22, 7:00 am ET Optimal Catheter Placement and Prediction of Drug Distribution is Focus of NeoPharm Sponsored Clinical Study LAKE FOREST, Ill.--(BUSINESS WIRE)--Nov. 22, 2004-- NeoPharm, Inc. (Nasdaq:NEOL - News) announced that new and updated Phase I/II trial data for its tumor-targeting compound IL13-PE38QQR were presented by John H. Sampson, MD, PhD, Associate Professor of Surgery and Assistant Professor of Pathology at Duke University on November 20th at the 9th Annual Meeting of the Society for Neuro-Oncology, held from November 18-21 in Toronto, Canada. The oral presentation was entitled "Convection-Enhanced Delivery of IL13-PE38QQR in Malignant Glioma: Comparison of Observed and Predicted Drug Distribution." ADVERTISEMENT "We are pleased with the results of this Phase I study," said Gregory P. Young, NeoPharm's President and Chief Executive Officer. "Optimizing catheter positioning in the Company's ongoing Phase III PRECISE Trial will help to maximize the efficacy of IL13-PE38QQR when administered to patients with recurrent glioblastoma multiforme (GBM)." Dr. Sampson's clinical study was based on observations to date from NeoPharm's other Phase I/II IL13-PE38QQR clinical trials indicating an increase in median survival is associated with optimal (70.3 weeks) vs. sub-optimal (41.4 weeks) catheter placement in the peritumoral setting. The median survival for this same patient population, according to publications of clinical studies with other treatments, is 20-26 weeks. Although not designed to be an efficacy study, the Dr. Sampson's study was designed to assess the effect of catheter positioning on drug distribution using a radioactive labeled iodine human serum albumin (123I-HSA) as a surrogate imaging tracer. This study also examined the predictive value of computer software in assessing drug distribution. In a previous poster presentation at the American Association of Neurological Surgeons (AANS) meeting in May of this year, Dr. Sampson compared the distribution of the drug when catheters were positioned according to the guidelines used in the PRECISE trial to the distribution of the drug when the positioning of the catheters did not meet these criteria. The drug distribution was assessed using radiologic imaging, including spectroscopy and MRI scans. At the SNO meeting, Dr. Sampson updated these results and also showed how using computer software could potentially help surgeons better position catheters. "The findings from this imaging study have helped to advance our understanding of how to administer agents such as IL13-PE38QQR by CED," commented John Sampson, MD, PhD, Associate Professor of Surgery and Assistant Professor of Pathology at Duke University. "The study findings also support the catheter positioning guidelines being used in the IL13-PE38QQR PRECISE Study." IL13-PE38QQR has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA). NeoPharm's IL13-PE38QQR development program was also selected to participate in the FDA Continuous Marketing Application Pilot 2 Program. Currently, IL13-PE38QQR is the subject of the ongoing Phase III "PRECISE" clinical trial (www.precisetrial.com) in patients with recurrent GBM.