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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (2339)	4/14/2008 11:07:48 PM
From: Jibacoa	Read Replies (1) \| Respond to of 3722

INGN started with an UG today after the announcement of the "presentation" at the AACR meeting during the weekend, but if couldn't deal with the resistance above the $3.50 level & came down with the rest of the market, closing down $0.04 for the day.<g> bigcharts.marketwatch.com New Phase III Data Confirm Phase II Findings of ADVEXIN(R) Efficacy Sunday April 13, 4:00 pm ET Data Highlight p53 Biomarker Prediction of ADVEXIN(R) Clinical Benefit AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News) today announced that ADVEXIN® Phase III clinical trial data in patients with recurrent head and neck cancer confirm earlier Phase II results of ADVEXIN efficacy. Biomarkers of the p53 tumor suppressor gene target of ADVEXIN treatment were predictive in selecting patients more likely to respond to ADVEXIN, a targeted tumor suppressor therapy being investigated for a number of solid tumor cancers. Abnormal p53 tumor suppressor function is associated with cancer initiation, progression and treatment resistance and is one of the most fundamental and common molecular defects in cancers. Preliminary results from the phase III trial were presented today at the American Association for Cancer Research (AACR) annual meeting in San Diego, California. To access the AACR presentation please visit the Events page at www.introgen.com. “ADVEXIN provides therapeutic benefit by restoring p53 tumor suppressor function which is blocked in the majority of head and neck cancers,” said Robert E. Sobol, MD, senior vice president, Medical and Scientific Affairs, Introgen. “The strength of these p53 biomarker data provides important insights to help guide the future use of ADVEXIN treatment while advancing the field of personalized cancer care.” These data were generated from a phase III study that prospectively evaluated patients with biomarkers identified from earlier clinical studies. These results confirm the predictive value of p53 biomarkers hypothesized from previous phase I and II ADVEXIN clinical trials. The earlier studies included patients with recurrent squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer, prostate cancer and Li-Fraumeni Syndrome cancers. Previously reported preliminary results demonstrated a strong correlation between p53 biomarkers and increased tumor responses and survival following ADVEXIN therapy. In the Phase III recurrent head and neck cancer trial, tumor response was correlated with a statistically significant increased survival. Importantly, p53 profiles favorable for ADVEXIN efficacy demonstrated a highly statistically significant correlation between ADVEXIN efficacy and tumor response. An analysis from recurrent SCCHN patients treated with ADVEXIN monotherapy in phase I, II and III trials showed tumor response in 79 percent of patients with p53 biomarkers favorable for ADVEXIN efficacy compared to 25 percent of patients with unfavorable p53 biomarkers for ADVEXIN (p=0.004 by Fisher’s Exact Test). “We are pleased with these positive preliminary phase III results,” said Max W. Talbott, PhD, senior vice president, Regulatory and Worldwide Commercial Development, Introgen. “The Biological Activity Markers were incorporated into the original phase III study protocols and the finalized phase III Statistical Analysis Plan. Populations and endpoint combinations shown in this presentation were all prospectively identified.” A comprehensive analysis of Introgen’s phase III data and additional pivotal studies of ADVEXIN in recurrent head and neck cancer, including prospective biomarker analyses demonstrating statistically significant correlations between p53 biomarkers and increased response and survival following ADVEXIN therapy, will be presented at medical conferences later this year. These and other data will be the basis for regulatory submissions in the United States and in Europe as previously reportrd. Snip Bernard