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

To: tuck who wrote (772)	5/28/2008 5:53:19 PM
From: Jibacoa	Read Replies (3) \| Respond to of 802

In this rehash for ASCO, INGN again claims improved survival in H&N cancer, but it turns out it's only in the ITT group, and there only for those with "p53 favorable profiles"; no difference overall. It seems that the PIII met its goals, but the shorts still have the upper hand.<g> At the last report the short position was > 44x the ADV. Stock is tanking to near all time lows on the "positive news" Yes, the stock was down 26.79% during the regular session & continued to drift down some AHs until a few minutes ago.<g> But it is still above its Sep 2002 L of $1.35 & remember that by June 2003 it was up to $10.16 & by Sep 2003 $11.24 so it seems it is still to early to tell what the final outcome will be, especially since the insiders & institutions hold a good % of the float.<g> finance.yahoo.com In the report from Reuters, the analyst from Canaccord Adams still has it as a "buy" with a "target" of $9.50 <g> reuters.com By Jennifer Robin Raj BANGALORE, May 28 (Reuters) - Introgen Therapeutics Inc said its experimental gene therapy, Advexin, met goals in a late-stage head and neck cancer study, but shares fell as the drug did not improve survival in certain patients. The study's main aim, which was met, was to demonstrate the clinical benefit of Advexin compared with chemotherapy drug methotrexate and the results showed statistically significant survival in a subset of patients being tested. However, the entire test population did not show a difference in survival versus methotrexate, though Advexin had a much superior safety profile with moderate side effects. "It (the trial) doesn't have to show improved survival. For example, just showing that it helps different patients - that satisfies the objective," said Robert Sobol, Introgen's senior vice president of medical and scientific affairs. Sobol said the study results were sufficient for regulators and the company expects to submit a marketing application by the end of June. Canaccord Adams analyst Joseph Pantginis called the results a "net positive with potential source of confusion." "Conventionally thinking, when you look at a phase III trial, you are looking for superiority with regard to efficacy...(but) here you are adding on several layers to show why Advexin could be promising for these patients," Pantginis said by phone The analyst reiterated his "buy" rating and a 12-month price target of $9.50 on the stock. STUDY MEETS PROTOCOL Advexin targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation. Normal p53 gene suppresses tumors and protects against cancer. Introgen said it believes the application of p53 biomarkers, or tests which predict response to treatment or increased survival following therapy, can help in showing which patients would be most likely to benefit from Advexin. The main goal of the study was survival with increased safety in the intent-to-treat (ITT) or biomarker populations and the secondary goal was tumor growth control with superior safety in the ITT or biomarker populations. "The study was a success according to the protocol," analyst Pantginis said. "The true measure of Advexin... is that the p53 biomarker data could clearly identify patients who could benefit and guide physician treatment decisions as well as having a clearly superior safety profile," Pantginis added. A patient death associated with methotrexate was reported, while no patient deaths were associated with Advexin, the company said in its statement. The ITT population included all patients -- those with p53 favorable and p53 unfavorable profiles. Advexin significantly improved survival, tumor responses in end-stage head and neck cancer patients with p53 favorable profiles, the company said. I was out of town & missed today's action on the stock. Apparently it did OK earlier after the "positive news".<g> ADVEXIN(R) Improves Survival in Recurrent, Refractory Head and Neck Cancer Patients Wednesday May 28, 6:00 am ET AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News): Highlights: * First Phase III Gene Therapy Cancer Trial in the US to Successfully Meet Study Objectives * Primary and Secondary Efficacy Endpoints Successfully Met, Study Objective Achieved * p53 Predictive Biomarkers Demonstrate ADVEXIN and Methotrexate Efficacy in Different and Complementary Patients * Clinical Utility of ADVEXIN in Comparison to Methotrexate Demonstrated RAGL Bernard

To: tuck who wrote (772)	5/30/2008 12:01:13 PM
From: tuck	Read Replies (1) \| Respond to of 802

>>Correction to Press Release Dated May 28, 2008: ADVEXIN(R) Improves Survival in Recurrent, Refractory Head and Neck Cancer Patients Thursday May 29, 3:14 pm ET AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News) announced today the following correction to its press release dated May 28, 2008 and titled “ADVEXIN® Improves Survival in Recurrent, Refractory Head and Neck Cancer Patients.” The correction pertains to the median survival in the ITT population. The correct information is: “As expected from the p53 biomarker profiles data indicating efficacy in different patients, there was no statistical difference in survival between ADVEXIN and methotrexate in the ITT population which included both p53 favorable and unfavorable patients in both study arms (median survival 4.4 vs. 6.1 months; p = 0.236).” To access the full data presentation presented at the American Society for Gene Therapy annual meeting in Boston earlier today, visit the Events page on Introgen’s web site at www.introgen.com. About Introgen Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle tumor suppressor therapies to treat a wide range of cancers using tumor suppressors, cytokines and genes. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility. Forward-Looking Statements Statements in this release that are not strictly historical may be “forward-looking” statements, including those relating to Introgen’s future success with its ADVEXIN clinical development programs for treatment of cancer and the use of biomarker data to support the regulatory approval of ADVEXIN and improve the care of patients. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen’s operations and business environment, including Introgen’s stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen’s product candidates, the ability to obtain the appropriate regulatory approvals, Introgen’s patent protection and market acceptance, as well as other risks detailed from time to time in Introgen’s filings with the Securities and Exchange Commission including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof. The data, opinions and conclusions presented in this release and in the above referenced ASGT presentation are preliminary. This information and additional relevant information have not yet been presented in their entirety to the U.S. Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA) or other regulatory authorities; although we anticipate submitting materially all of this information to the FDA, EMEA and corresponding foreign authorities in the future. Only the FDA, EMEA and corresponding regulatory agencies have the authority to approve pharmaceutical products. We cannot predict how such authorities may interpret the information contained in this release and the referenced ASGT presentation or may respond to our regulatory submissions. Editor's Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen’s Website at: www.introgen.com. << snip This might explain why the stock dropped back after the presentation, and is again below two bucks. Lucky for INGN the difference wasn't stat sig, because there was a trend towards patients doing worse on Advexin. Nor, in the May 28th release, did they say anything about what kind of survival number they were talking about: mean, median, or what. Cheers, Tuck