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 |
