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

To: Jibacoa who wrote (339)	6/7/2005 3:54:39 PM
From: zeta1961	Respond to of 802

Bernard..ya' beat me to it!.. Calling London: we need some of those pounds-g- to get this in the clinic.. Zeta

To: Jibacoa who wrote (339)	6/8/2005 12:38:15 PM
From: zeta1961	Read Replies (2) \| Respond to of 802

IMCL with h/n announcement today.. Message 21397610 although INGN's target population is different for it's BLA..recurrent SCCHN..it didn't stop the inevitable haircut.. For context: my summary of ASCO '04 presentation Message 20210252 Next abstract presented by Dr. J.A. Bonner, chief PI for this international trial. Phase 111 study of high dose radiation with or without cetuximab in the treatment of locoregionally advanced squamous cell cancer of the HEAD and NECK(SCCHN). Authors ranged from the University of Alabama, Vall D'Hebron Hospital in Barcelona, Spain, U's of Wisconsin, Virginia, Radiation Oncology Ctr in Sacramento, CA; Johannesburg Hospital, South Africa, U of Colorado, and U of Texas M.D. Anderson Cancer Center in Houston, TX From the abstract: Methods: Patients with locoregionally advanced SCCHN(squamous cell cancer of the HEAD and NECK) with one of three high dose radiation treatment schedules, single daily fractions(26%), twice daily fractions(18%), or concomitant boost fractionation(56%) to a dose of 70Gy, at the discretion of the treating physician. Patients were stratified by the type of radiation and and prospectively randomized 1:1 to receive or not to receive cetuximab. Cetuximab was given IV at 400mg/m2 one week prior to the start of radiation and for seven weekly doses of 250mg/m2 during radiation. Endpoints included local regional control, time to progression, and survival.Results: 424 patients were entered and randomized, meeting target accrual of 416. Median age was 57; 80% male; 83% white; median Karnofsky score 90; the two cohorts were well balanced. Patients on the C arm were more likely to experience fever/chills(38%/16%) and nausea vomiting(53%/41%) but not fatigue/malaise(56%/50%) or stomatitis(91%/93%) Rash was common in both groups, but more common in the C group (97%/90%); grade 3 rash(34%/18%). Six patients(3%) on the C arm experienced grade 3 or 4 allergic reactions. Presentation made by J.A. Bonner the principle investigator of the trial. I'll try to report everything he said, but the slides were gone through too rapidly for me to write down many figures...those with the digital cameras photographing the slides definitely with an edge... All patients were chemo/radiation naive...consisted of stage 1-4 disease, some patients had surgical dissection, salvage surgery, secondary radiation and chemotherapy during study...this has always puzzled me: re how it influenced outcome but it appears the independent panel reporters must have seen balance for them to put out the positive report today.. Overall survival was 54mos for C arm and 28 months for Radiation arm.P value?....slides too fast, but definitely under 0.05. Locoregional control 57% for C arm, 44% Radiation arm. P value=O.02(this I'm sure of)... Given the concommitant boost was used 56% vs 26/18% conventional standard radiation, wondering how this group influenced survival Don't matter..this population needs an alternative to conventional chemo.. Zeta