GNBT - Joe Moscato we believe in you (again) - tomo OTTO

ilpensionato · 31-12-11, 12:03

GNBT - Joe Moscato we believe in you - Tomo SETTE

veniamo da qui

31-12-2011 parte oggi il nuovo treddo.........e che il 2012 sia l'anno buono

Gianfe1 · 31-12-11, 18:42

Un augurio di buon anno a tutti!!!

buttonman crash · 01-01-12, 19:39

Citazione:

Originalmente inviato da Gianfe1

Un augurio di buon anno a tutti!!!

L'importante è esserne convinti.

Anche una torta di mer.a con la ciliegina di scarafaggio può essere buona se non c'è altro da mangiare...

ilnazareno · 01-01-12, 20:03

Citazione:

Originalmente inviato da buttonman crash

L'importante è esserne convinti.

Anche una torta di mer.a con la ciliegina di scarafaggio può essere buona se non c'è altro da mangiare...

Oddio...e' tornato il coprolaliaco...

Gianfe1 · 01-01-12, 21:54

Citazione:

Originalmente inviato da ilnazareno

Oddio...e' tornato il coprolaliaco...

No, perchè? Io lo trovo tanto simpatico.

kyro · 02-01-12, 11:33

Il 2012 comincia con la pubblicazione dei dati del SABCS.
Spicca il 99% degli effetti collaterali inferiore al grado 2 e la superiorità di AE37 sia sul nativo che sul ramo di controllo, quest'ultimo nella risposta immunitaria DTH è addirittura a zero.

Fra 4 mesi ci saranno 200 pazienti del ramo AE37 con follow up di 36 mesi e la FDA classifica come guarigione da cancro la DSF proprio a 36 mesi (disease free survival). Vediamoli allora questi dati di sopravvivenza... ormai non ci fanno più paura!

Oggi mi piacerebbe un +15%, tanto per cominciare bene l'anno...

[P1-13-01] An Update of a Phase II Trial of the HER2 Peptide AE37 Vaccine in Breast Cancer Patients To Prevent Recurrence.

Hale DF, Perez S, Sears AK, Clifton GT, Vreeland TJ, Holmes JP, Ardavanis A, Pistamaltzian N, Rellias G, Ponniah S, Papamichail M, Peoples GE, Mittendorf EA. Brooke Army Medical Center, Ft. Sam Houston, TX; Saint Savas Cancer Hospital, Athens, Greece; Naval Medical Center San Diego, San Diego, CA; Uniformed Services University of the Health Sciences, USMCI, Bethesda, MD; UT M.D. Anderson Cancer Center, Houston, TX

Introduction

AE37 is the Ii-Key hybrid of the HER2-derived peptide AE36 (HER2:776-790). A phase I trial administering AE37 with the immunoadjuvant GM-CSF demonstrated the vaccine to be safe and capable of stimulating CD4+helper T-cells with HER2-specific anti-tumor activity. Here we present an update of our prospective, randomized, single-blinded, phase II trial of the AE37 vaccine for the prevention of breast cancer recurrence in disease-free, high risk patients.

Methods

After completion of standard therapy, disease-free, node positive or high risk node negative breast cancer patients were randomized to receive either AE37+GM-CSF (vaccine) or GM-CSF alone (control) in six monthly intradermal inoculations. Patients were enrolled with any level of HER2 expression, (IHC 1+ 2+ or 3+). Specific immunologic responses to both AE36 and AE37 were evaluated in all patients at pre-determined intervals: before (RO), mid-series (R3), upon completion (R6), and at six (RC6) and 12 (RC12) months after completion of the vaccine series. In vitro responses were measured using the [3H]-thymidine incorporation assay and in vivo responses using delayed-type hypersensitivity (DTH) reactions. The trial's primary endpoint is disease recurrence.

Results

To date, 215 patients have enrolled (vaccine=92, control=123). 99% of local and systemic toxicities were ≤grade 2 or less. There were no grade 4-5 local or systemic toxicities and no difference between toxicity profiles of vaccine and control groups. Vaccine patients exhibited a statistically significant increase from baseline in AE36 and AE37 proliferative responses at each time point, including maintenance of this response up to 12 months post-vaccination (AE36 (cpm): R0=0, R3=1335, R6=1242, RC6=1586, RC12=1360; AE37: R0=0, R3=2859, R6=2300, RC6=3235, RC12=3279, p<0.001) while there have been no proliferative changes for control patients (AE36: R0=91, R3=95, R6=97, RC6=126, RC12=48; AE37: R0=291, R3=399, R6=319, RC6=103, RC12=0). Vaccine patients also had statistically significant increases in DTH reactions to both AE36 and AE37 (AE36 (mm): R0=0, R6=15, RC6=15, RC12=15; AE37: R0=0, R6=24, RC6=17, RC12=20 p=<0.001) while controls had no response (AE36: R0, R6, RC6, RC12=0; AE37: R0, R6, RC6, RC12=0). With a median follow up of 17 months, breast cancer recurrences were reduced by 42% in vaccine patients compared to control patients (7.6% vs. 13.2%, p=0.15). In an analysis of patients with low HER2 expression (IHC 1 or 2+), vaccine patients experienced a 49% reduction in recurrence compared to controls (9.5% vs. 18.6%, p=0.16) with no reduction seen in HER2 over-expressing patients (6.0% vs. 7.9%, p=0.49).

Conclusions

The AE37 vaccine is safe and well tolerated with only mild toxicity, which is attributable to the GM-CSF immunoadjuvant. The AE37 vaccine elicits strong peptide specific in-vivo and ex-vivo immune responses, which are maintained for 12 months after completion of the vaccine series. While the number of recurrences are still low, the recurrence rate appears to decrease in vaccinated patients. Administration of the AE37 vaccine may reduce the risk of breast cancer recurrence with the greatest benefit in patients with low levels of HER2 expression.

Result Content View

Questo è il poster
http://www.abstracts2view.com/sabcs1...hp?nu=P1-13-01

il-parigino7 · 02-01-12, 11:42

E oggi come andra' GNBT sul mercato?
grazie delle v.s. previsioni

ilpensionato · 02-01-12, 11:57

Citazione:

Originalmente inviato da il-parigino7

E oggi come andra' GNBT sul mercato?
grazie delle v.s. previsioni

oggi ?
beh oggi posso farti la previsione piu precisa del mondo

U.S. Economic Calendar

kyro · 02-01-12, 12:40

Citazione:

Originalmente inviato da ilpensionato

oggi ?
beh oggi posso farti la previsione piu precisa del mondo

U.S. Economic Calendar

Chiusoooooooooooo!

Allora per domani voglio un +20%

avion65 · 02-01-12, 12:42

Buon giorno e buon 2012 a tutti.

31-12-11, 12:03	#1 (permalink)
ilpensionato I have no dreams Data registrazione: Dec 2009 Messaggi: 5,991 Popolarità: 42949675	GNBT - Joe Moscato we believe in you (again) - tomo OTTO GNBT - Joe Moscato we believe in you - Tomo SETTE veniamo da qui 31-12-2011 parte oggi il nuovo treddo.........e che il 2012 sia l'anno buono

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31-12-11, 18:42	#2 (permalink)
Gianfe1 Member Data registrazione: Jan 2009 Messaggi: 600 Popolarità: 8605273	Un augurio di buon anno a tutti!!!

02-01-12, 11:33	#6 (permalink)
kyro Member Data registrazione: Feb 2004 Messaggi: 1,706 Popolarità: 42949681	Il 2012 comincia con la pubblicazione dei dati del SABCS. Spicca il 99% degli effetti collaterali inferiore al grado 2 e la superiorità di AE37 sia sul nativo che sul ramo di controllo, quest'ultimo nella risposta immunitaria DTH è addirittura a zero. Fra 4 mesi ci saranno 200 pazienti del ramo AE37 con follow up di 36 mesi e la FDA classifica come guarigione da cancro la DSF proprio a 36 mesi (disease free survival). Vediamoli allora questi dati di sopravvivenza... ormai non ci fanno più paura! Oggi mi piacerebbe un +15%, tanto per cominciare bene l'anno... [P1-13-01] An Update of a Phase II Trial of the HER2 Peptide AE37 Vaccine in Breast Cancer Patients To Prevent Recurrence. Hale DF, Perez S, Sears AK, Clifton GT, Vreeland TJ, Holmes JP, Ardavanis A, Pistamaltzian N, Rellias G, Ponniah S, Papamichail M, Peoples GE, Mittendorf EA. Brooke Army Medical Center, Ft. Sam Houston, TX; Saint Savas Cancer Hospital, Athens, Greece; Naval Medical Center San Diego, San Diego, CA; Uniformed Services University of the Health Sciences, USMCI, Bethesda, MD; UT M.D. Anderson Cancer Center, Houston, TX Introduction AE37 is the Ii-Key hybrid of the HER2-derived peptide AE36 (HER2:776-790). A phase I trial administering AE37 with the immunoadjuvant GM-CSF demonstrated the vaccine to be safe and capable of stimulating CD4+helper T-cells with HER2-specific anti-tumor activity. Here we present an update of our prospective, randomized, single-blinded, phase II trial of the AE37 vaccine for the prevention of breast cancer recurrence in disease-free, high risk patients. Methods After completion of standard therapy, disease-free, node positive or high risk node negative breast cancer patients were randomized to receive either AE37+GM-CSF (vaccine) or GM-CSF alone (control) in six monthly intradermal inoculations. Patients were enrolled with any level of HER2 expression, (IHC 1+ 2+ or 3+). Specific immunologic responses to both AE36 and AE37 were evaluated in all patients at pre-determined intervals: before (RO), mid-series (R3), upon completion (R6), and at six (RC6) and 12 (RC12) months after completion of the vaccine series. In vitro responses were measured using the [3H]-thymidine incorporation assay and in vivo responses using delayed-type hypersensitivity (DTH) reactions. The trial's primary endpoint is disease recurrence. Results To date, 215 patients have enrolled (vaccine=92, control=123). 99% of local and systemic toxicities were ≤grade 2 or less. There were no grade 4-5 local or systemic toxicities and no difference between toxicity profiles of vaccine and control groups. Vaccine patients exhibited a statistically significant increase from baseline in AE36 and AE37 proliferative responses at each time point, including maintenance of this response up to 12 months post-vaccination (AE36 (cpm): R0=0, R3=1335, R6=1242, RC6=1586, RC12=1360; AE37: R0=0, R3=2859, R6=2300, RC6=3235, RC12=3279, p<0.001) while there have been no proliferative changes for control patients (AE36: R0=91, R3=95, R6=97, RC6=126, RC12=48; AE37: R0=291, R3=399, R6=319, RC6=103, RC12=0). Vaccine patients also had statistically significant increases in DTH reactions to both AE36 and AE37 (AE36 (mm): R0=0, R6=15, RC6=15, RC12=15; AE37: R0=0, R6=24, RC6=17, RC12=20 p=<0.001) while controls had no response (AE36: R0, R6, RC6, RC12=0; AE37: R0, R6, RC6, RC12=0). With a median follow up of 17 months, breast cancer recurrences were reduced by 42% in vaccine patients compared to control patients (7.6% vs. 13.2%, p=0.15). In an analysis of patients with low HER2 expression (IHC 1 or 2+), vaccine patients experienced a 49% reduction in recurrence compared to controls (9.5% vs. 18.6%, p=0.16) with no reduction seen in HER2 over-expressing patients (6.0% vs. 7.9%, p=0.49). Conclusions The AE37 vaccine is safe and well tolerated with only mild toxicity, which is attributable to the GM-CSF immunoadjuvant. The AE37 vaccine elicits strong peptide specific in-vivo and ex-vivo immune responses, which are maintained for 12 months after completion of the vaccine series. While the number of recurrences are still low, the recurrence rate appears to decrease in vaccinated patients. Administration of the AE37 vaccine may reduce the risk of breast cancer recurrence with the greatest benefit in patients with low levels of HER2 expression. Result Content View Questo è il poster http://www.abstracts2view.com/sabcs1...hp?nu=P1-13-01

02-01-12, 11:42	#7 (permalink)
il-parigino7 Member Data registrazione: Mar 2010 Messaggi: 265 Popolarità: 1608431	E oggi come andra' GNBT sul mercato? grazie delle v.s. previsioni

02-01-12, 12:42	#10 (permalink)
avion65 Member Data registrazione: Aug 2010 Messaggi: 1,026 Popolarità: 13303065	Buon giorno e buon 2012 a tutti.

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