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Farmas USA

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#65153

Re: Farmas USA

At the time of the analysis, 75% of patients treated with VAL-083 had survived longer than predicted following failure of bevacizumab therapy with supportive care and 48% of patients treated with VAL-083 survived longer than predicted following failure of bevacizumab and subsequent treatment with a range of salvage therapies.
Sakruti et al. (2014) reported that the median OS from the start of bevacizumab was 12.2 months (95% CI, 10.0, 14.3) with no significant difference in OS whether bevacizumab therapy was initiated following first, second or later GBM recurrence.

At the time of the analysis, 59% of patients treated with VAL-083 survived longer than predicted following initiation of bevacizumab therapy.
In the Phase I/II study of dianhydrogalactitol in patients with recurrent malignant glioma, at the time of the analysis:

6 month OS following initiation of VAL-083 treatment across all dose cohorts was 41.4%, with two additional patients from later cohorts still alive, but not yet reaching 6 month OS.
12 month OS following initiation of VAL-083 treatment across all dose cohorts was 17.2%, with four additional patients from later cohorts still alive, but not yet reaching 12 month OS.
Median OS for refractory GBM patients receiving VAL-083 at doses >30mg/m2 was approximately 9.0 months offering the potential of meaningful survival benefit in this patient population compared to other available treatment options.
Doses in DelMar's clinical trial exceed those utilized in prior NCI-sponsored clinical trials with VAL-083 in GBM.

DMPI

#65156

Re: Farmas USA

NVAX.

Estaba mirando un dato curioso. La anterior venta de acciones por parte del Modi fue el 17 (1,481 millones de títulos) y 20 (0,519 millones) de Noviembre de 2014.
Lo curioso de esas ventas es que se produjeron con el anuncio del inicio de la Fase 2 de la cuadrivalente el día 17 y con la concesión del Fast Track para el programa de mujeres embarazadas del RSV el día 20 de Noviembre.
El día 17 Novavax cayó un 7.39 con un volumen de 4,2 millones de títulos.
El día 20 Novavax subió un 4.13 con 3,6 millones de títulos.
El 17 de Noviembre sus ventas fueron 1/3 del volumen total y el precio cayó con fuerza.
El 20 de Noviembre el medio millón que vendió supuso alrededor de un 15% y eso freno el precio en un día con una noticia de gran calado como el Fast Track.
A los 4 meses de vender en 5$ el precio casi se duplicó.
No parece que Modi esté muy enterado en lo que se cuece en Novavax, en aquella ocasión aprovechó noticias para vender y el papel puesto en el mercado daño el precio de manera clara.
En esta ocasión un mayor número de títulos vendidos a un precio casi un 80% más elevado ha encontrado compras y apenas ha afectado a la cotización.
Eso es un claro síntoma de fortaleza de Novavax en mi opinión.

#65158

Re: Farmas USA

Se comenta que hay muchas incognitas no resueltas sobre el estudio. Composicion exacta del farmaco, por ejemplo.

Copio/pego post usano

This was a 42 person Phase 1 clincal trial comparing Mat9001 to Vascepa.. 

http://money.cnn.com/news/newsfeeds/articles/globenewswire/10136660.htm 

To begin with we do not know exactly what Mat9001 is. The only clue is that it is an Omega 3 mixture that contains DPA and other omega 3s..Presumably these would be EPA and DHA. Among claims from this 2 month study is that MAT9001 significantly lowers PCSK9 compared to Vascepa, which apparently does not lower PCSK9, so we do not know how important that statement is. Come to think of it we do not know how important lowering PCSK9 is except in case of genetic disorders. 

Mat9001 lowers trigs to a greater degree than EPA. So does DHA. We do not know much DHA is in Mat9001. DPA also lowers non HDL-C more than EPA, but this is not what you take EPA for. 

Jerome Jabbour apparently is the CEO of MTNB. HDG is this guy one of your relatives? 

They are in P1 at the FDA and have between 2 and 3 mil dollars on the balance sheet..Doesn't sound too safe to me. A lot of unknowns here. EPA and DPA are inter convertible, possibly EPA's conversion into DPA effects some of the cell membrane receptors and as such DPA would be a metabolite of EPA. DPA is present in fish oil at very much lower concentrations than EPA and procuring a sufficient supply may difficult, or not possible. Maybe Amarin can sell them some DPA from the separations. 

 

AMRN

#65159

Re: Farmas USA

Yo no lo había leído :)
Solo estaba mirando los últimos artículos de Napodano y me he encontrado con esto y os lo he subido por si era de interés. En todo caso uno es un fármaco aprobado y en el mercado (vascepa) y lo otro un estudio que aún está por per ver si algún día será aprobado.

AMRN