España
no lo sabemos de momento en el clinicaltrial pone q la última vez q se produjo una revisión fue en abril, merck dice q para mediados de año yo pienso q todavía no se producido el nº de eventos pero q están al caer. cualquiera sabe pero desde thld son bastante reservados asón q ......
esto forma parte del juego si no sería muy fácil.
me sigo preguntando por q han iniciado una fase 1 páncreas en japón, será por el tema de comercialización???
bueno supongo q sea cual sea la respuesta por lo menos muestra confianza
A ver si se animan y sacan ya la artilleria pesada con la info de sarcoma.
@HELLOAGAIN, como dice HIRO , a saber que pasa con el interim data de sarcoma ...
Mañana intentaré mirarme la conference de hoy.
Mientras tanto ahí dejo un gráfico y una sugerencia fea ... y otra que no lo es tanto
Hola Framus.
¿Algo nuevo en esto?
Jefferies Presentation, Part 1.Here are just a few highlights from today's presentation. Nothing new or earth shattering, but another strong indication as to where THLD and TH-302 are going.
Dr. Selick made note of the fact that TH-302 continues to show a "remarkably consistent profile with respect to both safety and efficacy" in a wide range of cancers and tumor types. TH-302 is fast approaching dosing in almost 1,000 patients in more than 12 different tumor types both in combination and mono therapy. TH-302 "is clearly and active agent in oncology".
Dr. Selick seemed very excited about the current PH1/2 which to date has evaluated 6 patients with Resectable Recurrent Glioblastoma. The patients treated are indeed very sick patients who have each relapsed after previously failed front line treatment with radiation therapy plus Temozolodine, failed Avastin, followed by surgical resection. (note...this study is typical of what we have seen so far with evry trial of TH-302 in that Threshold certainly does not shy away from treating critically ill cancer patients who have failed heretofore FDA approved therapies)
* Median TTP (Time To Progression) of the TH-302 + Bevacizumab for the first 2 cohorts was 128 days (ongoing),
* O/S (Overall Survival) post surgery is 175 days (on going),
4 of 6 pts. achieved stable disease,
1 of 6 achieved partial response,
1 of 6 achieved progressive disease,
To quote Dr. Selick: "...very promising early stage trial, but from the perspective of having what I call a 'wild card' indication that may provide an excellent path to regulatory approval, GBM is one such indication that we are exited about..."
Jefferies Part 2
Dr. Selick did not go into great detail on both of the PH3 Trials that we are all so obviously interested in other than to give a brief overview. As of 4/13, 91 patients have been dosed in the STS Trial, which commenced in 9/11. Enrollment is ahead of schedule with enrollment expected to be completed by the end of 2013 / beg. of 2014 (that's 6-7 months away from completion of enrollment - outstanding in my opinion and testimony to the excitement in TH-302 by the investigators and the oncology community!!) Final date expected by end of 2014 / early 2015 and the study, as we know, is in operation under and SPA AGREEMENT BETWEEN THE FDA AND THLD (again, HUGE in my opinion ).
PC PH 3 Trial...660 total patients to be enrolled with Primary Endpoint of O/S. The first patient was enrolled in January, 2012 with total enrollment expected to take between 18 - 24 months. Also in operation under SPA AGREEMENT WITH THE FDA AND THLD.
Upcoming KEY Milestones are expected by mid 2013...what could that be?!?!?!
In summary, Dr. Selick noted that TH-302 has shown consistent activity across MULTIPLE INDICATIONS as monotherapy as well as in combination...the consistency of the activity of TH-302 is "STRIKING".
TH-302 is well positioned for ongoing development in multiple indications both alone and in combination with approved, widely used anti-cancer drugs in LARGE, WELL ESTABLISHED MARKETS.
The good doctor also made note that Threshold is "well capitalized with no need to raise additional capital"!!
He also commented on our partner, Merck, noting that they have been outstanding and support the same breadth of vision for TH-302 as does Threshold. He also stated that they have been a pleasure to work with and have provided everything that was promised in the original agreement, and more.
All in all, very positive developments for Threshold and TH-302.
I can wait with both unbridled enthusiasm, confidence, and patience.
Can you?
Los interim data de sarcoma para Junio era sobre los primeros 113 pacientes.
Tal y como cuenta, se reitera que para Abril llevaban 91 y que el reclutamiento va por delante de lo esperado. En fin, ni se menciona este tema desde hace ya un mes. :(
Por lo demas, se hace eco de los recientes resultados presentados en el ASCO y que todo va según lo previsto.
Lo que esta claro es que TH-302 esta ganando credibilidad en el mercado con estas fases 1/2.
En realidad, si echamos la vista atrás, todavía no se ha presentado ni un dato negativo. Vale, habrá datos geniales, otros muy buenos, y otros simplemente normales ... pero negativo ninguno. La dirección esta abordando tantas indicaciones con su extenso pipeline que esta claro que tienen muchísima confianza en TH-302 y la creencia de que, quizás, tengan un producto no para un tipo de cancer o de dos o de tres ... sino para tratar el estado de hipoxia DEL cancer.
Yo hoy tengo que salirme de THLD para recuperar liquidez y garantías, tengo un follón de mil pares con SNTA y he de reagrupar doblones para maniobrar. Ya volveré.
saludos
Muchas gracias Framus... eres un crack... lo llevas controlado al máximo... da gusto leerte.
Offtopic: Con SNTA y APPY ¿vas a cortos plazo? ¿unas semanas?
Saludos.