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#90890

Re: Farmas USA

Top 100
Eleuterio_invierte

NVAX

He preguntado aquí:

http://www.ask8ball.net/

"¿Novax va a subir?", y me dice "Outlook good"

"Buf, se me está haciendo más largo que un dia sin bolsa"

#90893

Re: Farmas USA

Top 10
framus_morrigan

Bioinvest Letter 831

http://www.bioinvest.com/wp-content/uploads/2016/07/MTSL-Issue-831.pdf

ANTH, IONS, MDCO, ZIOP

 

ZIOP – Breaking News – 3 Patients Die In The IL-12 Trial ZIOP is down sharply this morning (7/15) on the report that three patients have died in their ongoing multicenter Phase I trial of Ad-RTShIL-12 + orally administered veledimex in recurrent or progressive glioblastoma (GBM) or grade IIImalignant glioma. ZIOP issued the following statement:

  • “This Phase I study is being conducted in late-stage, recurrent GBM, so these patients are all, unfortunately, medically fragile. The first two patient deaths, which occurred 6.7 months and 3.9 months after treatment, were unrelated to study drug. A third death has just been reported to us and we are collecting and analyzing information in order to properly and timely report it to the FDA. The cause of death is intracranial hemorrhage, which occurred 15 days after the patient had been discharged from the treating center. This is an isolated case, and there have been no reported related instances of brain hemorrhage in any pervious cohort or prior studies with Ad-RTS-hIL-12 + veledimex. “Enrollment remains open in the study, and we will be discussing with our Safety Review Committee the appropriate course of action. For patients who have experienced multiple recurrences, as these patients have, prognoses are particularly poor. Median follow up in the first dose cohort from our study is now 8 months, in a population with an expected overall survival of 3 to 5 months for patients that have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy. For the patients that remain in follow up in this Phase I study, we believe that preliminary overall survival remains encouraging. The Company expects to provide an update once a course of action has been determined.”

The key is the third patient who recently died of a brain hemorrhage as this potentially could have been caused by the gene therapy. Since this seems to have just recently happened, we do not know the true source of the fatality nor the response of the FDA (e.g., JUNO’s clinical hold of the past week). We have been proponents of the GBM study, but at this point it is an unknown and this creates an overhang of doubt on Wall Street. In our view, the current pullback more than discounts the possibility of the IL-12 gene therapy ever becoming a marketed treatment and assigns minimal value to the pipeline of second-generation of gene therapy candidates. It is important to remember that the GBM patients are very sick and are expected to have significant comorbidities. We also believe that Dr. Cooper’s clinical experience and judgement should be given some credence while ZIOP sorts this out with the FDA.

http://www.rankia.com/foros/bolsa/respuestas/2437438-hemeroteca-biblioteca-farma

#90895

Re: Farmas USA

lo miraremos! de la última que pusiste, había 10, me quedé con RARE después del due dilligence y no fue nada nada mal :-)