Re: Farmas USA
ATHX
Artículo de pumpeo con el CEO en SA:
finished the second quarter with a healthy balance sheet, reflecting around $32.3 million in cash, and a pretty modest burn rate- > dado que ya no tienen los pagos de Chugai, que van a tener que rediseñar el estudio y que tienen uno en fase de diseño, otro reclutando y otro en curso, a falta del informe trimestral que está al caer, leo dilución.
we are very busy on the partnering front- > dicen que además de Chugai tuvieron más ofertas y están en ello.
Dice que partieron peras con Chugai por cuestiones de reasignación del pago por hitos y porque querían ir más despacio. Mi lectura aquí es que ATHX quiere correr demasiado aprovechando la legislación japonesa, y es precisamente por este motivo por lo que van cagando en los ensayos.
"there are two basic reasons why the relationship ended. First, Chugai proposed to restructure / defer a key economic element of the deal, the milestone payment that they owed us in September, and while we tried to work it out, ultimately that was something we were not comfortable with. Second, Chugai had a very different vision with respect to near term development activities and timing. We believe that the new regenerative medicine regulatory framework in Japan represents a substantial opportunity for accelerated development there, as evidenced by two recent product approvals, whereas Chugai was envisioning a different, more traditional approach that emphasized development outside of Japan. We weren't comfortable with that either, and ultimately decided to go in another direction.
Given the results of the study, there were members of the Chugai development team that preferred a more deliberate approach, and one that had a more significant weighting on near term development outside of Japan, which means we (or another partner) would bear more of the cost for that work. That just didn't make sense to us, and was an important factor in our ultimate decision. We believe that we should be moving as fast as possible with our development efforts in Japan (and elsewhere), especially in light of the new regulatory framework.
headway in our ongoing Phase 2 trial involving administration of MultiStem to patients that have suffered damage from an acute myocardial infarction (estudio de fase II que pego abajo)
in the process of launching our trial exploring treatment of patients suffering from ARDS (Acute Respiratory Distress Syndrome). (aún no consta en ningún lado)
Y se me olvidaba: que hacen hincapié sobre todo que el estudio del infarto es muy prometedor a pesar de no haber cumplido los objetivos.
seekingalpha.com/article/3593736-wst-exclusive-why-chugai-and-athersys-parted-ways-on-japan-stroke-stem-cell-program
Estudios que constan
Reclutando:
Fase I: Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
https://clinicaltrials.gov/ct2/show/NCT01841632?term=Athersys&rank=6
En curso:
Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (MI-NSTEMI)
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
https://clinicaltrials.gov/ct2/show/NCT02277613?term=Athersys&rank=1
