kman and mr.negative 2c spp sircorp.Some how I don't think...

kman and mr.negative 2c spp sircorp.

Some how I don't think Bioshares got this info from Joe Blow walking down the street. Cheers



Phase IIb/III Clinical Trial Plan for CVac
Prima Biomed has made significant progress towards filing an Investigational New Drug
application for CVac with the FDA. The company has been guided by Professor Ian
Frazer from the University of Queensland, who is noted for his co-invention with Jian
Zhou of the vaccine HPV vaccine Gardasil (Merck/CSL). Frazer has provided, along with
several other interested parties, in-kind support for the next stages of clinical development
of CVac. Other members of the Prima scientific team include Dr Bruce Loveland, who
was involved with the Phase I and Phase II trials of CVac and Dr Cassian Yee and Dr Heidi
Gray from the Fred Hutchinson Cancer Research Center in Seattle.Interestingly Prima Biomed now looks set to follow positively in
the path of Dendreon and benefit from the questions posed to
Dendreon by the FDA regarding manufacturing of autologous
immunotherapies, with a clearer pathway mapped out. Prima will
also be using the same manufacturer that Dendreon has used.
Based on discussions with the FDA, instead of running a 120
patient trial as was considered at one stage, the company may
only need to conduct a randomised 60 patient trial, with 35 in a
treatment arm and 25 in a standard of care arm ( e.g. second line
therapy that includes a platinum based drug and taxol). The trial is
likely to require 15 sites in the US and 15 sites in Australia and
New Zealand. While the primary endpoints have yet to be made
known, they will not include stabilization of CA125 biomarker levels
as occurred in the Phase II trial.
The trial is likely to commence as a Phase IIb and roll into a Phase
III trial. The company anticipates receiving the IND acceptance
by June with enrollments to commence in the September quarter.
For Australia, Prima plans to submit the Phase IIb data to the
Therapeutic Goods Administration (TGA) and seek approval for
CVac as a Category 3 product, which are applications that do not
need to include clinical, preclinical, or bioequivalence data. If successful,
this would then enable the Australian New Zealand Gynaecological
Oncology Group (ANZGOG) to administer CVac offlicence
although Prima would be providing CVac on a not-forprofit
basis.



Bioshares edition 308 24th april 2009