
Pancreatic Cancer Clinical Trial Halted by SciClone
Pharmaceuticals
Brisbane,
Australia, October 5 2009 : Clinical trials of a new pancreatic
cancer drug under development by biotechnology powerhouse SciClone
Pharmaceuticals have been halted, following recommendations from an
independent Data Monitoring Safety Committee.
Australian
company Acuvax Limited holds 43 per cent of Avantogen Oncology Inc,
which is in a licensing partnership with SciClone.
Acuvax took a
cash gain by selling all assets related to Rest of World rights to
this drug in April 2009.
The RP101 drug
was in Phase 2 clinical trials, all paid for by
SciClone. The Avantogen/Acuvax group had decided on a strategy to
share the development risks of the RP101 for treatment, in
combination with chemotherapy drug gemcitabine, for pancreatic
cancer.
As part of this
risk sharing strategy, the group received significant upfront cash
and milestone payments. In February, 2008, SciClone paid
approximately A$4 million in upfront fees and milestone
payments, and also agreed to pay for the full costs of
initiation and completion of a phase 2 clinical trial, and
also paid to initiate this trial in the USA, Europe and Latin
America.
In addition,
success-based regulatory and commercial payments up to $22 million,
and royalties on future sales were also agreed. In March,
2009 SciClone announced that it had invested heavily to accelerate
enrolment completion ahead of schedule of the RP101 Phase II global
clinical trial of 167 patients, and in September 2009 provided
guidance that top line results were expected in early to mid
2010.
Acuvax CEO Dr
William Ardrey said news of the trial's suspension was
disappointing, but remained hopeful the pancreatic trial
program may resume.
"We are
obviously concerned by this development, but have every confidence
that SciClone will carefully evaluate next steps as they have
invested heavily in the success of RP101 for pancreatic cancer," Dr
Ardrey said.
SciClone is
currently evaluating next s