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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