Exhibit 10.1
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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 steps, pending a detailed review and
analysis of safety and efficacy once data are unblinded, and will inform Acuvax
and its investors in due course. A copy of the Announcement from SciClone is
attached.

For More Information Contact

Acuvax CEO Dr William Ardrey: 0400 544 502 or Emma Power Monsoon Communications
0419 149 525.

 
 

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About Acuvax Ltd:
A publicly listed developer and commercialiser of drugs in the fast growing
oncology and vaccine markets, the Company has announced a number of high value
commercial licensing revenue partnerships with leading US biotechnology players.
The Company has reported strong success on clinical progress and revenue
generation, and has collected multimillion dollar upfront payments for its
promising proprietary products, with promise of future up front and milestone
payments as well as royalty streams. The Dengue program noted above has been
financially supported by the Bill & Melinda Gates Foundation/PDVI, and also
attracted support of eminent immunologist and Australian of the Year Professor
Ian Frazer.
For more information contact www.acuvax.com
 
 
 

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Corporate Contacts
  
 
Gary Titus
  
Ana Kapor
Chief Financial Officer
  
Investors/Media
650.358.3456
  
650.358.3437
gtitus@sciclone.com
  
investorrelations@sciclone.com

 
PHASE 2 TRIAL OF RP101 IN LATE-STAGE PANCREATIC CANCER
 
DISCONTINUED
 
FOSTER CITY, CA – October 2, 2009 – SciClone Pharmaceuticals, Inc. (NASDAQ:
SCLN) today announced the discontinuation of the investigational treatments
under its randomized, placebo-controlled, double-blind Phase 2 trial that is
evaluating RP101—a nucleoside analog known as BVdU—for the treatment of
late-stage pancreatic cancer. This decision followed the recommendation of the
Data Safety Monitoring Committee (DSMC) with oversight responsibility for this
clinical trial that was based upon the data reviewed at the most recent DSMC
meeting. Further details will be reported when these data have been unblinded
and reviewed by SciClone.
 
SciClone has notified the study investigators and appropriate regulatory
authorities of the decision to discontinue the study. The company expects to
conduct a detailed safety and efficacy analysis once the data are unblinded and
will then evaluate what effect these data will have on any future RP101
development potential. At this time, SciClone anticipates that all remaining
significant clinical trial expenses for this phase 2 trial will be incurred
during 2009 and that this discontinuation will not adversely impact its
previously provided financial guidance.
 
“We are disappointed with the discontinuation of this study and we will continue
to evaluate future opportunities to bring new and effective treatments to these
patients,” said Friedhelm Blobel, PhD., President and Chief Executive Officer of
SciClone. “We remain committed to our pipeline of promising compounds to treat
cancer and infectious diseases including our ongoing phase 2 trials of SCV-07 in
oral mucositis and HCV, our phase 3-ready trial of thymalfasin for Stage IV
melanoma, and our planned human trial of thymalfasin for influenza H1N1 virus.”
 
About RP101
 
RP101, also known as BVdU, is a nucleoside analog which has shown, in several
preclinical and clinical studies, the potential to prevent the induction of
resistance to chemotherapy by suppressing genes involved in development of that
resistance and enhancing sensitivity to chemotherapy

 
 

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About SciClone
 
SciClone Pharmaceuticals (NASDAQ: SCLN) is a profit-driven, global
biopharmaceutical company with a substantial international business and a
product portfolio of novel therapies for cancer and infectious diseases.
SciClone is focused on continuing international sales growth, a cost-containing
clinical development strategy, and expense management. ZADAXIN (thymalfasin or
thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B
(HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant.
SciClone’s pipeline of drug candidates includes thymalfasin, in preclinical
studies as an enhancer of novel H1N1 flu vaccines; thymalfasin for stage IV
melanoma, for which SciClone has reached agreement with the FDA on the design of
a phase 3 trial; RP101; SCV-07 in a phase 2 trial for the delay of onset of
severe oral mucositis in patients receiving chemoradiation therapy for the
treatment of cancers of the head and neck; and SCV-07 with a ready-to-initiate
phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization
and distribution rights to DC Bead TM  in China, where the product is under
regulatory review. The Company also has commercialization and distribution
rights to an anti-nausea drug ondansetron RapidFilm TM  in China and Vietnam,
for which it is seeking regulatory approval. For additional information, please
visit www.sciclone.com .
 
Forward-Looking Statements
 
This press release contains forward-looking statements regarding development
objectives and timing expectations. You are urged to consider statements that
include the words “may,” “will,” “would,” “could,” “should,” “might,”
“believes,” “estimates,” “projects,” “potential,” “expects,” “plans,”
“anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the
negative of those words or other comparable words to be uncertain and
forward-looking. These statements are subject to risks and uncertainties that
are difficult to predict and actual outcomes may differ materially.. All
forward-looking statements are based on information currently available to
SciClone and SciClone assumes no obligation to update any such forward-looking
statements.

 
 

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