Attached files
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| 8-K - Avantogen Oncology, Inc. | v162549_8k.htm |
Exhibit
10.1
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.
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
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Gary
Titus
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Ana
Kapor
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Chief
Financial Officer
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Investors/Media
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650.358.3456
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650.358.3437
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gtitus@sciclone.com
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investorrelations@sciclone.com
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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
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.