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ABRAXANE® Plus Gemcitabine Improves Survival in Phase III Study of Patients with Advanced Pancreatic Cancer



 ABRAXANE® Plus Gemcitabine Improves Survival in Phase III Study of Patients
                       with Advanced Pancreatic Cancer

ABRAXANE plus gemcitabine demonstrated highly statistically significant and
clinically meaningful results across primary and key secondary endpoints and
patient subgroups

ABRAXANE plus gemcitabine patients showed 59% higher chance of survival at one
year; survival rates doubled at two years

A new standard of care for patients with advanced pancreatic cancer

Oral Presentation Scheduled for Friday, January 25th at ASCO's
Gastrointestinal Cancers Symposium Annual Meeting

PR Newswire

MELBOURNE, Australia, Jan. 22, 2013

MELBOURNE, Australia, Jan. 22, 2013 /PRNewswire/ -- Australian
biopharmaceutical company Specialised Therapeutics Australia announces that a
phase III clinical trial of world leading breast cancer drug ABRAXANE^®
(nanoparticle albumin-bound paclitaxel) in combination with current standard
of care gemcitabine in patients with advanced pancreatic cancer has
demonstrated substantially improved survival times, with double the number of
patients surviving two years.^1

The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) investigation
involved 861 treatment naïve patients internationally.

Researchers found those patients treated with ABRAXANE plus gemcitabine had a
statistically significant improvement in overall survival compared to patients
receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72,
P=0.000015)].^1

Moreover, ABRAXANE plus gemcitabine demonstrated a 59% increase in one-year
survival (35% vs. 22%, p=0.0002) and demonstrated double the rate of survival
at two years (9% vs. 4%, p=0.02) as compared to gemcitabine alone.^1

ABRAXANE plus gemcitabine also demonstrated statistically significant
improvements in key secondary endpoints compared to gemcitabine alone,
including a 31% reduction in the risk of progression or death with a median
progression-free survival (PFS) of 5.5 vs. 3.7 months (HR 0.69, P=0.000024)
and an overall response rate (ORR) of 23% compared to 7% (response rate ratio
of 3.19, p=1.1 x 10^-10).  Another endpoint assessed included time to
treatment failure, which was significantly improved with the ABRAXANE
combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR
0.70, P<0.0001)].^1

"The past few decades have brought us very few treatment advances for patients
with advanced pancreatic cancer, which is both deadly and incredibly difficult
to treat with success," said Daniel D. Von Hoff, M.D., F.A.C.P., Lead
Principal Investigator of the MPACT study and Chief Scientific Officer for
Scottsdale Healthcare's Virginia G. Piper Cancer Centre Clinical Trials and
Physician-In-Chief for TGen.  "The fact that ABRAXANE plus gemcitabine
demonstrated an overall survival benefit, and also did so at one and two
years, is a significant step forward in offering potential new hope for our
patients."

Professor John Zalcberg, Chief Medical Officer and Executive Director of
Cancer Medicine at the Peter MacCallum Cancer Centre in Melbourne, said the
evidence strongly supported using ABRAXANE in combination with gemcitabine as
a new standard of care to treat appropriate patients, many of whom were not
diagnosed until the disease was metastatic.

While acknowledging that this advance could not be seen as a cure for
pancreatic cancer, Professor Zalcberg said the 59% increase in the number of
patients who lived beyond 12 months was very encouraging. 

"We are extremely encouraged by the results of this study involving ABRAXANE
and regard this outcome as a significant breakthrough in terms of the future
management of this disease," he said.

"In addition to treating women with metastatic breast cancer with ABRAXANE in
the appropriate setting, we look forward to its approval in Australia for
treating patients with advanced pancreatic cancer."

Specialised Therapeutics Australia (STA) Chief Executive Officer Mr. Carlo
Montagner said the positive data paved the way for Australian patients with
advanced pancreatic cancer to access more effective treatment options.

He commented: "In Australia, pancreatic cancer is the fourth most common cause
of death from cancer for both men and women^2 and very few treatment options
exist for this group of patients. We are extremely pleased to demonstrate that
ABRAXANE is capable of prolonging survival for patients with advanced
pancreatic cancer and we hope to have ABRAXANE approved by the Australian
Therapeutic Goods Administration (TGA) in the latter half of 2014."

The most common grade ≥ 3 treatment-related adverse events in the study for
ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs.
27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%).  In the ABRAXANE plus
gemcitabine arm, the median time to neuropathy improvement was 29 days. There
was no difference in serious life threatening toxicity (4% in each arm).^1

Further details of the study will be highlighted in a late-breaking oral
presentation by Dr. Daniel D. Von Hoff:

  o Abstract: LBA #148: Final results of a randomized phase III study of
    weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in
    patients with metastatic adenocarcinoma of the pancreas. Friday, January
    25^th between 2:00 to 3:30 pm PST at the American Society of Clinical
    Oncology's (ASCO) 2013 Gastrointestinal Cancers Symposium in San
    Francisco, CA.

These results are from an investigational study. ABRAXANE is not approved for
the treatment of advanced pancreatic cancer.  Following TGA review and
approval, STA will seek to have ABRAXANE included on the Pharmaceutical
Benefits Scheme (PBS) for the reimbursement of ABRAXANE for advanced
pancreatic cancer.

About the MPACT Study^1

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a
Celgene-sponsored, open-label, randomised, international study of 861 patients
with metastatic pancreatic cancer were randomised to receive either ABRAXANE
plus gemcitabine (125 mg/m^2 followed by 1000 mg/m^2 gemcitabine for 3 weeks
followed by a week of rest) or gemcitabine alone (1000 mg/m^2 administered
weekly for 7 weeks followed by a week of rest followed by cycles of weekly
administration for 3 weeks followed by one week of rest). 

The primary endpoint for the study is improvement in overall survival.
Secondary endpoints were progression-free survival, and overall response rate
determined by independent radiological review. Other endpoints included
progression-free survival, overall response rate determined by investigator
and the safety and tolerability of this combination in this patient
population.

About Advanced Pancreatic Cancer

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest
survival rates among all cancer types.  Across all patients with pancreatic
cancer, relative 5-year survival is 6% and is less than 2% for those with
advanced disease.  There are two main types of pancreatic cancer -
adenocarcinomas, which accounts for approximately 90% of all pancreatic
cancer, and neuroendocrine tumors.  Pancreatic cancer is relatively uncommon
with new cases accounting for only 2.1% of all newly diagnosed cancers.
However, pancreatic cancer is the fourth most common cause of cancer death for
men and women in the United States and Australia, and the ninth most commonly
diagnosed cancer in Australia.^2 

About ABRAXANE^® 

ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for
metastatic breast cancer.^3 In Australia, ABRAXANE is currently listed on the
PBS for the treatment of metastatic breast cancer and HER2 positive breast
cancer in combination with trastuzumab.

ABRAXANE is approved for metastatic breast cancer in over 40 countries
including the U.S., Canada, European Union, Japan and China, and more than
500,000 cancer patients have received ABRAXANE therapy in the past five years.

In Australia, ABRAXANE has been granted orphan drug designation by the
Therapeutic Goods Administration for the treatment of pancreatic cancer.
Orphan drug status is granted to drugs used to treat relatively rare diseases
such as pancreatic cancer and may allow for priority evaluation by the TGA.

ABRAXANE is currently in various stages of investigation for the treatment of
the following cancers: metastatic melanoma, bladder, ovarian, and expanded
applications for breast cancer.

Developed using the proprietary nab™ technology platform, ABRAXANE is a
nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel
with albumin, a naturally-occurring human protein, to deliver the drug and
eliminates the need for solvents in the administration process. Nanoparticle
technology allows ABRAXANE to deliver a 49% higher dose compared to regular
solvent-based paclitaxel without compromising safety and tolerability.^3-4

In a randomised phase III study of metastatic breast cancer patients, ABRAXANE
demonstrated nearly double the overall tumour response rate compared to
solvent-based paclitaxel. ^3-4

Anthracycline pre-treated patients in the study lived significantly longer.^5
The tolerability with ABRAXANE and solvent-based paclitaxel was comparable,
despite the 49% greater dose of paclitaxel administered as ABRAXANE.^3-4
Neutropenia was lower with ABRAXANE compared to solvent-based paclitaxel,
although there was an increase in incidence of grade 3 peripheral neuropathy
with ABRAXANE. However the median time to improvement, from grade 3 peripheral
neuropathy to grade 2 or lower, was 22 days.  No adverse events were reported
that were not already known for paclitaxel.^3-4

Contraindications and side effects^3:

Like all medications, ABRAXANE may cause side effects.

ABRAXANE should not be used in patients who have baseline neutrophil counts of
<1.5 x 10^9 /L.
In patients who have exhibited hypersensitivity reactions to paclitaxel or
albumin, patients should not be treated with ABRAXANE.

ABRAXANE is contraindicated during pregnancy and lactation.

Most common side effects (≥1/10) caused by ABRAXANE include; neutropenia,
anemia, leucopenia, thrombocytopenia, lymphophenia, anorexia, peripheral
neuropathy, hypoaesthesia, paraethesia, nausea, diarrhoea, vomiting,
constipation, stomatitis, alopecia, rash, arthralgia, myalgia, fatigue,
asthenia, pyrexia.

For further information regarding ABRAXANE and potential side effects,
physicians should review the ABRAXANE Product Information and patients should
consult their oncologist or the ABRAXANE Consumer Medicine Information
available on www.specialisedtherapeutics.com.au.

ABRAXANE^® is a registered trademark of Celgene Corporation.

ABRAXANE^® is distributed by STA under license from Celgene Corporation in
Australia and New Zealand.

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) is a biopharmaceutical
company dedicated to working with leading pharmaceutical companies worldwide
to provide acute care therapies for high unmet medical needs to people living
in Australia and New Zealand.

Currently STA markets two world leading cancer and cancer supportive care
therapies, ABRAXANE^® (nab-paclitaxel) and ALOXI^® (palonosetron HCl)
respectively, and has recently licensed two new agents from the Helsinn Group.
Firstly Anamorelin, which is a novel ghrelin receptor agonist for the
treatment of anorexia-cachexia in NSCLC, and a fixed-dose combination product
(in both oral and intravenous forms) containing netupitant, a neurokinin-1
(NK1) receptor antagonist, combined with Aloxi, a serotonin-3 (5-HT3) receptor
antagonist. STA also has interests in the therapeutic areas of anti-infectives
with the rights to commercialise DIFICID® (fidaxomicin) for the treatment of
Clostridium difficile infections, respiratory, dermatology, endocrinology and
central nervous system (CNS). Additional information can be found at
www.specialisedtherapeutics.com.au

References:

 1. Von Hoff DD et al. Abstract: LBA #148: Final results of a randomized phase
    III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine
    alone in patients with metastatic adenocarcinoma of the pancreas. ASCO GI
    2013
 2. Cancer in Australia. An Overview 2012. Australian Institute of Health and
    Welfare (AIHW)
 3. Abraxane Product Information
 4. Gradishar WJ et al. J Clinical Oncology 2005;23:7794-7803
 5. Vukelja SJ et al. ASCO 2008, Abstract 1082

Media Inquiries:

Emma Power
Monsoon Communications
Level 12 15 William Street
Melbourne VIC 3000
Ph: +61-3-9620-3333

SOURCE Specialised Therapeutics Australia Pty Ltd

Website: http://www.specialisedtherapeutics.com.au
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