Study Explores Potential Benefit of Nab®-Paclitaxel in Combination with Bevacizumab for the First-Line Treatment of Metastatic Breast Cancer

Data from phase II study to be presented at 45th Annual Meeting of the American
Society of Clinical Oncology
LOS ANGELES--(Business Wire)--
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology
company, today announced results from a new ongoing study demonstrating
anti-tumor activity for three dosing regimens of nab®-paclitaxel (ABRAXANE® for
Injectable Suspension) (paclitaxel protein-bound particles for injectable
suspension) (albumin-bound) given in combination with bevacizumab in the
first-line treatment of patients with metastatic breast cancer. The overall
response rate for patients receiving a combination of weekly nab-paclitaxel (130
mg/m2) with twice weekly bevacizumab (10 mg/kg) was 46 percent. Patients who
received a combination of nab-paclitaxel (260 mg/m2) with bevacizumab (10 mg/kg)
plus filgrastim administered every two weeks and patients who received
nab-paclitaxel (260 mg/m2) with bevacizumab (15 mg/kg) administered every three
weeks had overall response rates of 39 percent and 44 percent, respectively. The
safety profile was generally consistent with the known safety of nab-paclitaxel
and of bevacizumab, although sensory neuropathy was limiting in the weekly
nab-paclitaxel dosing arm suggesting a three week on treatment, one week off
treatment regimen may be preferable.

Results also demonstrated a prolonged time to progression (9.0 months) among
patients who received weekly nab-paclitaxel, compared to the every two and three
week dosing regimens (6.3 months and 7.7 months, respectively). Overall survival
data has not yet been established, and is currently being evaluated. Findings
were discussed during an oral presentation (Abstract #1006) on June 1 at the
45th Annual Meeting of the American Society of Clinical Oncology (ASCO) being
held in Orlando, Fla.

"This study was initiated to expand on previous findings, such as the pivotal
ECOG 2100 trial, demonstrating the benefit of Cremophor®-based paclitaxel given
in combination with bevacizumab in the treatment of patients with advanced
breast cancer," said study lead investigator Andrew D. Seidman, M.D., Attending
Physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer
Center. "Further evaluation of nab-paclitaxel given weekly for three weeks
followed by one week off treatment is ongoing in the CALGB 40502 trial. This
Phase III study will help us better define a role for the combination of
nab-paclitaxel and bevacizumab as a first-line treatment option for metastatic
breast cancer."

Nab-paclitaxel is currently approved for the treatment of breast cancer after
failure of combination chemotherapy for metastatic disease or relapse within six
months of adjuvant chemotherapy. Prior therapy should have included an
anthracycline unless clinically contraindicated.

The open-label, Phase II study evaluated nab-paclitaxel in three dosing regimens
in combination with bevacizumab, including:

* nab-paclitaxel (260 mg/m2) given every three weeks in combination with
bevacizumab (15 mg/kg) every three weeks;
* nab-paclitaxel (260 mg/m2) given every two weeks in combination with
bevacizumab (10 mg/kg) every two weeks plus filgrastim; and
* nab-paclitaxel (130 mg/m2) given every week for three weeks plus bevacizumab
(10 mg/kg) given every two weeks.

About the Study

Randomized phase II trial of nanoparticle albumin-bound paclitaxel in three
dosing schedules with bevacizumab as first-line therapy for HER2-negative
metastatic breast cancer (MBC) (Abstract #1006)

In the randomized Phase II, open-label study, patients had HER-2 negative
metastatic breast cancer and no prior chemotherapy treatment in the metastatic
setting. The primary endpoints were safety and tolerability and overall response
rate (defined as confirmed complete and partial responses according to RECIST
criteria). Secondary study endpoints include time to progression and overall
survival. Of the 209 patients randomized, 205 patients with similar patient
demographics and baseline characteristics were treated. Seventy-three patients
were treated with nab-paclitaxel in combination with bevacizumab every three
weeks, 54 patients every two weeks (plus filgrastim) and 78 patients weekly. The
majority of patients in all treatment arms had visceral disease (88 percent, 92
percent and 87 percent of patients for the three treatment arms, respectively)
and received prior neoadjuvant or adjuvant chemotherapy (63 percent, 61 percent
and 61 percent for the three treatment arms, respectively).

Overall, the combination of nab-paclitaxel and bevacizumab was well-tolerated
and grade 2, 3 and 4 neurotoxicities were comparable across all three dosing
regimens, with febrile neutropenia occurring in less than 2 percent of patients
in all study arms. Grade 3-4 toxicities occurring in at least one patient in
each treatment arm included: sensory neuropathy (30 percent for the
nab-paclitaxel every three weeks arm, 48 percent for the nab-paclitaxel every
two weeks arm and 40 percent for the weekly nab-paclitaxel arm); fatigue (15
percent, 30 percent and 14 percent for the three treatment arms, respectively);
nausea (4 percent, 6 percent and 0 percent, respectively); and diarrhea (0
percent, 2 percent and 4 percent, respectively). Patients taking nab-paclitaxel
(130 mg/m2) on a weekly dosing regimen in combination with bevacizumab (10
mg/kg) experienced significantly less grade 2-3 arthralgia, myalgia and nausea,
compared to the every two and three week dosing regimens. The every two week
dosing arm crossed an early stopping rule because of excess toxicity and was
closed early. Results suggest a three week on treatment, one week off treatment
regimen may be preferable.

About ABRAXANE®

ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast
cancer which was developed using Abraxis BioScience's proprietary nab®
technology platform. This protein-bound chemotherapy agent combines paclitaxel
with albumin, a naturally-occurring human protein. By wrapping the albumin
around the active drug, ABRAXANE can be administered to patients at higher
doses, delivering higher concentrations of paclitaxel to the tumor site than
solvent-based paclitaxel. ABRAXANE is currently in various stages of
investigation for the treatment of the following cancers: expanded applications
for metastatic breast, non-small cell lung, malignant melanoma, pancreatic,
gastric and head and neck.

The U.S. Food and Drug Administration approved ABRAXANE for Injectable
Suspension (paclitaxel protein-bound particles for injectable suspension)
(albumin-bound) in January 2005 for the treatment of breast cancer after failure
of combination chemotherapy for metastatic disease or relapse within six months
of adjuvant chemotherapy. Prior therapy should have included an anthracycline
unless clinically contraindicated. For the full prescribing information for
ABRAXANE please visit www.abraxane.com.

IMPORTANT SAFETY INFORMATION

The use of ABRAXANE has not been studied in patients with hepatic or renal
dysfunction. In the randomized controlled trial, patients were excluded for
baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.

ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of
childbearing potential should be advised to avoid becoming pregnant while
receiving treatment with ABRAXANE.

Men should be advised to not father a child while receiving treatment with
ABRAXANE. It is recommended that nursing be discontinued when receiving ABRAXANE
therapy. ABRAXANE contains albumin (human), a derivative of human blood.

Caution should be exercised when administering ABRAXANE concomitantly with known
substrates or inhibitors of CYP2C8 and CYP3A4.

ABRAXANE therapy should not be administered to patients with metastatic breast
cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is
recommended that frequent peripheral blood cell counts be performed on all
patients receiving ABRAXANE. Patients should not be retreated with subsequent
cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and
platelets recover to a level >100,000 cells/mm3. In the case of severe
neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE
therapy, a dose reduction for subsequent courses is recommended. Sensory
neuropathy occurs frequently with ABRAXANE.

If grade 3 sensory neuropathy develops, treatment should be withheld until
resolution to grade 1 or 2 followed by a dose reduction for all subsequent
courses of ABRAXANE. Severe cardiovascular events possibly related to
single-agent ABRAXANE occurred in approximately 3% of patients in the randomized
trial. These events included chest pain, cardiac arrest, supraventricular
tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism,
and hypertension.

In the randomized metastatic breast cancer study, the most important adverse
events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory
neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%),
myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections
(24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any
27%; severe <1%), and mucositis (any 7%; severe <1%).

Other adverse reactions have included ocular/visual disturbances (any 13%;
severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction
(elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), renal
dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe <1%),
hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe
3%), and injection site reactions (<1%). During postmarketing surveillance, rare
occurrences of severe hypersensitivity reactions have been reported with
ABRAXANE.

About Abraxis BioScience, Inc.

Abraxis BioScience is a fully integrated global biotechnology company dedicated
to the discovery, development and delivery of next-generation therapeutics and
core technologies that offer patients safer and more effective treatments for
cancer and other critical illnesses. The company's portfolio includes the
world's first and only protein-bound nanoparticle chemotherapeutic compound
(ABRAXANE®), which is based on the company's proprietary tumor targeting
technology known as the nab® platform. The first FDA approved product to use
this nab platform, ABRAXANE, was launched in 2005 for the treatment of
metastatic breast cancer and is now approved in 36 countries. The company
continues to expand the nab platform through a robust clinical program and deep
product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol
ABII. For more information about the company and its products, please visit
www.abraxisbio.com.

Investors and Media Inquiries
Abraxis BioScience, Inc.
Maili Bergman, 310-883-1300
investorrelations@abraxisbio.com
or
Media Inquiries
Zeno Group
Victoria Fort, 301-873-8671
Victoria.Fort@zenogroup.com

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