CORRECTING and REPLACING Abraxis BioScience Completes Enrollment of Pivotal Phase III Advanced Lung Cancer Study Evaluating ABRAXANE® Vs. Taxol®

Tue Jul 14, 2009 2:45pm EDT
 
[-] Text [+]
- Study Compares ABRAXANE and Taxol in Combination with Carboplatin, in the
First-Line Treatment of 1,050 Patients with Metastatic Non-Small Cell Lung
Cancer -
LOS ANGELES--(Business Wire)--
Fifth graph, first sentence of release dated July 13, 2009, should read: The
phase III study involves 1,050 patients randomized in a one-to-one ratio to two
treatment arms: patients in Arm A (n=525) receive ABRAXANE 100 mg/m2 weekly plus
carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in Arm
B (n=525) receive Taxol 200 mg/m2 plus carboplatin AUC 6 on Day 1 of a
three-week treatment cycle (sted xxx and patients in Arm B (n=525) receive Taxol
200 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment
cycle). 

The corrected release reads: 

ABRAXIS BIOSCIENCE COMPLETES ENROLLMENT OF PIVOTAL PHASE III ADVANCED LUNG
CANCER STUDY EVALUATING ABRAXANE® VS. TAXOL®

- Study Compares ABRAXANE and Taxol in Combination with Carboplatin, in the
First-Line Treatment of 1,050 Patients with Metastatic Non-Small Cell Lung
Cancer -

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology
company, announced today that the company has completed patient enrollment of a
pivotal, phase III clinical study comparing the company`s chemotherapy agent
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) (albumin bound) with Taxol® (paclitaxel) injection, both
in combination with carboplatin, in the first-line treatment of patients with
advanced non-small cell lung cancer (NSCLC). The study, which is being conducted
at 111 sites globally, includes 1,050 patients and is being led by principal
investigator Dr. Mark Socinski at the University of North Carolina Lineberger
Comprehensive Cancer Center. It is one of the largest NSCLC clinical studies to
complete enrollment. 

"The completion of enrollment of this phase III study marks a significant
milestone in our efforts to evaluate ABRAXANE for the treatment of patients with
metastatic lung cancer," said Lonnie Moulder, President and Chief Executive
Officer of Abraxis BioScience, Inc. "We anticipate filing a supplemental new
drug application (sNDA) with the FDA in the first half of 2010 for what will be
the second indication for ABRAXANE." 

ABRAXANE 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. 

NSCLC comprises 85 to 90 percent of lung cancers. Lung cancer is the leading
cause of cancer death, and treatment options for patients are limited.i

Study Design

The phase III study involves 1,050 patients randomized in a one-to-one ratio to
two treatment arms: patients in Arm A (n=525) receive ABRAXANE 100 mg/m2 weekly
plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in
Arm B (n=525) receive Taxol 200 mg/m2 plus carboplatin AUC 6 on Day 1 of a
three-week treatment cycle. The primary study endpoint is disease response,
measured as complete and partial responses as defined by RECIST (Response
Evaluation Criteria in Solid Tumors). Secondary study endpoints include: safety
and tolerability; disease control rate and duration of response;
progression-free survival (PFS); patient survival; and assessments of ABRAXANE
efficacy correlated with specific tumor biomarkers, including secreted protein
acidic and rich in cysteine (SPARC). 

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 and
gastric. 

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. 

FORWARD-LOOKING STATEMENTS

The statements contained in this press release that are not purely historical
are forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking statements in this
press release include statements regarding our expectations, beliefs, hopes,
goals, intentions, initiatives or strategies, including statements regarding the
clinical development plan, and the timing and scope of clinical studies and
trials, for ABRAXANE and the global commercialization of ABRAXANE. Because these
forward-looking statements involve risks and uncertainties, there are important
factors that could cause actual results to differ materially from those in the
forward-looking statements. These factors include, without limitation, the fact
that results from pre-clinical studies may not be predictive of results to be
obtained in other pre-clinical studies or future clinical trials; delays in
commencement and completion of clinical studies or trials, including slower than
anticipated patient enrollment and adverse events occurring during the clinical
trials; decisions by regulatory authorities regarding whether and when to
approve ABRAXANE or product candidates for various indications as well as their
decisions regarding labeling and other matters that could affect the
availability or commercial potential of ABRAXANE and other products and product
candidates; unexpected safety, efficacy or manufacturing issues with respect to
ABRAXANE or product candidates; the need for additional data or clinical studies
for ABRAXANE or product candidates; regulatory developments (domestic or
foreign) involving the company`s manufacturing facilities; the market adoption
and demand of ABRAXANE and other products, the costs associated with the ongoing
launch of ABRAXANE; research and development associated with the nab® technology
platform; the impact of pharmaceutical industry regulation; the impact of
competitive products and pricing; the availability and pricing of ingredients
used in the manufacture of pharmaceutical products; the ability to successfully
manufacture products in a time-sensitive and cost effective manner; the
acceptance and demand of new pharmaceutical products; and the impact of patents
and other proprietary rights held by competitors and other third parties.
Additional relevant information concerning risks can be found in the company`s
Annual Report on Form 10-K for the year ended December 31, 2008 and in other
documents it has filed with the Securities and Exchange Commission. 

The information contained in this press release is as of the date of this
release. Abraxis assumes no obligations to update any forward-looking statements
contained in this press release as the result of new information or future
events or developments. 

TAXOL® is a registered trademark of Bristol-Myers Squibb Company. 

i Detailed Guide: Lung Cancer - Non-Small Cell. American Cancer Society Web
site. 2009. http://www.cancer.org/docroot/CRI/CRI_2_3x.asp?rnav=cridg&dt=15.
Accesses July 9, 2009. 



Investors and Media Inquiries
Abraxis BioScience, Inc.
Maili Bergman, 310-883-1300
investorrelations@abraxisbio.com
or
Media Inquiries
Zeno Group
Victoria Fort, 202-361-0445
Victoria.Fort@zenogroup.com



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