Abraxane in Combination with Gemcitabine and Epirubicin Evaluated as Neoadjuvant Treatment for Patients with Locally Advanced Breast Cancer

Interim Data from Phase II Trial Presented at 31st Annual San Antonio Breast Cancer Symposium

SAN ANTONIO--(BUSINESS WIRE)--Dec 15, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today announced the presentation of preliminary results from a single-arm, open-label, Phase II clinical trial evaluating ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin- bound) in combination with gemcitabine and epirubicin for the treatment of patients with locally advanced breast cancer (neoadjuvant treatment). In the preliminary analysis, 18 percent of patients (n=23) given a regimen of ABRAXANE (nab™-paclitaxel), gemcitabine and epirubicin achieved a complete pathologic response (the disappearance of all target lesions), and 68 percent (n=84) achieved a partial response (a 30 percent or greater decrease in size of target lesions). The findings were presented during the CTRC-AACR San Antonio Breast Cancer Symposium.

In the ongoing Phase II study, 123 patients with locally advanced, early stage breast cancer were treated with nab-paclitaxel (175 mg/m2), gemcitabine (2,000 mg/m2) and epirubicin (50 mg/m2) once every two weeks for 12 weeks followed by surgery. Following surgery, patients were given additional treatment with nab-paclitaxel (220 mg/m2) and gemcitabine (2,000 mg/m2) administered once every two weeks for eight weeks. With this regimen, 88 percent of patients were alive 24 months after treatment and the estimated progression-free survival at 24 months was 71 percent.

“The preliminary results of this study suggest antitumor activity for nab-paclitaxel in combination with gemcitabine and epirubicin in the treatment of breast cancer patients with locally advanced disease,” said Dr. Denise Yardley, Program Director, Breast Cancer, Sarah Cannon Research Institute. “Though further study is warranted, these results indicate that nab-paclitaxel could be an important addition to the combination treatments used in the neoadjuvant setting.”

About the Study

The Phase II study included 123 patients with early stage breast cancer with a median age of 51 years and a median tumor size of 4.5 cm. The majority of patients (81 percent) were diagnosed with ductal carcinoma, with an additional 10 percent having lobular carcinoma. The remaining patients (9 percent) had other types of tumors. Forty-two percent of patients were estrogen receptor and progesterone receptor negative and 55 percent of patients were diagnosed with stage T3/T4 disease. Pathologic responses were available for 112 patients and 82 patients consented to secreted protein acidic rich in cysteine (SPARC) testing.

Patients received six treatment cycles of nab-paclitaxel (175 mg/m2) in combination with gemcitabine (2,000 mg/m2) and epirubicin (50 mg/m2) given once every 14 days prior to surgery in the neoadjuvant setting. After surgery, patients were given another four treatment cycles of nab-paclitaxel (220 mg/m2) and gemcitabine (2,000 mg/m2) once every 14 days.

The study also assessed the relationship between the level of a specific tumor biomarker, SPARC, and the efficacy of the combination regimen. SPARC level 3 immunohistochemical (IHC) staining was noted in 85 percent of assessed tumors, and 86 percent of the SPARC-containing tumors were associated with a complete pathologic response or partial response.

Grade 3 or 4 adverse events that were reported in greater than 5 percent of patients included neutropenia or low white blood cell count (11 percent, with one patient reporting febrile neutropenia), thrombocytopenia (6 percent), arthralgias (7 percent), fatigue (8 percent) and infection (7 percent). Eleven patients did not complete study treatment due to disease progression (3 patients), unevaluable (7 patients) and patient request (1 patient). Tumors that were either ER negative, PR negative, or triple negative were associated with worse progression free survival. Despite reports in the literature of SPARC positivity being associated with poor prognosis, SPARC positive patients in this trial showed a trend towards improved progression free survival.

About Metastatic Breast Cancer

Breast cancer is a disease that will affect one in eight women during her lifetime.i Metastatic breast cancer is defined as the spread of a malignant tumor from its original site (the breast) to other parts of the body.ii It is estimated that nearly 155,000 women in the U.S. are currently living with metastatic breast cancer and this number is projected to increase to nearly 162,000 by the year 2011.iii Nearly all breast cancer deaths are attributable to advanced or metastatic breast canceriv and it is estimated that every thirteen minutes a woman dies from the disease.iv However, more women are surviving breast cancer than ever beforev; the current five-year survival rate for women with metastatic breast cancer is 27 percent.iv

About ABRAXANE®

The U.S. Food and Drug Administration (FDA) approved ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 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.

ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein.

ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.

ABRAXANE was developed by Abraxis BioScience and is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca.

Important Safety Information & Boxed Warning

WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) should be given under the care of a doctor experienced with cancer therapy in a health care facility that is capable of managing possible complications.

ABRAXANE should not be given to patients who have dangerously low white blood counts because of the risk for serious infections. Frequent blood tests are used to check white blood cell count during therapy with ABRAXANE.

An albumin form of paclitaxel may behave differently in the body than other paclitaxel medications. ABRAXANE SHOULD NOT BE SUBSTITUTED FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

One of the more important side effects associated with chemotherapy is a decrease in the number of infection-fighting white blood cells (neutrophils) called “neutropenia.” ABRAXANE should not be given to patients with dangerously low white blood cell counts because of the risk for serious infections. Your doctor will schedule blood tests to check your white blood cell count (absolute neutrophil count (ANC)) during therapy with ABRAXANE. Tell your doctor if you have a fever or notice any other signs of an infection.

Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk. Men should be advised not to father a child while receiving treatment with ABRAXANE.

ABRAXANE contains albumin (human), a derivative of human blood.

The most important side effects have included hair loss, infections due to low white blood cell count, numbness, tingling or burning in the hands or feet, fatigue and weakness, low red blood cell count, mouth or lip sores, joint and muscle pain, stomach upset and diarrhea, heart and blood vessel (cardiovascular) effects and irritation at the injection site.

Numbness, tingling, or burning in the hands and feet (neuropathy) occurs with ABRAXANE and other paclitaxel medications. Be sure to tell your doctor if you experience these symptoms. Your doctor may interrupt treatment and restart at a lower dose after symptoms improve.

Other side effects have included blurred vision or eye irritation, fluid retention, liver and kidney dysfunction, low platelet counts, and allergic reactions (which in rare cases were severe). Tell your doctor about any side effects that bother you.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information, visit www.astrazeneca-us.com.

About Abraxis BioScience

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 chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. 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. 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, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory developments (domestic or foreign) involving the company's manufacturing facilities; the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE; 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, 2007 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.

i Siedman, M.J., et al. Phase II study of weekly nanoparticle albumin bound (nab) paclitaxel in combination with carboplatine and trastuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer (MBC) [Abstract CA016]. ASCO, 2008

ii Detailed Guide: Breast Cancer What Are the Key Statistics for Breast Cancer? American Cancer Society. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_breast_cancer_5.asp.

iii Detailed Guide: Advanced Cancer What Is Metastatic Cancer? American Cancer Society. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Metastatic_Cancer.asp?sitearea=.

iv Data on file. DA-ABR-03, Abraxis Bioscience, Inc.

v ACS Cancer Facts & Figures 2008

 

 

Contact: Abraxis BioScience, Inc.
Maili Bergman, 310-405-7522
mbergman@abraxisbio.com
or
AstraZeneca
Laurie Casaday, 302-885-2699
laurie.casaday@astrazeneca.com

 

 

Posted: December 2008

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