New Data Highlighting the Potential Utility of ABRAXANE in Combination with Targeted Therapies and Other Chemotherapeutic Agents to Be Presented at ASCOLOS ANGELES--(BUSINESS WIRE)--May 16, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated, global biopharmaceutical company, today announced that multiple studies of ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) will be presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, May 30-June 3, 2008. Data will be presented from studies highlighting the potential utility of ABRAXANE (ABI-007) in combination with the targeted agents bevacizumab and trastuzumab, and other chemotherapeutic agents, for neoadjuvant and first-line treatment of metastatic breast cancer.
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.
Results from a study that evaluates first-line treatment of ABRAXANE and bevacizumab in HER2-negative metastatic breast cancer patients will be presented as a poster on Monday, June 2, from 2:00 p.m. - 6:00 p.m. (S Hall A1). The study, titled "Phase II trial of weekly nab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer" (Abstract 1075, Poster 34D), assesses ABRAXANE given weekly three out of four weeks combined with bevacizumab given weekly on the first and third week of a 28-day treatment cycle.
Data from a second study evaluating the safety and efficacy of weekly combination treatments of ABRAXANE, trastuzumab and carboplatin in metastatic breast cancer patients who are HER2-positive, will be presented as a poster on Monday, June 2, from 2:00 p.m. - 6:00 p.m. (S Hall A1). This study abstract (Abstract 1047, Poster 24D) is titled "Phase II study of weekly nanoparticle albumin bound (nab) paclitaxel in combination with carboplatin and trastuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer (MBC)."
Abraxis is continuing to expand its clinical experience with ABRAXANE and its potential in treating a variety of tumor types at multiple stages of disease as a single agent and in combination. Data from additional company and investigator-sponsored studies in breast cancer and melanoma will be presented during poster presentations, including:
Poster Presentations: Monday, June 2, 2008, 2:00 p.m. - 6:00 p.m., S Hall A1
Phase II study of neoadjuvant gemcitabine, epirubicin, and albumin-bound nab-paclitaxel (GEA) in locally advanced breast cancer with SPARC tumor assessments (Abstract 603, Poster 14G)
Phase II study of nab-paclitaxel, bevacizumab, and gemcitabine for first-line therapy of patients with HER2-negative metastatic breast cancer (MBC) (Abstract 1089, Poster 38H)
Phase II study of neoadjuvant bevacizumab and trastuzumab administered with albumin bound paclitaxel (nab-paclitaxel) and carboplatin in HER2+ locally advanced breast cancer (Abstract 627, Poster 19E)
Single-agent nab-paclitaxel given weekly (3/4) as first-line therapy for metastatic breast cancer (an International Oncology Network Study) (Abstract 1118, Poster 43G)
Nab-paclitaxel and carboplatin with or without trastuzumab as part of neoadjuvant chemotherapy in patients with stage II-III breast cancer (Abstract 567, Poster 5E)
Efficacy of nab-paclitaxel in patients with poor prognostic factors or with anthracycline-resistant metastatic breast cancer (Abstract 1082, Poster 37G)
Poster Discussion: Sunday, June 1, 2008, 2:00 p.m. - 6:00 p.m., W375e Lobby
Pharmacokinetics of ABRAXANE (albumin-bound paclitaxel) in combination with temozolomide and oblimersen sodium (ATG) in patients with advanced melanoma (Abstract 9027, Poster 16)
Poster Presentation: Saturday, May 31, 2008, 2:00 p.m. - 6:00 p.m., S Hall A1
A phase II trial of carboplatin and ABI-007 (ABX) in patients with unresectable stage IV melanoma (Abstract 9044, Poster 17G)
ABRAXANE(R) is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nab(TM) 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. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience and is marketed in the United States under a co-marketing and sales agreement between Abraxis and 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 nanoparticle chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab(TM) platform. The first FDA approved product to use this nab(TM) 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.
Posted: May 2008