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- Results Will be Reported from Studies Evaluating ABRAXANE in Metastatic Breast Cancer and Other Aggressive Tumor Types, Including Melanoma, Pancreatic Cancer and Prostate Cancer -
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that multiple clinical studies of the chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Orlando, Florida from May 29 to June 2. Clinical results from 14 company and investigator-sponsored studies will be reported, including an ongoing study evaluating three dosing regimens of nab®-paclitaxel in combination with targeted agent bevacizumab for first-line treatment of metastatic breast cancer.
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.
Interim data from an ongoing study evaluating three dosing regimens of ABRAXANE and bevacizumab in HER2-negative metastatic breast cancer patients will be presented in an oral presentation on Monday, June 1 at 11:30 a.m. on Level 2 in West Hall D2. The study, titled "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), assesses 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.
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. Results from company and investigator-sponsored studies in breast cancer, melanoma, pancreatic, prostate and other solid tumor types will be presented at the meeting, including:
-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) - Oral Presentation; Monday June 1, 11:30 a.m.; Level 2, West Hall D2
-Results of a multicenter pilot study of weekly nab-paclitaxel, carboplatin with bevacizumab and trastuzumab as neoadjuvant therapy in HER2+ locally advanced breast cancer with SPARC correlatives (Abstract #527) - Poster Discussion; Sunday May 31, 8 a.m. - 12 p.m.; Level 2, W240A
-Nab-paclitaxel weekly or q3w compared to docetaxel q3w as first-line therapy in patients with metastatic breast cancer: An economic analysis of a prospective randomized trial (Abstract #6592) - General Poster Session; Saturday May 30, 2 p.m. - 6 p.m.; Level 2, West Hall C
-Correlation of SPARC, ER, PR, and HER2 tumor with progression-free survival from a phase II neoadjuvant trial of gemcitabine, epirubicin, and nab paclitaxel (Abstract #618) - General Poster Session; Monday June 1, 1 p.m. - 5 p.m.; Level 2, West Hall C
-Evaluation of baseline blood pressure and plasma rennin activity (PRA) as potential predictors of bevacizumab (B)-mediated hypertension in patients with early stage breast cancer (Abstract #602) - General Poster Session; Monday June 1, 1 p.m. - 5 p.m.; Level 2, West Hall C
-Preliminary safety results from a multicenter phase II trial of nanoparticle albumin-bound paclitaxel/cyclophosphamide plus trastuzumab in HER2+ patients in early stage breast cancer - Publication
-Nab-paclitaxel and bevacizumab as first-line therapy in patients with unresectable stage III and IV melanoma (Abstract #9061) - General Poster Session; Monday June 1, 8 a.m. - 12 p.m.; Level 2, West Hall C
-A phase II trial of carboplatin (C) and nab-paclitaxel (ABI-007-nab-P) in patients with unresectable stage IV melanoma: Final data from N057E1 (Abstract #9055) - General Poster Session; Monday June 1, 8 a.m. - 12 p.m.; Level 2, West Hall C
-Survival of advanced melanoma patients with normal LDH treated with oblimersen, temozolomide, and nab-paclitaxel (Abstract #9080) - General Poster Session; Monday June 1, 8 a.m. - 12 p.m.; Level 2, West Hall C
-SPARC correlation with response to gemcitabine (G) plus nab-paclitaxel (nab-P) in patients with advanced metastatic pancreatic cancer: A phase I/II study (Abstract #4525) - Poster Discussion; Sunday May 31, 2 p.m. - 6 p.m.; Level 2, W230A
-Phase II trial of nab-paclitaxel as first-line therapy of hormone refractory metastatic prostate cancer (HRPC) (Abstract #5152) - General Poster Session; Sunday May 31, 2 p.m. - 6 p.m.; Level 2, West Hall C
-A multi-institutional phase II study of single agent Abraxane (ABI-007) as second line therapy in patients with advanced transitional cell carcinoma of the urothelium - Publication
-A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non-muscle-invasive transitional cell bladder cancer - Publication
-A Phase 1 study investigating the combination of Satraplatin and Abraxane in advanced solid tumors - Publication
Abraxis BioScience is also conducting research into the relationship between tumor biomarkers, including secreted protein acidic and rich in cysteine (SPARC), and its proprietary tumor targeting technology, known as nab® technology. Abraxis' ongoing research evaluates targeted cytotoxic drugs that utilize the novel nab technology and target SPARC to more effectively deliver chemotherapy to cancer tumors. Current Abraxis nab technology research suggests that SPARC binds to the albumin-bound medicine and delivers the chemotherapy to the tumor, killing cancer cells and halting angiogenesis.i
SPARC is an albumin-binding protein present in many types of cancer. SPARC is often found on the surface of cells for the most aggressive metastatic tumor types, including breast, lung, prostate, melanoma, and pancreatic cancers, and clinical studies have shown that the presence of SPARC is often associated with a poor prognosis for patients.ii Recent research suggests a potential role for SPARC as a target for the development of anti-cancer agents.iii
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.
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 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, 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, 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.
i Hawkins MJ, Soon-Shiong P, Desai N. Protein nanoparticles as drug carriers in clinical medicine. Adv Drug Deliv Rev. May 22 2008;60(8):876-885.
ii Podhajcer et al. 2008. Cancer Metastasis Rev. 27, 691-705.
iii Hawkins MJ, Soon-Shiong P, Desai N. Protein nanoparticles as drug carriers in clinical medicine. Adv Drug Deliv Rev. May 22 2008;60(8):876-885.
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