Tachycardia

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

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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 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%).

Keywords: , Health, Biotechnology, Clinical Trials, Oncology, Pharmaceutical, Pediatrics, Bioscience, Chemicals, Chemistry, Food, TechnologyAbraxane, Abraxis BioScience Inc., Biotechnology, Biotechnology Business, Biotechnology Company, Breast Cancer, Breast Carcinoma, Carboplatin, Chemotherapy, Clinical Trial Research, Cysteine, Dietary Supplement, Drug Development, Drug Therapy, Drugs, FDA, Infectious Disease, Lung Neoplasms, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nutritional Supplement, Oncology, Paclitaxel, Pharmaceuticals, Pulmonology, Respiratory Infection, Solid Cancers, Solid Carcinomas, Taxol, Therapy, Treatment, U.S. Food and Drug Administration, Women's Health, Abraxis BioScience Inc.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.