PipelineReview.com - Biotech News & Online Store - Three Studies Confirm Activity of ABRAXANE As First-Line Treatment in Non-Small Cell Lung Cancer and Show Higher Tumor Response Rates Than Current Standard of Care

Three Studies Confirm Activity of ABRAXANE As First-Line Treatment in Non-Small Cell Lung Cancer and Show Higher Tumor Response Rates Than Current Standard of Care

05 Jun 2006

ATLANTA, GA, USA | Jun 04, 2006 | Abraxis BioScience, Inc. (NASDAQ:ABBI): Abraxis BioScience, Inc. (NASDAQ:ABBI), an

integrated, global biopharmaceutical company, presented data today at the American Society of Clinical Oncology (ASCO) Annual Meeting from multiple Phase 2 studies with ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) as first-line treatment for late-stage non-small cell lung cancer (NSCLC). In a series of dose-ranging and efficacy studies, ABRAXANE as first-line treatment showed improved antitumor benefits over the solvent-based taxane treatment. These data form the basis for the Phase III registration trial. The protocol for this trial is being discussed with the U.S. Food and Drug Administration (FDA) and the registrational Phase III trial is expected to begin in the second half of 2006.

"These data in NSCLC are consistent with the clinical trial experience with ABRAXANE in the breast cancer setting where Abraxane demonstrated greater antitumor activity than Taxol," said Michael Hawkins, MD, chief medical officer of Abraxis BioScience. "We look forward to advancing ABRAXANE into larger pivotal trials to develop more active treatment regimens for critically ill cancer patients."

"These early studies show efficacy results that seem to be better than typically seen with solvent-based taxane therapy in advanced lung cancer treatment," said Mark A. Socinski, MD, Associate Professor of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine. "This is potentially hopeful news for patients with advanced non-small cell lung cancer, a setting in which we see limited treatment options."

In one of three ongoing Phase 2 studies presented (Poster 7127: A Phase 2 evaluation of the combination of 130-nanometer albumin-bound paclitaxel (ABRAXANE) and carboplatin in the first-line treatment of advanced non-small cell lung cancer (NSCLC)) chemotherapy naive patients (n=56) with stage 3 and 4 NSCLC received weekly ABRAXANE (100 mg/m2) and carboplatin (AUC 6). Fifty percent of the patients had either a complete or partial response, and an additional 36 percent had stable disease for at least 12 weeks resulting in a disease control rate of 86 percent; median time to disease progression (TTP) was 28 weeks. By comparison, previous clinical trial experience with solvent-based paclitaxel given weekly and standard carboplatin demonstrated a 32 percent response rate in a similar patient population. The grade three and four adverse events observed with ABRAXANE were neutropenia, thrombocytopenia and anemia.

Other data presented from another trial included a Phase 1/2 study of ABRAXANE as a first-line single-agent treatment for patients (n=40) with advanced NSCLC (Poster 7105 Phase I/II Study of ABI-007 as first-line chemotherapy in advanced non-small-call lung cancer). In the first phase of the dose-escalating trial, a weekly maximum tolerated dose of 125 mg/m2 was established. In the treatment phase of the trial, 30 percent of patients had an objective response, and median survival was 10.9 months. Hematological toxicity was minimal and the most common grade three toxicities were fatigue and sensory neuropathy.

A third Phase 2 study involved dose escalation exploring the use of ABRAXANE and carboplatin given every three weeks in patients (n=100) with advanced NSCLC as first-line therapy (Poster 7132: Dose escalation study of nab-paclitaxel followed by carboplatin as first line therapy in advanced non-small-cell lung cancer (NSCLC)) demonstrated a 29 percent response rate across all doses and a 46 percent disease control for 16 weeks or longer. The most common grade three and four toxicities were neutropenia, anemia and thrombocytopenia although no clear relationship between the dose of ABRAXANE and severe mylosuppression was established. The occurrence of sensory neuropathy was dose dependent and no grade four sensory neuropathy was observed.

About Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is a disease in which malignant cells form in the tissue of the lungs. It is the most common form of lung cancer, accounting for approximately 87 percent of all lung cancer cases. Currently, treatment provides limited success. The American Cancer Society (ACS) estimates that approximately 172,470 people will be diagnosed with lung cancer in the United States in 2006, with a resulting 162,460 deaths that same year. The five-year survival for stage III and IV NSCLC is between 1 and 7 percent.

About the nab Technology Platform

Abraxis' nanoparticle albumin-bound (nab) tumor-targeting technology exploits the natural properties of a human protein, albumin, for drug delivery. By wrapping albumin around active drug and creating particles of approximately 130 nanometers, Abraxis has found a way to eliminate the need for solvents and deliver higher concentrations of chemotherapy without the solvent-related toxicities compared with solvent-based taxanes. The first FDA-approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of patients with metastatic breast cancer.

About ABRAXANE(R)

The U.S. Food and Drug Administration approved ABRAXANE(R) 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(R) please visit www.abraxane.com.

About Abraxis BioScience, Inc.

Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE(R), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq National Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.

Forward-Looking Statement

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 expected cost benefits and the acceleration of the market penetration for ABRAXANE, global expansion, and the accretive effect of these transactions to earnings. 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 continued market adoption and demand of ABRAXANE in North America and its potential market penetration outside of the U.S., the costs associated with the ongoing launch of ABRAXANE, the continued market acceptance of the new products acquired from AstraZeneca, AstraZeneca's ability to satisfy its obligations under the supply agreement, the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing any other products, including those in the pipeline, 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, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2005 and other documents it has filed with the Securities and Exchange Commission.

SOURCE: Abraxis BioScience, Inc.

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