"Both pre-clinical studies evaluating the role of SPARC expression provide strong evidence in support of the mechanism of action for our nab-technology therapeutic candidates," said Neil P. Desai, Ph.D., vice president of research and development at Abraxis BioScience. "By leveraging the natural properties of albumin, nab-technology allows for the transport and delivery of higher concentrations of anticancer agent directly to the tumor without the use of toxic solvents. Both pre-clinical and clinical studies have shown that this may lead to an increase in the drug's antitumor effect without increasing side effects."
The first of two pre-clinical studies demonstrated that SPARC is an albumin-binding protein and that the level of the SPARC expression could be correlated with the response of tumors to nab-paclitaxel. This provides concrete support for the earlier hypothesis that higher levels of SPARC protein may lead to enhanced antitumor effect of nab-paclitaxel, which is marketed in the United States under the brand name ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particle for injection (albumin bound). (Abstract #3480; SPARC Overexpression Enhances Sensitivity to nab-paclitaxel In Vivo).
The second of the two pre-clinical studies identified a novel spliced variant of SPARC gene that differed from known human SPARC mRNA sequence by a single amino acid residue. Although the role of this form of SPARC is still under investigation, the existence of this spliced variant in human may explain the evolution biology of SPARC and enhance the understanding of SPARC roles in carcinogenesis (Abstract #2778; Identification of a Splice Variant of Human SPARC mRNA with a Q3 Deletion).
The results of these pre-clinical studies support previous findings presented at the 2006 AACR conference, which demonstrated an increase in tumor response with nab-paclitaxel in SPARC-positive, head-and-neck cancer patients (83 percent) versus SPARC-negative, head-and-neck cancer patients (25 percent).
Abraxis continues to explore the role of nab-technology for targeting SPARC and other biological pathways, as well as for the development of new therapeutic candidates such as nab-docetaxel (ABI-008), the mTOR inhibitor nab-rapamycin (ABI-009), and the HSP90 inhibitor nab-17-AAG (ABI 010), among others.
About nab(TM) Technology Platform
Developed by Abraxis BioScience, nanoparticle albumin-bound (nab(TM)) tumor-targeting technology harnesses the unique natural properties of the human protein albumin, to transport and deliver therapeutic agents to the site of disease. The binding of albumin to the anticancer agent creates nanometer-sized particles, which are approximately 1/100th the size of a single red blood cell. These nab particles are readily incorporated into the body's own transport processes and are able to exploit the tumors' attraction to albumin, enabling the delivery of higher concentrations of the active drug to the target site. This may lead to an increase in the drug's antitumor effect and the potential for an effective response. In addition, nab technology offers the ability to improve a drug's solubility by avoiding the need for toxic chemicals, such as solvents, in the administration process, thus potentially improving safety through the elimination of solvent-related side effects.
Abraxis BioScience received approval from the U.S. Food and Drug Administration for ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease in 2005, its first product developed using the nab technology. Studies are ongoing to evaluate several other therapeutic candidates that employ the nab technology including nab-docetaxel (ABI-008), nab-rapamycin mTOR inhibitor (ABI 009), and nab-17AAG HSP90 inhibitor (ABI 010), among others.
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. 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(R), please visit www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis BioScience, Inc. and AstraZeneca Pharmaceuticals LP.
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 t o 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 Global Market under the symbol ABBI. 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, including statements regarding the timing and scope of clinical studies and trials for nab-rapamycin mTOR inhibitor (ABI 009), and nab-17AAG HSP90 inhibitor (ABI 010). 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 fact that results from pre-clinical studies may not be predictive of results to be obtained in other pre-clinical studies and future clinical trials, delays in commencement and completion of clinical trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials, 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, 2006 and 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.
Abraxis BioScience, Inc.
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