Abraxis BioScience Presents Results from Pre-Clinical Study That Demonstrates nab-Rapamycin's Robust Antitumor Properties and Ability to Target Intracellular Sites Such as the mTOR PathwayLOS ANGELES--(BUSINESS WIRE)--Apr 19, 2007 - Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, presented first-time data from a pre-clinical study evaluating the toxicity and antitumor effect of nab-rapamycin (ABI-009), an albumin-bound mTOR kinase inhibitor, at the 98th American Association for Cancer Research (AACR) Annual Meeting held April 14-18, 2007 in Los Angeles. Results from the pre-clinical study demonstrated that nab-rapamycin was well-tolerated, showed linear pharmacokinetics, and was highly effective against a number of tumor models in vivo. (Abstract #4719; Nanoparticle Albumin-bound (nab) Rapamycin as an Anticancer Agent).
Leveraging Nab Technology with Rapamycin to Target mTOR Pathway
The mammalian target of rapamycin (mTOR) is a cell-signaling protein that regulates the response of tumor cells to nutrients and growth factors, as well as controls tumor blood supply through effects on vascular endothelial growth factor (VEGF). Rapamycin is an mTOR inhibitor. The mTOR pathway is thought to be overactivated in numerous tumors and plays a critical role in cell survival and resistance to chemotherapy. Inhibition of mTOR activity prevents the signaling to important pathways that control cell growth and lead to a lowering of VEGF levels, thus decreasing the ability of tumors to gain their own blood supply (angiogenesis).
The role of mTOR inhibition has led investigators at Abraxis to explore the use of the nanoparticle albumin-bound (nab(TM)) tumor-targeting technology to enhance the deregulation of mTOR signaling. Nab-rapamycin is also intended to address limitations posed by the poor water solubility of rapamycin and may enable higher concentrations of the drug to reach the tumor tissue. Abraxis plans to commence Phase I clinical trials with nab-rapamycin in 2007.
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) 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 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 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 or 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.
Investors and Media:
Christine Cassiano, 310-405-7417
Claire Campbell, 908-393-8238
Posted: April 2007