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Second nab Technology-based Cancer Therapy to Enter Clinical Development
Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that the company will begin enrollment in two Phase I/II clinical trials to investigate the use of nab™-docetaxel (ABI-008), an albumin-bound chemotherapeutic, for the treatment of hormone refractory prostate and metastatic breast cancer. Enrollment in the first study for hormone refractory prostate cancer is expected to begin in April 2007, with the second Phase I/II trial in metastatic breast cancer starting shortly thereafter in the second quarter of 2007. Both trials will be conducted at The University of Texas M. D. Anderson Cancer Center in Houston, Texas. Abraxis received FDA clearance for the nab-docetaxel investigational new drug (IND) application in January 2007. Nab-docetaxel is the second drug based on the company's proprietary nanoparticle albumin-bound (nab™) technology to enter clinical development. ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), the first drug to utilize the nab technology platform, was approved by U.S. Food and Drug Administration for the treatment of metastatic breast cancer in January 2005.
"We are very excited about the initiation of the clinical trials with nab-docetaxel. As presented at the American Association of Cancer Research in 2006, pre-clinical data indicated that higher doses of nab-docetaxel can be delivered with less toxicity compared to the solvent-based formulation of docetaxel, Taxotere (docetaxel injection)," said Michael Hawkins, M.D., chief medical officer, Abraxis BioScience. "These data with nab-docetaxel are similar to the comparative pre-clinical data seen with ABRAXANE versus Taxol (paclitaxel), which ultimately proved to be predictive of clinical results. We are hopeful that clinical data with nab-docetaxel will result in a similar outcome. If so, it will confirm that pre-clinical comparisons of nab-therapeutic candidates with their respective Referenced Listed Drugs provide a solid basis for taking compounds forward in the clinic."
"Because of its novel mechanism of action, nab-docetaxel may provide a more effective and possibly less toxic treatment option for patients with metastatic prostate cancer," said John Araujo, M.D., assistant professor, genitourinary medical oncology, M. D. Anderson Cancer Center. "We look forward to studying nab-docetaxel for the treatment of metastatic prostate cancer, a patient group which has very few treatment options."
"Unlike solvent-based taxane chemotherapy, nab-docetaxel utilizes albumin to deliver the active drug into the tumor," said Nuhad Ibrahim, M.D., associate professor, breast medical oncology, M. D. Anderson Cancer Center. "Solvents are associated with side effects like hypersensitivity reactions and neutropenia, which may impede the treatment of patients with metastatic breast cancer. Pre-clinical studies with nab-docetaxel are very promising, and we are eager to study this therapy in a clinical setting for the treatment of metastatic breast cancer."
The Phase I/II clinical trials for each indication will be open-label, single-arm dose escalation studies which will evaluate the safety, tolerability and anti-tumor activity of nab-docetaxel given every three weeks for the treatment of hormone refractory prostate cancer and metastatic breast cancer. The Phase I/II hormone refractory prostate cancer trial is expected to begin enrollment of an anticipated 77 patients in April 2007 and will be led by John Araujo, M.D., and Christopher J. Logothetis, M.D., Chair, Genitourinary Medical Oncology of M. D. Anderson Cancer Center. The Phase I/II metastatic breast cancer trial is expected to begin enrollment of an anticipated 85 patients in the second quarter this year and will be led by Nuhad Ibrahim, M.D., of M. D. Anderson Cancer Center.
Abraxis also filed an IND for the mTOR inhibitor nab-rapamycin (ABI 009) in December 2006, the third investigational product based on the company's nab technology platform. Abraxis anticipates filing four additional IND submissions over the next 12 to 18 months for new molecules which use the proven nab technology platform including the HSP90 inhibitor nab-17AAG (ABI 010).
About nab™ Technology Platform
Developed by Abraxis BioScience, nanoparticle albumin-bound (nab™) 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.
ABRAXANE was the first product developed and approved using the nab technology. Studies are ongoing to evaluate several other therapeutic candidates that employ the nab technology, including nab-rapamycin mTOR inhibitor (ABI 009) and nab-17AAG HSP90 inhibitor (ABI 010), among others.
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. 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®, 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 and AstraZeneca Pharmaceuticals LP.
About Abraxis BioScience
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™ 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®, 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 http://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 trials for nab-docetaxel. 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 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.
Taxotere® is a registered trademark of Sanofi-Aventis.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
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