Abraxis BioScience Inc. an integrated, global biopharmaceutical company, has announced that the company will begin enrolment 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.

Enrolment 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 MD Anderson Cancer Centre 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, the first drug to utilize the nab technology platform, was approved by US 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, MD, 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, assistant professor, genitourinary medical oncology, Anderson Cancer Centre. "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 tumour," said Nuhad Ibrahim, MD., associate professor, breast medical oncology, M. D. Anderson Cancer Centre. "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."