Abraxis BioScience, Inc. (NASDAQ:ABII) presented trial design information from its ongoing phase 3 registration trial of n anoparticle a lbumin b ound ( nab ®) driven chemotherapy, nab-paclitaxel (ABRAXANE ® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), in melanoma, an aggressive form of skin cancer that affects more than 68,000 people in the U.S. each year. Melanoma is the leading cause of skin cancer death in the United States, killing more than 8,000 people annually. i
Abraxis BioScience also presented an abstract describing the design of its ongoing phase 3 registrational trial of nab-paclitaxel for the treatment of metastatic malignant melanoma (MMM). The pivotal phase 3 clinical trial program exploring the use of nab-paclitaxel (150 mg/m 2) in advanced melanoma was discussed during the “Trials in Progress” session at the 46 th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
New data on Abraxis BioScience’s novel nab technology, which leverages albumin nanoparticles for the active and targeted delivery of chemotherapeutics to the tumor, has been presented at ASCO in a wide range of tumor types, including pancreatic, ovarian, breast, head and neck, and non-small cell lung cancers. The company is investigating the potential of nab-driven chemotherapy to deliver cytotoxic agents directly to the tumor microenvironment through a previously unrecognized tumor-activated, albumin-specific biologic pathway in the most difficult-to-treat cancer types, including metastatic malignant melanoma.
“As the body of evidence continues to build it validates our commitment to interrogating the activity of ABRAXANE in difficult-to-treat tumor types such as metastatic melanoma,” said Patrick Soon-Shiong, M.D., Executive Chairman and Founder of Abraxis BioScience.Currently approved for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy, ABRAXANE has also been granted orphan drug designation by the Food and Drug Administration for the treatment of stage IIB-IV melanoma as well as pancreatic cancer.