Abraxis shares rocket on positive Ph III results for Abraxane in lung cancer

Los Angeles, USA-based Abraxis BioScience saw its shares leap 30% to $52 in flat Nasdaq market trading yesterday, after the company announced that its randomized registrational Phase III clinical trial comparing Abraxane (protein-bound paclitaxel) with Bristol-Myers Squibb's Taxol (paclitaxel) injection, both in combination with carboplatin, met the study's primary endpoint, demonstrating that Abraxane showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

The Phase III trial completed enrollment of 1,052 patients in July 2009 at 102 sites globally and was led by principal investigator Mark Socinski, at the University of North Carolina Lineberger Comprehensive Cancer Center. It is one of the largest NSCLC clinical studies to be conducted. "This is exciting news for lung cancer patients and has important implications not only in late-stage cancer but also in earlier stages of the disease," said Dr Socinski. The data will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting.

Drug already approved for breast cancer

Abraxane was approved by the US Food and Drug Administration in January 2005 as a chemotherapy treatment for metastatic breast cancer, after other chemotherapy treatments fail or a relapse within six months occurs. Abraxis is seeking an added approval of the product, used with the chemotherapy drug carboplatin, as an initial treatment for the lung malignancies. According to Abraxis' latest financial filing, sales of Abraxane for the first nine months of 2009 were $228.6 million compared with $245.8 million for the same period in 2008.