This excerpt taken from the ABII 8-K filed Aug 13, 2008.
RESEARCH AND DEVELOPMENT HIGHLIGHTS
There are currently 30 company-sponsored clinical studies and approximately 90 investigator-initiated studies planned or underway, of which more than 25 have active patient enrollment.
At the American Association for Cancer Research (AACR) Annual Meeting in April 2008, Abraxis presented preclinical data demonstrating the effect of ABRAXANE in combination with Avastin® (bevacizumab) to eradicate large-sized (up to 600 mm3) orthotopic breast tumors and lymphatic and systematic metastasis. The findings presented suggest a novel mechanism through which ABRAXANE can overcome a newly discovered phenomenon of reactionary angiogenesis.
At AACR, Abraxis also presented data from a Phase I trial showing clinical benefit of ABRAXANE in combination with Gemzar® (gemcitabine) in more than 70 percent of patients with advanced pancreatic cancer. Based on the results, Abraxis plans to conduct additional studies to evaluate the safety and efficacy of ABRAXANE in patients with first- and second-line pancreatic cancer.
At the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in May 2008, Abraxis reported clinical results from 23 company and investigator-sponsored studies. Highlights included data from studies on the potential utility of ABRAXANE in combination with the targeted agents bevacizumab and trastuzumab, and other chemotherapeutic agents, for neoadjuvant and first-line treatment of metastatic breast cancer.
Abraxis BioScience, Inc.
2008 Second Quarter Financial Results
At ASCO, a preliminary analysis of an ongoing single-arm, open-label, Phase II clinical trial evaluating solvent-free ABRAXANE in combination with bevacizumab for the first-line treatment of metastatic breast cancer was presented. This analysis showed that ABRAXANE (125 mg/m2) given weekly for three weeks combined with bevacizumab (10 mg/kg) given weekly on the first and third week of a four-week treatment cycle demonstrated a 33 percent overall response rate and a median progression-free survival of 7.4 months.
Additionally, a preliminary analysis of an ongoing single-arm, open-label, Phase II clinical trial evaluating solvent-free ABRAXANE in combination with trastuzumab and carboplatin for the first-line treatment of patients with HER2-positive metastatic breast cancer was presented at ASCO. This analysis showed that weekly ABRAXANE (100 mg/m2 three weeks on treatment, one week off) followed by carboplatin (AUC of 6 every four weeks) plus trastuzumab (4 mg/kg loading dose followed by 2 mg/kg on subsequent visits) demonstrated a 53 percent overall response rate and median progression free survival of nearly 16 months.