This excerpt taken from the ABII 8-K filed Apr 1, 2008.
Abraxis intends to leverage its nab tumor targeting technology and internal clinical development and regulatory expertise to develop numerous drug candidates for the treatment of cancer and other critical illnesses. The drug candidates which have achieved Phase I or IND status include ABI-008 (nab-docetaxel), ABI-009 (nab-rapamycin), ABI-010 (nab-17AAG) and Coroxane.
Abraxis BioScience, Inc.
2007 Fourth Quarter/Full Year Financial Results
ABI-008 (nab-docetaxel): ABI-008 is a solvent-free nanometer-sized form of docetaxel, a widely used taxane marketed as Taxotere®. An investigational new drug application, or IND, was filed for ABI-008 in the fourth quarter of 2006. In the second quarter of 2007, the company initiated a Phase I/II trial with ABI-008, the second drug based on its nab technology to enter clinical development. The Phase I/II trial will evaluate the safety, tolerability and anti-tumor activity of nab-docetaxel given every three weeks for the treatment of hormone refractory prostate cancer. The company anticipates that pivotal trials for MBC, NSCLC and prostate cancer will be initiated in 2009.
ABI-009 (nab-rapamycin): ABI-009 is an albumin-bound nanoparticle of rapamycin able to be administered intravenously. An IND for ABI-009 was filed in December 2006. Clinical studies began in the fourth quarter of 2007.
ABI-010 (nab-17AAG): ABI-010 is a solvent-free albumin-bound form of 17AAG. The company has submitted an IND for nab-17AAG in the first quarter of 2008.
Coroxane: Coroxane is currently in Phase II clinical studies for coronary restenosis as well as peripheral artery (superficial femoral artery) restenosis. Administered with bare metal stents, Coroxane may address the issue of incomplete re-endothelialization and acute thrombosis associated with drug-eluting stents. Coroxane administered following balloon angioplasty in the superficial femoral artery may help reduce the incidence of restenosis in these patients. The company currently intends to seek a strategic partner for the further development and marketing of Coraxane.