SCHAUMBURG, Ill. and SANTA MONICA, Calif., Nov. 1 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (APP) and American BioScience Inc. today said the results of a Phase I study with ABRAXANE(TM) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) given weekly to patients with advanced cancer, including lung, ovarian and melanoma, published in the November 1 issue of the Journal of Clinical Oncology (http://www.jco.org/cgi/content/abstract/23/31/7785), reported that the maximum tolerated dose (MTD) observed in this trial for heavily and lightly pretreated patients was 100 mg/m(2) and 150 mg/m(2), respectively. The article was accompanied by an editorial that reviews the advantages of ABRAXANE compared with Taxol(R) and discusses areas for future research (http://www.jco.org/cgi/content/full/23/31/7765).
“ABRAXANE previously has demonstrated superior activity in metastatic breast cancer compared with Taxol. Interestingly, in our study, all three patients with ovarian cancer, each of whom had previously received Taxol, had objective responses to ABRAXANE. In addition, although only a Phase I safety study, we saw a response in a lung cancer patient whose tumor had progressed while receiving Taxol,” said Daniel D. Von Hoff, M.D., senior author of the paper and clinical professor of medicine, former director of the Arizona Cancer Center at The University of Arizona in Tucson, AZ, and currently Senior Investigator at the Translational Genomics Research Institute, Phoenix, AZ. “These doses were found to be approximately 50% higher than those typically used for Taxol when given weekly.”
ABRAXANE was designed to avoid solvent-related toxicities common to current preparations of paclitaxel and to deliver paclitaxel to tumors via a receptor-mediated pathway that is up-regulated in solid tumors such as melanoma, lung, breast and ovarian cancer. The pathway involves an endothelial cell-surface albumin receptor (gp60) and an albumin-binding protein (SPARC) expressed by tumor cells and secreted into the tumor interstitium.
The Phase I trial was designed to determine the safety and maximum tolerated dose (MTD) of ABRAXANE administered weekly. Thirty-nine patients were enrolled in the study and included those with melanoma (36%), breast cancer (23%), non-small cell lung cancer (13%), ovarian cancer (8%) and other cancers. Patients received ABRAXANE without premedication at dose levels ranging from 80 to 200 mg/m(2) as a 30-minute IV infusion administered once a week for three weeks followed by a week of rest. Ninety-two percent of patients had received previous chemotherapy including approximately 40% of patients who were taxane-refractory.
“On the basis of this study, we used this weekly dosing regimen in subsequent Phase II trials in patients with Stage IV non-small cell lung cancer and metastatic malignant melanoma. We are also evaluating various dosing regimen of ABRAXANE in ovarian cancer. Additional data pertaining to ABRAXANE and the key role of a protein secreted by multiple tumors, SPARC, will be presented this week at the Chemotherapy Foundation Symposium in New York,” said Michael Hawkins, M.D., chief medical officer of American BioScience, Inc.
About ABRAXANE(TM)
The U.S. Food and Drug Administration approved ABRAXANE(TM) in January 2005. ABRAXANE(TM) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE(TM) please visit www.abraxane.com.
ABRAXANE is composed only of 130 nanometer paclitaxel and albumin particles, and is free of toxic solvents, unlike all other paclitaxel products currently marketed. Because ABRAXANE contains no toxic solvents, administration of a 50% higher dose of paclitaxel is achieved with favorable response rates, even in heavily treated metastatic breast cancer patients who may have progressed on standard taxane therapy. ABRAXANE is devoid of the side-effects attributed to the solvents in Taxol.
Adverse Events Summary
In the randomized metastatic breast cancer study, the most important adverse events included neutropenia (all cases 80%; severe 9%), anemia (all 33%; severe 1%), infections (24%), sensory neuropathy (any symptoms 71%; severe 10%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 26%; severe < 1%), myalgia/arthralgia (any 44%; severe 8%), and mucositis (any 7%; severe < 1%). Other adverse reactions included asthenia (any 47%; severe 8%), ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), alopecia (90%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), and renal dysfunction (any 11%; severe 1%). Thrombocytopenia (any 2%; severe < 1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (1%) were uncommon.
About American BioScience, Inc.
American BioScience, Inc. (ABI) is a privately held biotechnology company focused on the discovery, development and delivery of next-generation therapeutic moieties including biologically active molecules already existing within the human biological system, for the treatment of life-threatening diseases. ABI owns a majority interest in American Pharmaceutical Partners, Inc.
About American Pharmaceutical Partners
American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP’s website at www.appdrugs.com and www.abraxisoncology.com.
Because these forward-looking statements, whether expressed or implied, involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, whether the results reported in this Phase I study, including those seen in non-small cell lung and ovarian cancer, will be observed in subsequent studies, the costs associated with the ongoing launch of ABRAXANE(TM), the market adoption and demand of ABRAXANE, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in our Form 10-K for the year ended December 31, 2004 and other documents filed by us with the Securities and Exchange Commission.
Taxol(R) is a registered trademark of Bristol-Myers Squibb Company. Contacts: American Pharmaceutical Partners, Inc. Nicole Williams Executive Vice President & CFO (847) 969-2700 Rob Whetstone/Robert Jaffe PondelWilkinson Inc. (310) 279-5963
American Pharmaceutical Partners, Inc.
CONTACT: Nicole Williams, Executive Vice President & CFO, AmericanPharmaceutical Partners, Inc., +1-847-969-2700; or Rob Whetstone or RobertJaffe, both of PondelWilkinson Inc., +1-310-279-5963, for AmericanPharmaceutical Partners, Inc.
