- Northwestern Memorial Oncologist Contributes to Research Leading to Approval
of First-in-Class of Protein-Bound Particle Chemotherapy Drug -
CHICAGO, Jan. 7 /PRNewswire/ -- Researchers at Lynn Sage Comprehensive
Breast Center played a significant role in the U.S. Food and Drug
Administration (FDA) approval of ABRAXANE(TM) (paclitaxel protein bound
particles for injectable suspension), indicated for the treatment of
metastatic breast cancer.
"This approval means that women with metastatic breast cancer no longer
need to endure the toxicities associated with solvents and will no longer need
steroid premedication when they receive this albumin-bound form of paclitaxel.
Our Phase III study in both first and second line metastatic breast cancer
patients showed that ABRAXANE could be administered at 50% higher dose,
resulting in almost doubling the response rates and longer time to tumor
progression when compared with Taxol," said principal clinical trial
investigator William J. Gradishar, M.D., Associate Professor of Medicine,
Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast
Cancer Program at Northwestern Memorial Hospital. "In addition, in our
research women who no longer responded to some of the more common treatments
showed improvement with ABRAXANE and experienced less severe side effects that
made treatment more tolerable."
ABRAXANE is engineered using a proprietary process (protein bound
nanoparticle technology) to create tiny particles (nanoparticles 100th the
size of a red blood cell) in which the active chemotherapeutic drug,
paclitaxel, is bound to a naturally occurring protein called albumin. By
using this nanotechnology, the active component (paclitaxel) can be delivered
into the body at a 50% higher dose over 30 minutes. This contrasts with Taxol
in which paclitaxel is dissolved in the toxic solvent Cremophor-EL(R),
requiring premedication with steroids and anti-histamines to avoid
hypersensitivity reactions and must be given using infusions of up to three
hours.
The approval of ABRAXANE was based on data from three clinical trials of
patients with metastatic breast cancer, including two Phase II open label
studies of 106 patients on ABRAXANE and a Phase III randomized study involving
454 patients randomized 1:1 into two arms of ABRAXANE or a Cremophor-based
paclitaxel injection (Taxol). Because ABRAXANE is solvent-free, solvent-
related toxicities are eliminated and premedication is not required. The
response rate was almost twice that for all patients treated with ABRAXANE
when compared those receiving the Cremophor-based paclitaxel injection.
Without the toxic solvents, ABRAXANE could be given at higher doses than
Taxol, which may account, in part, for the increased anti-tumor activity. In
addition, albumin is a protein that normally transports nutrients to cells and
has been shown to accumulate in rapidly growing tumors. Therefore, ABRAXANE's
increased effectiveness may also be due to preferential delivery of albumin-
bound paclitaxel to cancer cells.
ABRAXANE was developed by American Bioscience and will be marketed by
Abraxis Oncology, a division of American Pharmaceutical Partners
(Nasdaq: APPX).
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SOURCE Northwestern University
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CONTACT:
Elizabeth Crown of Northwestern University,
+1-312-503-8928
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