New Data Shows Promising Antitumor Activity with nab-paclitaxel (ABRAXANE(R)) in Combination and as a Single Agent for the Treat
05 Juin 2007 - 3:33AM
PR Newswire (US)
Results Presented at the American Society of Clinical Oncology
(ASCO) Annual Meeting HOUSTON, June 4 /PRNewswire/ -- Leading
cancer researchers affiliated with the US Oncology Research
Network, one of the nation's largest cancer treatment and research
networks focused on cancer treatment and research, and Abraxis
BioScience, Inc. (NASDAQ:ABBI), an integrated, global
biopharmaceutical company, presented preliminary findings from two
investigator-initiated Phase II studies evaluating albumin-bound
paclitaxel (nab-paclitaxel) in combination and alone for the
treatment of patients with advanced non-squamous non-small cell
lung cancer (NSCLC) and platinum-sensitive, recurrent ovarian,
peritoneal or fallopian tube cancer, respectively. In both Phase II
clinical studies, nab-paclitaxel, marketed under the brand name
ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound
particles for injectable suspension) (albumin bound) was found to
be well-tolerated with encouraging response rates, providing
support for further investigation of nab-paclitaxel for the
treatment of NSCLC and ovarian cancer. The study results were
presented at the 43rd Annual Meeting of the American Society of
Clinical Oncology (ASCO) held June 2 - 5, 2007 in Chicago. The
study titled "An open-label, Phase II trial of nab-paclitaxel,
carboplatin and bevacizumab in first-line patients with advanced
non-squamous non-small cell lung cancer (NSCLC)" (Abstract number
7610) was presented by principal investigator, Craig H. Reynolds,
M.D. of Ocala Oncology Center, Ocala, Florida, who also serves as
co-chair of US Oncology's National Lung Cancer Research Committee.
The randomized, open-label Phase II study was designed to evaluate
nab-paclitaxel dosed every three weeks in combination with
carboplatin and bevacizumab in 50 patients with advanced
non-squamous NSCLC. "The use of nab-paclitaxel has circumvented
many of the infusion difficulties that are associated with
solvent-based paclitaxel," said Dr. Reynolds. "Preliminary analysis
of this study indicates that treatment with nab-paclitaxel in
combination with carboplatin and bevacizumab was not only
well-tolerated, but showed encouraging response and median survival
rates in the first-line treatment of non-small cell lung cancer."
The primary end point of the study was response rate based on
Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Responding patients received at least four cycles of treatment.
Thirty-six patients completed all four cycles of therapy. So far,
31.3 percent of patients showed a partial response and 52.1 percent
had stable disease. Kaplan-Meier estimated median progression free
survival (PFS) was 9.8 months, and median survival was 15.8 months.
Grade 3-4 treatment-related toxicities were: neutropenia 52
percent; fatigue 17 percent; febrile neutropenia, thrombocytopenia
and neuropathy 10 percent each; and anorexia, constipation, and
diarrhea 4 percent each. The study titled "Results of a Phase II
evaluation of nab-paclitaxel in platinum-sensitive patients with
recurrent ovarian, peritoneal or fallopian tube cancer" (Abstract
number 5525) was presented in a poster presentation by the
principal investigator, Michael G. Teneriello, M.D. of Texas
Oncology, who also serves as co-chair of US Oncology's National
GU/Gyn Research Committee. This open level Phase II study was
designed to evaluate single agent nab- paclitaxel in a
platinum-sensitive patient population. A total of 47 patients were
enrolled for treatment with nab-paclitaxel every three weeks at 260
milligrams per meter(2). "The study results show that
nab-paclitaxel as a single agent is very active and well-tolerated
in patients with recurrent ovarian cancer," said Dr. Teneriello.
"There are multiple treatment options for patients with this
difficult to treat disease, but the results of this study are very
encouraging. Further studies with nab-paclitaxel in combination
with platinum as a first-line therapy for recurrent ovarian cancer
are warranted." Patients received nab-paclitaxel intravenously once
every three weeks until progressive disease or until completion of
six cycles, with two additional cycles if a complete response was
observed. Disease progression was measured by RECIST criteria or
elevated blood levels of the biological marker CA-125 in the
absence of measurable disease. For all eligible/treated patients,
the overall response rate was 63.6 percent with 14 complete and 14
partial responses out of 44 evaluable patients. Median duration of
response of was 6.5 months with a median progression free survival
of 8.5 months. The most frequent Grade 3-4 treatment-related
toxicities were: neutropenia 23.9 percent; leucopenia 13 percent;
and neuropathy 8.7 percent. "Both studies demonstrated ABRAXANE's
activity and tolerability, as a single agent for ovarian cancer and
in combination for non-small cell lung cancer," commented Michael
Hawkins, M.D., Chief Medical Officer, Abraxis BioScience. "Studies
of ABRAXANE in various tumor types, such as these done by US
Oncology Research, are continuing to expand of our collective
clinical experience with ABRAXANE." This research was supported, in
part, by a research grant from Abraxis BioScience, Inc. About US
Oncology Research The US Oncology Research Network is an
established community-based research operation specializing in all
phases of cancer clinical trials. The research network currently
has 528 physicians actively enrolling patients, 82 research sites,
and is currently involved in 65 open research trials. The network
has contributed to the development of 24 of 30 of the latest
cancer- fighting drugs approved by the Food and Drug Administration
for use. Since 1993, more than 32,000 patients have participated in
clinical trials managed by US Oncology network practices. For more
information, visit the "Research" section under "Our Services" on
the company's Web site, http://www.usoncology.com/. About US
Oncology, Inc. US Oncology, headquartered in Houston, is one of the
nation's largest cancer treatment and research networks. US
Oncology provides extensive services and support to its affiliated
cancer care sites nationwide to help them expand their offering of
the most advanced treatments and technologies, build integrated
community-based cancer care centers, improve their therapeutic drug
management programs, and participate in many of the new
cancer-related clinical research studies. US Oncology also provides
a broad range of services to pharmaceutical manufacturers,
including product distribution and informational services such as
data reporting and analysis. According to the company's last
quarterly earnings report, US Oncology is affiliated with 1,077
physicians operating in 433 locations, including 90 radiation
oncology facilities in 38 states. About ABRAXANE.(R) The U.S. Food
and Drug Administration approved ABRAXANE.(R) for Injectable
Suspension (paclitaxel protein-bound particles for injectable
suspension) (albumin-bound) in January 2005 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. The most serious adverse events
associated with ABRAXANE in the randomized metastatic breast cancer
study for which FDA approval was based included neutropenia,
anemia, infections, sensory neuropathy, nausea, vomiting, and
myalgia/arthralgia. Other common adverse reactions included anemia,
asthenia, diarrhea, ocular/visual disturbances, fluid retention,
alopecia, hepatic dysfunction, mucositis, and renal dysfunction.
For the full prescribing information for ABRAXANE(R), please visit
http://www.abraxane.com/. ABRAXANE was developed by Abraxis
BioScience, Inc. ABRAXANE is marketed in the United States under a
co-promotion agreement between Abraxis BioScience, Inc. and
AstraZeneca Pharmaceuticals LP. About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical
company dedicated to meeting the needs of critically ill patients.
The company develops, manufactures and markets one of the broadest
portfolios of injectable products and leverages revolutionary
technology such as its nab(TM) (nanoparticle albumin bound)
platform to discover and deliver breakthrough therapeutics that
transform the treatment of cancer and other life-threatening
diseases. The first FDA approved product to use this nab platform,
ABRAXANE(R), was launched in 2005 for the treatment of metastatic
breast cancer. Abraxis trades on The Nasdaq Global Market under the
symbol ABBI. For more information about the company and its
products, please visit http://www.abraxisbio.com/. ABRAXANE(R) is a
registered trademark of Abraxis BioScience, Inc. DATASOURCE: US
Oncology CONTACT: Kimberly Rutherford, +1-832-601-6193, or
Elizabeth Vocke, +1-813-240-0791, both of US Oncology, or Christine
Cassiano of Abraxis BioScience, +1-310-405-7417 Web site:
http://www.usoncology.com/ http://www.abraxane.com/
http://www.abraxisbio.com/
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