Opaxio
Generic name: paclitaxel poliglumex
Treatment for: Non Small Cell Lung Cancer, Ovarian Cancer, Glioblastoma Multiforme, Head and Neck Cancer
OPAXIO Phase II Study Results Confirm High Rate of Complete Response with Low Rate of Side Effects in Patients with Advanced Esophageal Cancer
CTI to explore Phase III study
CHICAGO, June 7 /PRNewswire-FirstCall/ -- Cell Therapeutics,
Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that updated
phase II study results of OPAXIO (paclitaxel poliglumex) in
patients with advanced esophageal cancer demonstrated that 38%
(15/40) patients receiving OPAXIO in combination with cisplatin and
concurrent radiation achieved a pathologic or endoscopic complete
response. A pathological complete response, observed in 32% of
patients, is recorded only when the esophagus is surgically removed
after therapy and no tumor can be found microscopically. In
historical studies, pathologic complete response has correlated
with prolonged survival. Pathologic complete response rates with
the current U.S. standard regimen of 5FU + cisplatin chemotherapy
with concurrent radiation for patients with esophageal cancer are
approximately 15% with 40% of patients experiencing severe (grade
3-4) inflammation and ulcers in the esophagus and stomach
necessitating tube feeding. The results were presented by Kimberly
Perez, M.D., Warren Alpert School of Medicine, Brown University, at
the American Society of Clinical Oncology Annual Meeting in
Chicago, Illinois. CTI plans to meet with the U.S. Food and Drug
Administration ("FDA") in the second half of 2010 to explore a
potential phase III registration study based on these
results.
"OPAXIO significantly improved the pathologic complete response
rate that has been shown in previous phase III trials using
standard chemotherapy plus radiation," said Dr. Perez.
"Importantly, we did not see the severe regional side effects
associated in treating patients with platinum, 5-FU, and radiation
based regimens with only one patient requiring a feeding tube in
this study. Typical rates of grade 3-4 esophagitis for this regimen
are on the order of 40%."
The phase II study enrolled 40 patients with
pathologically-confirmed, locally-advanced adenocarcinoma or
squamous cell carcinoma of the esophagus or gastro-esophageal
junction with no evidence of distant metastisis. The patients
received weekly paclitaxel poliglumex (50mg/m2) and cisplatin
(25mg/m2) for six weeks with concurrent 50.5Gy of radiation. The
updated data demonstrated that of the 37 patients who underwent
surgery, 12 patients achieved a pathologic complete response.
Additionally, three patients achieved a complete clinical
endoscopic response and refused surgery. Importantly, only one
patient required a feeding tube and one patient used total
parenteral nutrition. There were no grade 4 hematologic adverse
events. Grade 3 hematologic adverse events included neutropenia
(6%) and grade 3 non-hematologic toxicities included nausea (8%),
esophagitis (6%), allergy (6%) and fatigue (3%).
"The high pathologic complete response rate coupled with
tolerability confirms the striking efficacy of OPAXIO as a
tumor-specific radiosensitizer in preclinical studies (Milas et
al.; Int J Radiation Oncol Biol. Biophys, 55:2-7-12, 2003) and the
previous phase I study of OPAXIO and radiation in locally advanced
esophageal and gastric cancer (Dipetrello et al.: American Journal
of Clinical Oncology: 29:376-379, 2006)," said Jack Singer, M.D.,
Chief Medical Officer of CTI. "The important features of the
current study are both the higher than historical pathological
response rate, a potential excellent surrogate for long-term
survival, and the dramatically lower side effects than would be
expected from conventional neoadjuvant chemoradiotherapy with
cisplatin and 5-FU."
About OPAXIO(TM)
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly
known as XYOTAX(TM), is an investigational, biologically enhanced,
chemotherapeutic that links paclitaxel, the active ingredient in
Taxol®, to a biodegradable polyglutamate polymer, which results
in a new chemical entity. When bound to the polymer, the
chemotherapy is rendered inactive, potentially sparing normal
tissue's exposure to high levels of unbound, active chemotherapy
and its associated toxicities. Blood vessels in tumor tissue,
unlike blood vessels in normal tissue, are porous to molecules like
polyglutamate. Based on preclinical studies, it appears that OPAXIO
is preferentially distributed to tumors due to their leaky blood
vessels and trapped in the tumor bed allowing significantly more of
the dose of chemotherapy to localize in the tumor than with
standard paclitaxel. Once inside the tumor cell, enzymes metabolize
the protein polymer, releasing the paclitaxel chemotherapy.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company
committed to developing an integrated portfolio of oncology
products aimed at making cancer more treatable.
This press release includes forward-looking statements that
involve a number of risks and uncertainties, the outcome of which
could materially and/or adversely affect actual future results and
the trading price of CTI's securities. Specifically, the risks and
uncertainties that could affect the development of OPAXIO include
risks associated with preclinical and clinical developments in the
biopharmaceutical industry in general, and with OPAXIO in
particular, including, without limitation, the potential for OPAXIO
to be proved safe and effective (or to achieve response rates) for
the treatment of the indications noted in this press release or any
other indication, determinations by regulatory, patent and
administrative governmental authorities, the potential that OPAXIO
will not produce high rates of complete remission in patients with
advanced esophageal or other cancers, the possibility that the
registration trial for OPAXIO as a radiation sensitizer will not
occur, the possibility that CTI may not meet with the FDA in the
second half of 2010, the possibility that the FDA will not approve
a phase III registration strategy for paclitaxel poliglumex if
proposed by CTI, CTI's ability to continue to raise capital as
needed to fund its operations, competitive factors, technological
developments, and costs of developing, producing and selling
OPAXIO. You should also review the risk factors listed or described
from time to time in CTI's filings with the Securities and Exchange
Commission including, without limitation, CTI's most recent filings
on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI
does not intend to update or alter its forward-looking statements
whether as a result of new information, future events, or
otherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E: deramian@ctiseattle.com Investors Contact: Ed Bell T: 206.282.7100 Lindsey Jesch Logan T: 206.272.4347 F: 206.272.4434 E: invest@ctiseattle.com
Source: Cell Therapeutics, Inc.
CONTACT: Dan Eramian, +1-206-272-4343, or cell,
+1-206-854-1200,
deramian@ctiseattle.com,
Investors, Ed
Bell, +1-206-282-7100, or Lindsey Jesch Logan, +1-206-272-4347,
fax,
+1-206-272-4434, invest@ctiseattle.com,
all of Cell Therapeutics, Inc.
Posted: June 2010
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Opaxio (paclitaxel poliglumex) FDA Approval History
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