SEATTLE, Feb. 23, 2011 /PRNewswire/ — 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 conducted by the Brown University
Oncology Group were published in the February 3, 2011 issue of the
American Journal of Clinical Oncology, Dipetrillo, et al.,
which demonstrate that 38% (15/40) of the 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 in the study, 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.
“We are pleased to have the impressive and potentially important
results of the paclitaxel poliglumex phase II esophageal study
published in a peer reviewed journal,” said Dr. Howard Safran,
M.D., director of the Brown University Oncology Group. “In
this study, the treatment was well tolerated and we did not see the
severe side effects that are typically experienced with standard
treatment options. If these data can be validated in a
randomized controlled trial, the use of paclitaxel poliglumex along
with cisplatin and radiation could provide an important treatment
alternative for patients with lower esophageal cancer with an
attractive risk-benefit profile.”
The phase II study conducted by the Brown University Oncology
Group 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
metastases. 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
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