March 27, 2012
/PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) announced that the
University of Washington
's ("UW") School of Medicine, Departments of Neurology and Neurosurgery, Division of Neuro-Oncology has begun enrolling patients in a randomized phase II clinical study comparing the combination of OPAXIO™ (paclitaxel poliglumex, PPX, CT-2103) and radiation therapy ("RT") to the combination of temozolomide ("TMZ") and RT for patients with newly-diagnosed glioblastoma multiforme ("GBM"), which is a poor-prognosis high-grade malignant brain tumor with an active gene called MGMT. MGMT is active in more than half of patients with glioblastoma and it substantially decreases the effectiveness of standard therapy with TMZ. This study is a multicenter trial initiated and led by the Neuro-Oncology department of the
Oncology Research Group ("BrUOG") in
Providence, Rhode Island
. The first patient at UW recently has been enrolled.
, Associate Professor of Neurology, Neurological Surgery and Medicine at UW's School Of Medicine and Affiliate Investigator at Fred Hutchinson Cancer Research Center is leading the study at the UW site.
"Patients with glioblastomas are rarely cured, although current standard therapy with RT and TMZ has been shown to prolong survival. A Phase I/II study of paclitaxel poliglumex and TMZ with RT, performed by BrUOG, showed encouraging results with median progression free survival of 13.5 months. Two of the 4 patients tested retrospectively found to express MGMT had progression free survivals of greater than 16 and 18 months as of June 2011," said Dr. Mrugala. (Jepayalan et al, ASCO 2011).
"The current Phase II Trial randomizes patients 2:1 between paclitaxel poliglumex and standard of care and will only enroll patients with active (unmethylated) MGMT who are less likely to benefit from TMZ. I brought this study protocol to the attention of my colleagues in the Neuro-Oncology Program because the results of the BrUOG study were intriguing and there is a serious unmet medical need," Dr. Mrugala concluded.