University of Washington’s Neuro-Oncology Program to Investigate Cell Therapeutics’ Drug Candidate OPAXIO™ (Paclitaxel …

SEATTLE, 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 Brown University Oncology Research Group ("BrUOG") in Providence, Rhode Island. The first patient at UW recently has been enrolled.

Dr. Maciej Mrugala, 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.

The study objective is to determine whether paclitaxel poliglumex and RT are likely to improve progression-free survival ("PFS") and overall survival ("OS") compared to TMZ and RT. This study will also evaluate neuro-cognitive function and toxicities of these therapies. If positive, results from the study could be used to plan a phase III study of paclitaxel poliglumex added to standard RT in this disease.

About Glioblastoma

According to the National Cancer Institute, glioblastoma is the most common and deadliest type of primary brain tumor in adults. It is estimated that there will be 10,000 new cases of GBM diagnosed in the US this year. The prognosis for the great majority of patients with glioblastoma is poor, with less than 25% of patients surviving two years with current therapies.

About the Study

The study is expected to enroll 60 patients. Patients in the paclitaxel poliglumex arm will receive paclitaxel poliglumex once every week plus RT for six weeks. Patients in the TMZ arm will receive daily oral TMZ plus RT for six weeks. After completion of initial therapy, both arms will receive TMZ on day 1-5 and then every 28 days for up to 12 cycles for a total of 48 weeks.

Patients interested in participating in this study or wanting more information can call Sandra Johnston, PhD, RN at (206) 616-7117.

See the article here:
University of Washington's Neuro-Oncology Program to Investigate Cell Therapeutics' Drug Candidate OPAXIO™ (Paclitaxel ...