The Virtual Window: Clinical Trial Reports--April 2007

By Querida Anderson, Prachi Patel-Predd, and John D. Zoidis, MD
Published: Friday, Aug 13, 2010
THE VIRTUAL WINDOW

Clinical Trial Reports


%u25BA PHASE I

Cell Genesys and Medarex Remain Positive on Combination Immunotherapy Study

Cell Genesys, Inc. and Medarex, Inc. said that follow-up data from the ongoing phase I trial of Cell Genesys’ GVAX  immunotherapy for prostate cancer, administered in combination with Medarex’ fully human anti-CTLA-4 antibody, ipilimumab (MDX-010) were positive.

“We continue to be encouraged by the interim results of this trial, which now include evidence for the durability of the anti-tumor responses along with the frequency of such responses, observations which we believe have not been previously experienced for a combination of immunotherapies in advanced prostate cancer,” stated Rob Dow, MD, chief medical officer of Cell Genesys.

“Moreover, we believe these findings provide further support for our ongoing phase III trials of GVAX immunotherapy for prostate cancer.”

A maximum tolerated dose for the combination therapy has not yet been defined. Immunomonitoring studies showed that the combination therapy enhanced T-cell and dendritic cell activity, which was more pronounced at the higher dose levels.

To date, 12 patients with advanced prostate cancer completed treatment. Of the six patients treated in the two highest dose groups, anti-tumor activity was observed in five. Prostate-specific antigen (PSA) declines of greater than 50% were maintained in four of these patients for at least six months. The longest response is reportedly ongoing at more than 12 months. Moreover, evidence of anti-tumor activity has been observed in three of the PSA responders, including improvement of multiple lesions on bone scan, resolution of abdominal lymph node disease by CT scan and improvement in pain due to bone metastases. Additionally, two patients have had stable disease on bone scan for at least three months.

This dose-escalation combination trial is currently expected to enroll a total of approximately 25 to 30 patients with metastatic

HRPC.

                                                                                                                                                                                             —Querida Anderson

Active Biotech Achieves Success with TASQ for Prostate Cancer

Active Biotech reported positive data from its phase Ib study of TASQ for the treatment of prostate cancer. By step-wise dose escalation, a safedose of 1 mg/day was achieved. This represents a doubling of the previously reported maximum tolerated dose level.

“We now have a very complete data set that constitutes a solid base to move into phase II clinical trials,” stated Sven Andreasson, president and CEO.

The ongoing 10-week study comprises patients with HRPC. All patients entering the study had rising serum levels of prostate-specific antigen (PSA). PSA measurements were recorded and PSA velocity (PSAV) was calculated after 28 days of treatment. Out of six patients, five had greater than 50% decrease in PSAV compared to prior treatment. Of them, three exhibited a decrease in absolute PSA levels.

The study is being performed at the urological clinics at the University Hospitals in Lund, Malmoe and Uppsala, Sweden. Phase II studies are scheduled to start during 2007.

The objective of the TASQ project is to develop a pharmaceutical product that can be administered orally for the long-term treatment of prostate cancer. The market for prostate cancer is estimated at more than $3 billion a year, according to the company.


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