Aeterna Zentaris Begins Phase II Study on Prostate Cancer with its Drug AEZS-108

December 5, 2012 by  
Filed under Prostate Cancer News

Aeterna Zentaris Inc. is a company known to manufacture AEZS-108, a late stage drug that can help to treat patients with castration-resistant prostate cancer (CRPC). Already, preliminary study on the effect of AEZS-108 indicates that the drug was well tolerated and demonstrated antitumor activity in men with CRPC.

In the Phase II study, more detailed analysis would be made on this drug. An article published December 3, 2012 at equities.com provided details about this research or study that is about to be carried out be  Aeterna Zentaris.

Details from the article reveals the Phase II study is sponsored by a grant of about $ 1.6 Million from the National Institutes of Health. The grant was awarded to Jacek Pinski, who is an associate professor or medicine at the Norris Comprehensive Cancer Center of the University of Southern California.

More so, an excerpt from the article reveals how the study is being conducted:

This is a single-arm Simon Optimum design Phase II study involving up to 37 patients with pre treated CRPC, using the dose selected (210 mg/m2) in the Phase I portion. Six patients that were administered the 210 mg/m2 dose in the Phase I portion of the trial, have already been included in the Phase II portion.

For the Phase II portion, patients receive AEZS 108 intravenously over 2 hours in repeating 21 day cycles, until progression of the disease, unacceptable toxicity or patient withdrawal. If clinical benefit is observed, up to 6 cycles will be administered. Patient’s continuation beyond 6 cycles is left at the discretion of the principal investigator. Premedication includes dexamethasone 8 mg. Maximal Prostate Specific Antigen (PSA) response is calculated using PSA Working Group 2 guidelines. Response Evaluation Criteria in Solid Tumors is used to assess response for patients with measurable disease.

AEZS-108 Mechanism of Action ( credit: Google Image)

The primary endpoint of the Phase II portion is to evaluate the clinical benefit of AEZS 108 for these patients. Clinical benefit will be defined as non-progression at 12 weeks with no dose limiting toxicity or other toxicity requiring termination of treatment.

Secondary endpoints include toxicity, time to RECIST and PSA progression, RECIST response rate for patients with measurable disease, PSA response rate, pain palliation, and overall survival. In addition, there will be correlative studies to investigate potential predictors of response and outcomes.

So far, AEZS-108 has shown to be effective in treating prostate tumor, the success of the phase II study can provide more evidence for validations and complete approvals as a prescription treatment for castration resistance prostate cancer.

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