This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Aeterna Zentaris Announces Initiation Of Phase 2 Portion Of Phase 1/2 Trial With AEZS-108 In Prostate Cancer

QUÉBEC CITY, Nov. 12, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the start of the Phase 2 portion of its ongoing Phase 1/2 study in castration- and taxane-resistant prostate cancer (CRPC) with AEZS-108. The trial on the Company's targeted cytotoxic luteinizing hormone-releasing hormone (LHRH) analog, AEZS-108, is being supported by a three-year US$1.6 million grant from the National Institutes of Health to Jacek Pinski, MD, PhD, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California.

Preliminary data for the Phase 1 portion of this trial, presented in February 2012 at the American Society of Clinical Oncology Genitourinary Cancers Symposium, demonstrated that AEZS-108 was well tolerated and demonstrated early evidence of antitumor activity in men with CRPC. The poster on these preliminary data can be viewed on line through the following link. Final Phase 1 data are expected to be presented at an upcoming conference in 2013.

Dr. Pinski stated, "AEZS-108 has been very well tolerated in this heavily pre-treated population, and its efficacy, so far, is impressive. We are fully committed to the Phase 2 portion of the study as shown with the opening of additional sites at the Los Angeles County Hospital, West Los Angeles and Pasadena clinics."

Juergen Engel, PhD, President and CEO of Aeterna Zentaris said, "We would like to congratulate Dr. Pinski and his colleagues on the progress made with this study. AEZS-108 is a key element of our personalized medicine approach in oncology, and we look forward to results for the Phase 2 portion of this trial, as AEZS-108 could offer a novel targeted treatment for men suffering from prostate cancer."

Phase 2 Portion of the Phase 1/2 Study

This is a single-arm Simon Optimum design Phase 2 study involving up to 37 patients with pre-treated CRPC, using the dose selected (210 mg/m 2) in the Phase 1 portion. Six patients that were administered the 210 mg/m 2 dose in the Phase 1 portion of the trial, have already been included in the Phase 2 portion.

For the Phase 2 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 (RECIST, v. 1.1) is used to assess response for patients with measurable disease.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $94.19 -1.04%
FB $118.06 0.54%
GOOG $695.70 0.48%
TSLA $222.56 -4.20%
YHOO $36.00 -0.03%


Chart of I:DJI
DOW 17,651.26 -99.65 -0.56%
S&P 500 2,051.12 -12.25 -0.59%
NASDAQ 4,725.6390 -37.5850 -0.79%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs