Aeterna Zentaris Presented Poster On Oral Prostate Cancer Vaccine, AEZS-120, At International Urology Conference In Japan
Filing of Clinical Trial Application (CTA) in Prostate Cancer Expected in Q4 2012
QUEBEC CITY, Oct. 2, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that preclinical data on its oral prostate cancer vaccine candidate, AEZS-120, were presented over the weekend at the 32 nd Congress of the Société Internationale d'Urologie, which is being held in Fukuoka, Japan. The presentation underlined the feasibility of an oral therapeutic vaccination approach against prostate cancer. Furthermore, safety pharmacology and toxicology data suggest that the profile of AEZS-120 is similar to the approved carrier strain and, therefore, pave the way for Phase 1 clinical testing.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris, commented, "Now that we have completed the preclinical development program for AEZS-120, we look forward to filing a Clinical Trial Application in Europe during this quarter, in order to initiate a Phase 1 clinical trial in prostate cancer with this novel oral anticancer vaccine."
Summary and ConclusionsThe production, release, pharmacology, safety and toxicology program was conducted in agreement with the regulatory authorities and successfully finalized:
- The proof of concept has been shown in a tumor-challenge mouse model using the anticipated clinical application schedule;
- Biosafety and biodistribution studies did not reveal a different safety profile compared to the carrier strain;
- Pharmacological and toxicological studies did not reveal differences to the approved carrier strain;
- In all, the non-clinical studies suggest that the safety and toxicological profile of AEZ-120 is similar to the approved carrier strain S. typhi Ty21a, which has already been safely applied in more than 250 million doses;
- GMP material for clinical use has been produced and released; and CTA filing for Phase 1 clinical study is planned in 4Q 2012.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV