AEterna Zentaris Inc. (AEZS)

[chmcnfunds]

INTERIM ANALYSIS IS NOT LIKELY TO HAVE MUCH AFFECT ON PPS

Phase III second interim analysis in October probably will have little influence on pps. It will be merely stop or continue -- nothing more -- no data. This is true for interim analyses. This was reaffirmed by purported email from IR -- there will merely be a continue/stop announcement. The first go-ahead on 4-27-15 resulted in a 10% pop from .60 to .66 after hours and then the next day it was back to 0.60. Maybe a bit more this time, but probably will drop as fast.

http://ih.advfn.com/p.php?pid=nmona&article=66591935



Dan Ward and $heff have tweeted that the interim analysis will not benefit shareholders. I see no notable biotech blogger even paying attention to the "news".

Even with a go-ahead the top line results are not until late 2016 at the earliest. Prior to that AEZS must find a way to stay Nasdaq listed, a prospect which is dwindling as the market cap dives down. The F-R rule still applies suggesting there won't be final approval.

PAST HISTORY OF REACTION TO SUCH NEWS:

PPS went down on the interim analysis of the Phase III of perifosine:

August 31, 2011

Aeterna Zentaris Announces Completion of Interim Analysis by Data Safety Monitoring Board for the Phase 3 Study of Perifosine for the Treatment of Refractory Advanced Colorectal Cancer

Independent Committee Recommends Phase 3 X-PECT Study to Proceed as Planned

Québec City, Canada, August 31, 2011 - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the independent Data Safety Monitoring Board (DSMB) for the pivotal Phase 3 X-PECT study of perifosine in patients with refractory advanced colorectal cancer has completed a pre-specified interim analysis for safety and futility. The DSMB has recommended that the Phase 3 study continue to completion, as planned.

This Phase 3 study sponsored and conducted by our North American licensee for perifosine, Keryx Biopharmaceuticals, Inc., (Keryx), (NASDAQ:KERX), has completed enrollment, with over 465 patients from 65 U.S. sites. The study is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA) and with Fast-Track Designation. Furthermore, the Company has received positive Scientific Advice from the European Medicines Agency (EMA) for this ongoing Phase 3 trial, which is therefore expected to be sufficient for registration in Europe. Perifosine rights have also been licensed to Yakult Honsha for Japan and to Handok for Korea.

The Phase 3 trial, entitled the "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine vs. placebo + capecitabine in over 465 randomized patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin®), irinotecan, bevacizumab (Avastin®) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux®) and/or panitumumab (Vectibix®). The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. Approximately 360 events of death will trigger the unblinding of the study.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris, commented, "We are very pleased by the news that the DSMB has recommended that the study should proceed to completion as planned, and thank the DSMB members for their work. With this positive news we believe that our partner Keryx is well positioned to complete the Phase 3 program in refractory advanced colorectal cancer, which could bring this new therapy to patients suffering from this disease. We continue to prepare for the next steps and will work towards commercialization in the rest of the world."

08/31/201112.659712.659711.939812.0598371,07708/30/201112.059812.899712.059812.1798710,744

Read more: http://www.nasdaq.com/symbol/aezs/historical#ixzz3n2INy71P



Went down on the day of the final Phase 2 of AEZS-108 ( Zoptarelin doxorubicin acetate)

Aeterna Zentaris Presents Positive Final Phase 2 Efficacy and Safety Data for AEZS-108 in Advanced Endometrial Cancer at ESGO...
Date : 09/14/2011 @ 6:30AM
Source : PR Newswire (US)
Stock : Aeterna Zentaris Inc. (MM) (AEZS)
Quote : 0.0875 0.0025 (2.94%) @ 8:10PM

09/15/201111.639811.699811.099811.5198214,86709/14/201111.999812.239811.519811.6398279,93809/13/201111.579811.639811.339811.5198159,927

Read more: http://www.nasdaq.com/symbol/aezs/historical#ixzz3mz2NVybE

Briefly popped and was down lower the next day than at the time of the announcement
Phase II results of the same drug in Prostate Cancer:

Aeterna Zentaris' Zoptarelin Doxorubicin Meets Phase 2 Primary Endpoint in Men with Heavily Pretreated Castration and Taxane ...
Date : 09/28/2015 @ 11:00AM
Source : PR Newswire (Canada)
Stock : Aeterna Zentaris Inc. (MM) (AEZS)
Quote : 0.0905 0.0 (0.00%) @ 5:09AM
Aeterna Zentaris' Zoptarelin Doxorubicin Meets Phase 2 Primary Endpoint in Men with Heavily Pretreated Castration and Taxane ...

pps started the day at .0968 and went tp .11 following the announcement and finished the day at .0999. Finished the next day at .095, lower than before the announcement.

http://www.nasdaq.com/symbol/aezs/historical#/ixzz3ngkdj3LH

AEZS rarely maintains any gains to news about drug Trials.

(I do not have shares)

AEZS