Jun 4 2012
Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the "Company") today announced that Johanna Bendell,
MD, Director of Gastrointestinal Cancer Research and Associate Director
of Drug Development at the Sarah Cannon Research Institute in
Nashville, Tennessee, presented Phase 3 results for perifosine in
refractory colorectal cancer yesterday, at the American Society of
Clinical Oncology (ASCO) Annual Meeting which is being held in Chicago.
Dr. Bendell was the lead investigator of the trial. Data showed no
benefit in overall survival when adding perifosine to capecitabine in
the refractory colorectal cancer setting, confirming top line results
previously disclosed by the Company on April 2, 2012.
The Study
This was a randomized (1:1), double-blind Phase 3 trial conducted in the
United States by our former licensee Keryx Biopharmaceuticals,
comparing the efficacy and safety of capecitabine + perifosine (P-CAP)
vs capecitabine + placebo (CAP), involving 468 patients with metastatic
colorectal cancer which was refractory to all standard therapies.
Primary endpoint was overall survival (OS) with secondary endpoints
including overall response-rate (ORR) (complete (CR) + partial
responses (PR)), progression-free survival (PFS) and safety
(clinicaltrials.gov NCT 01002248).
Results
For the total intent to treat (ITT) patient population, median OS was
6.9 months for the CAP group compared to 6.4 months for the P-CAP
group. Median PFS was 11.4 months for the CAP group compared to 10.9
months for the P-CAP group. The differences were not statistically
significant. There were 7 complete and partial responses in the CAP
group compared to 6 complete and partial responses in the P-CAP group.
There was no significant difference in toxicity profiles between the two
arms. The most frequent hematologic adverse event was grade 1/2 anemia
(CAP = 30 vs P-CAP = 49). The most non-hematologic adverse event was
grade 1/2 fatigue (CAP = 95 vs P-CAP = 125).
In one pre-defined subgroup to which patients were stratified, those who
expressed the wild-type K-ras proto-oncogene and who had discontinued
oxaliplatin for toxicity rather than for disease progression, there was
a benefit in OS (P-CAP = 8 versus CAP = 6.2 months) and in PFS (P-CAP =
18.6 versus CAP = 6.6 months) for perifosine treated patients. The
reason for this finding is not clear at present and further analysis,
including biomarkers studies, are ongoing.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris commented,
"These data confirm the disappointing topline results disclosed in
April. However, they do not deter us from our decision to continue the
Phase 3 trial in multiple myeloma which, as previously stated, was
based first and foremost on existing solid preclinical and clinical
data, and on the support for this drug among key opinion leaders in
this field. Additionally, we believe that market opportunity, examples
of other drugs enjoying success after facing setbacks, as well as the
reasonable investment required to move forward with this study up to
the predefined interim analysis, also make this a sound decision for
the Company. Perifosine in multiple myeloma remains a key component of
our deep pipeline focused on providing novel, targeted treatment
options for cancer patients facing unmet medical needs."
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