QUÉBEC CITY, June 4, 2012 /CNW Telbec/ - 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.
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).
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."
A copy of the abstract #LBA350 titled, "Results of the X-PECT study: A Phase 3 randomized double-blind placebo-controlled study of perifosine plus capecitabine vs. placebo plus capecitabine in patients with refractory metastatic colorectal cancer", Bendell JC, Ervin T, Senzer N, Richards D, Firdaus I, Lockhart C, Cohn A, Saleh M, Sportelli P, Gardner L, Eng C. is available on ASCO's website at http://chicago2012.asco.org/.
Perifosine is a novel, oral anticancer compound that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It works by interfering with membranes of cancer cells, thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. Perifosine is currently in a Phase 3 trial in multiple myeloma. In this indication, it has been granted orphan drug and Fast Track designations by the FDA, as well as positive Scientific Advice and orphan medicinal product designation from the EMA. Rights for perifosine have been out licensed to Yakult Honsha for Japan, to Handok for Korea and to Hikma Pharmaceuticals for the Middle East and certain countries in North Africa. Aeterna Zentaris holds rights for the rest of the world.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
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