Aeterna Zentaris: Final Phase 2 Data Demonstrate Perifosine And Sorafenib Combination Therapy Well Tolerated By Heavily Pretreated Lymphoma Patients
For the 36 patients treated with combination therapy, 8 (22%) PR, 15 (42%) stable disease ("SD") and 13 (36%) PD were observed. Median time to achieve PR was 4 months (range 1-8) and median duration of response was 4 months (range 1-12). Median overall survival ("OS") and progression free survival ("PFS") for all patients were 16 and 5 months, respectively.
For the 25 patients in the HL subgroup also receiving combination therapy, the overall response-rate was 28%, with 7 PR; for HL patients, median OS and PFS were 16 and 5 months respectively, as it was for all patients.
A significant correlation between pErk and pAkt reduction during the first 2 months of therapy and clinical response was demonstrated by logistic regression model. The reduction of pErk and pAkt values (i.e difference between baseline values vs 60 day values) was related to a highly significant probability to observe a clinical response (p = 0.0003 and p = 0.005 for pErk and pAkt, respectively).
ConclusionCombination of perifosine and sorafenib was well tolerated by heavily pretreated lymphoma patients. Promising clinical response activity was observed in relapsed/refractory HL patients, suggesting that this subgroup could represent the target population for future studies. Early reduction of pERK and pAK has a significant predictive value of clinical response. The poster, "Dual Targeted Therapy with the AKT Inhibitor Perifosine and the Multikinase Inhibitor Sorafenib in Patients with Relapsed/Refractory Lymphomas: Final Results of a Phase II Trial", A Guidetti, S. Viviani, A. Marchiano, A. Dodero, L. Farina, S.L. Locatelli, D. Russo, P. Bulian, R. Sorasio, M. Di Nicola, L. Giordano, P. Corradini, A.M. Gianni, C. Carlo-Stella, can be viewed at this link. About Perifosine Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It has been granted orphan drug and orphan medicinal product designations for multiple myeloma ("MM") from the Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), respectively. Perifosine has also received Fast Track designation from the FDA for this same indication. The ongoing Phase 3 trial in MM is conducted under a Special Protocol Assessment from the FDA and positive Scientific Advice from the EMA, with positive results from this trial expected to be sufficient for registration in the US and Europe. Perifosine is also being explored in combination therapy and in monotherapy in other cancer indications. Aeterna Zentaris holds worldwide rights to perifosine except for Japan, Korea and MENA ( Middle East and North Africa) region, where licensing rights have been granted to Yakult Honsha, Handok Pharmaceuticals and Hikma Pharmaceuticals, respectively. 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. Forward-Looking Statements 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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