Aeterna Zentaris: Encouraging Clinical Data for Perifosine in Hodgkin Lymphoma Presented at ASH Meeting
Québec City, Canada, December 13, 2011 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today reported encouraging clinical data for an ongoing Phase 2 clinical study in patients with refractory/relapsed Hodgkin Lymphoma. Preliminary response data showed that perifosine combined with sorafenib significantly increased median progression free survival (PFS) in refractory/relapsed Hodgkin Lymphoma patients with high phosphorylation levels of Erk and Akt as compared to patients with low baseline phosphorylation levels of Erk and Akt. Data were presented yesterday by Anna Guidetti, MD, Fondazione IRCCS Instituto Nazionale Tumori, Milan, Italy, during the American Society of Hematology (ASH) Annual Meeting and Exposition currently being held in San Diego, California.
Dr. Carmelo Carlo-Stella, Associate Professor of Oncology at the University of Milano and Head of the Experimental Therapeutics Unit at Humanitas Cancer Center stated, “Identification of biomarkers predicting response to targeted therapy is a critical issue. Our study shows that Hodgkin Lymphoma patients who will respond to the combined perifosine/sorafenib therapy can be identified by a simple laboratory test performed prior to therapy initiation. In an era of strong financial constraints, this is a major advancement allowing not only a better selection of patients that might benefit of perifosine/sorafenib therapy, but also a positive impact on the cost-effectiveness of targeted therapy.”
Juergen Engel, PhD, President and CEO of Aeterna Zentaris added, “We would first like to thank Dr. Carlo-Stella and all those involved in this trial for their exciting work and clinical data achieved with perifosine in combination with sorafenib, which favourably demonstrate targeted therapeutic activity for patients with high phosphorylation levels of Erk and Akt. We now look forward to further perifosine/sorafenib combination studies which will validate the correlative effect of patients’ baseline phosphorylation levels and clinical response outcome.”
The Phase 2 Study
The abstract titled, “Phosphorylation Levels of Extracellular-Signal Regulated Kinase (Erk) and Akt in Circulating Lymphocytes Predict Response to Targeted Therapy with Perifosine and Sorafenib in Refractory/Relapsed Hodgkin Lymphoma Patients”, A. Guidetti, S. Locatelli, S. Viviani, A. Dodero, L. Farina, D. Russo, P. Bulian, R. Sorasio, M. Di Nicola, P. Corradini, A. Anichini, A. M. Gianni, C. Carlo-Stella evaluates phosphorylation levels of Erk (pErk) and Akt (pAkt) in circulating lymphocytes from patients enrolled in two consecutive Phase 2 trials evaluating activity and safety of sorafenib as a single agent or in combination with perifosine in relapsed/refractory Hodgkin Lymphoma patients.
Four patients were treated with sorafenib alone at a dose level of 400mg BID and twenty-one patients received a 4-week treatment with perifosine alone at a dose level of 50mg BID, followed by a perifosine/sorafenib combination therapy with 50mg BID and 400mg BID, respectively. Circulating lymphocytes were evaluated for their phosphorylation levels of Erk and Akt, in order to assess predictive value of the phosphokinase levels for therapy responses.
Clinical response data showed that baseline pErk and pAkt levels were significantly higher in responsive patients, as compared to unresponsive patients. The pErk and pAkt levels measured after 60 days of therapy with perifosine combined with sorafenib were significantly reduced in responsive patients. The median baseline value of pErk and pAkt efficiently discriminated responsive and unresponsive patients which was associated with a significantly improved median Progression Free Survival (PFS) for patients with baseline pErk =43% and/or pAkt >23%. Based on these data, the correlation of baseline pErk and pAkt levels with objective responses and time to tumor progression will need to be validated in prospective studies.
Refractory/relapsed Hodgkin Lymphoma patients with increased baseline levels of pErk and pAkt demonstrated increased PFS when treated with perifosine in combination with sorafenib.
The poster can be viewed online through the following link.
About Hodgkin Lymphoma
Hodgkin Lymphoma is a cancer of the immune system. The two major types of Hodgkin Lymphoma are classical Hodgkin Lymphoma and nodular lymphocyte-predominant Hodgkin Lymphoma. The most common symptom of Hodgkin Lymphoma is the painless swelling of the lymph nodes in the neck, underarm or chest. Other symptoms include fever, weight loss, fatigue, or night sweats. According to the National Cancer Institute, there will be 8,830 news cases of Hodgkin Lymphoma in the United States in 2011, resulting in 1,300 deaths.
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. Perifosine, in combination with chemotherapeutic agents, is currently being studied for the treatment of colorectal cancer, multiple myeloma and other cancers, and is the most advanced anticancer agent of its class. Perifosine, as monotherapy, is being explored in other indications. The FDA has granted perifosine orphan-drug designation in multiple myeloma and neuroblastoma, and Fast Track designations in both multiple myeloma and refractory advanced colorectal cancer. Additionally, an agreement was reached with the FDA to conduct the Phase 3 trials in both of these indications under a Special Protocol Assessment. Perifosine has also been granted orphan medicinal product designation from the European Medicines Agency (EMA) in multiple myeloma. Furthermore, perifosine has received positive Scientific Advice from the EMA for both the multiple myeloma and advanced colorectal cancer programs, with ongoing Phase 3 trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) for North America, to Yakult Honsha for Japan, to Handok for Korea and to Hikma Pharmaceuticals for the Middle East and North Africa (MENA) region.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, multiple myeloma, endometrial, ovarian, prostate and bladder cancer. The Company’s innovative approach of “personalized medicine” means tailoring treatments to a patient’s specific condition and to unmet medical needs. Aeterna Zentaris’ deep pipeline is drawn from its proprietary discovery unit providing the Company with constant and long-term access to state-of-the-art therapeutic options. 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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Posted: December 2011