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Last updated on April 20, 2014 at 17:20 EDT

AEterna Zentaris Partner, Keryx, Presented Updated Phase 2 Data on Perifosine (KRX-0401) for the Treatment of Advanced Metastatic Renal Cell Carcinoma at 8th International Kidney Cancer Symposium in Chicago

September 29, 2009
    Perifosine Continues to Demonstrate Impressive Efficacy, Safety and
    Tolerability in Metastatic Renal Cell Carcinoma Patients who Progressed
    after Failing Treatment with both a VEGF Receptor Inhibitor and an mTOR
    Inhibitor

QUEBEC CITY, Sept. 29 /PRNewswire-FirstCall/ – AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), (“the Company”) a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), its partner and licensee for perifosine in the North American market, reported updated clinical results from a Phase 2 study of perifosine, the Company’s PI3K/Akt pathway inhibitor for cancer, as a single-agent treatment for advanced metastatic renal cell carcinoma. Dr. Thomas E. Hutson, Director of the Genitourinary Oncology Program at Baylor-Sammons Cancer Center in Dallas, Texas, presented the data on Saturday, September 26th, in an oral presentation featured at the 8th International Kidney Cancer Symposium held in Chicago.

Dr. Hutson’s presentation, entitled “Phase 2 study of perifosine in patients with metastatic renal cell carcinoma progressing after prior therapy with both a VEGF Receptor Inhibitor and an mTOR inhibitor”, included results from a subgroup of patients who failed both a VEGF receptor inhibitor (sunitinib (Sutent(R)) or sorafenib (Nexavar(R))) and an mTOR inhibitor (temsirolimus (Torisel(R)) or everolimus (Afinitor(R))). Evaluable patients (n=16) were defined as those who had greater than 7 days of treatment (2 additional patients withdrew consent within 7 days). Patients received 100 mg of perifosine daily until progression or unacceptable toxicity. The primary endpoint of this study was clinical benefit, defined as response rate (CR/PR by RECIST) or percentage of patients progression-free for at least 3 months. Median progression-free survival (PFS) and overall survival were also analyzed for efficacy. Safety was a secondary endpoint. Perifosine was well tolerated with the most common adverse events being gastrointestinal discomfort and fatigue. Best response to single agent perifosine was as follows:

    -------------------------------------------------------------------------
                  SD             PD
                  more than      less than
          PR      12 wks         12 wks                          Overall
    N     N (%)   N (%)          N (%)      Median PFS           Survival
    -------------------------------------------------------------------------
    16    1 (6%)  7 (44%)        8 (50%)    16 wks               Not
                                           (95% CI (11.7, 28))   Reached
    ----------------------------------------------------------- (14/16 alive)
    Median PFS for patients SD              33 wks               at
    or more than                           (95% CI (19, NR))     22+ months
    -------------------------------------------------------------------------

    N: Number of patients; PR: Partial response; SD: Stable disease;
    PD: Progressive disease; CI: Confidence interval

This multi-center Phase 2 study was led by both Dr. Hutson and Dr. Nicholas Vogelzang, Chair and Medical Director of Developmental Therapeutics, Comprehensive Cancer Centers of Nevada/US Oncology Research. Drs. Hutson and Vogelzang also serve as co-chairs of the Genitourinary Committee for US Oncology Research. Data from this study was first presented by Dr. Vogelzang at the American Society of Clinical Oncology (ASCO) annual meeting in May 2009.

Juergen Engel, Ph.D., President and Chief Executive Officer of AEterna Zentaris commented, “These impressive data in metastatic renal cell carcinoma as well as recent positive results in colon cancer and multiple myeloma, are further proof of perifosine’s potential as an anti-cancer compound, both as a single agent or in combination therapy. We are pleased with Keryx’s progress with perifosine and look forward to the start of their Phase 3 trial in multiple myeloma.”

About Perifosine

Perifosine is a novel, first-in-class, oral anti-cancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated single agent anti-tumor activity in Phase 1 and Phase 2 studies and is currently being studied as a single agent and in combination with several forms of anti-cancer treatments for various forms of cancer. Most recently, positive results were reported for the single agent use of perifosine in patients with advanced metastatic renal cancer and in combination with capecitabine (Xeloda(R)) for advanced metastatic colon cancer (placebo-controlled), as well as for perifosine in combination with bortezomib (Velcade(R)) +/- dexamethasone in relapsed and refractory myeloma.

About Renal Cell Carcinoma (RCC)

Of all kidney tumors, 85% are classified as renal cell carcinoma (RCC) and of all patients with RCC, 25% present with advanced disease. Advanced RCC is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60% to 70%; but the survival rate is considerably lower after the cancer has metastasized to other parts of the body. Even with the recent approval of several biological therapies for the treatment of advanced metastatic RCC – VEGF inhibitors (sunitinib (Sutent(R)) or sorafenib (Nexavar(R)) and an mTOR inhibitor (temsirolimus (Torisel(R)) or everolimus (Afinitor(R)) – the National Cancer Institute reports a rising incidence of RCC with incidence and mortality rates more than twice as high in men as in women. In 2009, an estimated 49,000 new cases of RCC and 11,000 deaths attributable to RCC are expected in the US.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which 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 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 the 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 except if we are required by a governmental authority or applicable law.

SOURCE AETERNA ZENTARIS INC.


Source: newswire