Æterna 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
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
------------------------------------------------------------------------- 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
Juergen Engel, Ph.D., President and Chief Executive Officer of Æterna 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 Æterna Zentaris Inc.
Æterna 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.
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