Results show prolonged courses of stable disease and excellent tolerability and indicate potential for use as combination treatment for cancer
QUEBEC CITY, Sept. 21 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) ("the Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced the completion of a Phase 1 study of its orally-active tubulin and topoisomerase II inhibitor compound, AEZS-112, in patients with advanced solid tumors or lymphoma, which may potentially provide a new therapeutic approach for the treatment of cancer. Under the supervision of lead investigator, Daniel D. Von Hoff, MD, Senior Investigator and Physician in Chief at the Translational Genomics Research Institute in Scottsdale, Arizona, this open-label, dose-escalation, multi-center, intermittent treatment Phase 1 trial was conducted at 2 clinical sites in Scottsdale: the Mayo Clinic with principal investigator Donald W. Northfelt, MD, and at Premiere Oncology with principal investigator David Mendelson, MD.
The study was performed in two parts and included 42 patients overall. In Part I, 22 patients were studied on doses ranging from 13 to 800 mg/week. In Part II, the weekly dose was split into 3 doses taken 8 hours apart, and ultimately, 20 patients received doses from 120 to 600 mg/week. Stable disease with time to failure ranging from 20 to 60+ weeks was achieved in 12 patients with various cancer types, including melanoma and cancers of the colon/rectum, lung, pancreas, prostate, tongue, trachea and thyroid. In several of these patients, the duration of stabilization exceeded the duration of disease control on previous treatment regimens. Except for a dose-limiting gastrointestinal reaction in a patient with pre-existing GI problems, no clinically relevant drug-related adverse events or changes in laboratory safety parameters were observed.
"Prolonged courses of stable disease with minimal to no toxicity are encouraging signs", said Dr. Von Hoff. "The applications for an oral agent with these mechanisms of action are numerous."
Paul Blake, MD, AEterna Zentaris Senior Vice President and Chief Medical Officer added, "We are pleased with these Phase 1 results on AEZS-112, which indicate the potential for safe combination with other anticancer drugs. We now look forward to working on the further development of AEZS-112 in collaboration with our expert investigators."
About the AEZS-112 Phase 1 Study
This open-label, dose-escalation, multi-center, intermittent treatment Phase 1 study included patients with advanced solid tumors and lymphoma who had either failed standard therapy or for whom no standard therapy existed. Patients received a once-a-week oral administration of AEZS-112 for three consecutive weeks, followed by a one-week period without treatment. The cycles were repeated every four weeks based on tolerability and response, basically planned for up to four cycles, but allowing for continuation in case of potential benefit for the patient. The starting dose of AEZS-112 in this study was 13 mg/week, with doubling of doses in subsequent cohorts in the absence of significant toxicity. Primary endpoints of the Phase 1 trial focused on determining the safety and tolerability of AEZS-112 (maximum tolerated dose, MTD), as well as establishing a recommended Phase 2 dose and regimen. Secondary endpoints aimed at establishing the pharmacokinetics and determining the efficacy based on standard response criteria.
Preliminary results from this study were presented recently at the American Association for Cancer Research (AACR) Annual Meeting in Denver, Colorado. Poster #5567 entitled, "Phase I dose-escalation, safety, and pharmacokinetic study on weekly oral AEZS-112, a small molecule anti-cancer agent in patients with advanced cancer and lymphoma", was presented by D. W. Northfelt, M.D.
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.
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.
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