Grant awarded to Dr. Jacek Pinski to conduct the study at the Norris Comprehensive Cancer Center of the University of Southern California
QUÉBEC CITY, Aug. 5 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that the National Institutes of Health ("NIH") has awarded Dr. Jacek Pinski, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California, a grant of about US$1.5 million over three years to conduct a Phase 1/2 study in refractory prostate cancer with the Company's doxorubicin LHRH receptor targeted conjugate compound, AEZS-108. The study, entitled "A Phase I/II Trial of AN-152 (AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer", will enroll up to 55 patients and will be conducted in two portions: the first portion will be an abbreviated dose-escalation followed by a single arm, Simon Optimum two-stage design Phase 2 study using the dose selected in the Phase 1 portion. The primary objective of the Phase 2 portion is to evaluate the clinical benefit of AEZS-108 in men with castration- and taxane-resistant metastatic prostate cancer, for which the presence of LHRH receptors has been confirmed.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris commented, "We congratulate Dr. Pinski for the grant awarded by the NIH and we are very pleased to initiate this collaboration for AEZS-108. We are excited about this study since we believe AEZS-108, with its targeting approach, could represent an achievement in treating men with castration- and taxane-resistant prostate cancer, especially for those having LHRH-receptor-positive cells."
Jacek Pinski, MD, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California stated, "We are looking forward to working with Aeterna Zentaris which developed AEZS-108 in collaboration with the Nobel Laureate Dr. Andrew V. Schally, from the University of Miami and VA Medical Center in Miami. Given the positive results presented for LHRH-receptor-positive cells in prostate cancer at ASCO 2009, the positive results demonstrated for ovarian cancer at ASCO 2010 and the targeting action of AEZS-108 to be delivered specifically to the cancer cells, we hope to avoid damage to healthy tissue and to reduce side effects, since prostate cancer patients often have other medical conditions."
In previous research, Dr. Pinski found that cancerous cells in human prostate tissue contain the luteinizing hormone-releasing hormone (LHRH) receptor (ASCO 2009, abstract #5163), the cellular receptor specifically targeted by AEZS-108.
In addition to performing this Phase 1/2 trial, Dr. Pinski will also lead a team that uses new methods for collecting circulating tumor cells and analyzing data about AEZS-108's effectiveness in advanced prostate cancer.
AEZS-108 (formerly known as AN-152) represents a new targeting concept in oncology using a cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier and a well-known cytotoxic agent, doxorubicin. The design of this product allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH-receptor-positive tumors. The binding of AEZS-108 to cancerous cells that express these receptors results in its accumulation and preferential uptake in the malignant tissue. AEZS-108 has already been studied in gynecologic cancers and has been shown to be effective and well tolerated in endometrial and ovarian cancer. Preclinical studies in animal models with prostate cancer also have demonstrated positive results with the drug.
AEZS-108 is currently in a Phase 2 trial conducted in Europe by the German AGO Study Group (Study AGO-GYN5), in advanced ovarian and endometrial cancer. Positive final Phase 2 results for ovarian cancer were disclosed in June 2010 at the annual American Society of Clinical Oncology ("ASCO") meeting, while those for endometrial cancer are expected by year-end. AEZS-108 has been granted orphan-drug designation by the FDA and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer.
About Prostate Cancer
According to the National Cancer Institute (NCI), prostate cancer is the second most prevalent type of cancer after lung cancer. The NCI estimates that 217,730 men will be diagnosed with and 32,050 men will die of prostate cancer in 2010 in the United States alone.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. 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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