Collaboration is part of Aeterna Zentaris' strategy of personalized approach to treatment with AEZS 108, the Company's LHRH receptor targeted conjugate with doxorubicin, being investigated in multiple cancers
QUÉBEC CITY, June 28 /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 a collaborative study with Almac's Diagnostics division for the Company's doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, currently measured immunohistochemically. In humans, LHRH receptors are expressed in ovarian, endometrial, breast, bladder, prostate and pancreatic tumors. AEZS-108 is currently in Phase 2 trials for advanced LHRH receptor positive ovarian and endometrial cancer.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We are very pleased with the collaboration with Almac who have proven experience in the development and validation of companion diagnostic tools and potential biomarkers in cancer indications. AEZS-108 is a promising anticancer compound, as demonstrated by the positive final Phase 2 results in ovarian cancer expressing LHRH receptors, recently disclosed at the last ASCO meeting. This state of the art companion diagnostic tool will allow us to develop improved methods of selecting the most appropriate patients to be treated with AEZS-108 in order to enhance the efficiency of our clinical trials and help us with the future successful development of AEZS-108 in a number of different LHRH expressing cancers."
President and Managing Director of Almac Diagnostics, Professor Paul Harkin , said "We are very pleased to collaborate with Aeterna Zentaris on this exciting project. The plan to develop a companion diagnostic for AEZS-108 shows Aeterna Zentaris's clear commitment to personalized medicine, which will provide this compound with the best opportunity for success "
AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is currently in a Phase 2 trial in advanced ovarian and endometrial cancer. Positive final results in ovarian cancer were disclosed at this year's American Society of Clinical Oncology (ASCO) meeting*, while final results in endometrial cancer are expected by year-end. AEZS-108 has been granted orphan-drug designation by the U.S. Food and Drug Administration 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.
An Investigational New Drug (IND) in the U.S. is in place for the treatment of bladder cancer.
Additional clinical studies in hormone-resistant prostate cancer and other cancer types are being planned. There may be benefits during the regulatory review process from the medical and scientific logic of this personalized treatment approach to patient selection and possibly have value in reimbursement considerations.
* Asco poster presentation: abstract #5035 entitled, "Phase 2 study of AEZS-108, a targeted cytotoxic LHRH analog, in patients with LHRH receptor positive platinum resistant ovarian cancer.
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 2,600 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company's new $120m North American Headquarters started in July 2008 and will be completed 2010.
Almac's Diagnostics division is a personalised medicine company focused on the discovery and development of biomarkers. They utilise their proprietary technology and extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.
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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