Navigation Links
Aeterna Zentaris Announces NIH Grant for a Phase 1/2 Study in Advanced Prostate Cancer with AEZS-108

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.

About AEZS-108

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

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.

Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. AEterna Zentaris Announces Appointment of Prof. Jurgen Engel, Ph.D. as New President and CEO
2. AEterna Zentaris Reports Second Quarter 2008 Financial and Operating Results
3. AEterna Zentaris to Present at Upcoming CIBC World Markets 7th Annual Eastern Investor Conference
4. AEterna Zentaris to Present at BioContact Quebec on October 2, 2008
5. AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia
6. AEterna Zentaris Receives Notification from Nasdaq Relating to Minimum Bid Price
7. AEterna Zentaris to Present at Upcoming Oppenheimer 19th Annual Healthcare Conference
8. AEterna Zentaris Reaches 2nd Stage of Patient Recruitment for Phase 2 Trial in Endometrial Cancer with the Innovative LHRH Receptor Targeted Conjugate, AEZS-108
9. AEterna Zentaris Agrees to Sell Cetrotide(R) Royalty Stream for $52.5 Million to Cowen Healthcare Royalty Partners
10. AEterna Zentaris to Announce Third Quarter 2008 Financial and Operating Results on November 13, 2008
11. AEterna Zentaris Reports Third Quarter 2008 Financial and Operating Results
Post Your Comments:
(Date:11/24/2015)... ... 24, 2015 , ... This fall, global software solutions leader SAP and AdVenture ... develop and pitch their BIG ideas to improve health and wellness in their schools. ... to win the title of SAP's Teen Innovator, an all-expenses paid trip to Super ...
(Date:11/24/2015)... 24, 2015  Tikcro Technologies Ltd. (OTCQB: TIKRF) today announced that its ... at 11:00 a.m. Israel time, at the law ... Allon Street, 36 th Floor, Tel Aviv, Israel ... and Izhak Tamir to the Board of Directors; ... directors; , approval of an amendment to certain terms of options ...
(Date:11/24/2015)... ... November 24, 2015 , ... InSphero AG, the leading supplier of ... has promoted Melanie Aregger to serve as Chief Operating Officer. , Having ... management team and was promoted to Head of InSphero Diagnostics in 2014. ...
(Date:11/24/2015)... , Nov. 24, 2015 HemoShear ... on discovering drugs for metabolic disorders, announced today ... to its Board of Directors (BOD). Mr. Watkins ... of Human Genome Sciences (HGS), and also served ... Jim Powers , Chairman and CEO ...
Breaking Biology Technology:
(Date:10/29/2015)... Va. , Oct. 29, 2015 Daon, ... today that it has released a new version of ... customers in North America have ... IdentityX v4.0 also includes a FIDO UAF certified ... are already preparing to activate FIDO features. These customers ...
(Date:10/29/2015)... NXTD ) ("NXT-ID" or ... the growing mobile commerce market and creator of ... leading marketplace to discover and buy innovative technology ... on StackSocial for this holiday season.   ... a biometric authentication company focused on the growing ...
(Date:10/27/2015)... -- Munich, Germany , October ... automatically maps data from mobile eye tracking videos created ... that they can be quantitatively analyzed with SMI,s analysis ... , October 28-29, 2015. SMI,s Automated Semantic Gaze ... tracking videos created with SMI,s Eye Tracking Glasses ...
Breaking Biology News(10 mins):