Navigation Links
Aeterna Zentaris Receives Orphan-Drug Designation from the FDA for AEZS-108 in Ovarian Cancer
Date:5/6/2010

QUEBEC CITY, May 6 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. ( AEZS, TSX: AEZ), ("the Company") a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris stated, "We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year."

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. It also provides tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Ovarian Cancer

Ovarian cancer is one of the most common gynaecologic malignancies and the fifth most frequent cause of cancer death in women, with most of the cases occurring in women between 50 and 75 years of age. Overall, ovarian cancer accounts for 4% of all cancer diagnoses in women and 5% of all cancer deaths. Approximately 26,000 new cases and 17,000 deaths from this disease are estimated in the European community every year (Source: Gynaecologic Oncology 2004; 92:819-26). The National Cancer Institute estimates that in 2009, in the United States alone, there were 21,550 news cases of ovarian cancer and 14,600 related deaths.

About AEZS-108

AEZS-108 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.

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.

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.


'/>"/>
SOURCE AETERNA ZENTARIS INC.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. AEterna Zentaris completes management team with the appointment of Chief Medical Officer
2. AEterna Zentaris to Present at Upcoming UBS Global Life Sciences Conference in New York
3. AEterna Zentaris Announces Outcome of Managements Strategic Review
4. AEterna Zentaris to Further Develop Three Follow-up Multi-targeted Cytotoxic Candidates to AEZS-112 as Potential Novel Cancer Treatment
5. AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
6. AEterna Zentaris to Present at the Upcoming Roth Capital Partners 20th Annual OC Growth Stock Conference in Dana Point, California
7. Aeterna Zentaris to Announce Fourth Quarter and Full-Year 2007 Financial and Operating Results on March 5, 2008
8. AEterna Zentaris Announces the Departure of SVP, Administrative and Legal Affairs
9. AEterna Zentaris and Paladin Labs Announce Sale and Purchase of Miltefosine Rights
10. Aeterna Zentaris Reports Fourth Quarter and Full-Year 2007 Financial and Operating Results
11. Aeterna Zentaris Begins Second Phase 3 Trial of Cetrorelix for Benign Prostatic Hyperplasia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... Florida , February 11, 2016 ... and Promote Genetic Understanding to Support Research and Discovery ... GenomeAsia 100K, today announced an ambitious plan to sequence 100,000 ... South Asian countries and at least 7 of North and ... In the first phase, the project will focus on ...
(Date:2/11/2016)... 2016  Spectra BioPharma Selling Solutions (Spectra) is ... biopharma companies the experience, expertise, operational delivery and ... sales teams. Created in concert with industry leading ... strategic and tactical needs of its clients by ... both personal and non-personal promotion. ...
(Date:2/11/2016)... Feb. 11, 2016   BioInformant announces the ... Cell Research Products, Opportunities, Tools, and Technologies – Market ... The first ... stem cell industry, BioInformant has more than a decade ... cell market, by stem cell type. This powerful 175 ...
(Date:2/10/2016)... Early-career researchers from Indonesia , ... and Yemen honored ... Indonesia , Nepal , Peru ... are being honored for their accomplishments in nutrition, psychiatry, biotechnology, women,s health, ... scientists who are pursuing careers in agriculture, biology and medicine in their ...
Breaking Biology Technology:
(Date:2/2/2016)... , Feb. 2, 2016  Based on ... Frost & Sullivan recognizes US-based Intelligent Retinal Imaging ... & Sullivan Award for New Product Innovation. IRIS, ... North America , is poised ... rapidly growing diabetic retinopathy market. The IRIS technology ...
(Date:1/27/2016)... WEST CHESTER, Ohio , Jan. 27, 2016 /PRNewswire/ ... services supplier based in West Chester, Ohio ... and their award winning service staff, based in ... Track,s technical capacity and ability to provide modifications, installations ... John Dovalina , CEO of PLUS, commented, "PLUS ...
(Date:1/21/2016)... 21, 2016 --> ... market research report "Emotion Detection and Recognition Market by Technology ... (Facial Expression, Voice Recognition and Others), Services, Application ... to 2020", published by MarketsandMarkets, the global Emotion ... USD 22.65 Billion by 2020, at a CAGR ...
Breaking Biology News(10 mins):