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ErgomedAnnouncement

14/10/2015 07:00

RNS Number : 1679C
Ergomed plc
14 October 2015
Ergomed's Co-Development Partner Aeterna Zentaris Obtains Recommendation from Data Safety Monitoring Board to Continue ZoptEC Phase 3 Trial in Advanced Endometrial Cancer 
Follows second interim analysis Phase 3 Study of Zoptarelin Doxorubicin in Advanced Endometrial Cancer
Guildford, UK - 14 October 2015: Ergomed plc (LSE:ERGO or 'Ergomed'), a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, is pleased to note that its co-development partner Aeterna Zentaris (NASDAQ: AEZS) (TSX: AEZ), has received a recommendation from the Data Safety Monitoring Board (DSMB) to continue the Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) pivotal study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer.
Dr Miroslav Reljanovic, Chief Executive Officer of Ergomed, commented: "Having completed the recruitment ahead of schedule, the trial is progressing as planned and we are very pleased with this recommendation from the DSMB to continue the Phase 3 ZoptEC study. We believe that zoptarelin doxorubicin has the potential to provide treatment for advanced, recurrent endometrial cancer, and look to continue progressing this study with Aeterna Zentaris."
The announcement issued by Aeterna Zentaris follows:
Aeterna Zentaris: Data and Safety Monitoring Board Recommends Continuation of ZoptEC Phase 3 Trial in Advanced Endometrial Cancer 
DSMB's recommendation follows 2nd interim efficacy and safety analysis 
Quebec City, Canada, October 13, 2015 - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the independent Data and Safety Monitoring Board ("DSMB") has recommended that the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, continue as planned. The DSMB's decision follows completion of its pre specified second interim analysis on efficacy and safety for the ZoptEC Phase 3 trial at approximately 192 events. In April 2015, the DSMB made the same recommendation following its first pre-specified analysis on safety and futility at approximately 124 events. A final analysis of the data is expected at approximately 384 events.
David Dodd, Chairman and CEO of Aeterna Zentaris, commented, "This positive second recommendation from the DSMB is an important milestone since it supports our continuation of the ZoptEC Phase 3 trial in endometrial cancer until its completion. The DSMB recommendation was based upon a comprehensive review of the data on efficacy and safety. We believe that zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, would represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that won't be pursued by Aeterna Zentaris. In addition, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer."
About the ZoptEC Pivotal Phase 3 trial
The ZoptEC pivotal Phase 3 trial is a fully-recruited (over 500 patients), open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression free survival, objective response rate, and clinical benefit rate. The trial is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). 
For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).
The full announcement can be viewed here. 
ENDS
For further information, please contact:
Hume Brophy - for UK enquiries
Mary Clark, Supriya Mathur and Hollie Vile
Tel: + 44 203 440 5654
ergomed@humebrophy.com
Stifel 
NOMAD/Broker to the Company
Jonathan Senior
Tel: +44 207 710 7600
MC Services - for Continental European enquiries
Anne Hennecke
Tel: +49 211 529252 22
anne.hennecke@mc-services.eu
About Ergomed plc
Founded in 1997, Ergomed plc is a profitable UK-based company, providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 40 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 60 clients ranging from top 10 pharmaceutical and generics companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has wide therapeutic expertise, with a particular focus in oncology, neurology and immunology and the development of orphan drugs. Ergomed'sapproach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies. Here Ergomed shares the risks and rewards of drug development, leveraging its expertise and services in return for carried interest in the drugs under development. - a low risk investment model for potential high returns. For further information, visit: http://ergomedplc.com.
Global pharmacovigilance and medical information services are provided through its group company PrimeVigilance. www.primevigilance.com
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically 
to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while Phase 2 trials in ovarian and prostate cancer have been completed. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune's Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique modification of the manufacturing process resulting in significantly lower cost.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 50,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. For more information, visit www.aezsinc.com
Forward Looking Statements
Certain statements contained within the announcement are forward looking statements and are based on current expectations, estimates and projections about the potential returns of Ergomed plc ("Ergomed") and industry and markets in which Ergomed operates, the Directors' beliefs and assumptions made by the Directors. Words such as "expects", "anticipates", "should", "intends", "plans", "believes", "seeks", "estimates", "projects", "pipeline" and variations of such words and similar expressions are intended to identify such forward looking statements and expectations. These statements are not guarantees of future performance or the ability to identify and consummate investments and involve certain risks, uncertainties, outcomes of negotiations and due diligence and assumptions that are difficult to predict, qualify or quantify. Therefore, actual outcomes and results may differ materially from what is expressed in such forward looking statements or expectations. Among the factors that could cause actual results to differ materially are: the general economic climate, competition, interest rate levels, loss of key personnel, the result of legal and commercial due diligence, the availability of financing on acceptable terms and changes in the legal or regulatory environment.
These forward-looking statements speak only as of the date of this announcement. Ergomed expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in Ergomed's expectations with regard thereto, any new information or any change in events, conditions or circumstances on which any such statements are based, unless required to do so by law or any appropriate regulatory authority. 

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