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Follows first interim analysis Phase 3 Study of Zoptarelin Doxorubicin in Advanced Endometrial Cancer
Guildford, UK – 29 April 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 positive recommendation from the Data Safety Monitoring Board (DSMB) for the Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) pivotal study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer.
Miroslav Reljanovic, Chief Executive Officer of Ergomed, commented: “We are very pleased with this positive recommendation from the DSMB for the Phase 3 ZoptEC study. The study is progressing well – patient recruitment ahead of schedule with approximately 90% of patients enrolled. We believe that zoptarelin doxorubicin has the potential to provide a much needed new treatment option to women with late-stage endometrial cancer, and look forward to progressing this study with Aeterna Zentaris.”
The announcement issued by Aeterna Zentaris follows:
Aeterna Zentaris: Data Safety Monitoring Board Recommends Continuation of Phase 3 Study of Zoptarelin Doxorubicin in Advanced Endometrial Cancer
DSMB’s recommendation follows 1rst interim analysis
Québec City, Canada, April 27, 2015 – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced that the independent Data Safety Monitoring Board (“DSMB”) for the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, has completed a pre specified first interim futility analysis. The DSMB has recommended that the Phase 3 study continue as planned.
David Dodd, Chairman and CEO of Aeterna Zentaris, added: “We are very pleased with this positive recommendation from the DSMB on our ZoptEC Phase 3 trial in endometrial cancer, and I would like to thank everyone involved in this project for their unwavering dedication. With approximately 90 % of patients enrolled at this time, we are well on our way of completing patient recruitment ahead of the anticipated timeline. 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 & management, and therefore, could 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. Our commitment is to ensure that patients and their physicians have such therapies that can potentially improve and extend the quality of lives.”
The ZoptEC Phase 3 trial is an 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. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (“FDA”). 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.
At this time, sites initiation has been completed with over 120 sites in operation in North America, Europe and Israel. More than 465 patients out of an expected total of 500 have been recruited. A second interim analysis will be conducted according to protocol at approximately 192 events, with the final analysis planned at an anticipated 384 events.
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
For further information, please contact:
Mary Clark, Supriya Mathur and Hollie Vile
Tel: + 44 203 440 5654
Stifel Nicolaus Europe Limited
NOMAD/Broker to the Company
Jonathan Senior, Giles Balleny
Tel: + 44 207 710 7600
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 companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach 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 which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. For further information, visit: http://www.ergomedplc.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 zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. 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, significantly lower cost in the manufacturing process.
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 more than 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.