Completion of ZoptrexT Phase 3 Clinical Trial

RNS Number : 6392V

Ergomed plc

31 January 2017

 

PRESS RELEASE

FOR IMMEDIATE RELEASE

Ergomed notes co-development partner Aeterna Zentaris Completes Zoptrex™
Pivotal Phase 3 Clinical Trial in Advanced Endometrial Cancer with results expected in April

London, UK - 31 January 2017: Ergomed plc (LSE: ERGO) ('Ergomed' or 'the Company'), a 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 has today announced the completion of its Pivotal Phase 3 Clinical Trial of Zoptrex™ in women with advanced, recurrent or metastatic endometrial cancer.  

This outcome trial is designed so that the end of the study is reached when a total of 384 deaths occur, which has now been reached. Aeterna Zentaris is expected to report top-line results in April 2017.  As co-development partner, Ergomed co-invests into the trial in return for an share in the revenues generated from the product's commmercialisation. Previously, we have announced that several license agreements entered into by Aetera Zentaris involved up front payments, a portion of which were shared with Ergomed.

Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:

"We are delighted to see that our co-development partner Aeterna Zentaris has announced completion of this important study for the treatment of endometrial cancer. This trial in more than 100 centres globally, was a tremendous achievement by all involved and we are proud to have conducted it. We look forward to the results in April ‎which will be an important milestone in the development of our co-development pipeline."

The full text of the announcement from Aeterna Zentaris is as follows:

Aeterna Zentaris Announces Completion of Zoptrex™ Pivotal Phase 3 Clinical Trial in Advanced Endometrial Cancer; Expects to Report Top-Line Results in April 2017

CHARLESTON, S.C.--(BUSINESS WIRE [11])--Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the occurrence of the 384th death in the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with Zoptrex™ (zoptarelin doxorubicin) in women with advanced, recurrent or metastatic endometrial cancer, representing the clinical endpoint of the study. The Company currently expects to lock the clinical database and to report top-line results in April 2017. Zoptrex™ is the Company's proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the United States Food and Drug Administration (the "FDA").

Dr. Richard Sachse, the Company's Chief Scientific Officer, stated, "We are pleased to announce the completion of the clinical phase of our pivotal Phase 3 clinical study of Zoptrex™, which was conducted under a Special Protocol Assessment with the FDA. Reaching this important milestone took longer than we anticipated because the rate of events slowed significantly during the past year. As previously reported, the study was fully enrolled in June 2015 and the final dosing occurred in January 2016. Therefore, a significant number of patients survived more than 18 months since enrollment in the study. We are thankful that these patients continued to survive a devastating disease and are hopeful that their lives are continuing successfully. We are close to locking the clinical database and are focused on producing the top-line results of the study. Currently, we expect to release top-line results in April 2017."

David A. Dodd, President and Chief Executive Officer of the Company stated, "With the completion of the clinical portion of this trial, we will now focus on analyzing the data and, if warranted by the results, submitting a new drug application later this year. There is a significant unmet medical need for a treatment for women with advanced, recurrent or metastatic endometrial cancer and we are hopeful that Zoptrex™ will provide clinicians and their patients with an effective therapy for treating the disease. We are indebted to all 512 patients who participated in this important clinical program and, hopefully, we will advance to providing a very important new therapy for this devastating cancer."

About the ZoptEC Pivotal Phase 3 Trial

The ZoptEC pivotal Phase 3 trial was 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 were centrally randomized in a 1:1 ratio and received either Zoptrex™ (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every three weeks and for up to nine cycles.

Response was evaluated every three cycles during treatment, and thereafter, every 12 weeks until progression. All patients were 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).

About Zoptarelin Doxorubicin

Zoptrex™ (zoptarelin doxorubicin), a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE), is the Company's lead oncology compound. Zoptrex™ is the first targeted oncological therapy using a peptide as the targeting agent and, therefore, it represents potentially a new tool in the treatment of cancer tumors that overexpress the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors, typically found in gynecological cancers, prostate cancer and some forms of breast cancer. Potential benefits of this targeted approach may include enhanced efficacy and a more favorable safety profile with lower incidence and severity of adverse events, as compared to doxorubicin. Based on the results of Phase 2 studies, the Company believes it may be efficacious for the treatment of ovarian and prostate cancer. If Zoptrex™ is approved as a therapy for endometrial cancer, the Company intends to develop it for these additional indications. The Company has licensed marketing rights to Zoptrex™ to Sinopharm A-Think for China, Hong Kong and Macau; to Orient EuroPharma for Taiwan and Southeast Asia; to Rafa Labs for Israel and the Palestinian territories and to Specialised Therapeutics for Australia and New Zealand.

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 Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. We are engaged in drug development activities and in the promotion of products for others. We recently concluded Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus.

We also intend to license out certain commercial rights of internally developed products to licensees in non-US territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products.

Enquiries:

Ergomed plc	Tel: [phone]
Miroslav Reljanovic (Chief  Executive Officer)
Stephen Stamp (Chief Financial Officer)
Numis Securities Limited	Tel: [phone]
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black (Joint Broker)
Stifel Nicolaus Europe Limited	Tel: [phone]
Jonathan Senior (Joint Broker)
FTI Consulting - for UK enquiries	Tel: [phone]
Simon Conway / Mo Noonan / Natalie Garland-Collins
MC-Services - for Continental European enquiries	Tel: [phone]
Anne Hennecke

About Ergomed

Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.

Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 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. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: http://ergomedplc.com.

 

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