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ErgomedAnnouncement

21/10/2015 09:20

RNS Number : 9455C
Ergomed plc
21 October 2015
ERGOMED'S CO-DEVELOPMENT PARTNER SYNTA ANNOUNCES TERMINATION FOR FUTILITY OF GANETESPIB PHASE 3 GALAXY-2 TRIAL IN LUNG CANCER
Guildford, UK- 21 October 2015: Ergomed plc, ('Ergomed', AIM:ERGO) a profitable UK-based company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, today announces that its co-development partner Synta Pharmaceuticals, has announced the termination of its ongoing Phase III study in lung cancer. Ergomed had invested in the earlier Phase II study in lung cancer and has a minority carried interest in Ganetespib. Ergomed retains this carried interest the product but is not investing or participating in the remaining four ongoing studies with the compound that are referred to in the full Synta release below.
The termination of the study has no impact on the financial position or forecast cash flows of Ergomed and Ergomed remains committed to its strategy of participating in co-development and balancing the risk of investing in a range of drug development assets whilst also operating a profitable cash generative healthcare services business. Ergomed has four other co-development partnerships that are proceeding to plan and continues to plan to completing more partnerships in the future. Ergomed's balanced risk model means that it can operate effectively in the challenging drug development sector and be relatively unaffected by the fluctuating clinical trial results that are inherent.
Full details of the Synta release are shown below. Ergomed will provide any relevant updates after the Synta conference call later today (scheduled for 1.00pm BST).
Synta Announces Termination for Futility of Ganetespib Phase 3 GALAXY-2 Trial in Lung Cancer
Company to Host Conference Call on Wednesday, October 21 at 8:00 AM ET
LEXINGTON, Mass.October 20, 2015 07:30 PM EDT: Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the Company has decided to terminate the Phase 3 GALAXY-2 trial of ganetespib and docetaxel in the second-line treatment of patients with advanced non-small cell lung adenocarcinoma. Based on the review of a pre-planned interim analysis, the study's Independent Data Monitoring Committee (IDMC) concluded that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone. The IDMC noted that the combination of ganetespib and docetaxel was generally well tolerated in the study, with an adverse event profile consistent with previous studies combining these agents.
GALAXY-2 is a Phase 3 global, randomized, multi-center trial. Synta continues to support enrollment in four additional large, randomized, multi-center investigator-sponsored studies, including: the GANNET53 trial of ganetespib and paclitaxel in ovarian cancer; the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); the AML18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer.
"This disappointing outcome underscores the challenges of treating lung cancer in the second-line setting and determining the precise population for whom ganetespib may be most effective," said Chen Schor, President and Chief Executive Officer of Synta. "We thank the patients, caregivers and investigators who participated in GALAXY-2."
Mr. Schor continued: "Despite the outcome of this trial, and pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib. We also look forward to advancing candidates from our HDC platform into the clinic. With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward."
Upon formal acceptance of the IDMC's recommendation, Synta will communicate with regulatory authorities, and will notify study investigators that treatment with ganetespib should be discontinued in the GALAXY-2 trial.
Conference call
Synta will host a conference call at 8:00 AM ET on Wednesday, October 21st to discuss the outcome of the GALAXY-2 trial. The conference call will be webcast live and can be accessed by logging on to the "Investors" section of the Synta Pharmaceuticals website,www.syntapharma.com, prior to the event.
The conference call can also be accessed by dialing (877) 715-8365 (U.S.) or (440) 996-5675 (International). For those unable to join the live call, a replay will be available from 11:00 a.m. ET on October 21 through 11:59 p.m. ET on October 28. To access the replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406 (International) and refer to conference ID65923441.
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, Stewart Wallace, Ben Maddison
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
AboutSynta Pharmaceuticals
Synta Pharmaceuticals Corp. is an innovative, agile biopharmaceutical company focused on research, development and commercialization of novel oncology medicines that have the potential to change the lives of cancer patients. Synta's lead oncology drug candidate, ganetespib, a novel heat shock protein 90 (Hsp90) inhibitor, is currently being evaluated in several investigator sponsored clinical trials including clinical trials in acute myeloid leukemia (AML), ovarian cancer, breast cancer, and other tumor types. Building on its extensive expertise in the science of Hsp90, Synta also has a novel proprietary Hsp90 inhibitor Drug Conjugate (HDC) small molecule drug development program. IND enabling studies have commenced for the first clinical candidate from the HDC program, STA-12-8666, and preclinical evaluation of additional HDC candidates is ongoing. For more information, please visitwww.syntapharma.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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