Lausanne, Switzerland – January 13, 2016 – Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, today announced a collaboration in order to supply triptorelin pamoate 3.75 mg 1-month formulation for patients suffering from salivary gland cancer participating in a clinical study sponsored by the European Organisation for Research and Treatment of Cancer (EORTC).
The EORTC intergroup trial 1206:“A randomised phase II study to evaluate the efficacy and safety of chemotherapy vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor expressing, salivary gland cancer” is coordinated by the EORTC Head and Neck Cancer Group in collaboration with the International Rare Cancer Initiative UK Salivary Gland Cancer Group. This study will accrue 152 patients at approximately 30 sites in 10 countries: Austria, Belgium, France, Germany, Greece, Hungary, Italy, the Netherlands, Portugal and the United Kingdom. The clinical study is expected to last until mid 2021.
Dr. Lisa Licitra(photo) of the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, and Coordinator of this study says, “Androgen, estrogen and progesterone play a key role in the growth and development of several cancer types, e.g. breast, endometrium and prostate, and since the discovery of androgen receptors in salivary gland tumors, it is thought that androgen deprivation therapy might be beneficial for patients with androgen receptor expressing, salivary gland cancer. The EORTC 1206 intergroup trial will evaluate the efficacy and safety of androgen deprivation therapy versus chemotherapy in patients with recurrent and/or metastatic, salivary gland cancer.”
Salivary gland cancers are a rare and heterogeneous group of tumors. There is currently no standard of care for treating these cancers. The purpose of this study is to evaluate the efficacy and safety of chemotherapy versusandrogen deprivation therapy (ADT) in patients with recurrent and/or metastatic androgen receptors-expressing salivary gland cancers.
“Androgen deprivation therapy with triptorelin may slow progression of salivary gland cancers expressing androgen receptors”, says Dr Eija Lundstrom, Medical Director at Debiopharm. “We are committed to support the clinical investigation of this promising treatment option of these rare cancers”.
In addition to the support provided by Debiopharm, this phase II study is supported by a grant from Fonds Baillet Latour covering part of the EORTC operational cost and by Cancer Research UK for drug supply, as well as by AIRC (Associazione Italiana Ricerca Cancro) entirely covering the expenses of the translational research associated with the clinical protocol.
Triptorelin is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH). Debiopharm has developed three sustained-release formulations (1, 3 and 6 months) of triptorelin pamoate. The 1-, 3- and 6-month formulations have been registered in numerous countries in several indications, mainly for advanced prostate cancer and endometriosis, and are available under different brand names: Trelstar®, Decapeptyl® and Pamorelin®.
About Debiopharm International SA
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses, develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For more information, please visit www.debiopharm.com
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The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 2,500 collaborators from all disciplines involved in cancer treatment and research in more than 300 hospitals in over 30 countries. Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices. EORTC Headquarters, a unique pan European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.
For more information, please visit www.eortc.org