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Debiopharm Announces Additional Phase I Clinical Trial Evaluating Debio 1143 Combined With Chemotherapies for Patients With Selected Solid Malignancies


6/4/2013 9:13:10 AM

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LAUSANNE, Switzerland, June 4, 2013 /PRNewswire/ --

?Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, including oncology and companion diagnostics, today announced it treated its first patients in a phase I study of Debio 1143 combined with Carboplatin and Paclitaxel in patients with squamous non-small cell lung cancer (NSCLC), platinum-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer.

The aim of this study is to evaluate the safety and tolerability of Debio 1143, a small molecule neutralizing inhibitors of Apoptosis Protein (IAP), in combination with Carboplatin and Paclitaxel, to determine the maximum tolerated dose (MTD) and to establish dosing for further expansion phase.

"There are numerous cancers that are or become relatively insensitive to chemotherapy and other current treatments," said Rolland-Yves Mauvernay, President and founder of Debiopharm Group™. "We are happy about the initiation of this trial and hope to deliver a new tool that will bridge the gap in the treatment of these types of cancers."

About Debio 1143

In September 2011, Debiopharm entered into an exclusive worldwide license agreement with Ascenta Therapeutics Inc. concerning the development and commercialization of Debio 1143. It is currently being tested in monotherapy in a phase I clinical study in the US, on patients suffering from advanced solid tumors.

Debio 1143 is an orally available small molecule that neutralizes major inhibitors of apoptosis. By targeting those inhibitors, Debio 1143 can induce cancer cell death and/or potentiate the efficacy of other treatments and is expected to be effective in the treatment of various cancers in combination with anti-cancer therapies.

Evasion of apoptosis is a hallmark of cancer, enabling cancer cells to live indefinitely and grow uncontrollably. Most current cancer therapies, including chemotherapeutic agents, radiation, and immunotherapy, work by inducing apoptosis. However, because of molecular alterations in the apoptotic pathways, many cancer cells are resistant or develop resistance to these agents. Targeting apoptotic pathways directly to induce cell death and/or restore sensitivity to other treatments is a promising new direction for drug development.

About Debiopharm Group™

Debiopharm Group™ (Debiopharm) is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses, develops and/or co-develops promising biological and small molecule drug candidates having reached clinical development phases I, II or III, as well as earlier stage candidates. It develops its products for global registration and maximum commercial potential. The products are out-licensed to pharmaceutical partners for sales and marketing. Debiopharm is also active in the field of companion diagnostics with a view to progressing in the area of personalized medicine. Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

For more information about Debiopharm Group™, please visit: http://www.debiopharm.com.

Debiopharm International SA Contact

Beatrice Hirt

Communication Coordinator

Tel.: +41-(0)21-321-01-11

Fax: +41-(0)21-321-01-69

beatrice.hirt@debiopharm.com

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