LAUSANNE, Switzerland, November 3, 2015 /PRNewswire/ --
Recommended Dose reached and early signs of efficacy seen
Debiopharm International SA (Debiopharm) - part of Debiopharm Group(TM), a Swiss-based global biopharmaceutical company - today announced significant milestones in the clinical development of the SMAC mimetic Debio 1143.
Debio 1143 is an oral, small molecule inhibitor of IAPs (inhibitor apoptosis proteins) with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radiosensitizer in oncology.
Recommended Dose was achieved in two Ph I studies. Debio 1143 has shown a favorable safety profile in a dose-finding and efficacy Phase I/II trial in combination with chemoradiotherapy in squamous cell carcinoma of the head and neck (Debio 1143-201 [https://clinicaltrials.gov/ct2/show/NCT02022098?term=debio11... ] ). The randomized Phase II part of this study will start patient recruitment in November.
At the same time, Debiopharm has conducted an indication screening study in combination with carboplatin and paclitaxel in patients with advanced solid malignancies (Debio 1143-103 [https://clinicaltrials.gov/ct2/show/NCT01930292?term=Debio+1... ] ). The recommended dose of Debio 1143 with this combination has been determined with a good tolerability profile. Furthermore, encouraging early signs of efficacy in ovarian cancer patients have been observed (Poster #C2).
In addition, new preclinical data illustrating the immunomodulatory function of Debio 1143 will be presented during the conference (Poster #A93). These findings are highly supportive of clinical development in combination with immune checkpoints inhibitors which are currently under development in a wide range of therapeutic indications.
"The recommended dose of Debio 1143 with combined treatments has been determined," said Jean-Maurice Dumont, Vice President, Clinical Research & Development of Debiopharm International. "We have reached an important step in the development of Debio 1143. Its chemo/radiosensitization property will now be further investigated in phase II trials."
About Debiopharm International SA
Debiopharm Group(TM) 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 http://www.debiopharm.com
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