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news.Curis has announced that its licensee, Debiopharm has received approval from France's regulatory authority, Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly known as CUDC-305.
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Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8m milestone payment from Debiopharm for the achievement of this development objective.
Dan Passeri, president and chief executive of Curis, said: “We believe that Debio 0932 may have broad potential in a number of cancer indications based on its multiple mechanisms of action and client proteins, and its remarkable pharmacological properties, and we are pleased that the second compound generated from Curis’ proprietary targeted cancer platform has advanced into the clinic.
“The acceptance by the French regulatory authorities of Debiopharm’s CTA package is an important milestone in the development of this innovative cancer treatment and a testimony to Debiopharm’s regulatory expertise and commitment to Debio 0932.”
Rolland-Yves Mauvernay, president and founder of Debiopharm, said: “We are excited that Debio 0932 has reached this important milestone and that the clinical studies will start. Debiopharm is committed to the development of this compound and we believe that Debio 0932 can address a major unmet medical need and become an important tool available for the treatment of cancer.”
Debiopharm plans to open a phase I clinical trial evaluating the safety of Debio 0932 during the first quarter of 2010. The study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of multiple doses of Debio 0932 in patients suffering from advanced solid tumors or lymphoma.
Based on Curis’ research to date, the company believes that Debio 0932 may provide key benefits over Hsp90 inhibitors currently in clinical testing. Curis has evaluated the potency, safety, efficacy and pharmacological properties of Debio 0932 in multiple animal models. There it exhibits high oral bioavailability and selective retention in tumors, crosses the blood brain barrier and displays potent antitumor activity in several animal models, when given alone or in combination with standard-of-care agents, while robustly inhibiting multiple signaling pathways, including PI3K/AKT and RAF/MEK/ERK.
Mike Gray, chief financial officer of Curis, said: “The $8m milestone payment provides us with significant additional non-dilutive capital to continue our development of our first-in-class, network-targeted EGFR, Her2 and HDAC inhibitor CUDC-101 and other preclinical network-targeted agents, including an HDAC and Pi3K inhibitor, which we expect to advance as a development candidate in 2010.
“Curis currently has adequate cash to fund its operations well into the first half of 2012, not including any additional potential future milestone payments from our collaborations with Genentech and Debiopharm.”