Feb 12 2010
Curis, Inc. (NASDAQ: CRIS), announced today that its licensee Debiopharm
S.A. (“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 called CUDC-305.
Under the terms of Curis’ and Debiopharm’s August 2009 license
agreement, Curis will receive an $8 million milestone payment from
Debiopharm for the achievement of this development objective.
“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.”
“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,” said Dan
Passeri, Curis’ President and Chief Executive. “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.”
“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,” said Rolland-Yves Mauvernay, President and
Founder of Debiopharm Group™.
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,
where 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.
“The $8 million 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,” said Mike Gray, Curis’ Chief Financial Officer. “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.”
SOURCE Curis, Inc.