Curis & Debiopharm Announce Initiation of Phase Ib Expansion Study

Curis, Inc. and Debiopharm Group recently announced that Debiopharm has begun treating patients in a Phase Ib clinical trial of Heat Shock Protein 90 (HSP90) inhibitor Debio 0932. Debiopharm recently successfully completed a Phase Ia dose escalation study with Debio 0932 and has indicated that it expects to initiate a combination Phase I/II study in non-small cell lung cancer patients in the second quarter of 2012.

“Our team has been very pleased with the development of Debio 0932, which has become an important molecule in Debiopharm’s pipeline,” said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. “We believe HSP90 represents an important molecular target in cancer therapy, and we are eager to advance this molecule in the Phase Ib clinical trial, as well in our planned Phase I/II studies, which we hope will yield important new data for the further development of Debio 0932.”

“We have been highly impressed with the depth of Debiopharm’s development expertise and commitment to furthering Debio 0932 into additional clinical studies in 2012,” added Dan Passeri, Curis President and CEO. “Importantly, we continue to be very pleased with the clinical results that have been observed to-date, and we look forward to reporting further progress on this molecule in the future.”

Debiopharm initiated a Phase I clinical trial in April 2010 that was designed to evaluate the maximum tolerated dose and safety of Debio 0932. The first part of the study (Phase Ia), an open-label, multi-center dose escalation trial evaluating the safety and tolerability of escalating multiple dose levels of Debio 0932 given daily or every other day as a single agent by oral administration in patients suffering from advanced solid tumors, was recently completed.

Debio 0932 was generally well tolerated, with no evidence of ocular or liver toxicity, and showed promising signs of efficacy in patients with advanced solid tumors. The recommended dose, established at 1000 mg every day, will be tested in additional patients during the expansion phase (Phase Ib) of the ongoing Phase I study.

Debiopharm expects to treat approximately 30 patients as part of the Phase Ib expansion study. The objectives of this study will be to further assess the safety profile, pharmacokinetics, and pharmacodynamics of Debio 0932 at the recommended dose level and regimen, and to further assess anti-tumor activity in patients with advanced solid tumors, including patients with non-small cell lung cancer.

Debio 0932 is a novel heat shock protein 90 (HSP90) inhibitor with strong affinity for HSP90 alpha/beta, high oral bioavailability, and potent anti-proliferative activity against a broad range of cancer cell lines (with a mean IC50 of 220 nmol/L), including many non-small cell lung cancer (NSCLC) cell lines that are resistant to standard-of-care agents. Debio 0932 potently inhibits tumor growth in subcutaneous xenograft models of a number of solid and hematological malignancies, including models of NSCLC, which harbor mutations conferring acquired or primary erlotinib resistance. Furthermore, Debio 0932 is able to extend animal survival in models of brain metastasis due to its ability to cross the blood-brain barrier, and it enhances the activity of several standard-of-care agents in animal models of cancer.

Debiopharm Group 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.

Curis is a drug development company committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs.