$CRIS Reports Q2 2011 Financial Results

Recent Developments

-- Genentech presented positive data of vismodegib pivotal clinical trial in advanced basal cell carcinoma (BCC)

In June, Curis’ collaborator Genentech, a member of the Roche group, presented detailed results from its pivotal Phase II clinical trial of vismodegib (GDC-0449, RG3616) in advanced basal cell carcinoma patients at the Seventh European Association of Dermato-Oncology (EADO) Congress in Nantes, France.

The pivotal study (ERIVANCE BCC) is an international, single-arm, multicenter, two-cohort, open-label Phase II study that enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33). The overall response rate in the pivotal Phase II trial as assessed by an independent review facility showed that vismodegib substantially shrank tumors or healed visible lesions, with observed response rates of 43% of patients in the locally advanced BCC cohort and 30% of patients in the metastatic BCC cohort. In the pivotal Phase II trial, study investigators assessed the overall response rate to be 55%, with 60% in the locally advanced BCC cohort, and 46% in the metastatic BCC cohort. The clinical benefit rate (defined as patients who experienced response as well as those who experienced prolonged stable disease for more than 24 weeks) showed vismodegib shrank tumors or healed visible lesions, or prevented them from growing any further in 75% of patients with locally advanced BCC and 76% of patients with metastatic BCC, as assessed by independent review.

The median duration of progression-free survival (PFS) by independent review for both metastatic and locally advanced BCC patients was 9.5 months. The median duration of response by independent review was 7.6 months for both metastatic and locally advanced BCC patients. The median duration of response as assessed by study investigators was 12.9 and 7.6 months for metastatic and locally advanced BCC patients, respectively.

The most common adverse events observed in the study (observed in greater than 20% of patients) included muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhea. Serious adverse events (SAEs) were observed in 26 patients (25%). Four of these patients (4%) had SAEs that were considered to be related to vismodegib, including one case each of: blocked bile flow from the liver (cholestasis), dehydration with loss of consciousness (syncope), pneumonia accompanied by an inability of the heart to pump enough blood (cardiac failure) and a sudden arterial blockage in the lung (pulmonary embolism). Fatal events were reported in seven patients (7%); none were considered by investigators to be related to vismodegib. In all fatalities, pre-existing risk factors and comorbid conditions were present.

Based on the results of this study, Roche has indicated that it anticipates filing an NDA with the FDA in 2011 to seek approval to commercialize vismodegib in the U.S. The filing timeline for a European regulatory submission seeking to commercialize the drug in Europe is dependent on planned discussions with the European Medicines Agency (EMA). Curis is eligible to receive milestone payments for the U.S. and European territories, assuming that submissions are filed by Roche and accepted by the applicable regulatory agencies, and Curis is also eligible for milestone payments upon regulatory approval and royalties on any future sales of vismodegib.

-- Independent-study investigator presented promising interim results from investigator-initiated Phase II study of vismodegib; data shows effect in prevention and treatment of BCC in Basal Cell Nevus Syndrome (BCNS) patients

In April, interim Phase II clinical data on vismodegib were presented at the 2011 Annual Meeting of the American Association for Cancer Research (AACR) in patients with BCNS, which is also commonly referred to as Gorlin syndrome. Vismodegib reduced the rate of new BCCs from an average of 1.74 BCCs per month in the placebo group to 0.07 in the vismodegib group (p=<0.0001) in this study. Vismodegib also reduced the size of existing BCCs (-24 cm vs. 3 cm placebo, cumulative diameter, p=0.006). Some patients achieved near-complete remission with no BCC developing resistance during this period of time on trial. Importantly, these data demonstrate proof-of-concept for the therapeutic utility of vismodegib for BCC in Gorlin syndrome patients, for whom there is no approved pharmacological standard of care intervention. Common observations related to vismodegib's safety included grade 1-2 taste loss, muscle cramps; hair loss and weight loss. There were two grade 3-4 adverse events observed, including one grade 3 muscle cramp and one grade 4 depression. Overall, 28% of patients taking vismodegib discontinued participation due to adverse events. -- Highlighted breadth of targeted cancer platform with data presentations at AACR In April, Curis scientists delivered three poster presentations at the 2011 AACR Annual Meeting, highlighting the breadth of the Company’s targeted cancer portfolio, including presentations on Curis-discovered molecules CUDC-101, CUDC-907 and Debio 0932. Curis Reports Second Quarter 2011 Financial Results | Business Wire