Key Developments For Curis, Inc.
Curis, Inc. (CRIS.O) (Consolidated Issue listed on NASDAQ Global Market)
Curis, Inc. Announces GDC-0449 Phase I Clinical Data Published In New England Journal Of Medicine
Curis, Inc. announced that two publications describing clinical data generated with GDC-0449 were published in the current edition of The New England Journal of Medicine (NEJM). The first publication provides an overview of the Phase I data for the 33 basal cell carcinoma (BCC) patients treated in this study. The second paper provides an overview of the treatment of a single adult medulloblastoma patient with GDC-0449. The data published by this distinguished journal build upon the existing body of evidence and provide further support for the belief that aberrant Hedgehog signaling is strongly implicated in solid tumors such as basal cell carcinoma and medulloblastoma. In 18 patients with metastatic BCC, 8 patients had confirmed partial responses, 1 patient had an unconfirmed partial response by RECIST, 7 patients had stable disease as a best response and 2 patients had progressive disease. RECIST provides standard parameters to be used when documenting patient response for solid tumors. The overall response rate was 50% (9 partial responses out of the 18 metastatic BCC patients in the study). In 15 patients with clinically evaluable locally advanced BCC, 2 patients had complete clinical responses, 7 patients had partial responses, 4 patients had stable disease as the best response and 2 patients had progressive disease. The overall response rate was 60% (2 complete responses plus 7 partial responses out of the 15 locally advanced BCC patients in the study).
Genentech, Inc. Announces Potential Skin Cancer Breakthrough Tested At Scottsdale Healthcare Published In New England Journal of Medicine
Genentech, Inc. announced that a study published in the New England Journal of Medicine reports a potential new investigational therapy for advanced and metastatic basal cell skin cancer tested at the Virginia G. Piper Cancer Center at Scottsdale Healthcare and other sites appears to demonstrate tumor shrinkage and limited side effects in patients. The article appears online at NEJM.org and will be included in the September 17, issue of New England Journal of Medicine. In a Phase I clinical trial conducted in Arizona at the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Dr. Von Hoff and colleagues at Johns Hopkins University and Karmanos Cancer Institute demonstrated that GDC-0449, a Hedgehog Pathway Inhibitor, appears to shrink tumors in locally-advanced and metastatic basal cell carcinoma (BCC) while having limited side effects including a loss of sense of taste, and a small amount of hair loss and weight loss. GDC-0449 was discovered by Genentech and was jointly validated through a series of preclinical studies performed under a collaboration agreement between Genentech and Curis, Inc. Known as the Hedgehog trial, results suggest a durable clinical benefit, defined as tumor shrinkage visible on X-ray or other physical exam or improvement in symptoms without tumor growth, was observed in 18 of 33 patients evaluated.
Curis, Inc. and Debiopharm Sign Exclusive License Agreement Covering the HSP90 Inhibitor CUDC-305
Curis, Inc. announced that they have entered into a worldwide, exclusive license agreement for Curis' Heat Shock Protein (Hsp90) technology, including CUDC-305, the Company's lead Hsp90 inhibitor candidate. Under the terms of the agreement, Debiopharm will assume all future development responsibility and incur all future costs related to the licensed Hsp90 technology, including CUDC-305. Curis currently expects that Debiopharm will file an application with health authorities to begin Phase I clinical testing for CUDC-305 in Fall 2009. Curis will receive an up-front license fee and, pending approval of such application, Curis will receive additional near-term payments. Curis is further eligible to receive additional contingent payments assuming the successful achievement of specified clinical development and regulatory approval objectives as well as royalties on product sales, if any, on any products that are successfully commercialised by Debiopharm or its sublicensees.
Curis, Inc. Added To Russell 3000 and Russell 2000 Indexes
Curis, Inc. announced that it was added to the Russell 3000 and Russell 2000 Indexes when Russell Investment Group reconstituted its family of U.S. indexes after stock market close on June 26, 2009.
Curis, Inc. Announces Issuance of U.S. Patent Covering CUDC-101 Composition For l HDAC/EGFR/Her2 Inhibitor
Curis, Inc. announced the issuance of U.S. Patent Number 7,547,781, entitled Quinazoline Based EGFR Inhibitors Containing a Zinc Binding Moiety. The patent covers a genus of compounds that includes CUDC-101, Curis HDAC/EGFR/Her2 inhibitor, which is currently in a Phase I clinical trial.
