ImageCuris, Inc., a drug development company seeking to develop next generation proprietary targeted medicines for cancer treatment, announced that Curis' collaborator Genentech, Inc. and the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD) are planning to enter into a Cooperative Research and Development Agreement (CRADA) which will allow the NCI to explore GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, in a number of cancer indications.

"We are very pleased that Genentech is planning to enter into this CRADA with NCI to advance the development efforts of GDC-0449. Genentech has a broad GDC-0449 phase II clinical programme, including trials in colorectal cancer, advanced ovarian cancer and advanced basal cell carcinoma, and we believe that this agreement with the NCI may allow for GDC-0449 to be tested in many additional cancer indications," said Curis president and CEO Dan Passeri. "We believe that such trials can have a significant impact on the overall development of GDC-0449, since they provide an opportunity to generate additional data in tumour types not already under investigation by Genentech. We look forward to the possible future initiation of clinical trials under this NCI collaboration, which we hope will build on the exciting biological activity previously reported in advanced basal cell carcinoma."

A DCTD-sponsored phase I clinical trial is expected to be initiated to evaluate dose and safety of GDC-0449 in paediatric patients with medulloblastoma. Medulloblastoma is a rare but highly malignant brain tumour that occurs most often in children. In addition to this phase I medulloblastoma clinical trial, the NCI plans to sponsor additional clinical trials under this CRADA, including clinical trials in patients with small cell lung and pancreatic cancers, among others. Trial details of the medulloblastoma phase I trial are available on clinicaltrials.gov. Other trial information is expected to be posted to clinicaltrials.gov as the respective trial nears initiation.

Under Curis' ongoing collaboration agreement with Genentech, Curis provided broad intellectual property rights relating to the Hedgehog pathway, including several classes of proprietary small molecule inhibitors. Through this collaboration, GDC-0449 was discovered by Genentech and was jointly validated by the parties through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449. Curis is not entitled to receive additional cash payments on the initiation of clinical trials conducted under this collaboration with NCI.

Curis is a drug development company that is committed to leveraging its innovative signalling pathway drug technologies to seek to create new medicines for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signalling pathways for the development of next generation targeted cancer therapies.