Curis, Inc.a therapeutic drug development company, has announced that Curis and Genentech have halted enrolment in the basal cell carcinoma (BCC) phase I clinical trial, and have made a decision not to move forward with the phase I molecule in its current formulation. This decision does not impact the ongoing collaboration between Genentech and Curis pursuant to which the parties are conducting research in a systemic Hedgehog antagonist program for the treatment of solid tumour cancers.
The BCC phase I study enrolled patients into three segments Segment 1, a dose-escalation segment in which patient were randomized to receive treatment or placebo at one of four dose levels; Segment 2, a segment in which additional patients were randomized to the maximum tolerated dose from the dose-escalation segment (Segment 1); and Segment 3, a pharmacodynamic marker segment to evaluate biologic activity of the molecule.
As previously announced, preliminary data from segments 1 and 2 revealed no significant safety concerns in four weeks of topical treatment. Although histological clearance was observed in two subjects in segment 1 of this phase I trial, the clinical activity seen was far less than anticipated. The recent results from segment 3 of the study showed that the formulation did not down regulate the targeted pharmacodynamic marker in this tumour, suggesting a possibility that the drug candidate may not be adequately penetrating human skin.
"We believe that down regulation of the pharmacodynamic marker we are targeting remains a valid approach for the treatment of basal cell carcinoma. We are working with Genentech, to determine the next steps for this program and expect to make a decision in the coming months. We are currently sharing, in the development costs for this clinical candidate and we expect that our co-development expenditures will decline in the short term pending determination of the future basal cell carcinoma development plan," said Daniel R. Passeri, President and CEO of Curis, Inc.
Passeri said, "It is important to note that the systemic Hedgehog antagonist collaboration with Genentech for the treatment of, systemic solid tumour cancers is an entirely different drug development program, with different drug candidates. Pursuant to that collaboration, Genentech is currently conducting preclinical studies that may support an IND application for one or more drug candidates. Genentech will be required to make a milestone payment to Curis if it files an IND for a drug candidate."
The company's technology focus is on regulatory pathways that control repair and regeneration. Curis' product development involves the use of proteins or small molecules to modulate these pathways. Curis has successfully used this technology and product development approach to produce several promising drug product candidates in the fields of cancer (under collaboration with Genentech), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with Procter & Gamble), kidney and other diseases (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), and cardiovascular disease.