Curis Provides Update on Ongoing Basal Cell Carcinoma Phase I Clinical Trial
Monday January 23, 6:35 pm ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 23, 2006--Curis, Inc. (NASDAQ: CRIS - News), a therapeutic drug development company, today provided an update on a Phase I clinical trial for the treatment of basal cell carcinoma. This Phase I clinical trial is being conducted by Genentech (NYSE: DNA - News) and Curis, and is expected to be completed in the first half of 2006. At the conclusion of this Phase I clinical trial, Curis and Genentech plan to make a decision about whether to advance the drug candidate, a topical antagonist of the Hedgehog signaling pathway, into a Phase II clinical trial.
The Phase I clinical trial is a double-blind, randomized, placebo-controlled study that is expected to enroll approximately 60 patients with a single or multiple basal cell carcinoma. The primary objective of the Phase I clinical trial was to obtain data about the safety and tolerability of a four-week regimen of the drug candidate. In addition, Genentech and Curis are evaluating the clinical activity of the drug candidate, where activity is defined as the complete eradication of the treated basal cell carcinoma lesion and is determined by clinical and microscopic examinations of the lesions.
To date, 29 of the Phase I clinical trial patients have participated in a dose-escalation segment, in which seven patients were randomized to receive treatment in one of four dose levels. The dose-escalation segment of the Phase I clinical trial was recently completed, and the preliminary data have been reviewed by an internal Genentech data review board. The preliminary data from the dose-escalation segment suggest that the drug candidate appears likely to be safe, well tolerated, and has shown signs of activity. However, there has been less clinical activity observed to date than anticipated. Based on these data, the internal data review board recommended that Genentech and Curis temporarily suspend further enrollment in the second segment of the trial, in which additional patients were to be treated at the highest dose level from the dose escalation segment. The companies will determine to re-open enrollment in this segment based on a secondary interim analysis that will occur at a later date. The internal data review board also recommended that a third segment of the trial that is evaluating biological activity using a pharmacodynamic endpoint be enrolled as planned. This third segment, among other things, may shed light on the extent to which the active compound in the drug candidate as formulated is penetrating the patients' skin.
Genentech and Curis expect to have final results from the Phase I clinical trial during the first half of 2006. When the final results are obtained, Genentech and Curis will determine whether this drug candidate should proceed to Phase II clinical trials. Should this drug candidate not progress into Phase II clinical trials, Genentech and Curis will evaluate various criteria, including the data from the biological activity segment of the trial, and determine the alternatives for the basal cell carcinoma program. Possible scenarios include, but are not limited to the following: extending the duration of the treatment regimen of the existing drug candidate, developing a new topical formulation of the existing drug candidate, selection of a new drug candidate, negotiation of the return of the compounds to Curis for Curis' further development, or termination of the basal cell carcinoma drug program.
"In collaboration with Genentech, we plan to continue work on this ongoing Phase I clinical trial and are especially hopeful that the biological activity segment will yield meaningful data so that we can gain a better understanding of the drug's clinical activity. Depending on the outcome of the Phase I trial, we will work with Genentech to explore a number of possible options for the further development of the basal cell carcinoma program," said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc.
About the Genentech Curis Collaboration
In June 2003, Curis established a collaboration with Genentech for the continued development of Hedgehog pathway inhibitors. The focus of the collaboration is to identify lead clinical candidates for topical and systemic treatment of solid tumors. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several solid tumors, including basal cell carcinoma, medulloblastoma, pancreatic cancer, small cell lung cancer, prostate cancer, and others.
In March 2004, a lead clinical candidate was selected for the topical treatment of basal cell carcinoma. Under the terms of the collaboration, Curis retained a co-development option under which Curis may fund up to an equal share of the development costs and share in a commensurate portion of future net operating profits and losses, if any, of clinical candidates that are topical formulations of compounds intended to treat basal cell carcinoma. In January 2005, Curis elected to exercise this co-development option. Curis' co-development right applies solely to the U.S. marketplace and includes applications for basal cell carcinoma and any other indications for which a topically administered clinical candidate may be developed.
About Curis, Inc.
Curis, Inc. is a therapeutic drug development company. 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 two collaborations with Genentech, one of which includes a co-development arrangement for a basal cell carcinoma product candidate that is currently in Phase I clinical trials), 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. Curis also possesses robust small molecule drug screening technologies and preclinical scientific expertise that Curis believes it can use to create a sustainable drug candidate pipeline including, for example, its efforts in Spinal Muscular Atrophy (under sponsored research agreement with the Spinal Muscular Atrophy Foundation). For more information, please visit the Curis web site at www.curis.com. |
