>>CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 16, 2006--Curis, Inc. (NASDAQ: CRIS - News), a therapeutic drug development company, today announced the presentation of data at the 39th Annual Australasian College of Dermatologists Scientific Meeting. Preliminary clinical data were presented and suggest that a topical Hedgehog antagonist studied in 34 patients with basal cell carcinoma (BCC) was generally well tolerated. These data are from a Phase I trial that is part of Curis' ongoing collaboration with Genentech to develop a topically administered Hedgehog small molecule antagonist for the potential treatment of BCC.
The multi-center Phase I study evaluated the safety and tolerability of four dose levels of a topically applied Hedgehog antagonist in subjects with superficial or nodular BCC. Subjects were randomized to receive four weeks of administration with the Hedgehog antagonist or a placebo. The pharmacodynamic portion of the trial is ongoing, thus the trial is still blinded. This poster presentation focused on safety results.
Safety was assessed using the following measures: incidence of local skin reactions at the treatment site; incidence of adverse events, including serious or severe adverse events; and incidence of laboratory abnormalities. Overall, 34 patients were enrolled and treated. All of the adverse events reported for the 34 patients were mild or moderate except for severe erythema (redness of the skin) in one patient dosed at the highest dose level.
"We are pleased with the data presented today showing the tolerability of a topically applied Hedgehog antagonist for the treatment of basal cell carcinoma. We continue to await the final pharmacodynamic data from the Phase I trial to determine biological activity," said Daniel R. Passeri, President and Chief Executive Officer.
About BCC
Basal cell carcinoma is the most common form of skin cancer, affecting over one million Americans each year. In fact, it is the most common of all cancers. One out of every three new cancers is a skin cancer, and the vast majority are basal cell carcinomas, often referred to by the abbreviation, BCC. These cancers arise in the basal cells, which are at the bottom of the epidermis (outer skin layer). Chronic exposure to sunlight is the cause of almost all basal cell carcinomas, which occur most frequently on exposed parts of the body -- the face, ears, neck, scalp, shoulders, and back. The majority of BCC cases are believed to be caused by a mutation in the Hedgehog pathway.
Until recently, those most often affected were older people, particularly men who had worked outdoors. Although the number of new cases has increased sharply each year in the last few decades, the average age of onset of the disease has steadily decreased. More women are getting BCCs than in the past; nonetheless, men still outnumber them greatly. A recent article in the Journal of the American Medical Association showed that rates of non-melanoma skin cancer, including basal cell carcinoma, have tripled in women under the age of 40.<<
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Wonder if we'll see any actual DATA. I haven't the time nor sufficient interest to hunt down the abstract, if there is one.
Cheers, Tuck |
