Description | Importance | Current Treatments | Treatments in Development | IRM Rationale | IRM Status
Description
Superficial basal cell carcinoma (sBCC) is a malignant tumor of the skin that is linked to ultraviolet light exposure. Ultraviolet radiation causes DNA damage in basal cells of the epidermis, the outermost layer of the skin, leading to malignant transformation. Ultraviolet radiation also suppresses skin immune mechanisms; thus the growing cancer is not recognized or destroyed.
sBCC is a non-melanoma skin cancer (NMSC); it is far less likely to spread to other organs than melanoma but can cause significant local tissue destruction if left untreated.
Importance
The lifetime risk of developing NMSC for a Caucasian male born in 1994 is 33-39%. (Miller et al, Journal of the American Academy of Dermatology, 1994).
An estimated 900,000 to 1,200,000 cases of NMSC appear per year in the United States alone and about 80% of these are sBCC. (Miller et al, Journal of the American Academy of Dermatology, 1994).
Outside the United States, NMSC can be even more prevalent. sBCC is common in Australia, for example.
Current Treatments
The goals of treatment are to cure the tumor, preserve normal appearance and function of the skin, and avoid complications. Additional goals include maximizing the cost-effectiveness to the health care system and both convenience and cosmetic outcomes for the patient. Existing treatments leave room for improvement.
The dominant therapy for sBCC is some form of surgery. Typically, simple excision, electrodessication and curettage ("scoop out" the lesion and apply electricity), Mohs surgery (iterative surgical removal), cryosurgery (freezing tissue with liquid nitrogen) or laser surgery are used.
Current treatments are associated with a high rate of tumor clearance but treatment can be painful, may create scarring and destroy some healthy tissue.
Treatments in Development
As with all common diseases with unmet clinical and patient needs, much research is being done with new approaches for treatment of sBCC. The newest treatment to enter the European market is photodynamic therapy; studies are ongoing in the U.S. Photodynamic therapy uses a combination of a topical chemical agent plus a specific light source to activate the chemical. Initial assessments suggest market acceptance of photodynamic therapy is likely to be limited, but the market progress will be closely monitored.
IRM Rationale
A topical, patient-applied IRM would induce anti-tumor cytokines locally at the tumor site and selectively destroy tumor cells. An IRM would provide a high rate of tumor clearance without the limitations of existing therapies. An IRM may also provide protection against new tumors because it may enhance cell mediated immune recognition of new sBCCs. In addition, treatment of areas adjacent to the visible tumor may also treat developing (i.e., sub-clinical) sBCCs.
IRM Status
A pilot study using Aldara was published in the December 1999 issue of the Journal of the American Academy of Dermatology. In this randomized, double-blind, vehicle-controlled pilot study, Aldara was evaluated for safety and efficacy in the treatment of primary, superficial or nodular BCC. Five treatment schedules were used: twice daily, once daily, three-times-weekly, twice weekly, and once weekly. Patients continued treatment until either: two weeks after the target tumor was clinically resolved or 16 weeks of treatment were completed. All patients receiving once daily, twice-daily and three-times-weekly dosing had a complete response to treatment - no evidence of tumor remained after treatment with Aldara. Side effects were well-tolerated.
Phase II studies were completed successfully in Australia, North America, and Europe. A decision to move to Phase III studies was made in July 2000. Enrollment in Phase II studies was completed in April 2002. 3M Pharmaceuticals expects to file licensing dossiers for this new indication for Aldara in Q2, 2003. The first product launch could be as early as Q2, 2004. Other launches would proceed globally based on individual country registration and reimbursement feedback to 3M Pharmaceuticals. Other launches would proceed globally based on individual country registration and reimbursement feedback to 3M Pharmaceuticals.
To the extent that any statements made in this document contain information that is not historical, these statements are essentially forward-looking. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the timing and outcome of legal proceedings; the difficulty of predicting the timing of U.S. Food and Drug Administration ("FDA") approvals; the difficulty in predicting the timing and outcome of FDA decisions on patent challenges; market and customer acceptance and demand for new pharmaceutical products; ability to market proprietary products; the impact of competitive products and pricing; timing and success of product development and launch; availability of raw materials; the regulatory environment; fluctuations in operating results; and other risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "believes," "estimates," "intends," "may," and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should the Company's assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements.
Revised: September 2002
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