Scott W. McKane

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The immune response modifiers, imiquimod and resiquimod, are TLR7 agonists that induce type I interferon in numerous species, including humans. Recently, it was shown that plasmacytoid dendritic cells (pDC) are the primary interferon-producing cells in the blood in response to viral infections. Here, we characterize the activation of human pDC with the TLR7(More)
OBJECTIVE To evaluate the efficacy and safety of 5% imiquimod cream compared with vehicle in the treatment of actinic keratosis (AK). DESIGN Two phase 3 randomized, double-blind, parallel-group, vehicle-controlled studies. SETTING Twenty-six ambulatory care offices, including dermatologists in private practice or research centers. PATIENTS Four(More)
BACKGROUND Imiquimod 5% cream is a topically applied immune response modifier that has been shown to give effective treatment of actinic keratosis (AK). The therapeutic effects of imiquimod are likely to involve the provocation of a cutaneous immune response against abnormal cells, an assumption based on a strong correlation between complete clearance rates(More)
PURPOSE This phase I study aims at assessing the safety and tolerability of LY2603618, a selective inhibitor of Checkpoint Kinase 1, in combination with pemetrexed and determining the maximum tolerable dose and the pharmacokinetic parameters. EXPERIMENTAL DESIGN This was an open-label, multicenter, dose-escalation study in patients with advanced solid(More)
The safety and efficacy of imiquimod 5% cream is being evaluated for the treatment of dysplastic lesions of the epidermis (actinic keratoses, AK). The objective of this clinical study was to describe the pharmacokinetics and safety of topical imiquimod during multiple dosing of AK subjects. A total of 58 adult subjects with 5 to 20 AK lesions at the(More)
Reliability demonstration tests require demonstrating, with some level of confidence, that reliability exceeds a given standard. Demonstration tests can be expensive and time-consuming. Careful planning of sample size and test length are essential. This paper develops exact theoretical methods, based on pivotal quantities and confidence intervals, to aid in(More)
Reliability demonstration tests require demonstrating, with some level of confidence, that reliability exceeds a given standard. Demonstration tests can be expensive and time-consuming. Careful planning of sample size and test length are essential. This paper develops exact theoretical methods, based on pivotal quantities and confidence intervals, to aid in(More)
PURPOSE To determine the recommended/maximum tolerated dose (MTD), pharmacokinetics (PK), and safety profile of tasisulam sodium (hereafter tasisulam), a novel anticancer agent. METHODS In this phase I study, tasisulam was administered as a 24-h continuous intravenous infusion on day 1, every 28 days, to patients with advanced solid tumors. A flat-dosing(More)
OBJECTIVE LY2603618, a selective inhibitor of checkpoint kinase 1 (CHK1) and key regulator of the DNA damage checkpoint, may enhance the effects of antimetabolites. This phase I study defined the recommended phase II dose of LY2603618 combined with gemcitabine. PATIENTS AND METHODS Patients with advanced/metastatic disease were administered doses of(More)
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