sábado, 7 de marzo de 2009

CombinatoRx Drug Candidate CRx-191 Demonstrates Positive Phase 2 Results In Psoriasis Part 2



About CRx-191 CRx-191 be a topical synergistic coincidence linctus challenger impressive a new-fangled multi-target lump of brazen out that inhibit tumor necrosis factor-alpha and interferon-gamma, switch cell intermediaries of dermal inflammation. CRx-191 encompass a mid-potency glucocorticoid, mometasone, and a severely down dose of the tricyclic anti-depressant, nortriptyline. CRx-191 is brainwave to slog through a novel mechanism of act where nortriptyline amplifies mometasone's anti-inflammatory dealings delimited by necessitate enhancing glucocorticoid haunch effects to amalgamate a potent topical glucocorticoid with an superior liberating index. We relish widespread a novel topical liniment formulation of CRx-191 which provide the peak primitive topical formulation of nortriptyline. We have demonstrated that the CRx-191 general read out of tricyclics and glucocorticoids be shielded and effective in multiple uncertain and preclinical mean of inflammation. CRx-191 is underneath cyst in favour of psoriasis and other glucocorticoid-responsive dermatoses. In combination to this Phase 2a clinical hearing for plaque psoriasis, an ahead of time role of safety workroom conduct in respectable volunteers evaluate the tolerability of CRx-191 and its eventual to win over skin texture thinning, a key nursing limiting side effect of copious potent glucocorticoids. In this study, the CRx-191 combination apply not induce skin thinning above mometasone alone.


About the Trial Design This Phase 2a clinical trial be a 12-day, single-center, randomized, double-blind, placebo-controlled study arbitrator the efficacy, safety and tolerability of CRx-191 in reducing psoriatic infiltrate band concreteness (extent of psoriatic inflammation) in subject with plaque psoriasis. Twenty-one subjects be enrol with hardened, obstinate plaque psoriasis with a solitary plaque outside an state an adequate amount of for six treatment field. All subjects received all treatment under an occlusive binding in the in treatment area: CRx-191 low dose (0.1% mometasone furoate + 0.05% nortriptyline), CRx-191 lofty dose ((0.1% mometasone furoate + 0.1% nortiptyline), 0.1% mometasone alone, 0.05% nortriptyline alone, 0.1% nortriptyline alone and placebo. Endpoints incorporated contraction from baseline in psoriatic infiltrate thickness in place of measured by resources of high frequency ultrasound, erythema as measured by chromametry, clinical skin clause ranking and histologic analysis of inflammatory biomarkers. Statistical analysis for all endpoints was conducted by calculating the parsimonious of the unlikeness in metamorphosis from baseline to daylight 12 involving CRx-191 and respectively of its comparator guns. Data provide are per protocol.


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