A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.

Start Date01 Nov 2011

Sponsor / Collaborator

ApoPharma, Inc.

100 Clinical Results associated with Orilotimod potassium

100 Translational Medicine associated with Orilotimod potassium

100 Patents (Medical) associated with Orilotimod potassium

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02 Nov 2018·Expert Opinion on Investigational DrugsQ2 · MEDICINE

Investigational drugs in phase II clinical trials for moderate to severe plaque psoriasis - potential new treatments on the horizon

Q2 · MEDICINE

Review

Author: Guda, Anisha ; Feldman, Steven R. ; Strowd, Lindsay

INTRODUCTIONPsoriasis is a common immune disorder for which there are many FDA-approved therapies. Older oral drugs had limited efficacy and considerable side effects. Biologics have been a major advance but require self-administered injections, and many patients prefer oral options. Because many patients fear needles, oral drugs are a welcome option. This review provides an update on oral drugs in Phase II development for psoriasis.AREAS COVEREDA literature review was performed to identify these drugs by using search terms such as 'psoriasis', 'agents', 'drugs', and 'phase 2 development'. Baricitinib and KDO 25 are the oral drugs that appear to hold the most promise due to the balance they maintain between efficacy and adverse effects. If a RORγt inhibitor can be identified that has no hepatotoxicity, then that may be the most promising new oral treatment.EXPERT OPINIONSeveral new oral psoriasis medications are currently being investigated. One major challenge remains medication cost and insurance coverage. Phase III studies are needed to determine efficacy and safety in large cohorts of psoriasis patients. An increase in the number of approved oral medications for psoriasis would mean more choice for psoriasis patients.

01 May 2016·Pharmaceutical Chemistry Journal

Microbiological Quality Control of Biotechnological Pharmaceuticals

Author: I. A. Builova ; O. V. Gunar

A new approach to microbiol. anal. of several pharmaceuticals, in particular, those that can be used in manufacturing sterile medical products, is presented.The proposed approach was verified using a series of 23 samples of various products, three of which were obtained by biotechnol. methods.The scheme includes inoculation of samples with test strains followed by isolation and anal. of the contaminants.Validation results showed that the amount of products for microbiol. anal. could be reduced to 3 g, which was sufficient for obtaining reliable results.Tryptic soy broth was used as the solvent (diluent) and enrichment broth for microbe growth.

01 Apr 2011·Bulletin of Experimental Biology and MedicineQ4 · MEDICINE

Status of Free-Radical Oxidation and Proliferation Processes in Patients with Atopic Dermatitis and Lichen Planus

Q4 · MEDICINE

Article

Author: Lebed'ko, O. A. ; Sapuntsova, S. G. ; Kozulin, E. A. ; Fleyshman, M. Yu. ; Timoshin, S. S. ; Shchetkina, M. V.

We studied the status of proliferation processes (by Ki-67 expression) and biogenesis of free radicals (by chemiluminescence method) in skin biopsy specimens from patients with atopic dermatitis and lichen planus. The index of Ki-67-positive nuclei significantly (p<0.05) increased to 28.40±2.00% in patients with dermatitis and to 32.6±1.9% in patients with lichen planus vs. 8.65±1.31% in the reference sample. Decompensated accumulation of free-radical oxidation products and inhibition of detoxification systems in skin biopsy specimens indicate the development of local oxidative stress. After therapy consisting of two 10-day courses of thymodepressin injections (0.1%, 1.0 ml) over 30 days, normalization of epidermis proliferation was observed. Labeling index in atopic dermatitis and lichen planus significantly decreased (p<0.05) to 17.00±1.87 and 10.9±1.1%, respectively. The role of free radicals in the development of hyperregeneratory processes during dermatoses is discussed.

100 Deals associated with Orilotimod potassium

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 2	Canada	ApoPharma, Inc.	01 Nov 2011
Plaque psoriasis	Phase 2	United States	ApoPharma, Inc.	01 Nov 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01483924 (CTgov)	Phase 2	Plaque psoriasis	60	placebo (Placebo)	xctgbwnoor(bflorrbadk) = rknsjaeghn hpbobbcsnf (ctutzragnd, xepcwwskfl - caromaxces) View more	-	20 Feb 2015
				Apo805K1 (Apo805K1 10 mg)	xctgbwnoor(bflorrbadk) = dbqoxirukd hpbobbcsnf (ctutzragnd, azudbhrzbg - adawaqlbkj) View more

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