Psoriasis drug data positive: Cytochroma
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BY OUR PHARMA CORRESPONDENT
17th August,2005: Priliminary results of clinical study with a novel vitamin D analog developed for the treatment of psoriasis are found positive, reports Cytochroma Inc.
The phase 1b study with drug CTA018, involving 28 subjects with plaque psoriasis, was designed to characterize the local and systemic safety. Results of the study indicate that the drug is safe and unlikely to produce adverse reactions.
``The phase Ib study results are highly promising,'' stated Jukka Karjalainen, M.D., Ph.D., Vice-President of Drug Development at Cytochroma. ``The results further corroborate existing pre-clinical and clinical safety data of CTA018. Problems with local and systemic tolerability of currently marketed topical products limit their daily use, and often require safety monitoring. There is a definitive need to develop more effective and better tolerated products for psoriatic patients.''
The phase Ib study was a multicentre, 4-arm, randomized, open-label, parallel-group comparison study of three doses of CTA018 (1, 3, and 10 µg/g) and corresponding cream base (vehicle control). Subjects had CTA018 or vehicle cream applied topically to psoriatic plaques on 5% of body surface area every 24 hours for 13 consecutive days with a subsequent follow-up 7 days post treatment.
Pharmacokinetics of CTA018 over 48 hours, post dosing, was studied in the high dose group which did not produce detectable systemic levels of CTA018. There were no severe or serious adverse events reported. All three doses were deemed safe and not likely to produce local or systemic adverse effects.
Based on this data and those obtained from the recent successfully completed phase Ia proof of concept study, Cytochroma plans to initiate a phase II clinical trial with CTA018 in the fourth quarter of 2005.
CTA018 has a dual mechanism of action. It is a strong activator of the vitamin D signaling pathway and also a potent inhibitor of CYP24 activity (the enzyme responsible for the breakdown of vitamin D). CTA018 was designed by Prof. Gary H. Posner and is protected under patents and patent applications exclusively licensed to Cytochroma Inc. from the Johns Hopkins University, the release said.
Psoriasis is a common immune-mediated chronic skin disease often characterized by red, scaly plaques that itch, burn, sting, and bleed easily. It afflicts approximately 125 million people worldwide; more than 70% of patients have the mild to moderate form. Psoriasis is found in all age groups and often seriously compromises the quality of life of those affected. Current methods of treatment are either inconvenient, show poor remission rates, and/or have serious side effects. Cytochroma has recognized that there is a need for improved therapies.
Cytochroma Inc. is a specialty drug development company targeting hyperproliferative disorders, autoimmune diseases and chronic kidney disease. The company is currently developing and commercializing vitamin D analogs, significantly having a dual mechanism of action, which address major medical needs in the treatment of psoriasis, secondary hyperparathyroidism, multiple sclerosis and cancer.
BY OUR PHARMA CORRESPONDENT
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