MARKHAM, ON, Nov. 13 /PRNewswire/ - Cytochroma Inc. has initiated the recruitment of patients with chronic plaque psoriasis for a Phase II clinical trial with CTA018 cream. CTA018 is a novel vitamin D analog with a dual mechanism of action designed to be both a strong activator of the vitamin D signaling pathway and a potent inhibitor of CYP24 activity (the enzyme responsible for the catabolism of vitamin D). CTA018 was previously studied in two Phase I clinical trials and demonstrated to be both well tolerated and efficacious in the treatment of patients with psoriasis.
“Patients are being enrolled quickly to the Phase II trial in clinical investigational sites around the United States”, said Jukka Karjalainen, M.D., Ph.D., Vice-President, Clinical Affairs at Cytochroma. “With its novel dual mechanism of action, it is expected that CTA018 will be more efficacious and also better tolerated than the existing topical treatments.”
“Despite the many products available for psoriasis, there is a need for safer, more effective topical therapies” said the Principal Investigator of the trial, Dr. Mark Lebwohl, Professor and Chairman, Department of Dermatology, The Mount Sinai Medical Center, New York.
The Phase II study is a multicenter, randomized, double-blind, parallel-group comparative study in subjects with chronic plaque psoriasis. Subjects will be placed into one of four separate dosing groups comprised of three different concentrations of CTA018 and corresponding cream base (vehicle control). All subjects will receive once daily topical treatment over a maximum of 15% body surface area for 12 consecutive weeks. The primary efficacy endpoint of the trial will be the Physician Static Global Assessment. Local and systemic safety and patient perception of CTA018 cream will be evaluated in addition to several secondary endpoints.
About Psoriasis
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.
About Cytochroma Inc.
Cytochroma (www.cytochroma.com) is an integrated specialty pharmaceutical company engaged in the development and commercialization of proprietary products to treat and prevent the clinical consequences of diseases and disorders related to vitamin D deficiency. The company has an advanced portfolio of new products targeting vitamin D deficiency and secondary hyperparathyroidism in patients with moderate to severe chronic kidney disease and end-stage renal disease. In addition, the company is developing novel vitamin D therapies to treat hyperproliferative disorders such as cancer and psoriasis.
Cytochroma Inc.
CONTACT: Eric J. Messner, Vice President, Commercial Operations, (905)479-5306 ext. 338, eric.messner@cytochroma.com
