MARKHAM, ON, June 28, 2007 /PRNewswire/ - Cytochroma Inc. announced today positive data from a Phase I clinical trial of CTA018 Injection. The initial top-line results from this trial showed that CTA018 was safe and well tolerated. Complete study results are expected in August 2007.
The recently completed Phase I trial was an open label, placebo-controlled, randomized study of CTA018 Injection administered to 20 healthy volunteers. In this trial, the safety of CTA018 Injection was evaluated after single doses of up to 180 mcg. Placebo and two strengths of CTA018, 90 mcg and 180 mcg, were subsequently studied during repeated dose administration. The trial was conducted at a single Canadian center. Key safety evaluations included adverse events, serum and urine calcium, serum ionized calcium and serum phosphorus. No drug-related adverse events were reported.
Significant reduction in the blood levels of parathyroid hormone (PTH) was observed in this trial, suggesting that CTA018 has potential as a treatment for secondary hyperparathyroidism in chronic kidney disease (CKD). Blood samples collected before and after repeated CTA018 administration documented a mean reduction in PTH level of more than 20% after five doses of 180 mcg.
"While this safety trial was not designed to demonstrate efficacy, we were pleasantly surprised to see a significant reduction of PTH levels after just a few doses of CTA018," stated Dr. Jukka Karjalainen, Executive Director, Product Development. "As expected, we did not see any elevations in serum or urine calcium or in serum phosphorus. Serum ionized calcium levels also remained unchanged. We believe that the PTH-lowering effect of CTA018 will be even more pronounced in CKD patients with secondary hyperparathyroidism."
CTA018 is the first compound in a new class of active Vitamin D analogs having a novel dual mechanism of action. CTA018 is designed to be both a strong activator of the Vitamin D signaling pathway and a potent inhibitor of CYP24, the intracellular enzyme responsible for normal catabolism of Vitamin D hormones. Based on its mechanism of action, CTA018 is expected to be effective in treating secondary hyperparathyroidism but safer than currently available therapies. This compound was specifically designed by Professor Gary H. Posner, Ph.D. and is protected under patents and patent applications exclusively licensed to Cytochroma Inc. from the Johns Hopkins University.
About Chronic Kidney Disease and Secondary Hyperparathyroidism
Vitamin D hormones and their analogues are currently used to treat secondary hyperparathyroidism in CKD and end-stage renal disease. According to the National Kidney Foundation, more than nine million North American patients suffer from moderate to severe CKD. Many develop Vitamin D insufficiency and secondary hyperparathyroidism which, if untreated, can cause debilitating bone diseases and increased patient morbidity and mortality. North American sales of Vitamin D therapies for the treatment of secondary hyperparathyroidism currently exceed $500 million per year and are expected to grow rapidly with the increasing incidence of CKD. CKD is most frequently caused by diabetes or hypertension, both of which are consequences of the widening North American epidemic of obesity.
About Cytochroma Inc.
Cytochroma (www.cytochroma.com) is a specialty pharmaceutical company engaged in the development and commercialization of proprietary products to treat and prevent the clinical consequences of Vitamin D insufficiency. The Company has an advanced portfolio of new therapies for Vitamin D insufficiency and secondary hyperparathyroidism associated with CKD. In addition, the Company is developing novel therapies to treat hyperproliferative disorders, such as cancer and psoriasis, and hyperphosp hatemia
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