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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."
About CTA018
CTA018 is the first compound in a new class of active Vitamin D
analogs having a novel dual mechanism of action. CTA018 is
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