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FDA agrees to clinical development plans for ISA247

Published in Medical Letter on the CDC and FDA, March 28th, 2004

Isotechnika, Inc., announced that the U.S. Food and Drug Administration (FDA) has agreed to the proposed dose range finding study for trans-ISA247 in humans.

The single-ascending-dose study involving approximately 46 subjects will be completed over a 6-week period by MDS Pharma Services in Phoenix, Arizona. Dosing was scheduled to commence on March 9th, 2004. This study will be used as the foundation to determine dosing of trans-ISA247 in future clinical trials for both psoriasis and renal transplantation.

"Based on analysis of previously collected data, trans-ISA247 is more bioavailable and therefore we expect to administer the drug at a lower dose...

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