GREY:IPHAF - Post by User
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diamason Feb 25, 2004 9:05am
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Post# 7114417
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FDA Agrees to Clinical Development Plans for ISA247
2/25/04
EDMONTON, Feb 25, 2004 /PRNewswire-FirstCall via COMTEX/ --
Isotechnika Inc. today announced that the Food and Drug Administration (FDA) of the United States of America during a recent teleconference call 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 six week period by MDS Pharma Services in Phoenix, Arizona. Dosing is 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 than the previous formulation which consisted of an equivalent mixture of the two geometric isomers (cis and trans),'stated Dr. Randall Yatscoff, Isotechnika's President &COO. 'This study coupled with the results from the upcoming QTc trial will facilitate Isotechnika making an application to regulatory agencies for commencement of Phase III psoriasis and Phase IIb renal transplant trials by the end of this year