RE: Ongoing Diabetes Trials....TT-223
Re: The ongoing clinicals for TT-223 for Type2 Diabetes....
Dr. Cruz........" So the clinical development for TT-223+GLP1 (GLP1-INT). We are just currently initiating two Phasel Studys to INCREASE OUR FLEXIBILITY with TT-223. That is being done in Canada. The first one starts on Sept. 29th/07. and the second one will start imediately upon finishing this and by the end of the year we expect to have that Data and then we are going to initiate a Phasell Study with TT-223 with Metformin/TZD Patients, 3 Month Repeat Dose. The previous study was one month, we think 3 months should give us better data, and that is expected to start at the beginning of next year. Once this is initiated we will then initiate a second study with TT-223+Byetta, that is currently in the market."
........TT-223 Stand Alone gets its own Phasell Before GLP1-INT.......or Byetta. As stated before........Change in focus with the INT Program has been ongoing for several months in-house preparing to support the Clinicals and is almost complete. The TT-223+EGF Phasell showed PROOF OF CONCEPT in Humans with 6 months Efficacy after treatment.
Transition finding the DLP for Gastrin and is dosing 30mg/kg and over to try and see if they get an adverse reaction. Gastro-intestinal type of event is postulated by the doctors.
First study started in Sept. and is already completed and next one is a MAD Trial now ongoing......... Phasell TT-223 SA to follow.
TT-223 Stand Alone has Better Results than either Byetta OR Liraglutide (Novo's STILL UNAPPROVED GLP1 Analogue) did at this stage of the game. Way better when you take into account the Nausea and vomiting that they both induce in Humans.......whereas TT-223 Does Not have ANY Nausea related adverse events in dosing up to 30mg/kg.
GPP All.