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During the first quarter of fiscal 2008 and up to the date of this pressrelease, the Company achieved the following significant milestones:
Transition's lead Alzheimer's disease compound ELND-005/AZD-103 is adisease modifying agent with the potential to both prevent and reduce diseaseprogression, and improve symptoms such as cognitive function.
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In September 2006, Transition announced a global collaboration with Elanto develop and commercialize ELND-005/AZD-103. In April 2007, Transitionannounced that the FDA granted Fast Track designation to the investigationaldrug candidate ELND-005/AZD-103.
On August 30, 2007, the Company announced the completion of Phase Iclinical studies with ELND-005/AZD-103. Transition and its development partnerElan have performed multiple Phase I studies evaluating the safety,tolerability and pharmacokinetic profile of ELND-005/AZD-103 in healthyvolunteers. Approximately 110 subjects have been exposed to ELND-005/AZD-103in multiple Phase I studies, including single and multiple ascending dosing;pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies.ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimensexamined. There were no severe or serious adverse events observed.ELND-005/AZD-103 was also shown to be orally bio-available, cross theblood-brain barrier and achieve levels in the human brain and CSF that wereshown to be effective in animal models for Alzheimer's disease. Transition andElan anticipate starting a Phase II clinical trial by the end of calendar 2007or early 2008.
TT-223 for Diabetes
Preclinical data in diabetes animal models demonstrate the efficacy ofgastrin analogues alone, or in combination with GLP-1 analogues or epidermalgrowth factor analogues. In humans, Transition's recent Phase IIa clinicaltrial data showed that 4-weeks of E1-I.N.T. therapy (combination of gastrinanalogue and epidermal growth factor analogue) in type 2 diabetes patientsresulted in sustained reductions in blood glucose control parameters,including haemoglobinA1C, for 6 months post-treatment. Pre-clinical andclinical data suggests gastrin plays an important role in beta celldifferentiation and function, capable of providing sustained glucose controlin type 2 diabetes. Based on these data, Transition has commenced the studiesto advance its lead gastrin analogue, TT-223, formerly known as "G1", intoPhase II clinical trials in type 2 diabetes patients.
To support the Phase II clinical development program for TT-223,Transition is currently performing two Phase I studies to expand the doseranges for TT-223. The first study, a single ascending dose study of TT-223 inhealthy volunteers has completed dosing. The second study, a multipleascending dose study of TT-223, is expected to begin later this year.Transition expects to initiate the following Phase II clinical studiesevaluating TT-223 in type 2 diabetes:
For the three months ended September 30, 2007, the Company recorded a netloss of $4,098,978 ($0.18 per common share) compared to a net loss of$2,324,722 ($0.13 per common share) for the three months ended September 30,2006.
This increase in net loss of $1,774,256 or 76% is largely due to the factthat the Company did not recognize a future income tax recovery in the currentquarter, compared to the future income tax recovery of $2,729,422 that wasrecognized in the same period in the previous year. After adjusting for theimpact of the future income tax recovery, the net loss for the perioddecreased $955,166 compared to the same per
