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As at December 31, 2007 the Company had 25,886,676 common shares outstanding, 4,322,000 warrants, and 1,335,224 options.
Outlook
SemBioSys is currently conducting all the necessary preclinical work
for safflower-produced insulin to enable it to file an IND application with
the FDA to proceed into human clinical trials in the second half of 2008.
The upcoming insulin milestone events include:
- Completion of the toxicology studies of safflower-produced insulin
- Completion of the production of clinical grade insulin supply for use
in Phase I/II human clinical trials
- Submission of an IND to the FDA in the second half of 2008
- Initiation of a 30 patient Phase I/II clinical trial of safflower-
produced insulin in the second half of 2008
- Continuation of business development activities toward an insulin
partnership
During 2007, SemBioSys successfully achieved commercial levels of both
Apo AI and Apo AI(Milano) accumulation in safflower. The Company is
currently conducting laboratory testing in an animal model to establish
equivalent functionality in animals of safflower-produced Apo AI(Milano) to
the Apo AI(Milano) that has already been successfully used in human
clinical trials. The upcoming milestone events include:
- Completion of in vivo efficacy studies of cholesterol mobilization
with safflower-produced Apo AI and Apo AI(Milano)
- Completion of in vivo efficacy studies of plaque regression with
safflower-produced Apo AI(Milano)
- Initiation of formal partnering process for Apo AI and Apo AI(Milano)
upon receiving the initial in vivo efficacy results
- Initiation of the preparatory work in order to submit an IND to the
FDA for a Phase I clinical trial of Apo AI or Apo AI(Milano) in the
first half of 200
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