SemBioSys expects to receive in vivo efficacy results from animal trials for Apo AI produced in its model plant system, Arabidopsis, before the end of 2007. The Company is currently scaling up safflower-produced Apo AI Milano in order to initiate preclinical animal trials as soon as sufficient material is available.
The Company currently intends to partner one, or both, of the native Apo AI and Apo AI Milano programs prior to or shortly after Phase I clinical trials in 2009. SemBioSys believes its proprietary oilbody-oleosin production system offers the potential to overcome the manufacturing cost and capacity challenges of traditional fermentation-based technologies that have impeded the commercial development of Apo AI.
About Apo AI
Apo AI is a developmental-stage cardiovascular therapy, designed to rapidly stabilize and diminish atherosclerotic plaque for the prevention and treatment of cardiovascular disease. Apo AI is the major apolipoprotein associated with HDL, commonly referred to as "good cholesterol", which naturally removes plaque from arteries. Apo AI Milano is a natural variant of native human Apo AI characterized by a single amino acid substitution in its primary structure. In an epidemiological study, Apo AI Milano appears to confer enhanced resistance to atherosclerosis, suggesting that it may offer clinical advantages in the treatment of cardiovascular disease.
In a six week clinical trial, Esperion Therapeutics (acquired by Pfizer
in 2003) demonstrated that its Apo AI Milano variant/phospholipid
formulation could reduce plaque volume at a level and speed of
atherosclerotic regression unattainable with any current drug therapy.
Similarly, both CSL Limited and Borean Pharma A/S h
|SOURCE SemBioSys Genetics Inc.|
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