Canadian Biotechnology Company hits key insulin and Apo AI(Milano)
TSX symbol: SBS
CALGARY, Aug. 5 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a portfolio of therapeutic
proteins for metabolic and cardiovascular diseases, today announced its
2008 second quarter financial and operational results.
- Submitted an Investigational New Drug Application (IND) for
safflower-produced insulin to the U.S. Food and Drug Administration
(FDA), subsequent to the end of the quarter.
- Met with the European Medicines Agency (EMEA) to agree upon a
clinical development strategy designed to allow simultaneous European
and U.S. submissions for safflower-produced insulin.
Apo AI Program
- Demonstrated that safflower-produced Apo AI(Milano) is functional, by
measuring increased cholesterol mobilization, in a widely accepted
- Received $4 million in funding from Avrio Ventures Limited
Partnership in the form of a convertible debenture to accelerate the
commercialization of Hydresia(TM) products from Botaneco Specialty
Ingredients Inc., a SemBioSys subsidiary.
SemBioSys intends to follow its recent IND application with the
submission of a Clinical Trial Application (CTA) to the appropriate
European authorities later in the third quarter of this year. In order to
meet both FDA and EMEA requirements, the Company plans to conduct a Phase
I/II clinical trial wherein safflower-produced insulin is compared to both
U.S. and European-sourced reference insulin. The upcoming insulin milestone
- Complete production of clinical grade insulin supply for use in Phase
I/II human clinical trials.
- Upon CTA approval, initiation of a single-do
|SOURCE SemBioSys Genetics Inc.|
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