TSX symbol: SBS
CALGARY, Dec. 3 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing protein pharmaceuticals in crop plants, today announced that it has initiated a phase I/II clinical trial of its plant-produced insulin with the first injection of its drug in humans. The trial, taking place in the United Kingdom (UK), will include up to 30 healthy volunteers in a three-arm study (SBS-1000 insulin and two commercial standards) to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products. Full results are expected to be available during the first half of 2009.
"We have commenced the planned phase I/II clinical trial with plant-made insulin. This is the largest volume biopharmaceutical ever produced in plants," stated Bruce Given, M.D., acting chief medical officer at SemBioSys. "This sophisticated trial is designed to show bioequivalence with respect to insulin concentrations as well as insulin action on blood glucose. Bioequivalence is being measured by comparing SBS-1000 to commercially available insulin currently used to treat diabetes."
"The initiation of the phase I/II clinical trial for plant-produced insulin is a major milestone for SemBioSys. The trial is the first in which plant-produced insulin has been injected into humans and supports the exciting potential for the establishment of plant-produced drugs in the pharmaceutical sector," said Andrew Baum, president and chief executive officer of SemBioSys. "This trial verifies the viability of plant made insulin and defines the regulatory path for plant-made biopharmaceuticals. This trial also represents significant risk reduction for potential large pharmaceutical partners for our insulin and Apo AI Milano programs."
SemBioSys prepared the clinical material in its Current Good Manufacturing Practice (cGMP) compliant manufacturing plant, which underwent a successful cGMP inspection as required by European Union (EU) regulations. Successful completion of this clinical trial in Europe should contribute to the satisfaction of regulatory requirements in Europe and North America. Both the United States and European regulatory authorities have confirmed that SBS-1000 insulin is eligible to receive approval through an abbreviated regulatory path.
SBS-1000 is human insulin produced from genetically enhanced safflower. SemBioSys has demonstrated that SBS-1000 insulin is physically, structurally and functionally indistinguishable from pharmaceutical-grade human insulin through analytical testing and pre-clinical sub-chronic toxicology studies in rodents and primates.
About SemBioSys Genetics Inc.
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals using its proprietary protein production technology. This technology enables the production of therapeutic proteins in plant seeds by genetically enhancing the safflower plant. The Company's lead pharmaceutical candidates are recombinant human insulin, which intends to serve the rapidly expanding global diabetes market, and Apo AI Milano. Apo AI Milano is a variant of Apo AI, the major protein associated with high density lipoprotein (HDL), or "good cholesterol", whose function is to remove excess cholesterol from arteries. In addition to its pharmaceutical products, SemBioSys' subsidiary, Botaneco Specialty Ingredients Inc., is selling oleosome-based all natural products in the global personal care ingredient market. More information is available and can be accessed at www.sembiosys.com.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions and market size, the acceptance of an IND by the FDA in respect of clinical studies, the submission of a CTA to the appropriate European authorities, the successful initiation and timely and successful completion of clinical studies, the fact that Apo AI is currently a development stage drug, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
|SOURCE SemBioSys Genetics Inc.|
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