Navigation Links
SemBioSys begins phase I/II trial of insulin produced in plant seeds
Date:12/3/2008

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.

About SBS-1000

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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND
2. SemBioSys announces second quarter 2008 financial and operational results
3. SemBioSys submits IND for safflower-produced insulin to U.S. FDA
4. SemBioSys Demonstrates Functionality of its Safflower Produced Apo AI(Milano)
5. SemBioSys to present at the Needham & Company Biotechnology and Medical Technology Conference
6. SemBioSys provides update on shrimp feed additive, Immunosphere(TM)
7. SemBioSys announces first quarter 2008 financial and operational results
8. SemBioSys receives milestone payments from AVAC Ltd.
9. SemBioSys initiates toxicology study for safflower-produced insulin
10. SemBioSys announces 2007 financial and operational results
11. SemBioSys GLA Partner Enters Strategic Alliance for the Sales and Marketing of GLA-Rich Safflower Oil
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 A person commits a crime, and ... to track the criminal down. An outbreak of ... Drug Administration (FDA) uses DNA evidence to track down the ... Sound far-fetched? It,s not. The FDA has increasingly used a ... of foodborne illnesses. Put as simply as possible, whole genome ...
(Date:6/23/2016)... MA (PRWEB) , ... June 23, 2016 , ... ... Peel Plate® YM (Yeast and Mold) microbial test has received AOAC Research Institute ... platform of microbial tests introduced last year,” stated Bob Salter, Vice President of ...
(Date:6/23/2016)... NEW YORK , June, 23, 2016  The ... students to envision new ways to harness living systems ... of Modern Art (MoMA) in New York ... more than 130 participating students, showcased projects at MoMA,s ... included Paola Antonelli , MoMA,s senior curator of ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry Network ... Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s mission is ... projects are designed, built and brought to market. , The Design Lab is ...
Breaking Biology Technology:
(Date:6/9/2016)...  Perkotek an innovation leader in attendance control systems is proud to announce the ... employers to make sure the right employees are actually signing in, and to even ... ... ... ...
(Date:6/7/2016)... , June 7, 2016  Syngrafii Inc. and ... business relationship that includes integrating Syngrafii,s patented LongPen™ ... project. This collaboration will result in greater convenience ... credit union, while maintaining existing document workflow and ... ...
(Date:6/2/2016)... 2, 2016 The Department of Transport ... the 44 million US Dollar project, for the , ... including Personalization, Enrolment, and IT Infrastructure , to ... production and implementation of Identity Management Solutions. Numerous renowned international ... Decatur was selected for the most compliant ...
Breaking Biology News(10 mins):