CALGARY, March 26 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it has initiated a toxicology study in animals to demonstrate the safety and comparability of its safflower-produced insulin to pharmaceutical grade human insulin. This study is a final key step in the Company’s preparations to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter in order to initiate a Phase I/II human clinical trial this year. The 28-day repeat dose study in monkeys and rats is the only toxicology study required before submission of the IND application to the FDA. The study is also a required component for the abbreviated 505(b)(2) application process that SemBioSys is eligible to follow, based on the well-characterized nature of insulin. The study aims to establish that the toxicology profile of insulin produced from SemBioSys’ plant system is appropriate to begin human trials.
“Insulin is currently one of the largest volume recombinant biopharmaceutical products on the market and demand is projected to increase dramatically in the coming years. The scalability of our safflower-produced insulin has the potential to provide a cost-effective source of insulin to meet this growing demand,” said Andrew Baum, President and CEO of SemBioSys. “In order to start the toxicology study we had to demonstrate that our safflower-produced insulin is chemically, physically and structurally equivalent to human insulin using a broad array of assays. The toxicology study is an important milestone for our insulin program and demonstrates that we are on track to begin human clinical trials in the second half of 2008.”
SemBioSys has already established that safflower-produced insulin is physically, structurally and physiologically indistinguishable from pharmaceutical-grade human recombinant insulin in laboratory testing. In a standard quantitative blood sugar assay performed in rabbits (insulin tolerance test), SemBioSys has demonstrated the pharmacodynamic equivalence of safflower-produced insulin to pharmaceutical-grade insulin. Thus the completion of this toxicology study fulfills the pre-requisite for filing the IND.
The world market for insulin is US$7.1 billion today and the demand for insulin is projected to increase due to two factors. Demographic and dietary choices in the western world are causing an increase in the incidence of diabetes. At the same time, countries in the rest of the world, that are currently underserved in the insulin market, are demanding greater access to insulin at an affordable price. By 2012, independent estimates predict a US$15 billion insulin market. SemBioSys’ plant-made insulin will offer dramatic capital and operating cost reductions with the potential to enter the market as a low-cost source of insulin to meet this exploding demand.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company’s lead pharmaceutical candidates, produced in the plant host safflower, are recombinant human insulin to serve the rapidly expanding global diabetes market and Apo AI, a next generation cardiovascular drug. In addition to its pharmaceutical products, SemBioSys is developing a series of non-pharmaceutical products addressing human topical, nutritional oils and agricultural biotechnology markets.
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 Canadian 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, the successful and timely completion of clinical studies, 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.
CONTACT: SemBioSys Genetics Inc., Mr. Andrew Baum, President and Chief
Executive Officer, Phone: (403) 717-8767, Fax: (403) 250-3886, E-mail:
bauma@sembiosys.com, Internet: www.sembiosys.com; Investor Relations, Ross
Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:
(416) 815-0080, E-mail: rmarshall@equicomgroup.com
