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What is Chlorogen? Chlorogen, Inc. is a biotechnology company that specializes in the expression of pharmaceutical proteins in the chloroplasts of plants. Through its patented chloroplast transformation technology, Chlorogen is committed to being a world-class producer of beneficial proteins for human therapy. In addition to co-developing our own pharmaceutical pipeline, we are selectively outlicensing CTT™ technology for use in other markets, such as food and feed and biodefense. What is a chloroplast and what is
significant about Chlorogen's ability to express Chloroplasts are compartments within cells, just as the nucleus and mitochondria are compartments. Photosynthesis is conducted within the chloroplasts.The ability to genetically transform chloroplasts is significant for two important reasons. First, chloroplasts are inherited maternally and therefore won?t be transferred via pollen to other sexually compatible plants. This is very important given environmental concerns about gene transfer. Second, protein production is several hundred times greater using chloroplast transformation compared with currently used nuclear transformation of plants. This is very significant from an economic and efficiency perspective if plants are to be used for producing therapeutic or industrial proteins. Increased protein output will also increase the effectiveness of agronomic traits, such as resistance to insects, diseases and herbicides. How is Chlorogen able to express proteins in chloroplasts? Chlorogen holds a patent on a genetic sequence referred to as a regulatory signal. This section of DNA instructs introduced proteins to function within the chloroplasts and only within the chloroplasts. Therefore, when new genes are introduced into a section of plant material using the gene gun, introduced genes that may enter other regions of the cell, such as the nucleus, will not be functional. The patented regulatory signal is unique in that other developers use regulatory signals that express proteins in the nucleus of cells. What will be your first product, and when do you expect to introduce it? Chlorogen's first product is a human therapeutic protein produced in tobacco. This protein is a member of the TGF-ß superfamily, with target application of women's reproductive cancers. We will begin field planting in 2007 and expect to enter Phase I clinical trials in 2009 and begin the FDA approval process by 2013. Why are you working with tobacco? Tobacco is an excellent host plant for production of proteins. It is a non-food crop that is relatively simple to transform, has a large biomass, can be harvested multiple times during a season, and each plant can produce about 1 million seeds, which enables rapid scale-up inside an enclosed greenhouse. Furthermore, Chlorogen uses a technique that greatly enhances protein production within chloroplasts of tobacco leaves. Have you successfully transformed the chloroplasts of crops other than tobacco? Research by Chlorogen and others has demonstrated that chloroplasts are inherited maternally in nearly every major crop and that it may be feasible to transform other crops, but our primary focus has been on tobacco. What further work must be done to bring a product to market? Our research has demonstrated proof of concept. We know that proteins can be expressed in large quantities in the chloroplasts of tobacco. Now we must develop an economical and efficient process to extract and purify the proteins that meet the quality standards for commercial use. In 2006, Chlorogen established a strategic alliance with Kentucky Bioprocessing, which will facilitate scale-up of our lead product candidate and other proteins in the pipeline. Will you be entering partnerships and licensing arrangements with other companies? Yes. Our business plan calls for Chlorogen to partner with pharmaceutical companies on our high-value therapeutic proteins and in-licensed proteins. We also intend to out-license our chloroplast transformation technology to or selectively partner with other biotech developers who currently are transforming cell nuclei to produce agronomic, industrial or food and feed traits. How many employees do you have? Chlorogen has approximately 12 full time employees and several part-time contract employees or consultants. Is your technology protected by patents? Yes. Chlorogen has secured exclusive commercial rights to chloroplast transformation technology, which has been trademarked as CTT™. The enabling CTT™ patents are the cornerstone of an extensive intellectual property portfolio, which includes methods, processes and composition for transformed chloroplasts, therapeutic uses of proteins/compounds produced in transformed chloroplasts, and future improvements to the technology. Chlorogen?s intellectual property position is embellished by commercial licenses to the gene gun and to specific therapeutic proteins. Why do you need to make pharmaceutical products in plants? What's wrong with Protein-based drugs open up a new frontier in medicine, helping the human immune system in fighting diseases and greatly expanding the limits of chemical-based treatments, which can have harmful side-effects. For the most part, proteins can only be produced in living organisms. Current methods produce proteins in mammalian cells, bacterial systems, or in yeast fermentation tanks. These systems require highly sophisticated factories that cost hundreds of millions of dollars. With such costs, most manufacturers will not venture to develop cures for rare diseases, and some people with more common diseases may not be able to afford the new or existing drugs that could help them.
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