PlantPharma

Biolex Therapeutics, a venture capital-backed, clinical development-stage protein therapeutics company, today announced the acquisition of LemnaGene S.A., a privately-held, French start-up biotechnology company researching potential applications of the small, aquatic plant Lemna to produce recombinant proteins. Biolex’ patented technology platform, The LEX System(TM), uses Lemna as a transgenic host for the development and manufacture of therapeutic proteins and monoclonal antibodies that are difficult to make (technically or economically) in traditional recombinant expression systems. The LEX System has been successfully employed in Biolex’ GMP biopharmaceutical manufacturing facilities (conforming to U.S. and international regulatory guidelines on current Good Manufacturing Practices), where multiple proteins have been produced for preclinical and clinical development.

“Last year we acquired Epicyte Pharmaceutical, strengthening our technical capabilities and patent position related to plant-based monoclonal antibody production,” said Jan Turek, Chief Executive Officer of Biolex. “The acquisition of LemnaGene represents a further consolidation of relevant protein capabilities and will enhance our position as a leader in this space. It is our belief that Biolex is now becoming the first choice for companies seeking a development partner for complex protein therapeutics reflecting our many recent accomplishments.”

LemnaGene, based in Lyon, France, provides biomanufacturing services to the pharmaceutical, vaccine, veterinarian, diagnostic, nutraceutical and industrial protein markets. The company has several research agreements with companies in the pharmaceutical and human/animal vaccine areas.

“I am pleased that LemnaGene has joined forces with Biolex,” said Georges Freyssinet, Ph.D., former Chief Executive Officer of LemnaGene. “Our research activities and collaborations will fit in well with Biolex’ development expertise and GMP capabilities.” Dr. Freyssinet will remain as Director of Research and Development of LemnaGene.

Biolex Therapeutics applies its unique drug development capabilities and expertise to commercialize complex proteins and monoclonal antibodies that until now have been impossible or very expensive to develop through traditional means. The company is advancing a proprietary pipeline of product candidates including Locteron(TM), a novel controlled-release form of alfa interferon which will enter Phase 1 clinical trials in 2005. Biolex has an extensive, multi-protein strategic alliance with Centocor and collaborations with other pharmaceutical/biotech companies including Medarex and OctoPlus. For additional information, please visit Biolex’ web site at www.biolex.com.

The following is testimony given by Scott Deeter, CEO and President of Ventria, for the Subcommittee on Rural Enterprises, Agriculture, and Technology on June 29, 2005 for the Different Applications for Genetically Modified Crops hearing.

Good afternoon Chairman Graves (R-MO), Members of the Committee, Ladies and Gentlemen. My name is Scott Deeter and I am President & CEO of Ventria Bioscience. I appreciate the opportunity to address the Committee on behalf of Ventria Bioscience. I will briefly describe the company, our technology and our products and would be happy to answer any questions.

First, let me provide an introduction to Ventria Bioscience. Ventria Bioscience is a plant-made pharmaceutical company that utilizes rice and barley as a factory to produce biologic products. Ventria’s initial products provide human health benefits, however the Company’s technology has the potential to address many challenges faced by other sectors of the economy including animal health, energy and industrial processing.

Ventria was founded with the support and guidance of several leaders in biotechnology and agribusiness who form the Company’s Board of Directors. Ventria’s Chairman is Thomas N. Urban, Jr. former Chairman and CEO of Pioneer Hi-Bred International. Other Board members include William J. Rutter, Ph.D. and Pablo Valenzuela, Ph.D., who were Co-Founders of Chiron; William H. Rutter, an attorney by training and an entrepreneur; William W. Crouse, a limited partner of Healthcare Ventures; Dean Hubbard, Ph.D. President of Northwest Missouri State University and Melvin D. Booth, former President of MedImmune, Inc. and Human Genome Sciences, Inc. These industry leaders have committed their resources, their time and their talents to realize the vision of improving healthcare on a global basis utilizing the tools of modern biotechnology combined with the industrial might of American agriculture.

The company’s core technology is a highly efficient and unsurpassed method of producing biological products in the seed of self-pollinating rice and barley. This technology was discovered in collaboration with University of California as well as other leading research institutions in the United States.

Ventria believes this technology will lead to more affordable medicines for a much broader patient population than what is possible with conventional biopharmaceutical production technology today. Ventria’s technological innovation results in a substantial improvement in the economics of biopharmaceutical production. For instance, the capital investment required for Ventria to produce 500 kilograms is estimated to be $4 million. As a comparison, to produce the same amount using conventional technology, such as mammalian cell culture, would require capital investment exceeding $125 million, a more than 30 fold increase. In addition, the operating costs of Ventria’s technology are less than 10% of the conventional technology.

There are several reasons for this economic advantage. First, Ventria has been able to achieve extraordinarily high yields of the product in the seed of rice and barley. Second, barley and rice are self-pollinating crops that can easily achieve the necessary geographic isolation from their food crop counterparts to eliminate concerns of cross contamination with the food supply. Third, because these crops can be stored in ambient conditions for up to two years without degradation, they allow for continuous operation of a processing facility, thereby increasing capacity utilization and reducing cost. Fourth, because rice and barley are safe for human consumption, they are ideal for products that can be delivered orally, thereby eliminating the need for expensive separation technology that is required by conventional systems to remove infectious or toxic contaminants. These advantages pave the way for a paradigm shift in biopharmaceutical production for the benefit of patients worldwide.

As an illustration of the strength of Ventria’s technology, I would like to describe some of the human health products in development. Ventria’s first two human health products are proteins called Lactiva™ and Lysomin™. These two proteins are found naturally in mother’s milk, saliva and tears and they have been suggested to contribute to the improved health status that has been widely reported for breast fed children when compared to their bottle fed counterparts. These proteins are part of the reason why breast feeding is the best form of nutrition for infants and is highly recommended by most pediatricians.

Ventria currently produces Lactiva™ and Lysomin™ in the seed of rice through contract relationships with selected and well trained growers. Ventria’s field production is regulated under a permit that is issued by the United States Department of Agriculture’s Animal and Plant Health Inspection Service (“APHIS”). In fact, last year alone, Ventria’s field location was inspected eight times by APHIS inspectors. Once harvested the seed is pulverized into a powder and transported to the processing facility where the final product is isolated into either a concentrate or isolate.

The United States Food and Drug Administration (“FDA”) has regulatory authority over Ventria’s products for human health. As part of Ventria’s pre-market activities, we reviewed the safety of Lactiva™ and Lysomin™ with a panel of scientific and medical experts that have unanimously concluded that these products are Generally Recognized as Safe (“GRAS”) for human consumption. The results of the panel review were summarized and submitted to FDA where they are awaiting clearance prior to commercial sales for human health.

There are several products being developed by Ventria that will incorporate Lactiva™ and Lysomin™. One product has been developed for children suffering from acute diarrhea. The World Health Organization estimates that 1.9 million children under the age of 5 die annually due to diarrhea. To address this crisis, Ventria added Lactiva™ and Lysomin™ to an oral rehydration solution, which is a common first line therapy given to children suffering from diarrhea. By adding Lactiva™ and Lysomin™, Ventria believes it can improve the recovery rate and reduce the severity or duration of diarrhea in these children. This hypothesis is the basis of a recently completed study in Peru with 150 children suffering from acute diarrhea. Ventria expects the results of this study to be published shortly. Ventria’s production technology enables the cost effective addition of Lactiva™ and Lysomin™ to oral rehydration solution for the benefit of millions of children globally.

Ventria is also exploring the use of Lactiva™ and Lysomin™ for the prevention of diarrhea in the military. During Operation Iraqi Freedom, 70% of deployed troops suffered a diarrheal attack and 43% reported decreased job performance as a result of this attack. During the Viet Nam War, it has been reported that hospitalizations due to diarrhea were four times more prevalent than malaria. This is a silent enemy attacking American troops. Ventria has set its goal to reduce the diarrheal attack rate by 50% with the preventive administration of Lactiva™ and Lysomin™. If we achieve our objective, it would improve military morale, efficiency, and manpower. In terms of manpower productivity alone, this may pay for itself due to the cost effectiveness of Ventria’s technology. Incidentally, this is a similar problem to that experienced by the millions of Americans who travel overseas.

Another use of Lactiva™ that is being developed is for the management of inflammatory bowel disease, or IBD. IBD afflicts over one million Americans and over four million people worldwide. IBD is an extremely debilitating disease that causes severe abdominal pain, weight loss, poor absorption of nutrients and chronic gastrointestinal ulcers. Ventria is testing the potential for Lactiva™ to improve the quality of life for the millions with this disease.

Ventria is also working with University of Cincinnati to develop a treatment for chronic lung infections caused by Pseudomonas, which is the leading cause of death for patients suffering from Cystic Fibrosis. Ventria and our collaborators have shown successful inhibition of this infection and we are jointly planning a pre-clinical program to further develop this product.

Recently, Ventria was the recipient of an SBIR grant from National Institutes of Health, National Institute on Aging relating to the use of one of Ventria’s products to inhibit biofilms constructed by pathogenic bacteria. These types of infections affect more than 10 million Americans annually. Infections that are protected by biofilms are 100 to 1,000 times more resistant to antibiotics, so it is important to inhibit the formation of these biofilms before they can establish themselves at the wound site. Ventria has worked with scientists from University of Iowa and Howard Hughes Medical Institute to develop a natural human protein that has been shown to inhibit the ability of pathogens to construct these biofilms. Using its plant -made pharmaceutical technology Ventria produced and purified this protein and has shown the effective inhibition of biofilm formation. With the SBIR grant, Ventria will further develop this product with the goal of improving patient recovery by reducing the establishment of biofilms that lead to antibiotic resistant pathogens.

This concludes my testimony on behalf of Ventria Bioscience. I would like to thank Chairman Graves and the Committee members for your kind attention and would be happy to answer any questions you may have.

In the heart of America’s rice industry, a fight has broken out between the King of Beers and a tiny biotech company. On one side is Anheuser-Busch, which uses Missouri-grown rice as an ingredient in beer. On the other side is Ventria Biosciences, which is moving to Missouri with plans to cultivate transgenic rice containing human genes. The genes prompt the plant to make two proteins normally found in breast milk, tears, and saliva. The biotech company intends to turn the substances into therapeutic food products to treat stomach disorders.

Anheuser-Busch executives seem to have been struck with indigestion at the thought that human proteins might conceivably crop up in bottles of Bud. Although highly unlikely, such a scenario isn’t unheard of: Bioengineered seeds have often turned up in places they don’t belong. So Busch vowed to boycott all Missouri rice last April, prompting Ventria to temporarily shelve its plans in the state. “We want to make sure rice growers in Missouri have a good relationship” with one of their biggest customers, concedes Ventria CEO Scott Deeter. Meanwhile, on June 28 the U.S. Agriculture Dept. approved Ventria’s application to plant in North Carolina instead.

The strange saga of Ventria and its alien rice casts a pall on a potentially promising area in biotech. Stretched by unprecedented demand for new drugs, biotech companies have been searching for alternatives to traditional manufacturing methods — an expensive process of growing drugs in delicate hosts, such as cells from Chinese hamster ovaries. Plants such as rice and corn may be ideal substitutes because they naturally churn out proteins by the bushel. Getting them to make human varieties is simply a matter of replacing pieces of their genetic code with human genes — just as technicians get hamster cells to produce protein drugs. Then, to ratchet up production, you just plant more acres.

The economic benefits are enticing, too. A traditional biotech factory might cost Ventria CEO Deeter $125 million. With rice, he can get the same output for $4 million — and he intends to pass the savings to consumers. Several other biotech startups are experimenting with drugs grown in plants, and giant Dow Chemical Co. is mulling the idea as well. Consulting firm Frost & Sullivan Inc. predicts the first plant-manufactured drugs will hit the market next year and sprout into a $2.2 billion-per-year industry by 2011.

That’s if fears about food safety don’t cause plant-grown pharmaceuticals to die on the vine. Consumer and environmental advocates worry that pollen from genetically engineered plants could drift into fields containing food crops and produce contaminated hybrids. But that’s not a worry with rice, Deeter insists, because the plant is self-pollinating — each seed contains everything it needs to produce another plant, so there is no risk of transplanted genes leaking to other plants. Still, environmentalists say, there’s nothing to prevent a bird from gobbling up the bioengineered seeds and then depositing them, intact, in a field hundreds of miles away. “It’s virtually certain this stuff will make it into food-grade rice,” says Margaret Mellon, director of the food and environment program for the Union of Concerned Scientists in Washington.

OVERSEAS QUEASINESS

Such certainty is backed up by one particularly horrifying breach that still haunts the food industry. In 2002 drug-producing corn made by ProdiGene Inc. somehow began sprouting in soybean fields near its Nebraska and Iowa sites. The USDA seized 500,000 bushels of soybeans and charged ProdiGene nearly $3 million in fines and disposal costs. Any further gaffes could threaten some $1.3 billion in annual U.S. rice sales to foreign countries, many of which are still queasy about biotech crops — even those tweaked to produce tastier food.

What’s needed, Ventria’s critics argue, is a tighter regulatory framework to ensure pharma crops stay out of the food supply. As it stands, the USDA is the only federal agency that tightly regulates drug-producing plants grown in outdoor test sites. The Food & Drug Administration generally steps in later, when it’s time to decide if the drugs themselves are suitable for human consumption.

Since part of the FDA’s mandate is to protect food, critics blast the agency for failing to get involved in biotech plantings from the very beginning. “It’s a convoluted process,” says Joseph Mendelson, legal director for the Center for Food Safety in Washington, one of many groups calling for the FDA to provide additional oversight on drugs made in plants. An FDA policy adviser says several agencies are looking at whether the system should be changed.

Some biotech outfits have dodged the protesters by avoiding food crops altogether. St. Louis-based Chlorogen Inc. is developing a way to make drugs in tobacco, which grows well in greenhouses, adding an extra barrier against genetic leaks. CEO David N. Duncan says he’s not surprised that ProdiGene’s mistake continues to reverberate, as Ventria and others manipulate crops that form the very staples of the human diet. “When you start messing with corn flakes and beer, you’re going to get in trouble,” Duncan says.

Ventria can’t seem to escape the controversy. Founded in 1997 in Sacramento, the company planted several small fields of pharma-rice in California. Despite an endorsement from California regulators, some environmentalists and traditional rice farmers cried foul. Earlier this year, Ventria decided to uproot itself and move to the plant-science incubator at Northwest Missouri State University. Deeter says he isn’t being chased out of California, but rather he feels Missouri offers more favorable economics for large-scale production.

It may be a while before Deeter can realize his dreams of amber waves of humanized grain. In April, Anheuser-Busch lifted its boycott threat after Ventria agreed to move its planned 200 acres from the southeast corner of Missouri to the northwest region of the state — 120 miles away from food-grade rice. “We believe Ventria is now sufficiently away from commercial rice producers,” says Francine I. Katz, spokesperson for the beer giant. But by the time the compromise was reached, Ventria had missed prime planting season, forcing the company to wait until next year to apply for a USDA permit to plant there. Meanwhile, Ventria planted 75 acres of rice in North Carolina in June, despite threats from the Center for Food Safety, which is considering a lawsuit to curb the company.

German biotechnology company ICON Genetics is to start field trials of a transgenic tobacco crop that will be used to produce an enzyme with potential as an active pharmaceutical ingredient and as a catalyst for the manufacture of industrial chemicals.

The field trial, carried out in collaboration with the Kentucky Tobacco Research and Development Centre (KTRDC) in Lexington, US, will involve transgenic plants with genetically engineered chloroplasts containing a phenylalanine ammonia lyase (PAL) gene from Arabidopsis thaliana.

An overexpression of the PAL gene in tobacco chloroplasts aims at both pharmaceutical and industrial applications: the purified enzyme can serve as a drug for the treatment of the inherited disease phenylketonuria (PKU). The enzyme also serves as a biocatalyst for industrial biochemical synthesis, particularly chiral compounds. Futhermore, expression of PAL in the plants will lead to the accumulation of metabolites from the phenylpropane pathway that are also of commercial value, according to Icon.

Making pharmaceuticals in crop plants such as tobacco is an attractive proposition because they are inexpensive to grow, and could produce vast quantities of drugs or vaccines at low cost, potentially making it possible to make drugs that were not economically feasible before. But moves in this area have been met with dismay by environmentalist groups, alarmed that the GM traits could find their way into the food chain.

ICON said that biosafety aspects of the field trial, which has been granted a release permit by the US Government’s Animal and Plant Health Inspection Service, have been ‘carefully considered’.

The firm maintains that chloroplast-located transgenes generally do not spread into the environment via pollen flow. Moreover, the genetically engineered plants do not contain antibiotic resistance genes, according to the company, since they were created using ICON’s proprietary resistance marker removal technology.

The opening Monday of the Mitchell Memorial Cancer Center at Owensboro Medical Health System is wonderful news in itself — for cancer patients who will receive their care there and for the hospital to have such a facility to offer the public.

But Tuesday’s announcement that a major cancer research center will be contained within the gleaming facility on the Breckenridge Street side of OMHS, in affiliation with the University of Louisville’s James Graham Brown Cancer Center, is real cause for celebration. Here are some of the reasons why:

- The research center is expected to attract scientsits from around the world.

- Researchers will explore tobacco-produced cancer medicines.

- Clinical trials will be performed.

- Dr. Don Miller, director of the Brown Cancer Cetner, will be in charge of the Owensboro research efforts, which will lend it instant credibility.

- The University of Kentuchky will be invited to be a partner.

- At the beginning, four to five research scientists, each supported by several staff members, will have up to $ 2 million in grant funds at their disposal. The number of scientists and money to suppor their activities will likely grow rapidly.

- Large Scale Biology, a biopharmaceutical company in Owensboro, will probably be involved in the manufacture of products used in the research center in the hopes that a tobacco-based vaccine can be created.

- Local tobacco growers may be asked to produce leaf for the research.

- It is not far-fetched to dream, as Owensboro Mayor Tom Watson does, that Owensboro can become the “plant-made pharmaceutical capital of the world.”

The benefits of having the Mitchell Memorial Center and a cancer research center within it are many and extensive for Owensboro and Daviess County. The community’s profile, as well as the hospital’s, will rise significantly in Kentucky and beyond. Residents will be able to point to the Mitchell complex with pride and excitement. The high-paying jobs it will create will spur the local economy.

Don’t tell anyone, but Doug Ausenbaugh has built an underground drug farm—in bucolic southern Indiana, no less. It’s cleverly cached in an old limestone mine near the hamlet of Marengo. There, carefully cultivated stalks flourish under the glare of artificial lights and the rainlike spatter of drip irrigation.

The facility, run by Ausenbaugh’s biotech startup firm, Controlled Pharming Ventures, in cooperation with researchers from Purdue University, is intended for growing pharmaceutical crops—corn, tomatoes, tobacco and other plants whose DNA has been altered to produce a vaccine or medicinal compound. Drug companies have hailed this new field, known as biopharming, as a low-cost alternative to traditional manufacturing. But environmentalists, food-industry officials and other critics have decried pharma crops—which aren’t meant to be eaten and in some cases are toxic to humans—because of the danger of contaminating food supplies.

The fears aren’t based on mere conjecture. In 2000, evidence of a genetically modified corn intended only for animal consumption showed up in Taco Bell taco shells. Aventis CropScience, the corn’s grower, quickly abandoned the product and was forced to pay $2.4 million to people who said they had suffered allergic reactions to it. Two years later, federal officials fined the biotech company ProdiGene $3 million for allowing pharma corn carrying an experimental pig vaccine to contaminate soybeans in Iowa and Nebraska. Regulations have since been tightened, and the young industry suffered a huge blow when biotech behemoth Monsanto abandoned its biopharming research in 2003. Although several plant-produced biopharmaceuticals are still under clinical evaluation, none have reached the market yet.

Going underground, Ausenbaugh says, will resolve many of the sector’s problems. The 60-acre mine in Indiana provides a formidable barrier between the grow room and the rest of the world, easing the burden of containment in several ways. It makes pesticides unnecessary (the space is free of bugs), and it reduces the threat of vandalism (the entrance is policed by armed guards). What’s more, the constant 51°F air temperature in the cavern serves as a natural cooling system for the hot grow lights. And there’s no danger of a Midwestern storm unhinging Ausenbaugh’s creation and strewing hazardous materials for miles. (A tornado flattened Marengo just last spring.)

All things considered, a properly run underground facility “would probably be an order of magnitude safer” than a surface operation for a typical crop such as corn, says geneticist Norman Ellstrand of the University of California at Riverside. As a result, it would let growers sidestep some of the regulatory rigmarole to which biopharming is usually subjected by the U.S. Department of Agriculture—one of at least three federal agencies that scrutinize the various aspects of production, along with the Environmental Protection Agency and the Food and Drug Administration. “We probably wouldn’t have regulatory authority inside a contained facility such as a mine,” says John Turner, director of policy coordination in the USDA’s Biotechnology Regulatory Services branch.

Best of all, the underground yield can be surprisingly bountiful. Scientists at the Marengo facility recently harvested their first test crop (a modified but edible variety of corn, not an actual pharma product), and the output was prodigious—the equivalent of 337 bushels per acre, more than twice the typical amount for field corn. Each plant was grown separately from a container full of a claylike artificial soil designed for the underground conditions and irrigated with fertilized water. A computer maintains the room’s environmental conditions, including temperature, humidity and carbon dioxide level.

For most farmers, the mention of biotech crops brings to mind Bt corn and cotton and herbicide resistant soybeans. The biotechnology in these cases affects input traits because it reduces the amount of inputs (herbicides or pesticides) that a farmer has to use to grow the crop.

Biotechnology can also be used to modify what are called “output traits”, where the output of the plant or animal is modified.

One of the best known examples is “Golden Rice” in which the rice has been modified to provide increased amounts of provitamin A (the compound needed to synthesize vitamin A). Vitamin A deficiency is a major problem in some developing countries.

One class of output traits that has generated significant interest is pharmaceutical compounds. Scientists have discovered that by applying the tools of biotechnology to various crops they can develop plants that will produce desirable pharmaceutical compounds. When this technology is applied to commercial crops like tobacco and rice, the resulting process is cleverly termed “bio-pharming” or just pharming.

Beginning in 2001, researchers at Virginia Tech, the University of Tennessee, North Carolina State University, Virginia State University and the International Rice Research Institute undertook a four year research project under USDA’s IFAFS program to “inform and sharpen public debate on the benefits, costs, risks, and tradeoffs associated with agricultural biotechnologies, using rice and tobacco as examples.”

At the time the project was initiated, tobacco growing was undergoing a dramatic change with demand for U.S.-grown tobacco declining. One of the questions was whether or not growing tobacco to produce pharmaceuticals could have a positive impact on tobacco dependent communities. At that time, tobacco was already the subject of research programs to identify pharmaceutical uses for the crop. One of the advantages of tobacco over a crop like corn is the fact that it is not used as a food crop.

Rice was chosen because rice is a staple crop for areas of the world in which poverty and malnutrition are significant issues. Depending upon the output trait bred into it, the resulting rice could either contain traits to alleviate malnutrition or include traits that would make rice growing more productive under a wider range of growing conditions.

We have been following the progress of this research undertaking with great interest. Who wouldn’t recognize the irony in a potential use of tobacco plants to produce a cancer-curing product? As this research effort wraps up, we’d like to share some of the findings about bio-pharming with you over the next few weeks.

US firms Large Scale Biology Corporation and privately-held Planet Biotechnology have expanded their biomanufacturing program to extract and purify the latter’s lead product, CaroRx, a plant-made antibody to control dental caries.

LSBC biomanufacturing approach relies on the use of tobacco plants as biological factories. The company inserts the genetic sequence coding for the desired compound – in this case a secretory immunoglubulin A (SIgA) - into a virus that infects tobacco plants. This tobacco mosaic virus is based on RNA, so it does not combine with the tobacco plant’s genetic material. This does away with the need to genetically modify the plant, avoiding the high cost and length of time taken to develop transgenics and also bypassing environmental concerns about GM material.

Using LSBC’s process, regular tobacco is planted and sprayed with the virus once the plants have emerged. The tobacco is then harvested as normal, and further processing takes place to extract and purify the target protein.

Making pharmaceuticals in crop plants such as tobacco is an attractive proposition because they are inexpensive to grow, and could produce vast quantities of drugs or vaccines at low cost, potentially making it possible to make drugs that were not economically feasible before. But moves in this area have been met with dismay by environmentalist groups, alarmed that the GM traits could find their way into the food chain.

CaroRx is claimed to be the world’s first recombinant plant-made antibody – or ‘plantibody’ – and has been shown in clinical studies to prevent the adhesion to the tooth surface of decay causing bacteria.

Planet’s tobacco plants expressing the proprietary CaroRx Protected SIgA will be extracted by LSBC at its Owensboro, Kentucky, manufacturing facility. CaroRx is currently approved for sale as a medical device in the European Union.

uly 1, 2005 — Academics and medical researchers have expressed their support for initiatives by state institutions and others to support the development of plant-made pharmaceuticals.

“Over the course of medical history it has been shown time and again that some of the greatest and most successful innovations have come when researchers have tested a broad range of options,” said Dr. Hilmar Stolte, president of the International Academy of Life Sciences (IALS).

Efforts to stall state-based initiatives, most recently in Iowa, limit the possibility for informed dialogue, as well as the options for development of quantities of pharmaceuticals that can be adjusted to meet demand, Stolte added.

“Plant-made pharmaceuticals have such potential to treat life-threatening illness, we need to provide scientists and researchers as many development alternatives as possible, always with appropriate regulatory oversight,” he said.

Meanwhile, Stolte applauded a vote by the Hawaii State Board of Agriculture, which has agreed to allow a Hawaiian company, Mera Pharmaceuticals, to test and grow microalgae for possible use in the production of treatments for asthma, inflammations and possibly cancer.

“The kind of innovation being explored by the plant-made pharmaceutical companies is what could ultimately lead us to the treatments that will help people suffering from such diseases as cancer, HIV, heart disease, diabetes, Alzheimer’s disease, kidney disease, Crohn’s disease, cystic fibrosis, and multiple sclerosis,” said Dr. Stolte. “The academic community represented by IALS is very happy that the Hawaii Board of Agriculture felt the processes being developed are safe and that it will allow Mera and its partner, Rincon Pharmaceuticals, to pursue their work.”

Stolte, IALS and its U.S. partner, the Biomedical Exchange Program (BMEP), host http://www.plantpharma.org, an online community dedicated to a science-based, medically oriented discussion on PMPs and their potential to help combat life-threatening illness. The community’s membership includes academics, researchers, patient organizations, consumers, regulators, government officials and others from more than 30 countries around the world.

IALS is a global network of universities, medical schools, and related institutions that are dedicated to education, training and research in key issues associated with the life sciences.

Resources:

http://www.plantpharma.org

http://www.lifesciences.net

Excerpt - For the full article please visit St. Joseph News-Press

The head of Ventria Bioscience, soon to relocate in Maryville, Mo., predicted Wednesday the public will embrace the emerging bioscience industry. It will happen once a mother sees her child saved by a plant-based drug that otherwise wouldn’t have been available.

“That will be the moment that knocks the public’s socks off,” Scott Deeter told a House subcommittee examining different applications for genetically modified crops.

Subcommittee Chairman Sam Graves, R-Mo., said genetically modified crops have the ability to revitalize rural communities and produce an “incredible” product for consumers.

“Developments in genetically modified plant research hold great promise not only for traditional agricultural crops to feed the world but also crops for medical purposes,” Mr. Graves said during the hearing of the House Subcommittee on Rural Enterprises, Agriculture and Technology.

“Embracing this new technology will allow us to keep our position as a world leader within the agri-business industry and help cure diseases.”

The emerging technology will lead to more affordable medicines for a broader population, Mr. Deeter said. For example, Ventria can produce 500 kilograms of a drug annually with a capital investment of $4 million compared with $125 million to produce the same product using more conventional methods, the company president testified.

Ventria, which produces biological products from self-pollinating plants like rice and barley, teamed up with Northwest Missouri State University last fall to become the anchor of a proposed $30 million center on the Maryville campus.

The Sacramento, Calif.-based Ventria will relocate to the town and grow 70 percent of its crops through Missouri farmers.

At the hearing, Mr. Deeter described how the company’s protein products, called Lactiva and Lysomin, have several human-health applications. The proteins, which are found in mother’s milk, saliva and tears, are being tested in drugs that would treat acute diarrhea, inflammatory bowel disease and lung infections caused by pseudomonas, the leading cause of death for cystic fibrosis patients.

“Ventria’s initial products provide human health benefits, however the company’s technology has the potential to address many challenges faced by other sectors of the economy including animal health, energy, food processing and industrial processing,” Mr. Deeter said.