Prana Biotechnology Limited (NASDAQ: PRAN / ASX: PBT), a biopharmaceutical company focused on the research and development of treatments for neurodegenerative disorders, today announced, subject to shareholder approval, a private placement of approximately 24.56 million new shares at a subscription price of A$0.285 (28.5 cents) per share, with a 2 for 6 free attaching option.
Prana will receive approximately A$7.0 million before allowing for issue costs from institutional and professional investors in Australia and the United States. The funds will be predominantly used for the ongoing development of its lead compound, PBT2, currently in a Phase IIa trial in patients with Alzheimer’s disease.
This trial, scheduled for completion in December 2007, is designed to advance the commercialization of Prana’s programs to develop novel treatments for neurodegenerative disorders.
“We are especially pleased to receive support from this group of investors, a number of whom have been strong supporters of the Company since inception,” commented Prana Chairman and Chief Executive Officer, Geoffrey Kempler. "This commitment reflects confidence in Prana and the potential of PBT2 as a disease modifying therapy for Alzheimer’s disease patients.”
The Phase IIa trial of PBT2 is a double-blind, placebo-controlled safety and tolerability study in patients with Alzheimer’s disease. PBT2 is Prana’s proprietary lead compound. The trial is well advanced, over 70% of study patients have been dosed and almost half of the target 80 patients have already completed the trial. “Given this progress, we are particularly pleased with the positive safety and tolerability demonstrated by PBT2 to date. We are on track to complete the trial by the end of the year and report results in the first quarter of 2008” said Mr Kempler.
New York based Brimberg & Co assisted with this transaction. The placement is subject to shareholder approval at an Extraordinary General Meeting, which is expected to occur on or about October 15, 2007. The Company will be seeking shareholder approval for the right to allot up to 35,087,700 shares with 2 for 6 attaching options which would raise up to $10 million if fully subscribed. The Company currently has firm commitments in place for $7.0 million of this total. The 2 attaching options, which will expire on 31 October and 30 November 2010 respectively, will be exercisable at A$0.37 cents and A$0.43 cents respectively.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise research into Alzheimer's disease and other major age-related neurodegenerative disorders. The company was incorporated in 1997 and listed on the Australian Stock Exchange in March 2000 and listed on NASDAQ in September 2002. Researchers at prominent international institutions including The University of Melbourne, The Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.
For further information, please visit the web site at www.pranabio.com.
Sunday, September 16, 2007
Prana to Raise A$7.0 million from Institutional and Professional Investors
Plants and stress; key players on the thin line between life and death revealed
Our crops are not doing well these days: too much water, too little sunlight... In short, they are suffering from stress. Scientists from VIB, associated with the Katholieke Universiteit Leuven (K.U.Leuven), have revealed a new mechanism demonstrating the intricate ways in which plants deal with stress. The newly discovered control system has a remarkable way of orchestrating the activity of hundreds of genes, forcing the plant into ‘safety mode’; the consumption of energy is contained while the organism is stimulated to mobilize reserves. This may have a negative impact on growth, but it allows the plant to temporarily safeguard itself against pernicious stress conditions. These findings also may prove to be useful beyond the case of plants, for the results are likely to be valuable in understanding disorders such as cancer and diabetes.
Life thanks to plants
Plants catch sunlight and use it as an energy source to produce sugars from CO2 and water. In doing so, they are at the very basis of the food chain. Ultimately, all life on earth depends upon this biochemical process: photosynthesis. Without plants, life as we know it today would simply not be possible. But what if things go wrong? When there is too little sunlight, for example? And what with other stressful conditions for plants? Environmental changes can compromise photosynthesis and exhaust energy supplies.
Plants control their own energy balance
Fortunately, plants have developed different mechanisms to detect and cope with 'stress’. Together with his American colleagues at Harvard Medical School (Boston, USA), VIB scientist Filip Rolland, associated with the Katholieke Universiteit Leuven, is uncovering a new system of detection and control. It is driven by KIN10 and KIN11. These ‘kinases’ – which are also found in human beings – react to energy shortages, when, for example, there is too little sunlight or too little sugar production. They control the activity of a broad network of genes, promoting the release of energy (catabolism) from alternative sources and blocking its assimilation (anabolism). In this way, the plant protects itself against stress conditions; like a really bad summer.
The key players: KIN10 & KIN11
The model organism for this study was Arabidopsis thaliana or thale cress. For decades, this small weed has been used as a model in molecular and genetic plant research. The scientists have tested numerous stress conditions that affect photosynthesis and energy production, such as darkness, herbicide treatment and flooding (lack of oxygen). By overexpressing the KIN10 gene, causing the plant to produce more of this protein, stress tolerance is increased and plants survive longer. By switching off these genes, their control function is eliminated.
With this research, the Flemish and American scientists have succeeded for the first time in attributing KIN10 and KIN11 a key role in the control of the plant energy budget and metabolism and thus the fragile balance between growth and survival; in short, the choice between life and death.
Are humans similar to plants?
The new insights gained by this study are not limited to the functioning of plants; they may also be important for human beings. KIN10 and KIN11, as ’fuel gauges’ controlling the expression of a whole set of genes, are also found in mammals. The results with plants, therefore, may play a pioneering role in discovering new functions of these proteins in disorders such as diabetes, cancer, obesitas, and aging.
Relevant scientific publication
The research findings are published in the leading scientific journal Nature (Baena-González et al., A central integrator of transcription networks in plant stress and energy signalling, Nature, 2007).
EU Court Rejects Austrian Biotech Ban
“This is great news for farmers, for the scientific based risk assessment of the EFSA and for the EU biotech regulatory framework which the Member States put in place. Industry now calls on the region of Upper Austria to drop its illegal and unscientific opposition to approved biotech crops and allow Austrian farmers the choice to grow GMOs if they so wish.” said Johan Vanhemelrijck, Secretary General EuropaBio – the EU association for bioindustries. “Attempts to create so called “GMO-free regions” should be seen for what they are: a denial of the
freedom of choice for farmers and consumers.”
The Judgement says that practices like organic agriculture and small scale farming cannot be used as an argument to ban cultivation of approved biotech crops. Both the Commission and the Commissioner for Agriculture, Mariann Fischer Boel have stated in the past that “farmers should be able to produce in a traditional way, be it conventional or organic, according to the high quality and safety standards in the EU. And they should as well have the choice to produce
GM-crops, if they see advantages in doing so and find a market for them.” (1) Farmers can take official action against their region if it tries to stop them from cultivating EU approved biotech crops, while freedom of choice guarantees that individual or groups of farmers are free to cultivate conventional, organic or biotech crops. Today’s decision confirms that it is illegal for regional or national governments to impose bans and deprive individual farmers of the choice to grow biotech crops which have been approved for commercial cultivation in the EU.
Monday, September 3, 2007
Assesment of Cloned Animal Products
Recent articles (December 2006 and January 2007) in the Washington Post dealt with the U.S. Food and Drug Administration (FDA) assessment that products from cloned animals including meat and milk do not present a risk to food safety. Editorials in the same paper applauded the FDAs reliance on science to come to their conclusions but reminded readers that was not the same as acceptance in the market place.
The FDA made the decision based on its regulatory authorities to perform “a comprehensive risk assessment of the health of animal clones, their progeny, and the food products derived from them”. The approach that FDA used was apparently a cooperative one with the industries that were to be scrutinized for the impact of their products of cloning. The Center for Veterinary Medicine (CVM) of FDA asked that such products be withheld from the food supply. They also asked the National Research Council of the National Academies of Science to characterize “the hazards in animal biotechnology”.
The FDA asserted several principles related to cloned animals that were the underlying basis for their risk assessment: (1) cloning is not a form of genetic engineering; (2) “Animals used for food in the US are inspected without regard to the method by which they are bred”; (3) “The only remaining hazard(s) from cloning are likely to be subtle in nature.”
The presumption by FDA that cloning is not a form of genetic engineering recognizes that it is not an attempt to improve for some purpose the genetic composition of animals. Nonetheless, cloning may be an important part of many current and future approaches to genetic engineering which will be discussed later.
Points 2 and 3 clearly define the scope of the FDA risk assessment and indicate that current food safety procedures and the nature of cloned animals limit science-based concerns about cloning to potential subtle effects of cloning. Based on a voluminous literature review, FDA recognized that the problems most likely associated with cloning would be from the failure of the somatic cells used as nuclear donors in the cloning procedure (SCNT) to completely transform from a pluripotent state to the totipotent state found in germ cells. They acknowledge that the most severe errors in “reprogramming” will result in early death and thus the observed poor efficiency of cloning. This failure to reprogram completely may result in epigenetic variation between clones and the original individual. FDA is concerned that persistent epigenetic differences might result in a “subclinical physiological effect.”
FDA, in their review of the literature and submitted data, found that clones have the same type of health risks as other animals but at a higher frequency. As reported in the literature they recognize that hydroallantois and dystocia are sometimes present in the surrogate dams carrying cloned lambs or calves. They recognized the potential for large offspring syndrome in cows and lambs and some potential for small offspring in pigs. Cattle and sheep neonates were found to need more support for respiration and body temperature control. Reproductive health was found to be normal and they expect the second generation to lose their epigenetic variances. They found that the available literature and submitted data supports the notion that meat and milk from clones was within normal ranges for most compositional analyses. FDA concluded that meat and milk derived from clones is as safe as that “derived from animals produced using contemporary agricultural practices.” They suggest that data on sheep products needs additional data prior to lifting a moratorium on the products from sheep clones.Source:
Regulation of animal biotechnology: Research needs
Theriogenology, Volume 68, Supplement 1, 1 September 2007, Pages S3-S8
C.E. Rexroad Jr., R.D. Green and R.J. Wall
New light-sensing ability discovered in disease-causing bacteria
The bacteria that cause brucellosis can sense light and use the information to regulate their virulence, according to a study in the August 24 issue of the journal Science. The discovery comes after 120 years of research into the disease, which causes abortions in livestock and fevers in humans. Researchers found that two other bacteria, including a species that attacks plants, sense light using the same type of protein structure, and at least 94 more species possess the code for it in their DNA.
"These bacteria have been very well studied for years, and no one knew they could sense light," said lead author Trevor Swartz, who initiated the study as a research scientist at the University of California, Santa Cruz. "Now it seems like it's a common thing rather than being an anomaly."
The ubiquity of the structure suggests that light may play a much more important role in bacterial life than has previously been recognized. And because the recurrent structure can be paired with a variety of signaling proteins, it gives organisms immense versatility in the ways they use light, Swartz said.
"We have bumped into an entirely new family of light receptors in nature," said coauthor Roberto Bogomolni, professor of chemistry and biochemistry at UCSC.
The receptor molecule contains a light-sensing region known as an LOV domain because it resembles similar units in other proteins that sense light, oxygen, or voltage, said coauthor and longtime collaborator Winslow Briggs, of the Carnegie Institution of Washington. The structure crops up in a variety of proteins, where it lends its light-sensing ability to the whole molecule. The light-sensing structure is very different from either the light-harvesting molecules of photosynthesis or the light-gathering pigments in our own eyes.
Full article here