Millennium Ph. - 500 Beiträge pro Seite

[Börsenguru2001]

Stimmt es, daß Campath zugelassen wurde?????

[seinfeld]

Nein, ganz im Gegenteil!!
Die FDA verlangt weitere Unterlagen und neue Studien,
Zulassung frühestens in zwei Monaten.
Gruß Seinfeld

[Börsenguru2001]

Dann fällt Mill noch weiter

[seinfeld]

Nicht unbedingt, dürfte schon längst eingepreist sein,
wurde ja schon vor 10 Tagen von Analysten erwartet.
Zudem kam die Meldung bereits vor Börsenbeginn in den
USA, so daß das jetzt keine Neuigkeit mehr ist.
So long, Seinfeld

[bigguru]

Millenium seeks "to discover and develop novel, proprietary therapeutic and diagnostic products that address diseases at their root causes." The company`s primary means of doing this is through research in genetics, molecular biology, and related fields. The intended targets of this research are complex, multi-gene or enviroment-influenced hereditary conditions with large numbers of afflicted patients and strong medical and marketing potential such as obesity, Type II or Non-Insulin-Dependent Diabetes Mellitus (NIDDM), atherosclerosis, asthma, cancer, and Central Nervous System (CNS) diseases.
Millenium`s approach to research involves identifying the genes which trigger or cause particular diseases and then determining precisely how these genes act to cause disease within the body. This information can then be used to develop effective treatments which target the root genetic basis of illness. Millenium`s strategy combines many elements of different areas of biotech and genetic research and also makes use of technological advances based on the Human Genome Project including computer and robotic technology.



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Genetic Diseases
Because of the extreme complexity of genetics research, most biotechnology companies working in this field focus on very specific areas of research such as gene therapy or on particular body systems like the central nervous system (CNS). Millenium has embraced the opposite approach and instead seeks to use and combine the best of existing areas and techniques of genetic research in a broad approach applicable to many major diseases. Millenium therefore plans to discover and develop drugs from start to finish based on research into the fundamental genetic causes of disease.

Mutation
The genetic information encoded within DNA contains the blueprints needed by the cell to manufacture proteins, the building blocks and chemical machinery of the cell. Mutations are errors in the genetic code which cause some variation in the protein manufactured based on that incorrect code. Some mutations are beneficial; most either have little effect or are detrimental to the cell because the proteins made from the incorrect blueprint do not function properly. When the latter case is true, the malfunctioning protein can cause disease within an organism by impairing its normal functioning. For example, phenylketonuria (PKU) is a rare, inherited metabolic disease caused a mutational defect within the genetic code. Individuals with PKU lack a certain enzyme (phenylalanine hydroxylase) needed to digest the amino acid phenylalanine. When this enzyme is missing, phenylalanine is not broken down and remains in the body, where it builds up into levels toxic to the central nervous system.


Gene Expression
Even when the correct genetic information to build proteins is stored within DNA, disease can result if the genes are not expressed properly. Gene expression is the process of translating portions of the DNA code into the proteins used by the cell. Normally, gene expression is regulated to appropriate levels by many different factors and conditions within the cell. However, errors in the genes which regulate protein production can cause proteins to be over or underproduced. This can result in disease as there may be insufficient protein present to accomplish its task or the addition protein may disrupt the chemical equilibrium of the cell.


Polygenic Diseases
Most biological characteristics are controlled by more than one section of genetic code and are therefore called polygenic. This means that most genetic-linked diseases result from a combination of one or many different genetic factors. Generally, the more factors involved, the greater the complexity of the resulting condition or disease, since each genetic factor contributes slightly differently to the overall condition. Isolating the genetic components of polygenic conditions can also be extremely difficult and time consuming due to the large number of possible locations for incorrect genes.


Environmental Influences on Genetic Diseases
Many conditions linked to genetics can be triggered or influenced by environmental factors as well. A genetic predisposition to heart disease, for example, might lead to an acute case of heart disease when influenced by diet and stress. In another example, exposure to radiation might trigger a latent genetic possibility for cancer. Environmental influences such as these also make root genetic causes much harder to identify because environment has such a variable influence upon different people.



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Millenium`s Research Program
Millenium`s research program takes complicated genetic-linked diseases through a multi-stage process of gene identification and treatment development.

Gene Identification
The most basic stage of research is for scientists to identify major genes involved in each disease. Millenium has several traditional and non-traditional methods of locating and sequencing disease genes using both human and mouse genomes. Through research collaborations with many academic medical centers, Millenium searches for disease genes in specific study human populations at various locations throughout the world. The use of international populations is intended to speed up research and increase the applicability of Millenium`s findings, since results from one ethnic group are not always applicable to others.

With humans, the usual procedure is for gene identification is for researchers to study small population groups with long histories of the disease in the family. Researchers then examine the genetic profiles of individual family members and try to correlate the presence (or absence) or particular genes (linkages) with the presence (or absence) of disease in order to determine the general region of the chromosome on which the disease gene is located. Finally, researchers pinpoint the exact location of the gene on the chromosome using genes called markers whose exact positions are already known. This technique is called positional cloning.

Millenium also uses mouse populations to search for mouse genetic defects analogous to human problems. With mice, as with other research animals, many strains have been developed with diseases or conditions which model human diseases. While these disease models are not exactly like those found in humans, often they are analogous enough to be of considerable assistance in the human studies. Research animals like mice are useful in genetics research because of their shorter lifespans, which allow researchers to study generations at a time, the greater amount of information known about animal genomes, and the fewer number of ethical difficulties in conducting experiments on animals.

Once the position of the disease gene on the chromosome is known, the next step is to determine the complete DNA sequence of the gene, i.e. the order of the nucleotides within the DNA strand. This is accomplished by many different techniques, including standard laboratory sequencing techniques as well as computer-automated DNA sequencing equipment and other computer and robotic technological advances based on research from the Human Genome Project. The goal of sequencing is to determine the order and identity of nucleotides in the disease gene. Sequencing is performed for normal as well as afflicted individuals in order to be able to compare the correctly functioning DNA with its malfunctioning counterpart.

Millenium also uses other, less conventional methods to identify and locate disease genes. These methods use differing levels of gene expression (i.e. protein synthesis) in different cells to compare patterns and levels of gene expression in diseased e.g. cancerous) and healthy tissue. Different levels of gene expression suggest possible connections between the genes and the diseases. Cancer cells, for example, produce different levels of different proteins compared to healthy cells; some of these proteins may be important to understanding the underlying cancer disease mechanism. The messenger RNA (mRNA) used to express these genes can be isolated and copied to produce a copy of the original DNA sequence.

Finally, Millenium uses two additional techniques to search for potential disease genes. Automated cDNA sequencing, done selectively, finds the DNA nucleotide sequences of many potential disease genes. Millenium`s research has focused on using automated sequencing to examine genes which code for hormones (intercellular signalling molecules) and some classes of enzymes. Expression cloning is an additional technique of identifying unknown genes based on extensive knowledge of the proteins for which they code. In essence, this technique reverses other methods of research; instead of starting with the DNA and using it to learn about the protein, expression cloning starts with the protein and uses it to learn about the DNA.


Target Validation
Target validation is the process of determining a target gene`s role in the progression of a genetic-linked disease. In other words, researchers use the target gene as a starting point to understand what is different in diseased cells as compared to normal cells. As the mechanism of the disease is unraveled, researchers look for ways to correct the problems using staple biotech technologies like gene therapy and enzyme inhibitors.
Millenium has two main target validation technologies, bench biology and computational biology.


Bench biology combines many traditional molecular biology research technologies into one method of approach.

Tissue profiling compares gene expression in diseased and non-diseased tissues (similar to part of the gene identification process as described above). Tissue profiling is particularly useful in the target validation process because it also allows some scrutiny of the possible side effect profile of potential treatments. For example, if a gene not normally expressed in healthy cells were being expressed in diseased cells, stopping expression of the gene in all cells might stop the illness in disease cells but have little or no effect on healthy cells since these cells would not normally express the gene anyway.

Biochemical pathways are sequences of biochemical processes which accomplish some general task within a cell. For example, a de novo pathway is a sort of cellular assembly line in which a large biomolecule is synthesized from simpler molecules. The "machines" the cell uses in a pathway are enzymes. Locating and sequencing a disease gene often puts researchers somewhere in the middle of an errant pathway for some normal cell function. Once the gene and pathway are found, researchers can examine the entire pathway, not just the gene, for ways to correct the underlying problem. This method can lead to many possible molecular targets for drugs and research.

Cellular and animal models are used to help determine the physiologial function of discovered disease genes. For a long time, researchers have manipulated gene expression in cells and lab animals, particularly mice, by changing the level of gene expression (and, therefore, protein production), by eliminating gene expression entirely in strains called knockout mice, and by adding new or altered genes to their genetic codes in transgenic mice.

A bioassay (short for "biological assay") is a controlled experiment for the quantitative estimation of a subtance by measuring its effect in a living organism. Millenium`s bioassay group combines the results of other bench biology research to create bioassays for drug screening. This group therefore uses the information from other bench biology groups to create tests used to evaluate (in a very general way) the potential of various drugs and treatments. Bioassays are how researchers know which of the hundreds or thousands of potential treatments they have found might actually be effective against the disease. For example, if researchers discovered the the overproduction of a certain enzyme resulted in disease, they might then look for compounds which inhibited production of that enzyme. To determine the most effective of these, they might then run a bioassay on all the potential treatments to see which specfic compound was most effectively inhibiting the enzyme without creating other side effect problems.

Computational biology refers to a set of computer-assisted techniques and algorithms for inferring information about a protein directly from the DNA sequence that encodes the protein. On the surface this may seem simple, since each unique DNA nucleotide sequence codes for a specific string of amino acids which makes up the protein. However, many, many different factors affect the actual three-dimensional structure of the protein, and three-dimensional structure cannot be reliably predicted by the order of the amino acids. Since the structure of the protein in space is really what determines its function, in the past it has previously been necessary for researchers to either synthesize the protein based on the DNA and then attempt to analyze the protein to determine its shape, structure, and method of functioning. Protein analysis is a whole field of research unto itself; traditional analysis of proteins to the level needed to research pharmaceuticals can take years of time and millions of dollars.
Computational biology bypasses and/or directs many of the more time-consuming and expensive steps involved in this analysis through the use of computer analysis of protein shape and structure. Though exact structure may not necessarily be determined by this method, computer analysis can greatly speed up the process of protein analysis and allow research to proceed at a much faster rate.

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