Drug DiscoveryBiotechnology has the potential to improve our lives greatly. It can find a cure for cancer, extend life, and many other things, but some technologies that are close to existing or already exist are xenotransplantation and a few "miracle" drugs. Transplantable animal organs: XenotransplantationOver the past few years the demand for organ transplants has skyrocketed. There are too few individuals signing up as organ donors to meet this growing demand. Even when an individual has signed up and is available, it is often just too hard and there is not enough time to schedule the necessary appointments, fill out the paperwork, and actually do the operations. Gattaga recognized this potential problem in the year 1997, and we have worked hard since then to bring an alternate solution to the problem. Now, after extensive testing, our solution will soon be ready for testing on humans. The Basics:The words cloning, stem cell research, and genetic engineering are hot words in the public world. You hear about them daily in the papers, online journals, and chat rooms. Stem cell research and cloning are still expensive, and controversy still surround them, while genetic engineering is simply not geared to face this problem. As opposed to transplanting from clones, or growing organs from stem cells, Xenotransplantation is cheap, effective, and timely. Xenotransplantation is the procedure of transplanting organs from one species to another. Certain animals have organs, organ structures, and body tissues similar to humans, including certain pigs and non-human primates. The organs from these species have been found compatible with humans. Gattaga started to review viable species for Xenotransplantation in 1997, and now after careful breeding and genetic alteration, Gattaga has stocks of several animals, including swine and several species of ape, that will soon be ready to take organs and tissues from for transplantation. How It Works:As mentioned above, there are several species that have similar organ structures to humans, most notably swine, and non-human primates. The question of the transplantation is similar to transplantation from a human to a human. The three largest barriers are, organ rejection and immune response, endogenous retrovirus, and size. For size there was the comparably simple task of just breeding over time to reduce the stock in size. This was done with inbreeding to reach a useful size. Swine in particular are usually around one thousand pounds at full development. Through careful breeding and inbreeding, we have reduced the average size of full development to two hundred and fifty pounds, making their organs comparable in size to humans. In swine in particular, there is one endogenous retrovirus known as PERV or Porcine Endogenous Retrovirus. This virus is part of the genetic makeup of swine, and does not harm swine. One could say swine are the host species for this virus. Though it was never administered to humans, it was expected that it could cause infection, this suspicion arising from tests on non-human primates. Seven years ago, a less virulent strain of this virus was discovered, and through careful breeding and inbreeding, this allele became the only one present in our stocks. This process was replicated for most other species we use. Though now, with several apes under development, we are simply looking to modify the genes instead of waiting for a less virulent strain, which may take 3 months to 30 years to appear. Another important part of Xenotransplantation is getting over the rejection of the organ, increasing the tolerance of the individual receiving the organ. One key step in this process is to reduce and/or eliminate cell identifiers or signals to the human immune system that this is a foreign object. These identifiers or signals could include sugars on the outside of cells, small proteins, or other macro or simple molecules. Gattaga is making progressgot around this by replacing these areas in the gene code with null sequences, where nothing is generated. Another method that will be utilized by Gattaga to ease the transplantation process is tolerance induction. Tolerance induction is the process of using cells from the source animal to get the recipient to accept them as their own and not reject foreign cells. This eliminates the need for prolonged immunosuppressive use, though there is a slim possibility of a weakened immune system due to not rejecting enough foreign matter. One method of tolerance induction involves transporting thymus and/or bone marrow cells from the donor to the recipient. What the Customer Needs to Know:The keys to making Xenotransplantation accessible are intricate. First there was the question of size, which was answered through careful breeding to reduce or enlarge certain aspects or the species on a whole. Second there was the question of endogenous retroviruses. This is being answered initially by looking for alleles with less potent and ineffectual version of the virus, or if this fails, genetic modification of the gene containing the virus. The third question is that of tolerance and recipient rejection. We are confident removing foreign markers from the cells and with tolerance induction can solve this. The final barrier is a question of availability and affordability. Gattaga has solved this with local stocks around the US and in several foreign countries, soon ready to be delivered at reasonable prices. Miracle Drugs & Biologics: Cure for ArthritisIn the late 90s bio-pharmaceuticals became available for the first time, with tabs ranging from 15 thousand to 250 thousand dollars a year. They could treat a number of diseases, but nowhere near everything. Now in the year 2004, the cost has gone down, and more and more diseases and variations can be treated daily. BioTech drugs, also known as biologics or biotherapeuticals, are used to treat a variety of diseases linked with proteins and certain genes. The drugs are most often derived from genetic engineering, or manipulation of proteins in organisms. Biologics, though they can be used to treat a variety of diseases and problem, each biologic is specified to one problem. Conventional drugs treat symptoms in a broad sense, where biologics treat the disease or problem specifically and intensely. The Basics:A problem that has now become very prevalent is Rheumatoid Arthritis, RA for short. RA is an autoimmune disease, a disease where the immune system does not function correctly and attacks the body. Rheumatoid Arthritis causes inflammation in the joints and can also cause inflammation in tissue around the joints and around the body. In some patients the inflammation leads to destruction of cartilage and bone causing deformities. RA is a progressive disease; it gets worse the longer you have it. One of the scariest parts of RA is that the amount of pain you feel is not correlated completely to the progressive damage done, so you can be getting a lot worse and not even know it until you are near crippled. At Gattaga we have worked hard to develop a drug capable of relieving an individual from the pain, stress, and the sometimes-crippling stiffness that are symptomatic of Rheumatoid Arthritis. Reavs provides a way to alleviate your pain. Reavs helps: Reduce pain Reduce stiffness Inhibit the progression of joint damage Reduce swelling Reduce fatigue How it Works:Reavs is a treatment for the symptoms of RA, not the cause. In RA, there are inflammatory responses around the bone, joint, or region of pain. Reavs works by blocking tumor necrosis factor alpha (TNF alpha). TNF alpha causes inflammation, the bodies auto response to pain or injury. TNF alpha also causes fever, pain associated with inflammation, tenderness, and swelling. Normally, in a body's immune response, the body sends out TNF to certain cells throughout the body to cause inflammation, part of the bodies line of defense against infection and injury. Patients with RA often produce too much TNF when it is needed, or produce TNF when there is no need for it at all. When the cells are getting too much TNF, it overwhelms the immune systems capabilities to control the inflammation. Reavs is a synthetic protein that works by bonding to the TNF alpha molecules. It thus eliminates the effectiveness of a large portion of the TNF alpha, causing the symptoms, inflammation, swelling, etc., to be reduces or disappear entirely. Since inflammation makes the problem get worse, by the inflamed area rubbing against the bone and causing abrasion, Reavs essentially stops most progression of the disease. Reavs is most effective when taken with methotrexate, an antimetabolite used in the treatment of many illnesses. Methotrexate is used to make one's immune system less active. This helps with RA since RA is an autoimmune disorder. It is not known specifically how methotrexate works in the treatment of RA, since RA itself is not fully understood. In general, though, methotrexate interferes with DNA production, and has a greater effect on fast reproducing cells, for example skin cells and cancer cells. Taking methotrexate with Gattaga's Reavs can save you from years of pain and disability. ActivitiesPlease see the additional resources and links sections for more information on this topic. Additional Resources and LinksXenotransplantation: Risks, Clinical Potential, and Future Xenotransplantation (animal to human transplants) Generic biotech drugs on horizon / US begins to consider issues ReferencesEnbrel Information Page. (n.d.). Retrieved September 6, 2004, from http://www.enbrel.com/index.jsp Etanercept. (n.d.). Medicine Net. Retrieved September 7, 2004, from http://www.medicinenet.com/etanercept/article.htm Immer Biotherapeutics. (n.d.). Retrieved September 2, 2004, from http://www.immergebt.com/index.php Methotrexate. (n.d.). Drugs Dot Com. Retrieved September 8, 2004, from http://www.drugs.com/methotrexate.html |