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Market Research in the Healthcare Field with Expertise in Medical Imaging and Radioisotopes
Bio-Tech Systems, Inc. - 4167 West Pinecrest Circle - Las Vegas, Nevada 89121 phone: (702) 456-7608 - fax: (702) 456-2189
New Radiopharmaceuticals Will Drive Future Growth of PETNov 15, 2010
Neurological applications are being actively pursued in the diagnosis of Alzheimer's disease by imaging amyloid plaque in the brain, which is believed to be a primary cause of the disease. Other neurological diseases, such as Parkinson’s disease, are also being pursued with specialized PET agents. Therefore, target expression will be the key to using PET to measure the in vivo effect of drug therapy. New cardiology perfusion agents are also in an advanced stage of development to better identify myocardial defects. These PET agents produce better images than SPECT and have the benefit of attenuation correction. PET imaging also eliminates dependence on variable supplies of technetium. In addition, reimbursement for PET cardiology procedures is favorable. Another class of new PET cardiology agents is for neuronal imaging to identify defects in electrical conduction patterns in the heart that lead to congestive heart failure if not treated properly. These are important applications with a large patient base that should expand the scope of PET in cardiology. New oncology agents are also in late stage development for imaging apoptosis, where the clinician can observe cell death that occurs from chemotherapy or radiation therapy. Imaging apoptosis allows therapy to be tailored to the individual and minimizes the therapy burden on the patient. The use of a positive biomarker indicating cell death allows more accurate assessment of therapy compared with FDG, which shows reduced cellular metabolism. This requires a negative inference (absence of metabolic uptake) rather than a positive indicator of cell destruction. Other important biomarkers are also being developed to image angiogenesis, which is the formation of new blood vessels that feed tumor growth. Cancer therapies are available to limit this growth including anti-angiogenic drugs which deprive the tumor of nutrients and cause it to shrink. Another class of agents in development indicates metabolism of amino acids in slow growing tumors, such as prostate cancer. This is a more sensitive indicator than glucose metabolism in tumors of this type. This will allow earlier diagnosis and treatment of these cancers before they metastasize, improving the prognosis for these patients. Another oncology platform entails imaging hypoxia in tumors. Reduced oxygen content occurs in tumors that have outgrown their blood supply and these tumors are more resistant to chemo and radiation therapy. Therefore, if the hypoxia is imaged, the radiotherapy dose can be adjusted to fit the oxygen level, allowing an extra dose to those areas with low oxygen content, while reducing the dose to areas that are well oxygenated. These new radiopharmaceutical agents will find a place in PET imaging because of their ability to measure biochemical processes that show patient response to therapy. These developments will expand the use of PET and Increase its effectiveness with a broader range of patients. It will also provide more options for referring physicians in applying PET effectively. Ultimately, this will create an expanded platform for PET that will increase its utility and create a good foundation for continued growth. New Criteria Proposed for Diagnosing Alzheimer's Disease
Experts on Alzheimer's have indicated that there are 26 million worldwide afflicted with the disease. They are proposing new criteria for diagnosing the dementia which would pick it up at an earlier stage and should get more patients onto treatment or into trials of new drugs. An international expert group said the new guidelines would revise the definition of Alzheimer's to take into account recent scientific developments, including the use of biomarkers which can show if a person is at risk of the disease before they have any symptoms.This preclinical stage, which can be about 10 years before dementia sets in, is widely seen as the best time to intervene in Alzheimer's. Recent studies have shown that imaging amyloid plaque can help predict who will develop Alzheimer's and this information is becoming crucial to researchers and drug firms trying to develop new treatments. Many physicians believe that there is no longer a reason to wait until patients have developed full-blown dementia. Currently only a postmortem examination can absolutely confirm that a person has Alzheimer's. But in a recent paper in the Lancet Medical journal it was indicated that Alzheimer's should be defined as a clinical-biological syndrome to allow a diagnosis to be made on the basis of biomarkers in living patients and at an early stage of disease. To meet these new criteria for a diagnosis of Alzheimer's, patients would not necessarily have clinical symptoms of dementia, but would have episodic memory impairment together with at least one positive biomarker shown on a PET brain scan. Several large clinical trials of potential Alzheimer's drugs from firms such as Pfizer, Medivation, and Eli Lilly have failed in recent years, partly because they were tested in people whose brains had already been too damaged by the disease. Alzheimer's advocacy groups are concerned that these costly failures may dissuade drugs companies and government-funded institutions from investing further in Alzheimer's research. Therefore, experts on Alzheimer's disease are proposing new criteria for diagnosing the dementia which would pick it up at an earlier stage and should get more patients onto treatment or into trials of new drugs. An international expert group said the new guidelines would revise the definition of Alzheimer's to take into account recent scientific developments -- including the use of biomarkers, or biological signals, which can show if a person is at risk of the disease before they have any symptoms. New PET Agents and Methodologies for Cardiology
New fluorine-based PET products for myocardial perfusion imaging are in the pipeline and should be ready for market introduction beginning in 2012. The first will be a cardiac perfusion agent from Lantheus, designated Flurpiridaz. This radiopharmaceutical has high, rapid, and sustained cardiac uptake proportional to blood flow, slower washout, high target to nontarget uptake ratios, ability to image perfusion deficits, and capability to produce high quality images compared with current SPECT products. Another fluorine-based perfusion agent is being developed by FluoroPharma, Inc., which is a venture company with a broad technology platform developed by scientists at the Massachusetts General Hospital and Harvard Medical School. FluoroPharma’s technology consists of novel molecular PET agents to rapidly target either the myocardial cells or the vulnerable plaque within the coronary arteries. According to management, FluoroPharma’s proprietary molecules labeled with F-18 provide a highly specific assessment of heart metabolism and physiology. Neuronal Imaging Agents
Lantheus and FluoroPharma are also developing neuronal imaging agents labeled with F-18 which should begin introduction around 2012-2013. These products will add stimulus to PET in cardiology and create a good platform for growth. Neuronal imaging is used to examine the electrical conduction pathways of the heart. In abnormal cases, these pathways get out of synchronism causing irregular ventricular contractions that often lead to congestive heart failure. Neuronal imaging can accurately diagnose this condition and determine whether installation of a pacemaker or catheter-based ablative methodologies should be implemented to synchronize ventricular contraction. New PET Biomarkers for Oncology
There are several ongoing programs to develop new PET biomarkers for oncology. There most active are at GE, Siemens and its subsidiary PETNet, as well as the Israeli company Aposense Ltd. and IBA Molecular. Research is also ongoing at various university sites that have active PET programs. Many of these developments have promise and their sponsors are dedicated to introducing products with good clinical and economic potential.Various classes of agents are being developed including:
Apoptosis Imaging
Molecular imaging and therapy developer Aposense is currently in Phase 2 clinical trials of its apoptosis molecular imaging agent, ML-10. An important study is being conducted at Memorial Sloan-Kettering Cancer Center in New York City and will evaluate the safety and efficacy of the company's fluorine-18-ML-10 compound for the early assessment of metastatic brain tumor response to stereotactic radiosurgery. Aposense reported that recent research revealed that its PET imaging agent helped oncologists detect apoptosis (programmed cell death) early in radiation treatment for brain metastases.Integrin Peptides and Integrin Binding Agents
There are two biomarker development programs that are directed toward integrins, which are components of the blood that are linked to angiogenesis. This is a process in which uncontrolled growth of new blood vessels feeds malignant tumors and encourages their growth. There have been several anti-angiogenic drugs developed over the past several years that have been successful in discouraging these neovascular formations, thereby limiting the growth of these destructive tumors. An example is Avastin (from Genentech), which has been most successful in treating a large class of tumors.Research is being conducted by both Siemens and GE to develop new PET biomarkers that target integrins that will help identify the growth of these vascular formations and tumor beds. Therefore, imaging angiogenesis with PET would allow early targeted treatment with appropriate anti-angiogenic therapies. Siemens has a product in development that is in Phase 2 that is an RGD peptide, which consists of three amino acids that bind to the integrin. Researchers are hopeful that the product will have broad application toward multiple tumor groups. GE also has an integrin development program that is in Phase 2, which is directed toward melanoma and renal cell carcinoma. They refer to this as F-18 Cyclitide imaging, which is an integrin-based peptide directed toward angiogenesis. Flucyclidine Amino Acid Metabolism
GE has a product in development in conjunction with Emory University known as flucyclidine (fluoro-amino cyclobutane) or FACBC. This measures the metabolism of amino acids in tumors and indicates amino acid synthesis. This is a sensitive indicator of tumor growth that is being applied to prostate imaging, where glucose metabolism is too slow for accurate visualization of tumor growth. Prostate imaging is an important application, which has eluded conventional FDG PET. Therefore, researchers have been seeking other alternatives. The group at Emory in conjunction with scientists at GE has demonstrated encouraging results with their FACBC agent.Imaging Hypoxia with PET
Another Siemens product in Phase II trials is a hypoxia imaging agent. When tissues are deprived of oxygen because a tumor has outgrown its blood supply, they become more resistant to chemo and radiation therapy. Therefore, if one can image the hypoxia, it is possible to alter the radiotherapy dose to fit the oxygen level. Therefore, one can increase the dose to those areas with low oxygen content and reduce the dose to areas that are highly oxygenated. This would improve the outcome of therapy and lead to a more effective result.The hypoxic effect increases when the tumors get bigger because they outgrow the vasculature that feeds them. Certain cancers may be more susceptible to this effect than others and this is being explored in Phase 2. Therefore, if a hypoxic condition can be identified, one can either adjust the radiotherapy dose or administer a drug that will oxygenate the area. These are broad-based efforts that could have wide applications. PET is poised to expand its patient base as these new products are introduced. It will also bring more clinical disciplines into PET and increase its versatility. The investment community has already shown its confidence in PET's potential by supporting these multiple developments. With the increasing body of clinical data that will be derived from these products, the pace of research will increase and clinical applications expand well beyond our current projections. by Marvin Burns
Nov 15, 2010 BIO-TECH SYSTEMS, INC., founded in 1980, provides clients with market research services in the healthcare field. This focuses on strategic planning, market research and development of new business opportunities. Bio Tech specializes in product and market evaluation where technical insight is important as well as the ability to communicate with many levels of management and end-users. One objective is to assess technological risk and target new products and services effectively in order to generate the best market response. Bio-Tech's expertise is in medical imaging and radioisotope products covering a broad range of diagnostic and therapeutic applications. For further details and information, please visit us at: Related Reading:
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PET procedure volume has been growing at about 10% per year notwithstanding reimbursement pressures. PET providers have become more focused in selecting procedures that are useful and meet the necessary guidelines. An encouraging trend is that researchers are actively developing new PET agents that will extend its range beyond tissue metabolism. The objective is to characterize diseased tissue more accurately at an earlier stage so that effective drugs can be used for treatment. This should benefit producers of PET radiopharmaceuticals as well as PET imaging systems, encouraging greater investment to enhance market opportunities.
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