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Mozobil, a Novel Small Molecule CXCR4 Chemokine Receptor Antagonist, Enhances Mobilization of Hematopoietic Stem Cells for Transplantation

June 17, 2008--Genzyme Corporation announced that it has submitted marketing applications in both the United States and the European Union for Mozobil™ (plerixafor), a product candidate intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma. The company has requested priority review of its U.S. application and, if granted, Mozobil could be approved by the end of this year. European approval is expected in 2009. Additional global applications in up to 60 countries are expected to follow.   About Mozobil Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006   Important Clinical Role Mozobil is designed to mobilize stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for a patient with certain types of cancers to receive a successful transplant. Specifically, patients with non-Hodgkin’s and Hodgkin’s lymphomas and multiple myeloma often receive high-dose chemotherapy, a process that destroys bone marrow. A stem cell transplant is required to replenish blood-forming bone marrow cells destroyed by high-dose chemotherapy. Stem cells differentiate into the mature red blood cells, white blood cells, and platelets that a healthy person needs.   Currently, before a transplant can take place, patients may receive a prescribed dose of chemotherapy and/or other drugs, called growth factors, to help mobilize their hematopoietic stem cells into the bloodstream. Once the cells are released into the bloodstream, they are easier to collect in preparation for a transplant.   In order for the transplant to take place, a minimum number of approximately 2 million cells per kilogram of body weight must be collected. For many patients, this process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible.   Genzyme conducted two phase 3 studies that confirmed the potential of Mozobil to effectively and predictably prepare lymphoma and multiple myeloma patients for an autologous transplant. Both studies successfully met primary and secondary endpoints. Patients who received Mozobil in conjunction with a growth factor achieved more rapid and effective mobilization of stem cells in preparation for autologous transplant than patients treated with growth factor alone. In addition, more patients treated with Mozobil plus a growth factor achieved a composite endpoint of optimal stem cell collection and successful transplantation, compared to patients mobilized with placebo plus a growth factor. Mozobil was well tolerated in both trials, with the most common adverse events being gastrointestinal effects and injection site reactions.   “There is a lot of excitement among treating physicians about Mozobil,” said Mark Goldberg, M.D., senior vice president of clinical research at Genzyme. “The product has great potential to meet an important, unmet medical need and has numerous potential benefits for patients.”   More than 900 patients have received Mozobil through a compassionate use program in the United States, and similar compassionate use programs have recently begun in Europe.   Commercialization Plans Genzyme plans to launch Mozobil in the U.S. and Europe in 2009. Upon commercial launch, Mozobil will be marketed and sold by Genzyme’s existing Transplant sales force, which has a commercial presence in more than 55 countries worldwide. In addition, the company will leverage its Oncology business and clinical infrastructure.   Approximately 55,000 stem cell transplants are performed each year for multiple myeloma, Hodgkin’s and non-Hodgkin’s lymphoma, and other conditions in markets where Genzyme has a commercial infrastructure, including the United States, Europe, Latin America and the Asian Pacific countries. Genzyme believes that over time, Mozobil will be used in the majority of these procedures, and peak sales of the product in the transplant setting are expected to reach $400 million annually.   In addition to the patient benefit, Mozobil also may offer significant economic benefits for transplant centers. Mozobil has the potential to decrease the number of apheresis days and provide transplant centers with more predictable and efficient use of the apheresis center, while reducing the number of patients who may fail to mobilize sufficient numbers of cells and therefore require a second mobilization procedure.   Additional Therapeutic Opportunities Numerous Genzyme and investigator-sponsored trials are planned or underway to study Mozobil’s use in other settings such as allogeneic hematopoietic stem cell transplants. Genzyme is also studying the use of Mozobil to improve the efficacy of chemotherapy and/or immunotherapy in various types of hematologic malignancies such as chronic lymphocytic leukemia and acute myelogenous leukemia, and is pursuing preclinical work to explore the role that Mozobil may play in cord blood transplantation, solid organ transplantation, cardiovascular disease, renal ischemic disease, and a variety of additional types of solid tumor malignancies.   “We’re just beginning to unlock the potential of Mozobil,” said Joseph Lobacki, senior vice president of the Transplant business unit at Genzyme.   About Genzyme One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.   With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.   Genzyme® and AnorMED® are registered trademarks of Genzyme Corporation or its subsidiaries. Mozobil™ is an unregistered trademark of Genzyme Corporation or its subsidiaries. All rights reserved.   Source: Genzyme Press Release

FDA’s Sentinel Initiative - A National, Integrated, Electronic System for Monitoring Medical Product Safety

On May 22, 2008, FDA launched the Sentinel Initiative with the ultimate goal of creating and implementing the Sentinel System--a national, integrated, electronic system for monitoring medical product safety.   The Sentinel System will enable FDA to query multiple, existing data sources, such as electronic health record systems and medical claims databases, for information about medical products. The system will enable FDA to query data sources at remote locations, consistent with strong privacy and security safeguards.  Data sources will continue to be maintained by their owners.   This historic new system will strengthen FDA's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health. Such a system could also ultimately facilitate data mining and other research-related activities.   As envisioned, the Sentinel System can be achieved with minimal transfer of data, using tools and processes that will ensure the protection of patient information.   http://www.fda.gov/oc/initiatives/advance/reports/report0508.html

New Rapid Tests for Drug-resistant Tuberculosis- 2 Days Rapid Diagnosis

30 JUNE 2008, GENEVA -- People in low-resource countries who are ill with multidrug-resistant TB (MDR-TB) will get a faster diagnosis -- in two days, not the standard two to three months -- and appropriate treatment thanks to two new initiatives unveiled today by WHO, the Stop TB Partnership, UNITAID and the Foundation for Innovative New Diagnostics (FIND).   MDR-TB is a form of TB that responds poorly to standard treatment because of resistance to the first-line drugs isoniazid and rifampicin. At present it is estimated that only 2% of MDR-TB cases worldwide are being diagnosed and treated appropriately, mainly because of inadequate laboratory services. The initiatives announced today should increase that proportion at least seven-fold over the next four years, to 15% or more.   "I am delighted that this initiative will improve both the technology needed to diagnose TB quickly, and increase the availability of drugs to treat highly resistant TB," said British Prime Minister Gordon Brown, who helped launch the Stop TB Partnership's Global Plan to Stop TB in 2006 and whose government is a founding member of UNITAID. "The UK is committed to stopping TB around the world, from our funding of TB prevention programmes in poor countries, to our support of cutting edge research to develop new drugs."   In developing countries most TB patients are tested for MDR-TB only after they fail to respond to standard treatments. Even then, it takes two months or more to confirm the diagnosis. Patients have to wait for the test results before they can receive life-saving second-line drugs. During this period, they can spread the multidrug-resistant disease to others. Often the patients die before results are known, especially if they are HIV-infected in addition to having MDR-TB.   The initiative comes just one week after WHO recommended "line probe assays" for rapid MDR-TB diagnosis worldwide. This policy change was driven by data from recent studies, including a large field trial -- conducted by FIND together with South Africa's Medical Research Council and National Health Laboratory Services -- which produced evidence for the reliability and feasibility of using line probe assays under routine conditions.   "Five months ago, WHO renewed its call to make MDR-TB an urgent public health priority," said WHO Director-General Dr Margaret Chan, "and today we have evidence to guide our response. Based on that evidence, we are launching these promising initiatives."   Two projects The new initiative consists of two projects. The first, made possible through US$ 26.1 million in funding from UNITAID, will introduce a molecular method to diagnose MDR-TB that until now was used exclusively in research settings. These rapid, new molecular tests, known as line probe assays, produce an answer in less than two days.   Over the next four years -- as lab staff are trained, lab facilities enhanced and new equipment delivered -- 16 countries will begin using rapid methods to diagnose MDR-TB, including the molecular tests. The countries will receive the tests through the Stop TB Partnership's Global Drug Facility, which provides countries with both drugs and diagnostic supplies.   As part of the project, WHO's Global Laboratory Initiative and FIND will help countries prepare for installation and use of the new rapid diagnostic tests, ensuring necessary technical standards for biosafety and the capacity to accurately perform DNA-based tests. One country, Lesotho, is already equipped to start using these tests; Ethiopia is expected to be ready by the end of 2008. The tests will be phased in during 2009-2011 in the remaining 14 countries.   Under a second, complementary agreement with UNITAID for US$ 33.7 million, the Global Drug Facility will boost the supply of drugs needed to treat MDR-TB in 54 countries, including those receiving the new diagnostic tests. This project is also expected to achieve price reductions of up to 20% for second-line anti-TB drugs by 2010. All the countries receiving this assistance have met WHO's technical standards for managing MDR-TB and already have treatment programmes in place. Some will use grants from the Global Fund against AIDS, Tuberculosis and Malaria to purchase the drugs.   "Through the US$ 60-million support provided by UNITAID, these projects are expected to produce significant results in diagnosing and treating patients as well as reducing drug prices and the costs of diagnosis. These efforts illustrate the way in which innovative financing can be deployed for health and development," said Philippe Douste-Blazy, Chairman of UNITAID's Executive Board.   Source: WHO Press Release

Number of People with Diabetes Increases to 24 Million

--Estimates of Diagnosed Diabetes Now Available for all U.S. Counties--   Diabetes now affects nearly 24 million people in the United States, an increase of more than 3 million in approximately two years, according to new 2007 prevalence data estimates released today by the Centers for Disease Control and Prevention (CDC). This means that nearly 8 percent of the U.S. population has diabetes.   In addition to the 24 million with diabetes, another 57 million people are estimated to have pre-diabetes, a condition that puts people at increased risk for diabetes. Among people with diabetes, those who do not know they have the disease decreased from 30 percent to 25 percent over a two-year period.   “These new estimates have both good news and bad news,” said Dr. Ann Albright, director of the CDC Division of Diabetes Translation. “It is concerning to know that we have more people developing diabetes, and these data are a reminder of the importance of increasing awareness of this condition, especially among people who are at high risk. On the other hand, it is good to see that more people are aware that they have diabetes. That is an indication that our efforts to increase awareness are working, and more importantly, that more people are better prepared to manage this disease and its complications.”   Diabetes is a disease associated with high levels of blood glucose resulting from defects in insulin production that causes sugar to build up in the body. It is the seventh leading cause of death in the country and can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations.   Among adults, diabetes increased in both men and women and in all age groups, but still disproportionately affects the elderly. Almost 25 percent of the population 60 years and older had diabetes in 2007. And, as in previous years, disparities exist among ethnic groups and minority populations including Native Americans, blacks and Hispanics. After adjusting for population age differences between the groups, the rate of diagnosed diabetes was highest among Native Americans and Alaska Natives (16.5 percent). This was followed by blacks (11.8 percent) and Hispanics (10.4 percent), which includes rates for Puerto Ricans (12.6 percent), Mexican Americans (11.9 percent), and Cubans (8.2 percent). By comparison, the rate for Asian Americans was 7.5 percent with whites at 6.6 percent.   The data are an update of diabetes prevalence estimates last reported two years ago and now published in the 2007 National Diabetes Fact Sheet developed by CDC in collaboration with multiple agencies under the U.S. Department of Health and Human Services and other federal agencies.   CDC also is releasing estimates of diagnosed diabetes for all counties in the United States. Derived from the agency's Behavioral Risk Factor Surveillance Survey (BRFSS) and census data, the estimates provide a clearer picture of areas within states that have higher diabetes rates. Nationally, the data indicate increased diabetes rates in areas of the Southeast and Appalachia that have traditionally been recognized as being at higher risk for many chronic diseases, including heart disease and stroke.   “These data are an important step in identifying the places in a state that have the greatest number of people affected by diabetes,” said Dr.Albright. “If states know which communities or areas have more people with diabetes, they can use that information to target their efforts or tailor them to meet the needs of specific communities.”   CDC, through its Division of Diabetes Translation, funds diabetes prevention and control programs in all 50 states, as well as the District of Columbia and eight U.S. territories and island jurisdictions. The National Diabetes Education Program, co-sponsored by CDC and the National Institutes of Health (NIH), provides diabetes education to improve the treatment and outcomes for people with diabetes, promote early diagnosis, and prevent or delay the onset of diabetes.   For more information on diabetes, please visit www.cdc.gov/diabetes . To access the National Diabetes Fact Sheet and county-level estimates of diagnosed diabetes, click on the "data and trends" link at the left.   Source: CDC Press Release

Study Launched to Uncover the Mysteries of Chronic Fatigue Syndrome

Researchers from the Centers for Disease Control and Prevention (CDC) and Emory University School of Medicine in Atlanta recently launched the most comprehensive population-based clinical study to date of patients with chronic fatigue syndrome (CFS). The study includes about 90 patients from Atlanta who will participate in the three-day in-patient clinical trial. Researchers hope results from the study will help them better understand how the syndrome affects people and lead to more successful treatment.   "We're learning more about the complexities of the illness that is chronic fatigue syndrome," said William C. Reeves, M.D., Chief of the Chronic Fatigue Syndrome Research Program at CDC. "Launching this research study with Emory will help us draw a clearer picture of how CFS affects people that ultimately could lead to more effective treatment of patients with CFS."   Each designated participant will spend three days at Emory University Hospital General Clinical Research Center (GCRC). Participants will undergo repeated blood draws and salivary sampling in addition to computerized testing and functional Magnetic Resonance Imaging (fMRI) of the brain. The study is planned to be completed within a year.   CFS, a condition characterized by fatigue, memory problems, and pain, may be more widespread than once thought. Experts estimate that between one and four million people in the United States may suffer from CFS. Unfortunately, an estimated 80 percent of all CFS patients have not yet been diagnosed by a medical provider.   The CDC-Emory study is designed to evaluate mechanisms of the illness with an emphasis on alterations in the regulation of hormones and the immune system as well as alterations in the brain circuits involved in cognitive function and mental fatigue. The molecular and genetic aspects of these alterations will also be explored.   "We believe this research will lead us to a better understanding of the causes of CFS, both from a psychological and biological standpoint," says Andrew Miller, M.D., Timmie Professor of Psychiatry and Behavioral Sciences at Emory and Emory principal investigator of the study. "We believe that this study will open doors that may lead us to better ways of diagnosing and treating CFS in the future."     CFS – The Larger Public Health Impact It is estimated that only half of CFS patients have sought medical attention and fewer than one in five have been diagnosed and treated. This is a particular source of concern since early treatment could be associated with a significantly higher rate of recovery. Often, patients may report symptoms like being frequently exhausted, or having difficulty sleeping and concentrating, which may be linked to many other causes.   Dr. Reeves said, "CFS is often difficult to diagnose and physicians rely on patients reporting symptoms to identify the illness. There is no disease specific laboratory test for CFS, and the diagnosis is often made through a process of eliminating other causes that may explain the patients' signs and symptoms."   CFS occurs most frequently in women ages 40-60, but affects all races, sexes, and age groups, and can be as disabling as multiple sclerosis and chronic obstructive pulmonary disease. The condition can also take a tremendous personal and social toll on patients and their families, with a quarter of those affected by CFS either unemployed or on disability assistance.   "Our economic impact studies show that a family in which someone has CFS could forego up to $20,000 a year in annual earnings and wages, and that a quarter of them are either on disability or out of work following the illness," explains Reeves. "It is a serious public health problem."   If you think you or someone you know might be suffering from CFS, consult a health care professional to learn more about options that are available for you. For more information on CFS, visit www.cdc.gov/cfs.     Milestones of Previous CFS Studies   • CDC estimates that 2.5% of Georgians ages 18-59 years suffer from chronic fatigue syndrome. This represents a six- to ten-fold higher prevalence than previous estimates from other areas. More…   • CDC estimates that the average family in which a member suffers from CFS foregoes $20,000 in annual earnings and wages, nearly half the median US household income. More…   • CDC studies reveal that early life stress and accumulated lifetime stress are strongly and significantly associated with CFS. The current study at Emory Hospital will further clarify these findings. More…   • CDC research reveals that abnormally low morning concentrations of the hormone cortisol may be correlated with more severe fatigue in CFS patients, especially in women. More…   • CDC research has demonstrated that multiple types of early childhood trauma are important risk factors for CFS. More…   • CDC has conducted numerous studies to better understand the symptoms which would be included in the definition of chronic fatigue syndrome. Ultimately, this research has provided a formal case definition for CFS and provides clinicians a guide for diagnosing patients.      Additional Information CDC has a comprehensive provider education program that includes outreach nationally at conferences, grand rounds, and through on-line continuing education. This outreach is aimed at aiding providers in the diagnosis, management, and treatment of CFS. CDC purposely attempts to publish research on CFS in open-access journals to aid the public, patients, and providers in obtaining the most up-to-date information on this illness. For more information on the studies being conducted by CDC on chronic fatigue syndrome and the resulting research, please see the CFS website: http://www.cdc.gov/cfs/cfsresearch.htm.   Source: CDC Press Release

New Gene Methylation Test For Prostate Cancer

Veridex, LLC announced that its licensing collaborator, Laboratory Corporation of America Holdings (LabCorp), has commercially launched a new gene methylation test for prostate cancer. The new assay uses the biological specificity of ‘DNA methylation’ in prostate cancer, detecting the methylation of the gene GST-Pi. Methylation is a modification of DNA that occurs primarily in cancer. Veridex is developing the methylation markers in this tissue assay, GST-Pi, along with other markers, for a urine-based screening test for prostate cancer.   Prostate cancer is the leading cause of cancer death in men in the U.S., with more than 230,000 cases diagnosed annually.   LabCorp licensed the methylation technology from Veridex in 2007. Veridex licensed this technology from OncoMethylome Sciences, S.A. (OMS).   About Veridex Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. For additional information, please visit http://www.veridex.com.

Novozymes Receives Grant for Research in Sustainable Biodiesel

We must have biodiesel in our gas tanks to help the environment. But biodiesel requires high-quality raw materials, and this limits its supply. Now a new technology opens the possibility to use waste oils to produce biodiesel.   Biodiesel requires good-quality raw materials. Today, this usually means using rapeseed and soy, which are also used in the manufacture of food products. Now Danish researchers will develop a new technology to replace the chemical production of biodiesel with an enzymatic process that will reduce concerns about biodiesel, both for the environment and the supplies of food.   The Danish National Advanced Technology Foundation has granted DKK 15 million towards research in biodiesel over the next 3.5 years. The leader of the project, Per Munk Nielsen from Novozymes A/S, says, ”The chemical process demands raw materials of high quality that can often also be used as food. With a process based on enzymes we will be able to use raw materials of poorer quality, such as animal fats, recycled restaurant oils, and waste products, all materials that cannot be used as food.   ”We will also deliver processes that reduce the CO2 contribution, so that in 3.5 years we will have a technology that is well documented as more environmentally friendly. The plan to document the research results includes a pilot-scale plant that will be ready at the end of the 3.5 year grant period,” Per Munk Nielsen adds.   Emmelev A/S, one of the participating companies, already produces biodiesel and sees great possibilities for the project. "With the new enzymatic process we will be able to use many more different raw materials than we can use today, being mainly rapeseed and soy. We will be able to use waste oils that today are simply thrown away. We will produce only the main products and no by-products,” says Morten Simonsen, Sales Director at Emmelev A/S.   The five partners in the research project are three Danish research institutes, located at the Technical University of Denmark and Aarhus University, and two Danish companies, Novozymes A/S in Bagsvaerd and Emmelev A/S in Otterup.

Pioneering Eye Surgery Network from India Receives 2008 Bill Gates Award for Global Health

-Nonprofit Aravind Eye Care System Wins $1 Million Prize for Preventing and Curing Blindness in India's Poorest Communities-   SEATTLE -- In recognition of its groundbreaking work to prevent debilitating blindness and provide affordable, world-class eye care to the poor, the Aravind Eye Care System, based in Tamil Nadu, India, has won the 2008 Gates Award for Global Health. The $1 million Gates Award—the world's largest prize for international health—honors extraordinary efforts to improve health in developing countries.   Founded by Dr. G. Venkataswamy in 1976, Aravind has saved millions of people in India from debilitating blindness. Cataracts account for more than half the cases of blindness in India. In the past year, Aravind provided out-patient care to approximately 2.4 million patients and performed more than 280,000 surgeries. Thanks in part to Aravind's efforts, the estimated number of blind people in India fell from 8.9 million in 1990 to 6.7 million in 2002, a decline of 25%.   William H. Gates Sr., co-chair of the Bill & Melinda Gates Foundation, will present the award on May 29 at the Global Health Council's 35th Annual International Conference in Washington, DC.   "Being blind in a rural village in the developing world leaves a person in darkness and dependence, often unable to earn a living or assist in the duties of their household," said Mr. Gates. "Aravind has given sight to millions of men, women, and children, enabling them to participate fully in the lives of their families and communities."   Since 1976, Aravind has grown from a rented house with 11 beds to a thriving network of hospitals and satellite clinics that provide eye exams and surgeries, train health care professionals, conduct research, and manufacture eye care products.   Outreach teams from Aravind hospitals coordinate with local leaders and service groups across India to organize "eye camps" that provide free exams. Since 2004, Aravind has used high-speed broadband access to link these camps directly to on-call doctors in central hospitals. The doctors can diagnose and refer patients in real time, ensuring that only those who require surgery make the journey to the hospital.   "All people have a right to sight," said Dr. Perumalsamy Namperumalsamy, chairman of Aravind. "We hope that this award will encourage others to develop creative, sustainable solutions to blindness and other global health challenges."   Aravind's innovative business model enables it to provide the same high-quality care to every patient, regardless of their ability to pay, without charitable contributions. The organization enlists local businesses to sponsor eye care hospitals, and subsidizes care for the poor through fees from paying patients and global sales of eye care products.   "Ensuring that the world's poorest people can access essential health care is an ongoing challenge in global health," said Dr. Nils Daulaire, president of the Global Health Council. "Aravind has demonstrated that there are ways to do good and commit to providing the highest quality services while utilizing the latest technologies and scientific advances."     About the Gates Award for Global Health The Gates Award for Global Health was established by Bill and Melinda Gates in 2000 to recognize exemplary work in international health. The Global Health Council coordinates the selection process for and presentation of the Gates Award at its Annual International Conference.   Previous recipients of the Gates Award include Thailand's Population and Community Development Association for its innovative work in family planning and HIV prevention (2007); the Carter Center, for its pioneering work to fight neglected diseases (2006); the African Medical and Research Foundation, for improving health in some of Africa's poorest communities (2005); the Bangladesh Rural Advancement Committee, for community-based health programs (2004); the Brazilian National AIDS Program, for its integrated approach to HIV prevention and treatment (2003); the Rotary Foundation of Rotary International, for contributions to polio eradication (2002); and the ICDDR,B Center for Health and Population Research, for the discovery of a diarrhea therapy that has saved millions of lives (2001).     Bill & Melinda Gates Foundation Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, the foundation is led by CEO Patty Stonesifer and co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

Fiveprime And Pfizer Enter Oncology And Diabetes Collaboration

SAN FRANCISCO, California – May 20, 2008. Five Prime Therapeutics, Inc. and Pfizer Inc. announced the initiation of a worldwide collaborative research and license agreement. The collaboration will focus on the discovery of antibody targets and novel therapeutic protein products to treat certain areas of cancer and diabetes. Under the collaboration, FivePrime will screen its comprehensive protein library in both cell-based assays and primary in vivo screens directed toward finding potential therapeutic protein products and antibody targets.   Upon the commencement of the collaboration, FivePrime will receive an up-front payment and an equity investment from Pfizer and three years of committed research funding. Pfizer will have exclusive worldwide rights to develop and commercialize certain products and targets discovered during the research term, in exchange for future milestones and royalties. Further details of the agreement have not been disclosed.   “Pfizer’s commitment to biotherapeutics and its extensive development and commercialization capabilities are an ideal match for FivePrime’s powerful biologics discovery platform. This combination will increase the likelihood and speed of discovering and developing new biotherapeutics for patients in need” stated Lewis T. (“Rusty”) Williams, MD, PhD, FivePrime’s Founder and Executive Chairman.   FivePrime’s existing investors made a co-investment in FivePrime in conjunction with Pfizer’s equity purchase. “This is a very significant transaction for FivePrime,” commented Gail Maderis, President and CEO of FivePrime. “It provides the financial runway to take several of our oncology products into clinical trials in addition to greatly expanding our discovery efforts.”   A key component of the collaboration is FivePrime’s comprehensive, rapid protein discovery system. Its protein screening library contains essentially all human secreted proteins and their receptors, including many that are unavailable in public collections. FivePrime screens its protein library in both complex, primary cell assays and in high-throughput in vivo systems. The in vivo technology is also used for rapid validation of hits, significantly reducing the time from an idea to an Investigational New Drug.   “We are very excited about this research collaboration, as it will fill a core need for Pfizer’s new biologics enterprise, the Biotherapeutics and Bioinnovation Center (BBC),” said BBC President Corey Goodman, PhD. “Our mission is to gain access to the best internal and external science and to achieve Pfizer’s corporate ambition of becoming a global leader in biotherapeutics. The investment and partnership with FivePrime represents a key milestone in our efforts as we are confident it will generate therapeutic proteins and antibodies that will ultimately lead to innovative medicines for patients worldwide.”   About FivePrime FivePrime is a privately held protein therapeutics discovery and development company located in San Francisco’s Mission Bay development. FivePrime’s most advanced programs are in oncology, with its lead biotherapeutic (FP-1039) slated to enter clinical testing in 2008, and two additional products in advanced preclinical development. FivePrime has discovery collaborations with Boehringer Ingelheim in the field of rheumatoid arthritis and with Centocor in the field of pulmonary fibrosis and osteoarthritis to identify new biotherapeutics and antibody targets. For more information please visit www.fiveprime.com.   About Pfizer Inc. and the Biotherapeutics and Bioinnovation Center (BBC) Pfizer Inc. is the world's largest research-based biomedical and pharmaceutical company, employing approximately 87,000 colleagues in more than 150 countries. In 2007, Pfizer earned $48.4 billion in revenues and invested $8.1 billion in research and development. The BBC is based in the San Francisco Bay Area of California and combines cutting-edge biology, new platform technologies, and advanced research tools to discover and develop new medicines. This new venture is a significant departure for Pfizer and the pharmaceutical industry. Located in one of the hubs of biotechnology, the BBC has the entrepreneurial spirit of biotech and will collaborate broadly with the academic, biotech, and venture communities to focus on discovering and developing new medicines. For more information please visit www.pfizer.com.

New Technique to Use Light to Detect Alzheimer's

New Technique May Help Identify Ways to Predict and Prevent Deadly Disease   WASHINGTON, March 14—A team of researchers in Bedford, Mass. has developed a way of examining brain tissue with near-infrared light to detect signs of Alzheimer's disease.   In the March 15 issue of the journal Optics Letters, published by the Optical Society of America, the team describes how they used optical technology to examine tissue samples taken from different autopsies and correctly identified which samples came from people who had Alzheimer's disease, which currently afflicts some 4.5 million Americans and is the most common cause of dementia among older people in the United States.   "We're primarily interested in finding a way of diagnosing and monitoring Alzheimer's disease during life," says U.S. Department of Veterans Affairs Research Scientist Eugene Hanlon. "We think this technique has a lot of potential for detecting the disease early on."   The new technique developed by Hanlon and his collaborators at Harvard Medical School/Beth Israel Deaconess Medical Center and Boston University can detect alterations to the optical properties of the brain that occur as the tissue undergoes microscopic changes due to Alzheimer's—sometimes far in advance of clinical symptoms. The technique is now being tested for its effectiveness at diagnosing Alzheimer's disease in living people.   For several years, Hanlon and his colleagues have looked at the possibility of analyzing the brain with near-infrared light, which has the advantage of being able to safely penetrate the skull and pass harmlessly through the brain.  Inside the head, some of the infrared light scatters, however, and how the light scatters can tell researchers about the condition of the brain.   In their paper, the team reports observing an optical effect due to the presence of microscopic features of Alzheimer's. Amyloid plaques, one of the telltale signs of Alzheimer's disease, scatter light differently from normal brain tissue. What Hanlon and his colleagues showed was that as the microscopic plaques accumulate, the optical properties of the brain change. The team found that this change is detectable and that their technique could quantify differences between in-vitro samples and correctly identify signs of Alzheimer's.   This technique will be a boon to medicine if it is able to detect microscopic changes that can be related to disease progression. While techniques like MRI are good at identifying the gross anatomical features associated with Alzheimer's, they cannot detect more microscopic changes.   Although Alzheimer's disease is one of the leading causes of death in the United States, claiming tens of thousands of American lives a year, there is no definitive way to diagnose it—at least not while someone is alive. After someone with Alzheimer's dies, pathologists can perform an autopsy and examine slices of the brain under the microscope, looking for the same signs that Alois Alzheimer first recognized when he identified the disease more than a century ago. Finding accumulations of amyloid plaques in the brain substance and tangle-like proteins in nerve cells is the only way to confirm with certainty that someone had Alzheimer's while they were alive.   Since there is no way to safely examine the brains of living people this way, doctors currently diagnose Alzheimer's disease using other methods. They rely on reviewing medical histories, administering physical exams, and taking into account the results of a battery of neuropsychological assessments that measure cognitive performance. A positive diagnosis is made when all other possible causes have been eliminated, but even under the best of circumstances, these diagnoses can be incorrect 10 percent of the time or more.   Accurate, early detection of Alzheimer's could save many lives. While there is no cure for the disease, clinically proven treatments can slow its progress—especially if they are administered early on. Moreover, being able to follow the disease progression over time would greatly enhance the ability of researchers and pharmaceutical companies to find new and improved drugs and treatment strategies for people at all stages of the disease.   A current rich area of research seeks to get information about what is going on in the brain without actually looking at the tissue. Some scientists, for instance, look at whether proteins and other biomarkers in the blood or spinal fluid indicate disease progression. Others try to image the brain with established techniques like MRI or PET scans. Optical methods, like the one used by the Bedford researchers, are an emerging approach to imaging.   The research was funded by the U.S. Department of Veterans Affairs, the National Science Foundation, and a New Concept Award from the Center for Integration of Medicine & Innovative Technology.   Paper: "Scattering Differentiates Alzheimer Disease In Vitro," by Eugene B. Hanlon et al., Optics Letters, Vol. 33, No. 6, March 15, pp. 624-26, abstract at http://www.opticsinfobase.org/abstract.cfm?URI=ol-33-6-624 .   About OSA Uniting more than 70,000 professionals from 134 countries, the Optical Society of America (OSA) brings together the global optics community through its programs and initiatives. Since 1916 OSA has worked to advance the common interests of the field, providing educational resources to the scientists, engineers and business leaders who work in the field by promoting the science of light and the advanced technologies made possible by optics and photonics. OSA publications, events, technical groups and programs foster optics knowledge and scientific collaboration among all those with an interest in optics and photonics. For more information, visit www.osa.org.

University of California, Davis Study Shows that Global Warming could Radically Change Lake Tahoe in 10 Years

March 24, 2008-A new UC Davis study predicts that climate change will irreversibly alter water circulation in Lake Tahoe, radically changing the conditions for plants and fish in the lake -- and it could happen in 10 years.One likely result would be a warmer lake overall, with fewer cold-water native fish, and more invasive species, such as large-mouth bass, bluegill and carp.Still unclear is how the changes would affect the lake's phenomenal clarity and cobalt-blue color, which have helped to make the Tahoe Basin an international vacation destination.   The new findings were announced March 18 at a Tahoe scientific conference by three lake experts from the Tahoe Environmental Research Center at UC Davis -- Director Geoffrey Schladow, Associate Director John Reuter and postdoctoral researcher Goloka Sahoo."What we expect is that deep mixing of Lake Tahoe's water layers will become less frequent, even non-existent, depleting the bottom waters of oxygen. This will result in major, permanent disruption to the entire lake food web," Schladow said. "This is not unheard of," he continued. "Anoxia (oxygen depletion) occurs annually in most lakes and reservoirs in California in the summer. But Tahoe has always been special. It's been above and beyond such things.   "A permanently stratified Lake Tahoe becomes just like any other lake or pond. It is no longer this unique, effervescent jewel, the finest example of nature's grandeur." Schladow said research is ongoing to determine if lowered global greenhouse-gas emissions would significantly slow the lake's decline, or even prevent it.   UC Davis researchers are in their 50th year of teasing apart the intertwining threads of biology, chemistry and physics that determine what Lake Tahoe looks like and what organisms live in it.One of their chief objectives has been to understand the clarity-clouding effects of pollution from population growth and development, so that policymakers can devise solutions. Then, in December 2004, they reported that the lake was showing a new influence: Its water was warming up, probably because of global climate change.   The new study combined 40 years of weather data in the basin with mathematical models of global climate to create likely scenarios of future climate conditions at Lake Tahoe. Using those scenarios, the team employed a lake physics model to see how various combinations of probable air temperatures, cloudiness and wind speed would affect the mixing of water layers in the lake.   Currently, Lake Tahoe water mixes, on average, every four years. The deepest mixing typically occurs in late February. This winter -- a particularly cold and snowy one -- Lake Tahoe experienced mixing throughout its entire 1,644-foot depth.   This mixing has profound ecological and water-quality impacts. Deep mixing moves nutrients from the lake bottom to the water surface, where they promote the growth of algae. And it takes oxygen from the surface and distributes it throughout the lake, which supports aquatic life.The new study showed that, if global greenhouse-gas emissions continue at current levels, mixing could become less frequent and less deep -- even stop altogether as soon as 2019.   Schladow said that was quite a shock. "While we expected that the lake would mix less in the future, learning that we may be only a decade or two from the complete shutdown of deep mixing was very surprising."If mixing shuts down, then no new oxygen gets to the bottom of the lake, and creatures that need it, such as lake trout, will have a large part of their range excluded," Schladow said.   Equally worrying, he said, is the likelihood that when the oxygen is gone, phosphorus that is currently locked up in the lake-floor sediments will get released. This phosphorus will eventually reach the lake's surface, where it will fuel algal growth. Algae blooms can cause many problems, including reduced lake clarity, unpleasant odors and bad-tasting drinking water.   The climatic changes that are expected to affect Lake Tahoe are also impacting lakes around the world. These widespread concerns have been the topic of a science workshop at the Tahoe Environmental Research Center that runs through March 25. Researchers from Japan, New Zealand, Chile and the United States will discuss strategies to pool and analyze data from many of the lakes in the Pacific Rim region. Their goal is to learn more about the security of drinking-water supplies and the ecological sustainability of these lake systems.   About the Tahoe Environmental Research Center at UC Davis The Tahoe Environmental Research Center conducts and supports multidisciplinary research, education and public outreach on lake systems and their contributing watersheds and airsheds. Lake systems encompass the physical, biogeochemical and human environments, and the interactions between them. The center is committed to providing objective scientific input to support the restoration and long-term sustainability of the Lake Tahoe Basin. It is a program of the John Muir Institute of the Environment at UC Davis.

Spinal Injury Regeneration Hope Using the Enzyme Chondroitinase

Scientists believe they are close to a significant breakthrough in the treatment of spinal injuries. The University of Cambridge team is developing a treatment which could potentially allow damaged nerve fibers to regenerate within the spinal cord. Although it is possible for nerves to regenerate, they are blocked by the scar tissue that forms at the site of the spinal injury. The Cambridge team has identified a bacteria enzyme called chondroitinase which is capable of digesting molecules within scar tissue to allow some nerve fibers to re-grow.   The enzyme also promotes nerve plasticity, which potentially means that remaining undamaged nerve fibers have an increased likelihood of making new connections that could bypass the area of damage. It may also encourage the remaining undamaged nerve fibers to work more effectively.   Spinal injuries are difficult to treat because the body cannot repair damage to the brain or spinal cord. We are very hopeful that at last we may be able to offer paralyzed patients a treatment to improve their condition  In preliminary tests, the researchers have shown that combining chondroitinase with rehabilitation produces better results than using either technique alone.  What often happens in a clinical setting is that you don't get to see the results you would have liked  However, trials have yet to begin in patients.   Lead researcher Professor James Fawcett said: "It is rare to find that a spinal cord is completely severed, generally there are still some nerve fibers that are undamaged. "Chondroitinase offers us hope in two ways; firstly it allows some nerve fibers to regenerate and secondly it enables other nerves to take on the role of those fibers that cannot be repaired.   "Along with rehabilitation we are very hopeful that at last we may be able to offer paralyzed patients a treatment to improve their condition." Dr Yolande Harley, of the charity Action Medical Research which funded the work, said: "This is incredibly exciting, ground-breaking work, which will give new hope to people with recent spinal injuries."   Medical advances mean that spinal injuries have ceased to be the terminal conditions that they often once were, but they still had a huge impact on quality of life.

New Clue in Motor Neuron Disease (MND)

Researchers say they have made the most significant breakthrough in the quest to understand the fatal condition Motor Neuron Disease (MND). A team says a mutated gene is behind one form of the disease - and can be used to understand it better. The international team, led by King's College London, found that in one family affected by a rare, inherited form of the condition, there were mutations in the gene coding for the protein TDP-43.   The study, published in Science, is the most important since a first gene was identified in 1993.   MND involves the progressive wasting of the muscles - while usually leaving the mind unaffected. Stephen Hawking, who has lived for 35 years with MND, is an exception. This new information will be a springboard to greater understanding of the processes that cause motor neurons to die. The protein has long been known to accumulate abnormally in MND patients, but it had been thought this was an innocent by-product of the disease.   Now, says Professor Chris Shaw, who led the research, it is clear that this protein is "directly toxic" to motor neurons. While the inherited form of the disease this mutation causes is extremely rare - accounting for just 1% of MND cases - researchers can use their findings to give animals the disease and investigate how it develops. "It is a new biological tool to understand the disease and develop treatments," says Professor Shaw. "It is another part of the jigsaw, but there are still, admittedly, a lot of pieces missing."   The first part of that jigsaw was uncovered in 1993, when researchers found the gene mutation SOD1 was responsible for one form of MND. Experts say this finding improved understanding, although it has yet to impact significantly on treatment.   This new information will be a springboard to greater understanding of the processes that cause motor neurons to die. It is through such understanding that we will develop the treatment strategies to defeat this devastating disease.

Secure Vaulted Global Seed Bank Opened in Arctic region off Norway

Oslo - Dignitaries including 2004 Nobel Peace Prize laureate Wangari Maathai celebrated the official opening of a global seed vault on an island off northern Norway. Blasted into a mountain, the three chambers in the Svalbard Global Seed Vault will contain seeds from key staple crops including maize, rice, wheat, beans, sorghum, cowpeas and soybeans. 'It is a Noah's Ark for our biological heritage,' Norwegian Prime Minister Jens Stoltenberg said of the Norway-funded vault that cost 50 million kroner (9.3 million dollars) to build. The vault is located about one kilometer away from the airport serving Longyearbyen, the main settlement on Svalbard, an archipelago off northern Norway some 1,000 kilometers from the North Pole. Arctic temperatures, permafrost and stable geological conditions were decisive factors in the choice of Svalbard. The seed bank is to serve as a safety net and store copies of seeds from other seed banks and collections worldwide. Capacity is estimated at 4.5 million samples - some 2 billion seeds. The seeds will be stored at -18 degrees Celsius. Should there be a power failure, the permafrost of -4 degrees will keep temperatures below freezing, organizers said. Deposits have been made from gene banks including the International Rice Research Institute (IRRI) in the Philippines and the International Maize and Wheat Improvement Centre (CIMMYT) in Mexico. The Rome-based Global Crop Diversity Trust has provided funds for the transport of the seeds that are stored in vacuum-sealed aluminium bags packed in special boxes. Cary Fowler, Executive Director of the Trust, said 'crop diversity will soon prove to be our most potent and indispensable resource for addressing climate change, water and energy supply constraints, and for meeting the food needs of a growing population.' The vault would likely be accessed only a few times a year, mainly to deposit new samples. Stoltenberg and Maathai carried the first box of seeds into the vault. Maathai founded the Kenya-based Green Belt Movement which has planted millions of trees across Africa and she was the first environmentalist to win the Nobel Peace Prize. 'We now understand that along with international movements to save endangered species and the rainforests of the world, it is just as important for us to conserve the diversity of the world's crops for future generations,' Maathai said. Other dignitaries present followed suit, including Jose Manuel Barroso, head of the European Commission, and Jacques Diouf, Director-General of the UN Food and Agriculture Organization (FAO).

University of California at Davis Launches a Unique Dog Blood Bank that will Include 13 Different Blood Types for Dogs

February 26, 2008-Dogs and their owners can now give the gift of life to other dogs, thanks to a new community-based canine blood donor program that was launched by the University of California, Davis, School of Veterinary Medicine.   Dogs have 13 different blood types; the preferred donor type is dog erythrocyte antigen 1.1 negative.   The UC Davis veterinary hospital currently is limiting its community blood collection to dogs because the tests necessary for screening the health of cats are too expensive. The hospital will continue to keep its on-campus colony of blood donor cats. In addition to providing blood products for dog transfusions, the teaching hospital annually carries out 400 to 500 transfusions for cats, pigs, horses, cows, sheep and goats. The new animal blood bank will store regular blood products for all of these species. It also will store umbilical cord blood for future use and will process adult stem cells from horse patients, which can be used to treat ligament, tendon or joint injuries and promote healing of some fractures.   Until today, the hospital has obtained blood for its canine patients from a group of about 30 blood-donor dogs that live for a few years at the hospital and then are adopted out. Now, as the blood-donor program develops, those dogs are being matched with good homes.    Approximately 1,200 pet dogs and canine law-enforcement officers will be screened during the coming year to develop a group of 200 to 400 regular donors. Although dogs are capable of donating blood monthly, the regular donors will probably come in two to three times per year. The donor program and its new UC Davis Animal Blood Bank are housed in the campus's William R. Pritchard Veterinary Medical Teaching Hospital. It is the largest such program west of the Mississippi.   "Each year, the teaching hospital provides 200 to 300 transfusions for dogs to treat conditions ranging from surgical complications to kidney failure," said Dr. Sean Owens, the blood bank's medical director and head of the veterinary hospital's Transfusion Medicine Section. "This new donor program will allow us to develop a large, reliable source of blood products for our patients, without maintaining a colony of donor dogs here at the hospital."    Until today, the hospital has obtained blood for its canine patients from a group of about 30 blood-donor dogs that live for a few years at the hospital and then are adopted out. Now, as the blood-donor program develops, those dogs are being matched with good homes.   (Members of the public who might be interested in adopting a retired canine blood donor can obtain more information about the dogs by e-mailing caninebloodbank@gmail.com )   Donor dogs for the new program must be 1 to 8 years old, weigh at least 55 pounds and have never been pregnant or had puppies. To make regular donation practical, the dogs and their owners must live within 100 miles of UC Davis.   The animal's first visit to the blood bank will last for about one hour. During that appointment, each dog will be given a health check and screened for infectious diseases, and a unit of blood (about one pint) will be collected. If any health problems are detected, the owner will be advised to follow up with the dog's regular veterinarian. If cleared for further donation, the animal will return in two to three months for a half-hour donation visit. The initial health check, which includes veterinary services valued at $300, will be free, as will all subsequent donation visits.   Eventually, the program plans to establish a mobile blood bank that could be taken to dog shows and other canine events to make donating more convenient for dogs and their owners.Dog owners interested in learning more about the blood donor program or scheduling a health-screening appointment for their dog should contact the Veterinary Medical Teaching Hospital at (530) 752-1393, ext. 421.

International Consortium Announces the 1000 Genomes Project

--Major Sequencing Effort Will Produce Most Detailed Map Of Human Genetic Variation to Support Disease Studies--   Jan 2008-An international research consortium announced the 1000 Genomes Project, an ambitious effort that will involve sequencing the genomes of at least a thousand people from around the world to create the most detailed and medically useful picture to date of human genetic variation. The project will receive major support from the Wellcome Trust Sanger Institute in Hinxton, England, the Beijing Genomics Institute,Shenzhen (BGI Shenzhen) in China and the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH).   Drawing on the expertise of multidisciplinary research teams, the 1000 Genomes Project will develop a new map of the human genome that will provide a view of biomedically relevant DNA variations at a resolution unmatched by current resources. As with other major human genome reference projects, data from the 1000 Genomes Project will be made swiftly available to the worldwide scientific community through freely accessible public databases.   “The 1000 Genomes Project will examine the human genome at a level of detail that no one has done before,” said Richard Durbin, Ph.D., of the Wellcome Trust Sanger Institute, who is co-chair of the consortium. “Such a project would have been unthinkable only two years ago. Today, thanks to amazing strides in sequencing technology, bioinformatics and population genomics, it is now within our grasp. So we are moving forward to build a tool that will greatly expand and further accelerate efforts to find more of the genetic factors involved in human health and disease.”   Any two humans are more than 99 percent the same at the genetic level. However, it is important to understand the small fraction of genetic material that varies among people because it can help explain individual differences in susceptibility to disease, response to drugs or reaction to environmental factors. Variation in the human genome is organized into local neighborhoods called haplotypes, which are stretches of DNA usually inherited as intact blocks of information.   Recently developed catalogs of human genetic variation, such as the HapMap, have proved valuable in human genetic research. Using the HapMap and related resources, researchers already have discovered more than 100 regions of the genome containing genetic variants that are associated with risk of common human diseases such as diabetes, coronary artery disease, prostate and breast cancer, rheumatoid arthritis, inflammatory bowel disease and age-related macular degeneration.   However, because existing maps are not extremely detailed, researchers often must follow those studies with costly and time-consuming DNA sequencing to help pinpoint the precise causative variants. The new map would enable researchers to more quickly zero in on disease-related genetic variants, speeding efforts to use genetic information to develop new strategies for diagnosing, treating and preventing common diseases.   The scientific goals of the 1000 Genomes Project are to produce a catalog of variants that are present at 1 percent or greater frequency in the human population across most of the genome, and down to 0.5 percent or lower within genes. This will likely entail sequencing the genomes of at least 1,000 people. These people will be anonymous and will not have any medical information collected on them, because the project is developing a basic resource to provide information on genetic variation. The catalog that is developed will be used by researchers in many future studies of people with particular diseases.   “This new project will increase the sensitivity of disease discovery efforts across the genome five-fold and