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Period Ending June 06, 2008
PERSONALIZED MEDICINE: GENETIC INFORMATION CAN HELP PEOPLE SELECT VITAMINS TO CORRECT SMALL DNA FLAWS
University of California, Berkeley scientists have found a reason to delve into your genetic heritage: to find the slight genetic flaws that can be fixed with remedies as simple as vitamin or mineral supplements. In a study published in the online edition of the journal Proceedings of the National Academy of Sciences, the researchers found that there are many genetic differences that make people’s enzymes less efficient than normal, and that simple supplementation with vitamins can often restore some of these deficient enzymes to full working order. They said their studies have convinced them that there is a lot of variation in the population in these enzymes, and a lot of it affects function, and a lot of it is responsive to vitamins. They believe it may turn out the people are going to require a different optimal dose of vitamins based on their genetic makeup, based upon the kind of variance they are harboring in vitamin-dependent enzymes. Though the initial study tested the function of human gene variants by transplanting them into yeast cells, where the function of the variants can be accurately assessed, the researchers said they are confident the results will hold up in humans.
University of California, Berkeley scientists have found a reason to delve into your genetic heritage: to find the slight genetic flaws that can be fixed with remedies as simple as vitamin or mineral supplements. In a study published in the online edition of the journal Proceedings of the National Academy of Sciences, the researchers found that there are many genetic differences that make people’s enzymes less efficient than normal, and that simple supplementation with vitamins can often restore some of these deficient enzymes to full working order. They said their studies have convinced them that there is a lot of variation in the population in these enzymes, and a lot of it affects function, and a lot of it is responsive to vitamins. They believe it may turn out the people are going to require a different optimal dose of vitamins based on their genetic makeup, based upon the kind of variance they are harboring in vitamin-dependent enzymes. Though the initial study tested the function of human gene variants by transplanting them into yeast cells, where the function of the variants can be accurately assessed, the researchers said they are confident the results will hold up in humans.
DIAGNOSTICS: FDA CLEARS INVITROGEN DIAGNOSTICS SYSTEM TO DETERMINE TRANSPLANT COMPATIBILITY
Carlsbad, California-based Invitrogen said it received U.S. Food and Drug Administration clearance for its DynaChip Antibody Analysis System to match organ donors to transplant recipients. The DynaChip system is the only automated chip-based system for human leukocyte antigen or HLA antibody detection and identification. Human leukocyte antigens are proteins found on the surface of certain cells in the body that are used by the immune system to identify material foreign to the body, such as viruses or bacteria. HLA antibody identification is important for organ transplant donor-recipient matching. In the case of organ donation, a patient’s immune system may fight cells from the donor, causing organ donation failure or rejection.
Carlsbad, California-based Invitrogen said it received U.S. Food and Drug Administration clearance for its DynaChip Antibody Analysis System to match organ donors to transplant recipients. The DynaChip system is the only automated chip-based system for human leukocyte antigen or HLA antibody detection and identification. Human leukocyte antigens are proteins found on the surface of certain cells in the body that are used by the immune system to identify material foreign to the body, such as viruses or bacteria. HLA antibody identification is important for organ transplant donor-recipient matching. In the case of organ donation, a patient’s immune system may fight cells from the donor, causing organ donation failure or rejection.
DIABETES: STUDY LINKS VITAMIN D TO REDUCING RISK OF TYPE 1 FORM OF THE DISEASE
Sun exposure and vitamin D levels may play a strong role in risk of type 1 diabetes in children, according to new findings by researchers at the Moores Cancer Center at University of California, San Diego and the Department of Family and Preventive Medicine. The study, published in the online version of the scientific journal Diabetologia, found that populations living at or near the equator, where there is abundant sunshine (and ultraviolet B irradiance), have low incidence rates of type 1 diabetes. Conversely, populations at higher latitudes, where available sunlight is scarcer, have higher incidence rates. These findings add new support to the concept of a role of vitamin D in reducing risk of this disease. Ultraviolet B exposure triggers photosynthesis of vitamin D3 in the skin. This form of vitamin D also is available through diet and supplements. The association of UVB irradiance to incidence of type 1 diabetes remained strong even after the researchers accounted for per capita healthcare expenditure. This was an important consideration because regions located near the equator tend to have lower per-capita healthcare expenditures, which could result in under-reporting of type 1 diabetes. In the paper the researchers call for public health action to address widespread vitamin D inadequacy in U.S. children.
Sun exposure and vitamin D levels may play a strong role in risk of type 1 diabetes in children, according to new findings by researchers at the Moores Cancer Center at University of California, San Diego and the Department of Family and Preventive Medicine. The study, published in the online version of the scientific journal Diabetologia, found that populations living at or near the equator, where there is abundant sunshine (and ultraviolet B irradiance), have low incidence rates of type 1 diabetes. Conversely, populations at higher latitudes, where available sunlight is scarcer, have higher incidence rates. These findings add new support to the concept of a role of vitamin D in reducing risk of this disease. Ultraviolet B exposure triggers photosynthesis of vitamin D3 in the skin. This form of vitamin D also is available through diet and supplements. The association of UVB irradiance to incidence of type 1 diabetes remained strong even after the researchers accounted for per capita healthcare expenditure. This was an important consideration because regions located near the equator tend to have lower per-capita healthcare expenditures, which could result in under-reporting of type 1 diabetes. In the paper the researchers call for public health action to address widespread vitamin D inadequacy in U.S. children.
DOWN SYNDROME: SEQUENOM REPORTS POSITIVE RESULTS OF NONINVASIVE PRENATAL TEST
San Diego-based Sequenom said studies using its noninvasive test that makes use of maternal blood to detect of fetal chromosomal abnormalities including Down syndrome produced positive results. The Company reported that in blinded studies performed at Sequenom involving about 200 clinical samples collected both prospectively and retrospectively, its proprietary test for Down syndrome correctly identified 100 percent of all Down syndrome samples without any false-positive outcomes. The company said with currently available serum-testing options having detection rates between 70 percent to 90 positive rates as high as 5 percent, its technology shows promise for significant performance advantages over the current prenatal screening. Sequenom expects to continue its development activities through the end of 2008, at which time it expects to initiate transfer of the technology to laboratory partners.
San Diego-based Sequenom said studies using its noninvasive test that makes use of maternal blood to detect of fetal chromosomal abnormalities including Down syndrome produced positive results. The Company reported that in blinded studies performed at Sequenom involving about 200 clinical samples collected both prospectively and retrospectively, its proprietary test for Down syndrome correctly identified 100 percent of all Down syndrome samples without any false-positive outcomes. The company said with currently available serum-testing options having detection rates between 70 percent to 90 positive rates as high as 5 percent, its technology shows promise for significant performance advantages over the current prenatal screening. Sequenom expects to continue its development activities through the end of 2008, at which time it expects to initiate transfer of the technology to laboratory partners.
BEAUTY: ALLERGAN TO FILE APPLICATION WITH FDA TO MARKET SYNTHETIC COMPOUND TO STIMULATE EYELASH GROWTH
Irvine, California-based Allergan said it intends to file a New Drug Application by end of the third quarter of 2008 with the U.S. Food and Drug Administration for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan has completed its clinical trial program, which it said demonstrated that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth. The global mascara market is presently estimated to be $3.7 billion annually. If approved by the FDA for eyelash growth, which Allergan currently anticipates in 2009, the company estimates global peak sales of bimatoprost for this indication could exceed $500 million per year. Allergan has exclusive U.S. and foreign patents on the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate natural eyelash growth. If approved by the FDA, Allergan’s bimatoprost product for eyelash growth will be available by prescription only to consumers in the United States.
Irvine, California-based Allergan said it intends to file a New Drug Application by end of the third quarter of 2008 with the U.S. Food and Drug Administration for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan has completed its clinical trial program, which it said demonstrated that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth. The global mascara market is presently estimated to be $3.7 billion annually. If approved by the FDA for eyelash growth, which Allergan currently anticipates in 2009, the company estimates global peak sales of bimatoprost for this indication could exceed $500 million per year. Allergan has exclusive U.S. and foreign patents on the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate natural eyelash growth. If approved by the FDA, Allergan’s bimatoprost product for eyelash growth will be available by prescription only to consumers in the United States.
LIVER DISEASE: FDA ACCEPTS ANTIPODEAN APPLICATION TO BEGIN CLINICAL TRIALS
San Francisco-based Antipodean Pharmaceuticals said that the U.S. Food and Drug Administration has accepted for filing the its Investigational New Drug application for its lead compound, MitoQ. With the acceptance, the company said it will involve clinical centers in the United States in the development of MitoQ for the treatment of liver diseases such as non-alcoholic fatty liver disease. Antipodean said it is actively seeking a pharmaceutical partner for MitoQ, a mitochondria-targeted antioxidant that selectively blocks mitochondrial oxidative damage and prevents liver cell apoptosis. In April, the Company announced positive results of a clinical study of MitoQ in patients with Hepatitis C virus who had failed standard antiviral treatment. Results showed a significant reduction in elevated alanine aminotransferase levels as compared to placebo. The results, the company said, suggests that MitoQ can reduce necroinflammation and may halt disease progression to fibrosis or cirrhosis. The drug was well tolerated, with no significant safety issues.
San Francisco-based Antipodean Pharmaceuticals said that the U.S. Food and Drug Administration has accepted for filing the its Investigational New Drug application for its lead compound, MitoQ. With the acceptance, the company said it will involve clinical centers in the United States in the development of MitoQ for the treatment of liver diseases such as non-alcoholic fatty liver disease. Antipodean said it is actively seeking a pharmaceutical partner for MitoQ, a mitochondria-targeted antioxidant that selectively blocks mitochondrial oxidative damage and prevents liver cell apoptosis. In April, the Company announced positive results of a clinical study of MitoQ in patients with Hepatitis C virus who had failed standard antiviral treatment. Results showed a significant reduction in elevated alanine aminotransferase levels as compared to placebo. The results, the company said, suggests that MitoQ can reduce necroinflammation and may halt disease progression to fibrosis or cirrhosis. The drug was well tolerated, with no significant safety issues.
PAIN: SOUTH KOREAN REGULATORS APPROVE START OF CLINICAL TRIAL OF ANESIVA’S NON-OPIOID DRUG
Anesiva said that the South Korea Food and Drug Administration has approved Anesiva’s investigational new drug application for Adlea, the company’s long-acting, site specific, non-opioid drug candidate in late-stage clinical development for the management of acute pain following orthopedic surgery. Anesiva plans to initiate a mid-stage clinical trial of Adlea in patients undergoing arthroscopic shoulder surgery in South Korea this summer. The planned study is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of a single dose of Adlea compared to placebo administered at the conclusion of arthroscopic shoulder surgery. The trial is designed to enroll 74 patients. Adlea is currently in two pivotal late-stage trials in the United States: one in total knee replacement surgeries and one in bunionectomy surgeries. Top-line data from both trials are expected by year-end 2008.
PATENTS: GILEAD SAYS USPTO CONFIRMS SECOND OF FOUR VIREAD PATENTS
Foster City-based Gilead Sciences said that the U.S. Patent & Trademark Office has completed the second of four reexamination proceedings and has confirmed the patentability of a U.S. patent covering the composition of matter for its antiretroviral drug Viread. On May 20, Gilead announced that the U.S. PTO confirmed the patentability of a separate Viread patent. The four U.S. PTO review proceedings were initiated July 2007 in response to a challenge issued by the Public Patent Foundation in March 2007. In its request for the reexaminations, PUBPAT claimed that prior art existed that would have impacted the issuance of the original patents.
Anesiva said that the South Korea Food and Drug Administration has approved Anesiva’s investigational new drug application for Adlea, the company’s long-acting, site specific, non-opioid drug candidate in late-stage clinical development for the management of acute pain following orthopedic surgery. Anesiva plans to initiate a mid-stage clinical trial of Adlea in patients undergoing arthroscopic shoulder surgery in South Korea this summer. The planned study is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of a single dose of Adlea compared to placebo administered at the conclusion of arthroscopic shoulder surgery. The trial is designed to enroll 74 patients. Adlea is currently in two pivotal late-stage trials in the United States: one in total knee replacement surgeries and one in bunionectomy surgeries. Top-line data from both trials are expected by year-end 2008.
PATENTS: GILEAD SAYS USPTO CONFIRMS SECOND OF FOUR VIREAD PATENTS
Foster City-based Gilead Sciences said that the U.S. Patent & Trademark Office has completed the second of four reexamination proceedings and has confirmed the patentability of a U.S. patent covering the composition of matter for its antiretroviral drug Viread. On May 20, Gilead announced that the U.S. PTO confirmed the patentability of a separate Viread patent. The four U.S. PTO review proceedings were initiated July 2007 in response to a challenge issued by the Public Patent Foundation in March 2007. In its request for the reexaminations, PUBPAT claimed that prior art existed that would have impacted the issuance of the original patents.
PERSONALIZED MEDICINE: GENOMIC HEALTH STUDIES COULD LEAD TO PREDICTIVE TESTS FOR TARGETED THEREAPIES
Redwood City based-Genomic Health reported on results of two separate studies presented at the annual meeting of the American Society of Clinical Oncology that it said could lead to the development of new tests for predicting benefit from certain targeted therapies in cancer including cetuximab (Erbitux) for colon cancer and docetaxel (Taxotere) for breast cancer. The company said these new data represent encouraging results of its work with leading cancer cooperative groups and drug manufacturers to discover and develop genomic tests to determine which patients are likely to benefit from treatment with targeted therapies. Based on the results from the first study, the company said it believes there is a potential to develop a multi-gene test comprising K-Ras mutation status in combination with the expression levels of a small number of genes to select patients for cetuximab. The second study looked at how the company could Oncotype DX test—a panel of 21 genes used to determine treatment in certain breast cancers—and additional breast cancer genes to predict the benefit of treatment with docetaxel. The company said further research is needed to narrow down which genes are most predictive and validate their use.
Redwood City based-Genomic Health reported on results of two separate studies presented at the annual meeting of the American Society of Clinical Oncology that it said could lead to the development of new tests for predicting benefit from certain targeted therapies in cancer including cetuximab (Erbitux) for colon cancer and docetaxel (Taxotere) for breast cancer. The company said these new data represent encouraging results of its work with leading cancer cooperative groups and drug manufacturers to discover and develop genomic tests to determine which patients are likely to benefit from treatment with targeted therapies. Based on the results from the first study, the company said it believes there is a potential to develop a multi-gene test comprising K-Ras mutation status in combination with the expression levels of a small number of genes to select patients for cetuximab. The second study looked at how the company could Oncotype DX test—a panel of 21 genes used to determine treatment in certain breast cancers—and additional breast cancer genes to predict the benefit of treatment with docetaxel. The company said further research is needed to narrow down which genes are most predictive and validate their use.
AGBIO: DOW AGROSCIENCES AND SANGAMO COMPLETE RESEARCH MILESTONES IN AGREEMENT
Dow AgroSciences and Richmond, California-based Sangamo BioSciences, said they have successfully completed research milestones as part of their joint research and commercial license agreement. These milestones represent the successful application of Sangamo’s zinc finger DNA-binding protein technology to the generation of specific traits in two major crop species—maize and canola. The milestones build earlier achievements and demonstrate the versatility and broad applicability of the ZFP platform to both regulate and modify genes in commercially important plant species, the companies said. They added that they have proven that the ZFP technology can accelerate the process of “trait stacking,” which will result in a shorter path to commercialization of crops containing new traits.
Dow AgroSciences and Richmond, California-based Sangamo BioSciences, said they have successfully completed research milestones as part of their joint research and commercial license agreement. These milestones represent the successful application of Sangamo’s zinc finger DNA-binding protein technology to the generation of specific traits in two major crop species—maize and canola. The milestones build earlier achievements and demonstrate the versatility and broad applicability of the ZFP platform to both regulate and modify genes in commercially important plant species, the companies said. They added that they have proven that the ZFP technology can accelerate the process of “trait stacking,” which will result in a shorter path to commercialization of crops containing new traits.
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