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Synopsis Allos Therapeutics has announced that it will submit a New Drug Application NDA ; to the U.S. Food and Drug Administration FDA ; to market efaproxiral for the treatment of brain metastases from breast cancer. Efaproxiral currently has a fast-track designation from the FDA, and the company expects to complete the application in the fourth quarter of this year. The application will be based on the results of a phase III trial involving 115 patients with metastatic breast cancer who received whole brain radiation therapy in combination with efaproxiral. Results showed that patients on efaproxiral achieved a median survival of 8.67 months compared with 4.57 months for patients who received radiation therapy alone P 0.006 ; . Overall, patients experienced a 51% reduction in risk of death in the efaproxiral arm versus control. Seventy-two percent of metastatic breast cancer patients receiving efaproxiral achieved either a complete or partial response compared to 53% of patients in the control arm P 0.04, because gliclazide diamicron.
Lacking on the effects of pioglitazone on LDL subfractions, although the changes we have seen in our study are in line with those using troglitazone in patients with type 2 diabetes 10 ; , as well as obese patients without diabetes 9 ; and those with insulin resistance after a myocardial infarction 11 ; . It would be anticipated that the reduction in LDL3 on pioglitazone and metformin would be associated with reduced atherosclerosis risk. Increased LDL3 is associated with increased rates of myocardial infarction 57 ; . LDL3 is more prone to oxidation and glycemic modification 23 ; and as a result does not bind as well to hepatic LDL receptors 24 ; and is more likely to bind to the extracellular matrix and be taken up by scavenger macrophages in atherosclerotic plaques 25 27 ; . The three drug groups differed in their effects on total HDL and HDL subfractions. HDL cholesterol is recognized as an important predictor of macrovascular disease, with increased risk being associated with a fall in total HDL cholesterol and also an increase in the total cholesteroltoHDL ratio. Outcome studies 28, 29 ; have shown that directly targeting and increasing HDL can improve long-term outcomes, both in those with isolated low HDL and in those with mixed dyslipidemia with high cholesterol, low HDL, and high triglycerides. Consistent with other studies, we have seen a significant increase in total HDL with pioglitazone. This is in contrast to the neutral effect with metformin and gliclazide, and such a change would be expected to be antiatherogenic. Although the change in the total cholesteroltoHDL ratio was of borderline significance on pioglitazone, this change was not different from that seen on either metformin or gliclazide. HDL particles are a heterogeneous group that can be separated by density HDL2 [1.0631.125 g ml] and HDL3 [1.1251.21 g l] ; or apo content apoA1 without AII or apoA1 with AII ; . An increase in HDL2, the HDL2-to-HDL3 ratio, and apoAI seem to be particularly associated with a reduction in macrovascular risk 8, 30 ; . Although the total HDL cholesterol did not change in the metformin group, the HDL3 cholesterol fell significantly and in association with this, the HDL2-to-HDL3 ratio significantly increased. Similarly, the increased total HDL on pioglitazone was associated with.
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The combination of insulin secretagogues with exogenous insulin is increasingly used for patients experiencing secondary failure to SU-based therapy, as glycaemic control can often be restored without undue weight gain using this approach 47 ; . Potentially, a prandial glucose regulator such as repaglinide could also be utilized in combination with an intermediate-acting insulin for drug-resistant patients a basal bolus approach ; , and further reductions in weight gain or hypoglycemia in comparison to SU-insulin combinations might be expected. Ongoing studies will determine the clinical profile of repaglinide-insulin combinations. HYPOGLYCEMIA An important predicted advantage of the PGR strategy is a reduction in the incidence and severity of hypoglycemia, relative to treatment regimens involving long-acting insulin secretagogues. The potential of this strategy to minimize the risk of hypoglycemia in everyday life was clearly demonstrated in a randomized study in which 43 patients with well-controlled Type 2 diabetes received either repaglinide with meals or glibenclamide given according to label recommendations 36 ; . These patients were subsequently assessed with and without omission of their midday meal; those receiving repaglinide also omitted their midday dose when lunch was withheld, according to the dosing recommendations for the drug. The two treatments were found to be equivalent in terms of postprandial blood glucose excursions. However, significant betweentreatment differences were found in terms of the influence that omitting the midday meal had upon glycaemia p 0.014 ; . The mean minimum blood glucose level remained unchanged at 4.3 mmol l in repaglinide-treated patients, whereas omission of lunch in glibenclamide-treated patients led to a fall from 4.3 to 3.4 mmol l. Six episodes of hypoglycemia four requiring treatment ; occurred, all in glibenclamide-treated patients and all in association with omission of lunch. No hypoglycemic episodes occurred in the repaglinidetreated patients when lunch was omitted. This study demonstrates the value of the PGR strategy for reducing the risk of hypoglycemia in everyday life, when flexible meal patterns may be followed. However, other data suggest that repaglinide may be associated with a reduced risk of hypoglycemia in comparison to SU therapy per se - even when dosing and food consumption are tightly controlled by strict study protocols in line with the requirements of SU therapy. Pooled data from comparative studies involving glibenclamide, gliclazide and glipizide show repaglinide to be.
23 comparison of gliclazide and glibenclamide treatment in non-insulin-dependent diabetes and phenytoin.
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Back-up compounds to Novartis to take advantage of their medicinal chemistry know-how. Taken together, these approaches represent less than half of all PPP projects. As would be expected under this classical model, the primary role of the PPP in these partnerships is to provide the company with funds and any technical support they may need. The level of PPP input needed will generally depend on the size of the company and its developing country experience. For example, multinational companies usually but not always ; minimise the need for PPP funding by providing substantial in-kind services, whereas small companies may often seek full cost-recovery on their neglected disease work. Likewise, technical support may be modest for a neglected diseasefocussed firm eg assisting with trial partners ; , but can range up to conduct or co-conduct of clinical trials for less experienced small companies and multinationals, or even require the PPP to take responsibility for manufacture and distribution in some partnerships with small companies. In the classical PPP category the IP situation will largely be out of the PPP's hands.XXV This lack of IP control could pose problems for PPPs whose main aim is to secure affordable and timely access to the new products for those in need. However, ownership of IP is only a means to an end control and if that control can be exercised in another way then that may suffice. PPPs generally deal with this issue by including binding contractual obligations on price and delivery in their agreements with companies. As noted above, these agreements can be easier to conclude with multinational companies, for whom this IP is low-value, than with small companies, for whom it may represent their only source of profits. Nevertheless, under current PPP agreements, the great majority of partners agree to provide the final product at a not-for-profit price or at a low mark-up 3-5 per cent ; to neglected disease patients in developing countries. This includes all multinational company partners around one-third of PPP projects ; , small companies focused on Western diseases, and the great majority of academic partners. The small number of companies who see the developing country market as commercially interesting tend to be less flexible, seeking larger margins for example, up to 15 per cent in public developing country markets ; or, as noted above, refusing to sign PPP deals that they feel would put their profits under pressure. New models A different approach arises when the PPP has more control over IP issues relating to the compound, for example, because the compound being developed is already in the public domain so no-one has background IP rights ; , because it has been licensed to the PPP by an academic or a company so the PPP has the rights it needs for its mission ; , or because the PPP owns the relevant background IP so the PPP owns all the rights ; . In these cases, the PPP takes full responsibility for developing the product, but it also has far greater control over issues such as price, production, registration and distribution to developing country patients. PPPs manage this responsibility in a number of ways. PPPs may: choose to work with no partner, by simply subcontracting out R&D to multiple industry and academic public groups; develop the compound itself, using academic or industry subcontractors for preclinical work, but bringing in an industry partner or subcontractor in some cases a developing country firm ; at a later stage to assist with regulatory work, manufacture and distribution; forgo industry input altogether, with R&D being conducted solely by public partners or public subcontractors. This happens particularly with early-stage projects although industry input would be expected further down the development line ; , but sometimes also with late-stage registration projects.
Referenz 292 Neurologie, 11. Auflage ; Feinberg TE, Schindler FJ, Flanagan NG, Haber LD. Two alien hand syndromes. Neurology 42: 19-24, 1992 Neurobehavior Center, Beth Israel Medical Center, New York, NY 10003. Review of the clinical characteristics and neuroanatomy of 20 reported cases of alien hand syndrome AHS ; and a patient of our own confirm that AHS is actually two distinct syndromes. Frontal AHS occurs in the dominant hand; is associated with reflexive grasping, groping, and compulsive manipulation of tools; and results from damage to the supplementary motor area, anterior cingulate gyrus, and medial prefrontal cortex of the dominant hemisphere and anterior corpus callosum. Callosal AHS is characterized primarily by intermanual conflict and requires only an anterior callosal lesion. the occurrence of frontal AHS in the dominant limb can be explained by an increased tendency for dominant limb exploratory reflexes coupled with release from an asymmetrically distributed, predominant nondominant-hemisphere inhibition. Callosal AHS is best explained by hemispheric disconnection manifested during behaviors requiring dominant-hemisphere control. Publication Types: * Review * Review of Reported Cases and valsartan.
By Diane Johnson Dr. Eric Klein of the Glickman Urologic Institute at the Cleveland Clinic and the research team from the University of California, San Francisco, announced a surprising finding at the ASCO Prostate Cancer Symposium last month: they discovered a new virus in patients with a rare form of prostate cancer. The virus, named XMRV, is closely related to a microbe that is known to cause cancer in mice. It was found in a small group of men with both prostate cancer and a genetic mutation--they are missing the genes that help cells fight off viruses. Only 13% of men have this mutation. The virus was found 25 times more often in this group than in men without that mutation. Although there are other cancers known to be caused by viruses--cervical cancer is caused by the human papilloma virus, also responsible for genital warts, and hepatitis B greatly increases the risk of liver cancer-this is the first virus linked to prostate cancer. Strangely, XMRV is not found in cancerous prostate cells; it resides in the tissue surrounding the prostate known as stroma, but only in 1% of the stroma cells. The team is now working on the following questions: 1. What percentage of men have the virus? 2. Are there any links between the virus and sexual activity? 3. Is personal and family medical history a factor? 4. Does it cause prostate cancer or any other disease? Finding the virus is significant even though it was found in only a small percentage of prostate tumors. Blood tests are being developed to detect antibodies, showing that someone had been exposed to it. It is possible that many people might be infected with the virus, but it may only reside in those who lack the enzyme to fight it. That infection might be a cause of the chronic inflammation that is suspected to cause prostate cancer. New drugs and vaccines could be developed to treat the virus. There are many more mysteries to solve about XMRV.
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19. Swenson JM, Tenover FC. Cefoxitin Disk Study Group. Results of disk diffusion testing with cefoxitin correlate with presence of mecA in Staphylococcus spp. J Clin Microbiol. 2005; 43 8 ; : 3818-23. 20. Cavassini M, Wegner A, Jaton K, Blanc DS, Bille J. Evaluation of MRSAScreen, a simple anti-PBP 2a slide latex agglutination kit, for rapid detection of methicillin resistance in Staphyloccocus aureus. J Clin Microbiol. 1999; 37 5 ; : 1591-4. Comment in: J Clin Microbiol. 1999; 37 11 ; : 3783-4. 21. Swenson JM, Williams PP, Killgore G, OHara CM, Tenover FC. Performance of eight methods, including two new rapid methods, for detection of oxacillin resistance in a challenge set of Staphylococcus aureus organisms. J Clin Microbiol. 2001; 39 10 ; : 3785-8. 22. Geha DJ, Uhl JR, Gustaferro CA, Persing DH. Multiplex PCR for identification of methicillin-resistant staphylococci in the clinical laboratory. J Clin Microbiol. 1994; 32 7 ; : 1768-72. 23. Rowe F, Vargas Superti S, Machado Scheibe R, Dias CG. Agar diffusion, agar dilution, E test, and agar screening test in the detection of methicillin resistance in staphylococci small star, filled. Diagn Microbiol Infect Dis. 2002; 43 1 ; : 45-8. 24. Pinna A, Zanetti S, Sotgiu M, Sechi LA, Fadda G, Carta F. Identification and antibiotic susceptibility of coagulase negative staphylococci isolated in corneal external infections. Br J Ophthalmol. 1999; 83 7 ; : 771-3. Comment in: Br J Ophthalmol. 2000; 84 2 ; : 229. 25. Puliafito CA, Baker AS, Haaf J, Foster CS. Infectious endophthalmitis. Review of 36 cases. Ophthalmology. 1982; 89 8 ; : 921-9. 26. Chalita MR, Hofling-Lima AL, Paranhos A, Jr., Schor P, Belfort R. Shifiting trends in vitro antibiotic susceptibilities for common ocular isolates during a period of 15 years. J Ophthalmol. 2004; 137 1 ; : 43-51. 27. Tenover FC, Jones RN, Swenson JM, Zimmer B, McAllister S, Jorgensen JH. Methods for improved detection of oxacillin resistance in coagulasenegative staphylococci: results of a multicenter study. J Clin Microbiol. 1999; 37 12 ; : 4051-8. 28. Archer Gl, Climo MW. Antimicrobial susceptibility of coagulase-negative staphylococci. Antimicrob Agents Chemother. 1994; 38 10 ; : 2231-7. 29. Hussain Z, Stoakes L, Lannigan R, Longo S, Nancekivell B. Evaluation of screening and commercial methods for detection of methicillin resistance in coagulase-negative staphylococci. J Clin Microbiol. 1998; 36 1 ; : 273-4. 30. Bush K. Beta-lactamase inhibitors from laboratory to clinic. Clin Microbiol Rev. 1988; 1 ; : 109-23. 31. Murakami K, Minamide W, Wada K, Nakamura E, Teraoka H, Watanabe S. Identification of methicillin-resistant strains of staphylococci by polymerase chain reaction. J Clin Microbiol. 1991; 29 10 ; : 2240-4. 32. Ferreira RB, Nunes AP, Kokis VM, Krepsky N, Fonseca LS, Bastos Mdo C, et al. Simultaneous detection of the mecA and ileS-2 genes in coagulasenegative staphylococci isolated from Brazilian hospitas by multiplex PCR. Diagn Microbiol Infect Dis. 2002; 42 3 ; : 205-12. 33. Ferreira RB, Iorio NL, Malvar KL, Nunes AP, Fonseca LS, Bastos CC et al. Coagulase-negative staphylococci: comparison of phenotypic and genotypic oxacillin susceptibility tests and evaluation of the agar screening test by using different concentrations of oxacillin. J Clin Microbiol. 2003; 41 8 ; : 3609-14. Erratum; J Clin Microbiol. 2004; 42 8 3913. 34. Hussain Z, Soakes L. John Ma, Garrow S, Fitzgerald V. Detection of methicillin resistance in primary blood culture isolates of coagulase-negative staphylococci by PCR, slide agglutination, disk diffusion, and a commercial method. J Clin Microbiol. 2002; 40 6 ; : 2251-3. 35. Hederstierna-Johnsen T, Schonheyder HC, Paulsen K. Detection of methicillin resistance in coagulase-negative staphylococci by cefoxitin disc diffusion and oxacillin E test. A study of consecutive bacteraemia isolates. APMIS. 2005; 113 10 ; : 688-92. 36. Caiero J, Musskopf M, Superti S, Roesch E, Dias CG, dAzevedo PA. Evaluation of phenotypic methods for methicillin resistance characterization in coagulasenegative staphylococci CNS ; . J Med Microbiol. 2004; 53 Pt 12 ; : 1195-9. 37. Grasmick AE, Naito N, Bruckner DA. Clinical comparison of the AutoMicrobic system gram-positive identification card, API Staph-Ident, and conventional methods in the identification of coagulase-negative Staphylococcus spp. J Clin Microbiol. 1983; 18 6 ; : 1323-8. 38. Sader HS, Sampaio JL, Zocoli C, Jones RN. Results of the 1997 SENTRY Antimicrobial Surveillance Program in Three Brazilian Medical Centers. Braz J Infect Dis. 1999; 3 2 ; : 63-79. 39. Ruoff KL, Ferraro MJ, Jerz ME, Kissling J. Automated identification of grampositive bacteria. J Clin Microbiol. 1982; 16 6 ; : 1091-5. 40. Almeida RJ, Jorgensen JH, Johnson JE. Evaluation of the automicrobic system gram-positive identification card for species identification of coagulasenegative staphylococci. J Clin Microbiol. 1983; 18 2 ; : 438-9 and didanosine.
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1. Supply patterns and costs Consumption figures of IPC stock issued from provincial pharmaceutical depots were requested from the Deputy Director, Procurement of the South African National Department of Health. Data for DMPA and NET-EN were made available for the KwaZulu-Natal KZN ; , Guateng and Free State Provincial Pharmaceutical depots and for the Port Elizabeth depot, which serves the western part of the Eastern Cape Province. These four provinces of nine South African provinces ; represent over 50% of the total South African population. Gauteng has a mostly urban population and KZN and Eastern Cape are more rural. The following data were analysed for financial years 1997 8, 1998 and for 1 04 99 the 1999 2000 financial year.
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Bult CJ, Krupke DM, Vincent MJ, Allio T, Sundberg JP, Mikaelian I, Eppig JT. 2006. The Mouse Tumor Biology Database: An Online Resource for Mouse Models of Human Cancer. In: Cancer Bioinformatics: From Therapy Design to Treatment, Nagl S, [ed], John Wiley & Sons Ltd., West Sussex, England, pp. 143-153. Eppig JT. Genetic and Strain Nomenclature in Mice and Rats: An Abbreviated Guide. In: The Mouse in Biomedical Research, Elsevier Press, in press. Conferences and Seminars Swine in Biomedical Research, Chicago, Ill., "Bioinformatics for Phenotypic Models of Human Disease, " January 2005. NIH Workshop to Examine Plans for Construction and Collection of a Full Set of Mouse Knockouts, March 2005. Federation of International Mouse Resources FIMRe ; Semi-Annual Meeting, "Bioinformatics Working Group Report, " Rome, Italy, April 2005. The Biology of Genomes, "Mouse Models: Mutant Phenotypes and Human Disease, " Cold Spring Harbor, N.Y., May 2005. Workshop for Mouse Mutants of Human Cancer Consortium MMHCC ; Informatics, Bethesda, Md., June 2005. Mouse Mutagenesis Workshop, "Integrating Mutagenesis Phenotype Data in the Mouse Genome Database, " Boston, Mass., September 2005. Federation of International Mouse Resources FIMRe ; Semi-Annual Meeting, "FIMRe Bioinformatics Committee, " Bethesda, Md., October 2005. 19th International Mammalian Genome Conference, "Mouse Models: Mutant Phenotypes and Human Disease, " Strasbourg, France, November 2005. 19th International Mammalian Genome Conference, "The Mouse Tumor Biology Database MTB ; , " Strasbourg, France, November 2005. Jean-Louis Guenet Symposium, Paris, France, November 2005. Rat Genomics & Models, "Accessing Mouse Models of Human Disease, " Cold Spring Harbor, N.Y., December 2005. Editorial Boards Bioinformatics, Ad Hoc Reviewer. BMC Bioinformatics, Ad Hoc Reviewer. Mammalian Genome, Ad Hoc Reviewer. Nature Biotechnology, Ad Hoc Reviewer. Nucleic Acids Research, Ad Hoc Reviewer. Reviews in Mutation Research, Editorial Board. Study Sections National Institute on Alcohol Abuse and Alcoholism Special Study Section. MRC Human Genetics Unit, Edinburgh, U.K., 5-Year Site Review. Sanger Institute, Hinxton, U.K., Wellcome Trust Strategic Plan Site Review.
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Poster #25 A Retrospective Cohort Study of Pulmonary Function, Radiographic Measures and Quality of Life in Children with Congenital Scoliosis: An Evaluation of Patient Outcomes after Traditional Spine Surgery David P. Roye, Jr., MD Morgan Stanley Children's Hospital of New York Presbytarian Hiroko Matsumoto; Michael Bye; Joshua E. Hyman, MD; Jaime Gomez; Whitney Booker; Michael G. Vitale, MD a - Synthes Spine Purpose: The purpose of this study is to evaluate pulmonary function and quality of life QOL ; of children who were treated with growing rods and or fusion for progressive congenital scoliosis and to compare them to those of healthy children. The relationships between radiographic measures, pulmonary function, and QOL in children with progressive congenital scoliosis will also be examined. Methods: Twenty three patients average 14 5 years ; with a primary diagnosis of congenital scoliosis who were treated with growing rod fusion and subsequent fusion were evaluated using radiographs, pulmonary function testing and QOL surveys using Child Health Questionnaire Parent Form CHQ ; . They were, on average, 6.5 years post definitive fusion. Average age at initial surgery was 6 years and average age at definitive fusion was 7 years. Results: Forced vital capacity FVC ; p 0.0001 ; , forced expiratory volume in one second FEV1 ; p 0.0001 ; , total lung capacity p 0.002 ; , and vital capacity p 0.0001 ; were significantly lower than those in healthy children. The average percent predicted FVC and FEV1 were 68.3% and 67.6% respectively. CHQ scores in our study patients were significantly lower than healthy children in physical function p 0.001 ; , general health p 0.001 ; , and physical summary p 0.001 ; and significantly higher in bodily pain p 0.001 ; and impact on parent time p 0.036 ; . Discussion: Compared with healthy peers, patients with congenital scoliosis treated with a growing rod technique and or subsequent fusion have significantly worse pulmonary function and quality of life scores when assessed at an average of 7.5 years following initial surgery. Current efforts are underway to ascertain the relative effects of spinal deformity, characteristics of the growing rod technique and time of definitive fusion on QOL and pulmonary function in this population and dibenzyline.
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