NV1FGF is a plasmid-based gene therapy that delivers FGF-1 to promote therapeutic angiogenesis in patients with critical limb ischemia. This study evaluated NV1FGF versus placebo in 125 patients for whom revascularization was not an option. The primary outcome of ulcer healing was similar between groups. However, NV1FGF significantly reduced the risk of major amputation by over 50% and the combined risk of major amputation or death by over 35% compared to placebo. Adverse event rates were similar between groups, though severe adverse events were lower with NV1FGF. This suggests that NV1FGF improves amputation-free survival in critical limb ischemia patients.
Despitetheroutineuseofprophylacticsystemicantibiotics,sternalwoundin- fection still occurs in 5% or more of cardiac surgical patients and is associated with signifi- cant excess morbidity, mortality, and cost. The gentamicin-collagen sponge, a surgically implantable topical antibiotic, is currently approved in 54 countries. A large, 2-center, ran- domized trial in Sweden reported in 2005 that the sponge reduced surgical site infection by 50% in cardiac patients.
Treatment and early outcome of 11 children with hepatoblastoma.Dr./ Ihab Samy
Fouad A. Fouad saleep MD., Ihab samy Fayek MD.
Department of Surgical Oncology – National Cancer Institute – Cairo University - Egypt.
Kasr el-aini medical journal Volume 18, No.4, October 2012.
1) This study examined the effects of intracoronary (IC) versus intravenous (IV) administration of abciximab in STEMI patients undergoing primary PCI using cardiac magnetic resonance imaging (CMR).
2) CMR results showed no differences between IC and IV groups in infarct size, myocardial salvage, microvascular obstruction, or left ventricular function.
3) Clinical outcomes at 12-month follow up including death, reinfarction, congestive heart failure, and major adverse cardiac events were also similar between the two groups.
4) The CMR results of this large substudy confirm the main findings of the parent AIDA STEMI trial that IC abciximab administration did
Donor Lymphocyte Infusion in Patients with Hematological Malignancies after T...spa718
1. Donor lymphocyte infusion (DLI) is an effective method for treating relapse after hematopoietic stem cell transplantation. Modified DLI (mDLI) using G-CSF mobilized peripheral blood and short-term immunosuppression can reduce acute GVHD rates while maintaining the graft-versus-leukemia effect.
2. Prophylactic mDLI can significantly decrease relapse rates and increase survival in patients with advanced acute leukemia after HLA-identical or haploidentical transplantation.
3. Risk-stratified mDLI based on minimal residual disease monitoring may further reduce relapse and improve outcomes by targeting high-risk MRD-positive patients.
This document summarizes Dr. Chenhua Yan's work establishing and utilizing a modified donor lymphocyte infusion (mDLI) approach for the treatment of relapse after haploidentical hematopoietic stem cell transplantation (HSCT) for hematologic malignancies. The mDLI approach uses G-CSF mobilized peripheral blood stem cells and immunosuppressive agents after infusion to reduce graft-versus-host disease while preserving graft-versus-leukemia effects. Studies showed mDLI improved response rates and survival compared to chemotherapy or standard DLI alone for relapsed disease. Risk-stratified mDLI based on minimal residual disease also reduced relapse rates after transplantation.
Seventy-nine patients underwent valve replacement or repair surgery for active or healed native valve endocarditis between 1976 and 1992. The most common indications for surgery were congestive heart failure (73.4%) and multiple systemic emboli (21.5%). Operative mortality was 3.8% and late mortality was 15.1%. Streptococci were the most common infecting agents (41.8%), followed by Staphylococcus aureus (11.4%). The study assessed the influence of eight preoperative variables on mortality and late valve-related complications, finding that only Staphylococcus aureus infection significantly predicted late valve-related complications. There was no difference in survival or complications between active and
This presentation discusses the graft versus tumour effect (GVT) in hematopoietic stem cell transplantation (HSCT). It provides laboratory and clinical evidence that the immune cells from the donor (graft) can induce remissions in hematological malignancies (tumour) after transplant. However, these same graft cells can also cause graft-versus-host disease (GvHD). Recent research aims to separate these effects by using regulatory T-cells to suppress GvHD while preserving the GVT effect.
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...Raj Kiran Medapalli
This document summarizes a study examining the impact of transplant nephrectomy on mortality rates following kidney allograft failure. The study used data from the United States Renal Data System on over 19,000 patients who returned to dialysis between 1994-2004 after allograft failure. It found that patients who underwent nephrectomy after late graft failure (>1 year) had a 12% lower risk of death compared to those who did not undergo nephrectomy. However, nephrectomy after early graft failure (<1 year) was associated with a 13% higher risk of death.
Despitetheroutineuseofprophylacticsystemicantibiotics,sternalwoundin- fection still occurs in 5% or more of cardiac surgical patients and is associated with signifi- cant excess morbidity, mortality, and cost. The gentamicin-collagen sponge, a surgically implantable topical antibiotic, is currently approved in 54 countries. A large, 2-center, ran- domized trial in Sweden reported in 2005 that the sponge reduced surgical site infection by 50% in cardiac patients.
Treatment and early outcome of 11 children with hepatoblastoma.Dr./ Ihab Samy
Fouad A. Fouad saleep MD., Ihab samy Fayek MD.
Department of Surgical Oncology – National Cancer Institute – Cairo University - Egypt.
Kasr el-aini medical journal Volume 18, No.4, October 2012.
1) This study examined the effects of intracoronary (IC) versus intravenous (IV) administration of abciximab in STEMI patients undergoing primary PCI using cardiac magnetic resonance imaging (CMR).
2) CMR results showed no differences between IC and IV groups in infarct size, myocardial salvage, microvascular obstruction, or left ventricular function.
3) Clinical outcomes at 12-month follow up including death, reinfarction, congestive heart failure, and major adverse cardiac events were also similar between the two groups.
4) The CMR results of this large substudy confirm the main findings of the parent AIDA STEMI trial that IC abciximab administration did
Donor Lymphocyte Infusion in Patients with Hematological Malignancies after T...spa718
1. Donor lymphocyte infusion (DLI) is an effective method for treating relapse after hematopoietic stem cell transplantation. Modified DLI (mDLI) using G-CSF mobilized peripheral blood and short-term immunosuppression can reduce acute GVHD rates while maintaining the graft-versus-leukemia effect.
2. Prophylactic mDLI can significantly decrease relapse rates and increase survival in patients with advanced acute leukemia after HLA-identical or haploidentical transplantation.
3. Risk-stratified mDLI based on minimal residual disease monitoring may further reduce relapse and improve outcomes by targeting high-risk MRD-positive patients.
This document summarizes Dr. Chenhua Yan's work establishing and utilizing a modified donor lymphocyte infusion (mDLI) approach for the treatment of relapse after haploidentical hematopoietic stem cell transplantation (HSCT) for hematologic malignancies. The mDLI approach uses G-CSF mobilized peripheral blood stem cells and immunosuppressive agents after infusion to reduce graft-versus-host disease while preserving graft-versus-leukemia effects. Studies showed mDLI improved response rates and survival compared to chemotherapy or standard DLI alone for relapsed disease. Risk-stratified mDLI based on minimal residual disease also reduced relapse rates after transplantation.
Seventy-nine patients underwent valve replacement or repair surgery for active or healed native valve endocarditis between 1976 and 1992. The most common indications for surgery were congestive heart failure (73.4%) and multiple systemic emboli (21.5%). Operative mortality was 3.8% and late mortality was 15.1%. Streptococci were the most common infecting agents (41.8%), followed by Staphylococcus aureus (11.4%). The study assessed the influence of eight preoperative variables on mortality and late valve-related complications, finding that only Staphylococcus aureus infection significantly predicted late valve-related complications. There was no difference in survival or complications between active and
This presentation discusses the graft versus tumour effect (GVT) in hematopoietic stem cell transplantation (HSCT). It provides laboratory and clinical evidence that the immune cells from the donor (graft) can induce remissions in hematological malignancies (tumour) after transplant. However, these same graft cells can also cause graft-versus-host disease (GvHD). Recent research aims to separate these effects by using regulatory T-cells to suppress GvHD while preserving the GVT effect.
Transplant Nephrectomy Improves Survival following a Failed Renal Allograft (...Raj Kiran Medapalli
This document summarizes a study examining the impact of transplant nephrectomy on mortality rates following kidney allograft failure. The study used data from the United States Renal Data System on over 19,000 patients who returned to dialysis between 1994-2004 after allograft failure. It found that patients who underwent nephrectomy after late graft failure (>1 year) had a 12% lower risk of death compared to those who did not undergo nephrectomy. However, nephrectomy after early graft failure (<1 year) was associated with a 13% higher risk of death.
This study prospectively examined 15 patients with Graves' disease and associated exophthalmic eye changes who underwent total thyroidectomy. Exophthalmos (protrusion of the eye) and palpebral fissure height (distance between eyelids) were measured before and after surgery. At a mean follow-up of 15.6 months, exophthalmos had regressed in 12 patients by an average of 2.1 mm, which was statistically significant. Palpebral fissure height also decreased significantly. Surgery resulted in regression of exophthalmos in the majority of patients with Graves' disease and associated eye changes.
This document provides a programme for the Hepato-Biliary Centre Days conference on April 7-8 in Paris. It will include sessions on radiology, surgery, hepatology, and nursing. The guest of honour is Eleonora De Martin from Paul Brousse Hospital in Villejuif, France who will discuss liver toxicity from immunotherapy. The document includes studies on the prevalence and characteristics of liver toxicity from immune checkpoint inhibitors. Histological patterns include granulomas with fibrin rings, destructive cholangitis, and nodular regenerative hyperplasia. Biopsies are useful for diagnosis but the histological pattern does not correlate with response to steroids. Further research is needed to determine optimal management of immune-mediated hepatitis
Cytopenias, or low blood cell counts, are a common adverse effect of tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). Neutropenia is the most frequent cytopenia, followed by thrombocytopenia and anemia. Cytopenias occur more commonly in advanced disease and when switching to second-line TKIs after resistance or intolerance develops to first-line treatment. While cytopenias can result in serious infections and bleeding, they are generally a result of the drug's efficacy rather than true toxicity, as they tend to improve over time with continued treatment. Careful monitoring and dose modifications or growth factor support can help manage cytopenias while maintaining treatment continuity
This document discusses deep vein thrombosis (DVT) surveillance in patients with traumatic brain injury (TBI) or spinal cord injury (SCI). It outlines several challenges with diagnosing DVT in these patients, as clinical signs may be absent or difficult to assess due to their injuries. The Wells clinical prediction rule and D-dimer testing can help estimate DVT risk, though D-dimer may be elevated due to non-thrombotic factors as well. Ultrasound is the test of choice to diagnose DVT when suspected, while imaging like CT angiography or pulmonary angiography can identify pulmonary embolisms. More research is needed to develop optimal screening algorithms for this high-risk population.
This document summarizes considerations for clinicians in diagnosing acute interstitial nephritis (AIN). AIN is a common cause of acute kidney injury, particularly among hospitalized patients. It can be difficult to differentiate AIN from other causes of kidney injury based on clinical history, exams, and tests alone. No single test is diagnostic of AIN. While urine tests may provide some clues, kidney biopsy is often needed for a definitive diagnosis and to guide management. The document reviews the etiology, presentation, and utility of commonly ordered urine tests in evaluating for AIN.
Anemo 2014 - Lorusso - ESA nel paziente oncologicoanemo_site
This document discusses anaemia in cancer patients. Some key points:
- Anaemia is very common in cancer patients, occurring in 20-60% at presentation and increasing with chemotherapy cycles.
- Anaemia can be caused by the cancer itself, chemotherapy, radiotherapy, blood loss from surgery. It adversely impacts quality of life through fatigue and other symptoms.
- More severe anaemia is associated with worse survival outcomes and prognosis. This may be due to tumour hypoxia enhancing progression.
- While red blood cell transfusions are used to treat anaemia, over a third of anaemic cancer patients receive no treatment. Recombinant erythropoietin can increase hemoglobin levels and
Penetrating abdominal trauma. Difference in hematic biometry pre and postsurg...Juan de Dios Díaz Rosales
This study analyzed differences between pre-surgical and post-surgical levels of hemoglobin, platelets, leukocytes, and other blood markers in 93 patients with penetrating abdominal trauma who underwent exploratory laparotomy at a hospital in Ciudad Juarez, Mexico. The study found higher mean levels of hemoglobin, hematocrit, platelets, and leukocytes in pre-surgical tests compared to post-surgical tests, with the exception of neutrophils which increased slightly after surgery. While not conclusive, the study provides initial baseline data on expected blood marker levels before and after surgery for penetrating abdominal trauma. Larger multi-institutional studies are still needed to establish more reliable standard values.
This document reviews antithrombotic therapy in patients with acute coronary syndromes, focusing on balancing protection from ischemic events with risk of bleeding. It discusses the standard dual antiplatelet therapy of aspirin and clopidogrel, variability in individual response to clopidogrel, and strategies to optimize therapy including higher clopidogrel doses and newer P2Y12 receptor antagonists like ticagrelor and prasugrel. The review concludes that an individualized antiplatelet approach guided by platelet function testing may help optimize this balance of ischemic protection and bleeding risk.
This randomized controlled trial compared romiplostim (a thrombopoietin mimetic) to standard of care treatments in 234 adult patients with immune thrombocytopenia who had not undergone splenectomy. It found that patients receiving romiplostim had higher platelet counts, lower rates of treatment failure and splenectomy, less bleeding, and an improved quality of life compared to the standard of care group. Adverse events occurred in 23% of the romiplostim group and 37% of the standard of care group.
EVIDENCE OF POSTTRAUMATIC COAGULOPATHY IN CASE OF THE SEVERE COMBINED THORACI...pijans
Early coagulopathy associated with trauma – result of exaggerate activity during the initiation phase of
coagulation. The aim of this study was to determine the diagnostic value of the coagulopathy markers for
metabolic monitoring of the severe combined thoracic trauma and it’s possibly to help in outcome
prediction. This retrospective study was performed on 73 male polytrauma patients from 20 to 68 years
old. The prothrombin time, fibrinogen concentration and β-Naphthol test were estimated on 1-2-d, 3-4-th
and 5-6-th days after trauma. The results suggest that hypocoagulation occurs early in equal extent for
survivals and non-survivals. Coagulation abnormalities are the result of vital functions disturbances rather
than direct tissue injury.
Cuando empeza y cuando parar la profilaxisAnderson David
1) Patients undergoing major orthopedic surgeries like hip or knee replacements are at high risk of developing dangerous blood clots in their legs or lungs.
2) Current guidelines recommend using blood thinners to prevent clots, but there is debate around when to start and how long to continue the medication.
3) This article discusses the timing of increased clot risk after surgery and reviews evidence on balancing clot prevention with bleeding risks of blood thinners at different postoperative times.
This study evaluated the efficacy of colchicine in preventing in-stent restenosis in 90 patients undergoing percutaneous coronary intervention with bare-metal stents. Patients were divided into 3 groups: those receiving a bare-metal stent plus colchicine, bare-metal stent alone, or a drug-eluting stent. After 6 months of follow up, the rates of in-stent restenosis and target vessel revascularization were significantly lower in patients receiving colchicine plus bare-metal stent compared to bare-metal stent alone. There was no difference in stent thrombosis rates between groups. The study suggests that colchicine may be useful for reducing restenosis and need for repeat procedures when
This document discusses challenges in treating elderly AML patients and recent advances. It notes that survival has improved over time but remains poor for those over 60. New agents target specific molecular abnormalities but a multi-agent approach is still needed. Emerging targeted therapies and hypomethylating agents are promising for some subgroups. Allogeneic stem cell transplant remains the mainstay of therapy for many high-risk patients, though reduced-toxicity conditioning regimens have increased safety for older patients eligible for transplant.
This study evaluated D-dimer levels in 80 patients with chronic atrial fibrillation to determine if D-dimer could diagnose left atrial appendage thrombus. The patients underwent transesophageal echocardiography and were divided into two groups: those with thrombus and those without. All patients in the thrombus group had elevated D-dimer levels, while only 28.5% of patients without thrombus had elevated levels. After 3 months of anticoagulation therapy, D-dimer levels decreased significantly in the thrombus group and thrombus resolved in 77.8% of patients. The study concludes that D-dimer has 100% sensitivity and 71.4% specificity for diagnosing left
Three cases of acute myocardial infarction are presented. All three patients had type 2 diabetes and other cardiovascular risk factors like hypertension and dyslipidemia. They presented with chest pain and ST-segment changes on electrocardiogram. All underwent emergency cardiac catheterization and had stents placed in obstructed coronary arteries. Strict control of blood sugar, blood pressure, and lipids is emphasized going forward to prevent further cardiovascular complications. The role of SGLT2 inhibitors in cardiovascular and renal protection for patients with diabetes is also discussed.
This study evaluated the cardiac event rate in 428 patients with known coronary artery disease (CAD) who had a normal stress myocardial perfusion scan (SPECT MPI). During a median follow-up of 3.1 years, all-cause mortality occurred in 60 patients (14%) and 41 patients (10%) died from cardiac causes. Non-fatal myocardial infarction (MI) occurred in 77 patients (18%). The annualized cardiac mortality and non-fatal MI rates were 2% and 3.6%, respectively. Smoking, congestive heart failure, and failure to achieve 85% of the age-predicted maximum heart rate were predictors of all-cause and cardiac mortality. Diabetes, dyslipidemia, smoking, and limited
Cryopreserved saphenous vein allografts were evaluated for infragenual bypass surgery in 92 patients with critical limb ischemia over 15 years. Primary and primary assisted patency rates at 1 year were 49.9% and 55.7%, and limb salvage rates at 1, 3, and 5 years were 85%, 70%, and 64%. While allografts are an alternative to prosthetic materials when autologous veins are unavailable, better patient selection and use of statins may improve results, though availability remains limited.
1. The document discusses various treatment strategies for acute coronary syndromes (ACS), including ST-segment elevation myocardial infarction (STEMI) and non-STEMI.
2. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for STEMI as it provides better outcomes than fibrinolytic therapy. However, fibrinolytics remain important when PCI is not accessible in a timely manner.
3. For non-STEMI ACS, an early invasive strategy with urgent catheterization and PCI improves long-term survival compared to a conservative approach. The optimal use of antiplatelet and anticoagulant therapies over time is also discussed.
The combos study an expert interview with william sJames Hilbert
The document summarizes the COMBOS study which evaluated the effects of adding prescription omega-3 ethyl esters (Lovaza) to stable statin therapy in patients with persistent hypertriglyceridemia. The study found that Lovaza plus simvastatin led to greater reductions in non-HDL cholesterol and other lipid parameters compared to simvastatin alone. Non-HDL cholesterol is a measure of total cholesterol carried by LDL, VLDL, and their remnants, and is a better predictor of cardiovascular risk than LDL alone, especially in patients with high triglycerides.
RepliGen is a biopharmaceutical company with late-stage clinical programs and commercial assets. Their lead program, RG1068, is in Phase 3 trials for pancreatic imaging and could file for approval in 2011. RG2417, for bipolar depression, showed efficacy in a Phase 2a trial and expects Phase 2b results in Q1 2011. RepliGen is also developing treatments for orphan diseases and generates revenue from bioprocessing operations. Their goal is to advance their pipeline while maintaining a strong cash position to fund development.
This study prospectively examined 15 patients with Graves' disease and associated exophthalmic eye changes who underwent total thyroidectomy. Exophthalmos (protrusion of the eye) and palpebral fissure height (distance between eyelids) were measured before and after surgery. At a mean follow-up of 15.6 months, exophthalmos had regressed in 12 patients by an average of 2.1 mm, which was statistically significant. Palpebral fissure height also decreased significantly. Surgery resulted in regression of exophthalmos in the majority of patients with Graves' disease and associated eye changes.
This document provides a programme for the Hepato-Biliary Centre Days conference on April 7-8 in Paris. It will include sessions on radiology, surgery, hepatology, and nursing. The guest of honour is Eleonora De Martin from Paul Brousse Hospital in Villejuif, France who will discuss liver toxicity from immunotherapy. The document includes studies on the prevalence and characteristics of liver toxicity from immune checkpoint inhibitors. Histological patterns include granulomas with fibrin rings, destructive cholangitis, and nodular regenerative hyperplasia. Biopsies are useful for diagnosis but the histological pattern does not correlate with response to steroids. Further research is needed to determine optimal management of immune-mediated hepatitis
Cytopenias, or low blood cell counts, are a common adverse effect of tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). Neutropenia is the most frequent cytopenia, followed by thrombocytopenia and anemia. Cytopenias occur more commonly in advanced disease and when switching to second-line TKIs after resistance or intolerance develops to first-line treatment. While cytopenias can result in serious infections and bleeding, they are generally a result of the drug's efficacy rather than true toxicity, as they tend to improve over time with continued treatment. Careful monitoring and dose modifications or growth factor support can help manage cytopenias while maintaining treatment continuity
This document discusses deep vein thrombosis (DVT) surveillance in patients with traumatic brain injury (TBI) or spinal cord injury (SCI). It outlines several challenges with diagnosing DVT in these patients, as clinical signs may be absent or difficult to assess due to their injuries. The Wells clinical prediction rule and D-dimer testing can help estimate DVT risk, though D-dimer may be elevated due to non-thrombotic factors as well. Ultrasound is the test of choice to diagnose DVT when suspected, while imaging like CT angiography or pulmonary angiography can identify pulmonary embolisms. More research is needed to develop optimal screening algorithms for this high-risk population.
This document summarizes considerations for clinicians in diagnosing acute interstitial nephritis (AIN). AIN is a common cause of acute kidney injury, particularly among hospitalized patients. It can be difficult to differentiate AIN from other causes of kidney injury based on clinical history, exams, and tests alone. No single test is diagnostic of AIN. While urine tests may provide some clues, kidney biopsy is often needed for a definitive diagnosis and to guide management. The document reviews the etiology, presentation, and utility of commonly ordered urine tests in evaluating for AIN.
Anemo 2014 - Lorusso - ESA nel paziente oncologicoanemo_site
This document discusses anaemia in cancer patients. Some key points:
- Anaemia is very common in cancer patients, occurring in 20-60% at presentation and increasing with chemotherapy cycles.
- Anaemia can be caused by the cancer itself, chemotherapy, radiotherapy, blood loss from surgery. It adversely impacts quality of life through fatigue and other symptoms.
- More severe anaemia is associated with worse survival outcomes and prognosis. This may be due to tumour hypoxia enhancing progression.
- While red blood cell transfusions are used to treat anaemia, over a third of anaemic cancer patients receive no treatment. Recombinant erythropoietin can increase hemoglobin levels and
Penetrating abdominal trauma. Difference in hematic biometry pre and postsurg...Juan de Dios Díaz Rosales
This study analyzed differences between pre-surgical and post-surgical levels of hemoglobin, platelets, leukocytes, and other blood markers in 93 patients with penetrating abdominal trauma who underwent exploratory laparotomy at a hospital in Ciudad Juarez, Mexico. The study found higher mean levels of hemoglobin, hematocrit, platelets, and leukocytes in pre-surgical tests compared to post-surgical tests, with the exception of neutrophils which increased slightly after surgery. While not conclusive, the study provides initial baseline data on expected blood marker levels before and after surgery for penetrating abdominal trauma. Larger multi-institutional studies are still needed to establish more reliable standard values.
This document reviews antithrombotic therapy in patients with acute coronary syndromes, focusing on balancing protection from ischemic events with risk of bleeding. It discusses the standard dual antiplatelet therapy of aspirin and clopidogrel, variability in individual response to clopidogrel, and strategies to optimize therapy including higher clopidogrel doses and newer P2Y12 receptor antagonists like ticagrelor and prasugrel. The review concludes that an individualized antiplatelet approach guided by platelet function testing may help optimize this balance of ischemic protection and bleeding risk.
This randomized controlled trial compared romiplostim (a thrombopoietin mimetic) to standard of care treatments in 234 adult patients with immune thrombocytopenia who had not undergone splenectomy. It found that patients receiving romiplostim had higher platelet counts, lower rates of treatment failure and splenectomy, less bleeding, and an improved quality of life compared to the standard of care group. Adverse events occurred in 23% of the romiplostim group and 37% of the standard of care group.
EVIDENCE OF POSTTRAUMATIC COAGULOPATHY IN CASE OF THE SEVERE COMBINED THORACI...pijans
Early coagulopathy associated with trauma – result of exaggerate activity during the initiation phase of
coagulation. The aim of this study was to determine the diagnostic value of the coagulopathy markers for
metabolic monitoring of the severe combined thoracic trauma and it’s possibly to help in outcome
prediction. This retrospective study was performed on 73 male polytrauma patients from 20 to 68 years
old. The prothrombin time, fibrinogen concentration and β-Naphthol test were estimated on 1-2-d, 3-4-th
and 5-6-th days after trauma. The results suggest that hypocoagulation occurs early in equal extent for
survivals and non-survivals. Coagulation abnormalities are the result of vital functions disturbances rather
than direct tissue injury.
Cuando empeza y cuando parar la profilaxisAnderson David
1) Patients undergoing major orthopedic surgeries like hip or knee replacements are at high risk of developing dangerous blood clots in their legs or lungs.
2) Current guidelines recommend using blood thinners to prevent clots, but there is debate around when to start and how long to continue the medication.
3) This article discusses the timing of increased clot risk after surgery and reviews evidence on balancing clot prevention with bleeding risks of blood thinners at different postoperative times.
This study evaluated the efficacy of colchicine in preventing in-stent restenosis in 90 patients undergoing percutaneous coronary intervention with bare-metal stents. Patients were divided into 3 groups: those receiving a bare-metal stent plus colchicine, bare-metal stent alone, or a drug-eluting stent. After 6 months of follow up, the rates of in-stent restenosis and target vessel revascularization were significantly lower in patients receiving colchicine plus bare-metal stent compared to bare-metal stent alone. There was no difference in stent thrombosis rates between groups. The study suggests that colchicine may be useful for reducing restenosis and need for repeat procedures when
This document discusses challenges in treating elderly AML patients and recent advances. It notes that survival has improved over time but remains poor for those over 60. New agents target specific molecular abnormalities but a multi-agent approach is still needed. Emerging targeted therapies and hypomethylating agents are promising for some subgroups. Allogeneic stem cell transplant remains the mainstay of therapy for many high-risk patients, though reduced-toxicity conditioning regimens have increased safety for older patients eligible for transplant.
This study evaluated D-dimer levels in 80 patients with chronic atrial fibrillation to determine if D-dimer could diagnose left atrial appendage thrombus. The patients underwent transesophageal echocardiography and were divided into two groups: those with thrombus and those without. All patients in the thrombus group had elevated D-dimer levels, while only 28.5% of patients without thrombus had elevated levels. After 3 months of anticoagulation therapy, D-dimer levels decreased significantly in the thrombus group and thrombus resolved in 77.8% of patients. The study concludes that D-dimer has 100% sensitivity and 71.4% specificity for diagnosing left
Three cases of acute myocardial infarction are presented. All three patients had type 2 diabetes and other cardiovascular risk factors like hypertension and dyslipidemia. They presented with chest pain and ST-segment changes on electrocardiogram. All underwent emergency cardiac catheterization and had stents placed in obstructed coronary arteries. Strict control of blood sugar, blood pressure, and lipids is emphasized going forward to prevent further cardiovascular complications. The role of SGLT2 inhibitors in cardiovascular and renal protection for patients with diabetes is also discussed.
This study evaluated the cardiac event rate in 428 patients with known coronary artery disease (CAD) who had a normal stress myocardial perfusion scan (SPECT MPI). During a median follow-up of 3.1 years, all-cause mortality occurred in 60 patients (14%) and 41 patients (10%) died from cardiac causes. Non-fatal myocardial infarction (MI) occurred in 77 patients (18%). The annualized cardiac mortality and non-fatal MI rates were 2% and 3.6%, respectively. Smoking, congestive heart failure, and failure to achieve 85% of the age-predicted maximum heart rate were predictors of all-cause and cardiac mortality. Diabetes, dyslipidemia, smoking, and limited
Cryopreserved saphenous vein allografts were evaluated for infragenual bypass surgery in 92 patients with critical limb ischemia over 15 years. Primary and primary assisted patency rates at 1 year were 49.9% and 55.7%, and limb salvage rates at 1, 3, and 5 years were 85%, 70%, and 64%. While allografts are an alternative to prosthetic materials when autologous veins are unavailable, better patient selection and use of statins may improve results, though availability remains limited.
1. The document discusses various treatment strategies for acute coronary syndromes (ACS), including ST-segment elevation myocardial infarction (STEMI) and non-STEMI.
2. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for STEMI as it provides better outcomes than fibrinolytic therapy. However, fibrinolytics remain important when PCI is not accessible in a timely manner.
3. For non-STEMI ACS, an early invasive strategy with urgent catheterization and PCI improves long-term survival compared to a conservative approach. The optimal use of antiplatelet and anticoagulant therapies over time is also discussed.
The combos study an expert interview with william sJames Hilbert
The document summarizes the COMBOS study which evaluated the effects of adding prescription omega-3 ethyl esters (Lovaza) to stable statin therapy in patients with persistent hypertriglyceridemia. The study found that Lovaza plus simvastatin led to greater reductions in non-HDL cholesterol and other lipid parameters compared to simvastatin alone. Non-HDL cholesterol is a measure of total cholesterol carried by LDL, VLDL, and their remnants, and is a better predictor of cardiovascular risk than LDL alone, especially in patients with high triglycerides.
RepliGen is a biopharmaceutical company with late-stage clinical programs and commercial assets. Their lead program, RG1068, is in Phase 3 trials for pancreatic imaging and could file for approval in 2011. RG2417, for bipolar depression, showed efficacy in a Phase 2a trial and expects Phase 2b results in Q1 2011. RepliGen is also developing treatments for orphan diseases and generates revenue from bioprocessing operations. Their goal is to advance their pipeline while maintaining a strong cash position to fund development.
This document provides a weekly options watch from Goldman Sachs with trade recommendations and updates. It summarizes 4 new trade ideas involving buying calls on JOYG, AAPL, VRTX, and UTHR. It also recommends adding to 10 existing positions and continuing to hold 6 positions, while closing recommendations for PCLN and UTHR. A chart provides initial and current prices for these recommendations.
Pluristem Therapeutics is developing placental stem cells (PLX) for the treatment of peripheral arterial disease. The company's proprietary 3-D bioreactor technology appears to produce therapeutic stem cells that release multiple angiogenic factors in response to local disease. Research by an independent group confirmed the potential benefit of 3-D culturing versus traditional 2-D technologies. Pluristem reported encouraging results from an open-label study and is finalizing pivotal studies with regulators, which are anticipated to commence by year-end. The analyst initiates coverage with an Outperform rating and $5 price target.
Pluristem Therapeutics is developing allogeneic stem cell therapies using its proprietary 3D bioreactor technology. Its lead product PLX-PAD has shown safety and efficacy in a Phase 1 trial for critical limb ischemia. Pluristem plans to initiate several clinical trials in 2011 for peripheral artery disease, including a Phase 2 trial for intermittent claudication and potential Phase 2/3 trials for critical limb ischemia and Buerger's disease. The analyst believes Pluristem represents a favorable investment given the advantages of allogeneic off-the-shelf cell therapy production using its 3D bioreactor technology which results in consistent, efficient manufacturing with low costs of goods sold.
Second or third additional chemotherapy drug for non-small cell lung cancer i...James Hilbert
This Cochrane review evaluated 65 randomized controlled trials with over 13,000 patients to determine the clinical benefit of adding additional chemotherapy drugs to treatment regimens for advanced non-small cell lung cancer. The review found that adding a second drug to a single-agent chemotherapy regimen improved tumor response rates and one-year survival rates. Adding a third drug to a two-drug chemotherapy regimen increased tumor response rates but did not improve one-year survival rates and was associated with higher toxicity.
1) The Phase III randomized trial compared tivozanib to sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma (RCC).
2) The trial found that tivozanib demonstrated superior progression-free survival compared to sorafenib, with median progression-free survival of 11.9 months for tivozanib versus 9.1 months for sorafenib.
3) Subgroup analyses found similar progression-free survival benefits with tivozanib compared to sorafenib across patient subgroups, including treatment-naïve patients for metastatic RCC.
1. A randomized trial compared restrictive (transfuse if Hb <7 g/dL) vs liberal (transfuse if Hb <9 g/dL) transfusion strategies in critically ill cancer patients with septic shock.
2. At 28 days, all-cause mortality was not significantly different between groups. However, at 90 days mortality was significantly higher in the restrictive group.
3. Secondary outcomes including ventilation, renal replacement therapy, inotropes, and length of stay showed no significant differences.
4. The results suggest a liberal transfusion strategy may be preferable for critically ill cancer patients with septic shock, as a restrictive strategy was associated with higher 90-day mortality.
This study developed a new prognostic index called MIPI for patients with advanced-stage mantle cell lymphoma based on data from 455 patients treated in 3 clinical trials. The MIPI stratified patients into low-, intermediate-, and high-risk groups based on 4 independent prognostic factors: age, performance status, lactate dehydrogenase level, and leukocyte count. Validation showed the MIPI provided better risk stratification than existing indices and may help guide treatment decisions. Proliferation marker Ki-67 also showed strong additional prognostic relevance when included in the index.
This research article compares the safety, efficacy, and cost-effectiveness of primary percutaneous coronary intervention (PCI) versus a pharmaco-invasive strategy for ST-segment elevation myocardial infarction (STEMI) patients in Gaza. 145 patients were randomized to primary PCI or streptokinase fibrinolysis followed by rescue or routine PCI within 2-24 hours. The primary composite endpoint of death, shock, or heart failure at 30 days was similar between groups. However, the pharmaco-invasive strategy had higher rates of major bleeding and required emergency angiography in 39.5% of patients. While index hospitalization costs were lower, the total estimated 30-day cost per 100 patients was higher for the pharmaco-invasive strategy compared
This study reviewed the management of 1432 grown-up congenital heart disease patients over 10 years at a tertiary hospital in India. It found a early morbidity rate of 5.2% and identified previous sternotomy, emergency procedures, cross-clamp time over 45 minutes, and cyanotic disease as significant risk factors. Outcomes were generally good with a mortality rate of 1.4% and 86% follow-up completeness. However, the study was limited by its single center retrospective design and loss to follow-up of simpler cases.
Austin Journal of Clinical Cardiology is an open access, peer reviewed, scholarly journal dedicated to publish articles in all areas of cardiology and angiology. The aim of the journal is to provide a forum for cardiologists, researchers, physicians, and other health professionals to find most recent advances in the areas of cardiology and cardiovascular diseases.
Austin Journal of Clinical Cardiology accepts original research articles, review articles, case reports, clinical images and rapid communication on all the aspects of cardiology and circulatory system.
Austin Journal of Clinical Cardiology strongly supports the scientific upgradation and fortification in related scientific research community by enhancing access to peer reviewed scientific literary works. Austin Publishing Group also brings universally peer reviewed journals under one roof thereby promoting knowledge sharing, mutual promotion of multidisciplinary science.
Austin Journal of Clinical Cardiology is an open access, peer reviewed, scholarly journal dedicated to publish articles in all areas of cardiology and angiology
Reperfusion strategy in patients with ST-Segment Elevation Myocardial Infarct...Premier Publishers
Reperfusion therapy is the cornerstone in management of STEMI. This study was designed to evaluate both In-hospital and 30 days outcome in patients with STEMI treated with primary percutaneous coronary intervention (PPCI) versus fibrinolysis. This prospective, controlled, study included 140 patients with STEMI who were eligible for reperfusion therapy. In hospital and 30 days major adverse cardiovascular events (MACE) were reported and head to head comparison was done between PPCI versus fibrinolysis. All-cause mortality was reported in 5% of patients (10% versus 0% in fibrinolysis and PPCI respectively, p=0.07), recurrence of ischemic symptoms was reported in 18% of patients (30% versus 7% in fibrinolysis and PPCI respectively, P =0.02), heart failure was evident in 22% of patients (33% versus 10% in fibrinolysis and PPCI respectively, P =0.02). PPCI is safe and effective treatment option for patients with STEMI
This document discusses treatment options for acute myeloid leukemia (AML) including induction therapy, post-remission therapy, and bone marrow transplant. The standard induction therapy is daunorubicin and cytarabine, achieving remission in 60-80% of young adults. Post-remission therapy such as additional chemotherapy or hematopoietic stem cell transplant is needed to maintain remission and cure the disease. Allogeneic stem cell transplant from a matched related donor provides the strongest anti-leukemic effect but also higher risks. The optimal treatment plan depends on patient characteristics and cytogenetic risks at diagnosis and after remission.
Presented at the American Society for Clinical Oncology Gastroenterology in January 2017 in San Francisco by Eric Raymond
Background: Sunitinib was approved by the FDA in 2011 for treatment of progressive, well-differentiated, advanced pancreatic neuroendocrine tumors (pNETs) based on a pivotal phase III study (NCT00428597) that showed a significant increase in progression-free survival (PFS) over placebo following early study termination. Subsequently, the FDA requested a post-approval study to support these findings.
Methods: In this open-label, phase IV clinical trial (NCT01525550), patients with progressive, well-differentiated, unresectable advanced/metastatic pNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase III study. Primary endpoint was investigator-assessed PFS per RECIST 1.0. This study is ongoing.
Results: Sixty one treatment-naïve and 45 previously treated patients with progressive pNETs were treated with sunitinib: mean age, 54.6 years; males, 59.4%; white, 63.2%; ECOG PS 0, 65.1% or PS 1, 34.0%; and prior somatostatin analog, 48.1% (treatment-naïve, 39.3%; previously treated, 60.0%). At the data cutoff date, 82 (77%) patients discontinued treatment, mainly due to disease progression (46%). Median duration of treatment was ~11.9 months. Investigator-assessed median PFS (mPFS) was 13.2 months (95% CI, 10.9–16.7) in the overall population, with comparable mPFS in treatment-naïve and previously treated patients (13.2 vs 13.0 months). mPFS per independent radiologic review was 11.1 months (95% CI, 7.4–16.6). Objective response rate (ORR) per RECIST was 24.5%: 21.3% in treatment-naïve and 28.9% in previously treated patients. Median overall survival, although not yet mature, was 37.8 months. Treatment-emergent, all-causality adverse events (AEs) reported by ≥20% of all patients included neutropenia, diarrhea, leukopenia, fatigue, hand–foot syndrome, hypertension, abdominal pain, dysgeusia, and nausea. Most common grade 3/4 AEs were neutropenia (22%) and diarrhea (9%).
Conclusions: The mPFS of 13.2 months and ORR of 24.5% observed in this study support the outcomes of the pivotal phase III study of sunitinib in pNETs and confirm its activity in this setting. AEs were consistent with known safety profile of sunitinib.
Therapeutic plasma exchange in patients with neurologic diseases: Retrospecti...Apollo Hospitals
Therapeutic plasma exchange (TPE) is commonly used in many neurological disorders where an immune aetiology was known or suspected. We report our experience with TPE performed for neuroimmunologic disorders at four university hospitals.
Zauderer, M.G., et al. Clinical Cancer Research, 2017.sellasq4
1. This randomized phase II trial evaluated the WT1 peptide vaccine galinpepimut-S combined with GM-CSF and Montanide in patients with malignant pleural mesothelioma after multimodality therapy.
2. The trial randomized 41 patients to galinpepimut-S plus adjuvants or adjuvants alone. The control arm was stopped early due to a futility analysis showing progression within 1 year in over 10 of the first 20 patients.
3. Trends toward improved progression-free survival (10.1 vs 7.4 months) and overall survival (22.8 vs 18.3 months) were observed in the vaccine arm compared to control, but the trial was
Kshivets O. Lung Cancer: Optimal Treatment StrategiesOleg Kshivets
This document describes a study examining optimal treatment strategies for non-small cell lung cancer (NSCLC) patients. The study reviewed data from 535 NSCLC patients who underwent complete surgical resection between 1985-2008. Patients received one of three treatments: surgery alone (316 patients), surgery plus postoperative radiotherapy (102 patients), or surgery plus adjuvant chemoimmunoradiotherapy (117 patients). The study found that adjuvant chemoimmunoradiotherapy resulted in significantly higher 5-year survival rates compared to radiotherapy or surgery alone, especially for patients with lymph node involvement. Overall 5-year survival for the entire group was 63.6%, demonstrating the benefit of aggressive surgical resection and adjuvant therapies.
This document summarizes a study evaluating the efficacy and safety of nivolumab compared to everolimus for treating advanced renal cell carcinoma (RCC) that has progressed after anti-angiogenic therapy (Checkmate 025). The study found that nivolumab provided a statistically significant improvement in overall survival compared to everolimus, with median survival of 25 months for nivolumab vs 19.6 months for everolimus. Nivolumab also had higher response and duration of response rates. While grade 3-4 adverse events were more common with nivolumab, fewer patients discontinued due to adverse reactions compared to everolimus. The study demonstrates the benefit of nivolumab immunotherapy for previously treated
Copeptin as a Novel Biomarker in the Diagnosis of Acute Myocardial Infarction...Premier Publishers
To evaluate the diagnostic value of Copeptin as a novel biomarker in early diagnosis of Acute Myocardial Infarction. 56 patients with acute Myocardial Infarction (STEMI) and 25 healthy controls who were admitted to the Cardiology and Clinical Pathology Departments, national heart institute (NHI) from October 2015 to April 2016. The kit used a double-antibody sandwich enzyme-linked immune-sorbent assay (ELISA) to assay the level of Human Copeptin in samples. As regard copeptin, the median range of copeptin level was 242.5pg/ml in patient group and 75pg/ml in control group. The comparative study between the two groups shows a significant difference (p < 0.05) Conclusion: Copeptin is a reliable diagnostic tool in patients with AMI (STEMI) with sensitivity 85.7%, specificity 86.7%, PPV 96% and NPV 61.9%.
This document discusses immunotherapy strategies for metastatic renal cell carcinoma (RCC), including cytokines like interleukin-2 (IL-2) and interferon-α (IFN-α). It finds that high-dose IL-2 produces durable responses in a small percentage of selected patients, while IFN-α provides a modest survival benefit. Combining cytokines with targeted therapies may improve outcomes compared to cytokine monotherapy. Biomarkers like carbonic anhydrase IX expression and histologic subtype may help predict which patients are most likely to benefit from IL-2 therapy. Ongoing research aims to better select patients for IL-2 and explore combination therapies and novel immunotherapies to optimize treatment of metastatic RCC.
The document summarizes research on treatments for idiopathic pulmonary fibrosis (IPF). It describes IPF as a fatal lung disease characterized by lung scarring. Two drugs are discussed: pirfenidone and nintedanib. Regarding pirfenidone, the document outlines clinical trials that demonstrated its ability to reduce lung function decline in IPF patients. For nintedanib, two replicate trials found it significantly reduced the rate of lung function decline compared to placebo and reduced the risk of acute exacerbations, though it commonly caused diarrhea. Both drugs represent new treatment options for slowing the progression of IPF.
The Role of Immunity in Chemotherapy-Resistant Patient with Pembrolizumab: A ...JohnJulie1
Approaches are limited for treating advanced Non-Small-Cell Lung Cancer (NSCLC) with multidrug resistance but without ALK and EGFR mutations. Pembrolizumab (KEYTRUDA) brings on unprecedented clinical benefit in various cancer types...
The presentation discussed Protalix's plant cell-expressed, chemically modified human alpha-galactosidase for the treatment of Fabry disease, called PRX-102. Fabry disease is caused by a deficiency of the enzyme alpha-galactosidase A, leading to accumulation of Gb3 substrate and increased risks of stroke, cardiomyopathy, and renal issues. Currently available treatments have short half-lives. PRX-102 aims to be a "bio-better" enzyme by using chemical modification via covalent cross-linking of the subunits to create a stable dimer, which may provide advantages like improved stability, longer half-life, and enhanced uptake in target organs, potentially leading to better clinical efficacy than
This phase 2b study compares the efficacy and safety of aldoxorubicin versus doxorubicin as first-line treatment for patients with advanced soft tissue sarcomas. As of June 2013, 107 patients had been randomized to receive either 350 mg/m2 of aldoxorubicin or 75 mg/m2 of doxorubicin every 3 weeks for up to 6 cycles. Preliminary results found that a higher percentage of patients receiving aldoxorubicin were still active in the study, received at least 4 or 6 cycles of treatment, and had a greater number of tumor responses and stable disease compared to doxorubicin. The major grade 3-4 adverse event for both treatments was neutropenia
Vintafolide showed promising results in a phase 2 study for treating non-small cell lung cancer (NSCLC). It met its primary endpoint of clinical benefit and was well tolerated. Patients with 100% folate receptor positive tumors had significantly improved progression-free survival of 7.2 months compared to 1.7 months for patients with 10-90% folate receptor positive tumors. Overall survival was also significantly improved at 10.9 months for fully folate receptor positive patients compared to 3.4 months for partially positive patients. These results suggest vintafolide has positive activity as a single agent, especially for fully folate receptor positive NSCLC patients who have failed multiple prior therapies.
5 understanding some basic trial designs in sarcomas (inclusive a placebo one...James Hilbert
The document summarizes three clinical trial designs:
1) A phase 3 trial compared doxorubicin alone versus doxorubicin plus ifosfamide as first-line chemotherapy for advanced soft tissue sarcoma. It found the combination improved response rates and progression-free survival but not overall survival, and was more toxic.
2) A phase 3 placebo-controlled trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease progressed on prior chemotherapy.
3) A phase 3 placebo-controlled trial of regorafenib in patients with gastrointestinal stromal tumor progressing on prior treatments including imatinib and sunitinib, with a cross-over design allowing patients
Transforming time for prostate cancer therapiesJames Hilbert
This document provides an overview of prostate cancer treatments and competitive landscape. Prostate cancer is the most commonly diagnosed cancer in men. Current standard of care includes local therapy for early stage, androgen deprivation therapy for advanced or recurrent disease, chemotherapy (e.g. Taxotere) for metastatic castration-resistant prostate cancer (mCRPC), and newer agents like Provenge, Zytiga, and Jevtana for mCRPC. The pipeline includes promising agents from Dendreon, Medivation, and OncoGenex that could change treatment paradigms and improve outcomes for mCRPC patients.
Vandetanib plus docetaxel versus docetaxel alone as second-line treatment for advanced NSCLC was evaluated in a randomized phase 3 trial (ZODIAC). The trial found:
1) Addition of vandetanib to docetaxel significantly improved progression-free survival compared to placebo plus docetaxel, with median PFS of 4.0 vs 3.2 months.
2) A similar PFS benefit was seen in the prespecified analysis of women.
3) Adverse events including rash, neutropenia, and febrile neutropenia were more common with vandetanib plus docetaxel.
CDX-011 is an antibody-drug conjugate targeting GPNMB, which is expressed in 40-75% of breast cancers and promotes metastasis. Preliminary results from the randomized Phase 2b EMERGE study show very encouraging activity of CDX-011 in triple-negative breast cancer patients and those with high GPNMB expression who have failed approved therapies. The EMERGE study randomized GPNMB-expressing advanced breast cancer patients to receive either CDX-011 or standard therapy to examine if anti-cancer activity depends on level of GPNMB expression. Over 99% of 338 screened patients were considered eligible based on ≥5% GPNMB expression.
This document summarizes a phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of enzyme replacement therapy (ERT) with recombinant human GALNS (BMN 110) in subjects with Mucopolysaccharidosis IVA (Morquio syndrome). The open-label, dose-escalation study enrolled 20 subjects aged 5-18 years who received weekly infusions of BMN 110 at doses of 0.1 mg/kg, 1.0 mg/kg, or 2.0 mg/kg for 12 weeks each. Key findings included improvements in measures of endurance like the 6-minute walk test and 3-minute stair climb, as well as decreases in urine keratan sulfate levels
MAP0004, an orally inhaled formulation of dihydroergotamine (DHE), was evaluated in a randomized, double-blind, placebo-controlled study for the acute treatment of migraine. 903 patients experiencing a migraine attack were randomized to receive either MAP0004 (0.63 mg emitted dose) or placebo via inhalation. The primary endpoints were pain relief and absence of photophobia, phonophobia, and nausea at 2 hours. MAP0004 was superior to placebo for all primary endpoints. A greater percentage of patients treated with MAP0004 experienced pain relief, absence of photophobia, absence of phonophobia, and absence of nausea compared to those receiving placebo. MAP0004 was well tolerated with no serious
This document discusses novel molecular therapies for hepatocarcinoma (HCC). It summarizes that sorafenib is the current standard of care therapy for advanced HCC based on two phase III trials showing improved median overall survival. However, sorafenib resistance can develop. The document reviews several other targeted agents that have shown some activity for HCC including bevacizumab, erlotinib, and sunitinib. Ongoing clinical trials are exploring combinations of sorafenib with other agents or replacing sorafenib. Biomarkers associated with response and resistance to therapies like sunitinib are also discussed.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses updates on second-line treatment of metastatic non-small cell lung cancer from the World Conference on Lung Cancer. It summarizes findings from studies comparing weekly versus 3-weekly docetaxel administration and pemetrexed versus docetaxel. Current guidelines recommend second-line cytotoxic chemotherapy or EGFR inhibitors for disseminated metastatic disease and radiation therapy for localized symptoms.
Docetaxel Versus Docetaxel/Cisplatin in NSCLCJames Hilbert
This study compared docetaxel alone versus docetaxel plus cisplatin as frontline treatment for advanced non-small cell lung cancer. 302 patients were randomly assigned to receive either docetaxel alone (146 patients) or the docetaxel/cisplatin combination (156 patients). The overall response rate was significantly higher for the combination at 36% versus 18% for docetaxel alone. However, median survival time, time to disease progression, and 1-year survival rates were similar between the two groups. Toxicity was higher with the combination therapy. Both regimens showed similar effectiveness in terms of survival, though the combination resulted in a higher response rate and more toxicity.
Soligenix is initiating coverage with a Buy rating for their lead product orBec®, an oral therapy for GI GvHD currently in a Phase 3 trial. Prior trials show efficacy for orBec® with a localized corticosteroid and the Phase 3 trial further lowers clinical risk. The treatment of acute GI GvHD is an unmet medical need and orBec® has the potential to generate $150-300 million in revenue. Soligenix is also developing therapeutics for radiation injury and vaccines for biodefense through additional platforms.
- Wedbush Securities provides an update on Cleveland BioLabs, Inc. (CBLI) and reiterates an OUTPERFORM rating and $10/share price target.
- CBLI is still anticipated to receive a $50+ million government contract award from BARDA now expected in July/August for development of CBLB502, though the announcement has been delayed.
- CBLI has a low $11 million annual cash burn and no fundamental reasons for its recent stock price decline. The BARDA contract delay does not jeopardize the company or CBLB502 program.
- CBLI expects to submit a BLA for CBLB502 in H1 2012 and anticipates FDA approval by H2 2012, positioning the company
The document provides an investment analysis on Optimer Pharmaceuticals, Inc. Key points include:
- An FDA advisory panel voted 13-0 that fidaxomicin was safe and effective for treating C. difficile infection, indicating an 85% likelihood of its approval by the May 30 deadline.
- The panel was ambivalent about whether fidaxomicin reduced infection recurrence, which could impact its labeling but not the analyst's expectations for use in vancomycin failures.
- The analyst maintains a $16 price target and "Buy" rating on Optimer, expecting peak fidaxomicin sales of $250 million by 2016, while acknowledging risks include regulatory issues and commercial challenges.
This document is a joint motion by Momenta Pharmaceuticals, Sandoz Inc. and Teva Pharmaceuticals USA to enter a scheduling order for a patent infringement case. It outlines a proposed discovery schedule including dates for initial disclosures, claim construction briefing, a Markman hearing, fact and expert discovery deadlines, summary judgment briefing and a trial date. It also sets limits on discovery including a limit of 10 depositions per side of up to 7 hours each. The parties request the court adopt this proposed scheduling order and discovery plan.
The document discusses the evolution of isolated hepatic perfusion (IHP) for patients with unresectable hepatic metastases, including improved techniques using percutaneous hepatic perfusion (PHP) to deliver higher doses of chemotherapy directly to the liver while minimizing systemic toxicity. Phase I and III clinical trials on PHP showed it significantly prolonged hepatic progression-free survival compared to best available care for patients with metastatic melanoma and liver metastases. Patient demographics are also presented for those treated with PHP for neuroendocrine tumors of the liver.