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Post by GodFather on Aug 30, 2013 15:22:10 GMT 5.5
Novartis holds annual healthcare entrepreneur competition
Novartis has invited 60 selected students from leading international universities in 21 countries to its headquarters in Switzerland for the International Biotechnology Leadership Camp (BioCamp). Over the course of three days, students will gain first-hand experience of starting a biotechnology company as well as developing and launching an innovative healthcare product. This year's BioCamp focuses on the Company's innovation efforts in new business approaches to the healthcare industry.
"With the aging population and increases in chronic disease around the world, demand for healthcare will continue to grow, well into the future. This will require innovative solutions as more healthcare systems focus on improving patient outcomes" comments Joseph Jimenez, CEO of Novartis. "As Novartis innovates in healthcare, BioCamp underscores our commitment to creating a unique learning environment for young entrepreneurs. This program enables us to forge ties between the healthcare industry and young talent from top universities. We believe this fosters the fresh thinking required to develop truly differentiated products and services with real-world outcomes."
Some of the Company's leading outcome-based business models include collaborations with payors on pricing arrangements, patient compliance programs as well as online support and education. For example, the Company looks at innovative business models that go beyond traditional philanthropic and commercial efforts to reach patients today and those of future generations. The Novartis Arogya Parivar ("Healthy Family") project is one such social healthcare business model involving a deep-rooted outreach program that trains local health educators and offers medicines in smaller, affordable packaging. Through this program, Novartis has reached 42 million people in 33,000 villages in India.
BioCamp is part of the Novartis commitment to supporting the exchange of ideas and thoughts between young talents in science and business and the Company. Top students will meet with leading scientists and members of top management at Novartis including, among others, Rolf M. Zinkernagel, M.D., a Nobel Laureate and member of the Novartis AG Board of Directors, and Prof. Susan Gasser, Director of the Friedrich Miescher Institute for Biomedical Research.
BioCamp students also interact with Novartis scientists and executives who lead the Company's approach to drug development and learn about new breakthrough medicines to address patients' unmet medical needs. The program is designed to help students understand trends and challenges in the biotechnology and life science sectors as well as gain first-hand experience about starting and running a biotech company. BioCamp has helped forge ties with local communities and build connections to aid future innovative collaborations in research and clinical development.
About BioCamp
First started nine years ago in Taiwan, BioCamp has developed into an international forum for science and business students from around the world to learn, exchange ideas and work together in a highly competitive business environment. Previously hosted in Tokyo, Hong Kong and Cambridge, Massachusetts, today's seminar marks the fourth time International BioCamp is hosted at the state-of-the-art Novartis global headquarters in Basel, Switzerland. Since launching BioCamp in 2004, Novartis has introduced more than 500 top graduate students to the life sciences industry and entrepreneurship.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 full-time-equivalent associates and operate in more than 140 countries around the world.
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Post by GodFather on Sept 5, 2013 22:08:45 GMT 5.5
Best of ESC Congress 2013
Close to thirty thousand delegates converged from all over the world, to the ESC Congress 2013 in Amsterdam, The Netherlands, this week. Cardiologists came to hear first-hand about the latest research. "A record number of Hot Lines and scientific sessions with new formats allowed for more exchanges between peers presenting results of clinical trials, new Clinical Practice Guidelines and new devices and treatments," said Professor Keith Fox, Chair of the ESC Scientific Programme Committee.
Some of the most important studies presented at ESC Congress 2013, according to Prof Fox were:
HOKUSAI-VTE: The oral anticoagulant edoxaban for the treatment of venous thromboembolism (VTE) resulted in equal efficacy and better safety compared to standard warfarin, when either drug was used with initial low molecular weight heparin (LMWH)
TASTE: The aspiration of the blood clot or "thrombus" that causes a heart attack before re-opening a patient's artery with a balloon catheter does not improve survival compared to performing balloon dilation and stenting alone
REALIGN: Results reaffirm current guidelines excluding patients with a narrow QRS for CRT, and expand the body of evidence that simple electrocardiographic determination of QRS duration remains the most important predictor of the clinical benefits of CRT, rather than measures of mechanical dyssynchrony by echocardiography. Based on the results of EchoCRT, the identification of patients who will obtain the benefit of CRT can be done most easily by a 12 lead-ECG.
DECAAF: Results showed that in patients with atrial fibrillation, delayed enhancement magnetic resonance imaging (DE-MRI) performed before ablative treatment can stage the degree of damaged heart tissue (atrial fibrosis) and help predict whether treatment will be successful or not
PRAMI: Heart attack patients with ST elevation who undergo a preventive procedure to unblock additional coronary arteries have significantly better outcomes than those whose treatment is confined to the culprit blockage only.
"These studies will influence clinical practice and will allow us to better understand how to manage these important conditions and how to devise even newer therapies," explained Prof Fox.
"We have come a long way in cardiovascular science, but many patients in Europe still do not have access to the latest treatments. This is unacceptable." said Professor Panos Vardas, President of the ESC. "Just as we have tackled innovation in the past - and we still do, as the enormous amount of research presented at this Congress shows - the society is now committed to making the needs of patients known to those in charge of designing and implementing policies in European institutions and in each of our member countries. We need to fight for better healthcare and guideline implementation." he said.
Earlier this year the ESC and its sponsors published a White Paper on the state of research and development in cardiology calling for urgent investment in CVD innovation. With a growing ageing population and considering the increase of cardio metabolic diseases, doctors are expecting the incidence of CVD to rise in the future. "We must not forget that CVD remains the number one killer in Europe." said Prof Vardas.
"Studies such as PURE and EUROASPIRE IV confirm these differences and also the need to strive for better and equal access of patients in all countries to better prevention programmes, to the best treatment and also rehabilitation." Prof Vardas concluded.
"Over five hundred journalists attended ESC Congress 2013." said Kurt Huber, Chair of the ESC Press Committee. "Once again, they helped us reach out to the public with key prevention messages. Eighty per cent of CVD could be avoided if people adopted healthier lifestyles and there is a long way to go between knowing what should be done and doing."
Some of the most popular "stories" with the wide range of media covering the event from Amsterdam were:
The Tour de France study demonstrating that French participants in the between 1947–2012 lived longer than their same-age French counterparts
Listening to music that makes you happy and relaxed alone and in addition to regular exercise training improves endothelial function (by releasing endorphins)
Cold weather is by far the most important environmental trigger for heart attacks whereas air pollution has a lesser effect
Statins show protective effect preventing cataracts, the leading cause of visual impairment worldwide affecting more than 20 million people
Prof Fox concluded: "It was great to see hundreds of doctors cycling to the congress centre in the morning. Let's just hope that their example will help drive home the importance of exercise to live a long and healthy life, even if we cannot emulate our Tour de France heroes!"
About ESC Congress 2013
ESC Congress is currently the world's premier conference on the science, management and prevention of cardiovascular disease. ESC Congress 2013 takes place 31 August to 4 September at the Amsterdam RAI congress centre.
About the ESC
The European Society of Cardiology (ESC) represents more than 80,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
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Post by GodFather on Sept 5, 2013 22:10:51 GMT 5.5
SAVOR-TIMI 53 sets new standard for cardiovascular outcome trials in diabetes
Uncertainty persists regarding whether drugs that lower sugar reduce the risk of heart attack, with some concerns that diabetes drugs may actually raise the risks. The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR-TIMI 53) trial was a large international clinical trial that randomized patients to the diabetes drug saxagliptin (Onglyza), a selective dipeptidyl peptidase 4 (DPP-4) inhibitor, or to placebo in order to determine the effect on heart attack risk. The study found no excess, or reduction, in the risk of the primary composite endpoint of heart attacks, stroke, or cardiovascular death, which was the primary safety goal of the study. An increase in hospitalization for heart failure in the saxagliptin arm was noted.
"This large cardiovascular outcome trial sets a new standard for examination of the safety of diabetes drugs," said trial co-principal investigator, Deepak L. Bhatt, MD, MPH, from the VA Boston Healthcare System and the TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
"Saxagliptin demonstrated better control of glucose compared with placebo, reduced the need for insulin therapy, and prevented deterioration in protein spilling from the kidneys to the urine," added co-principal investigator Itamar Raz, MD, Hadassah Medical Center, Israel.
SAVOR-TIMI 53, a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial conducted at 788 sites in 26 countries, included patients with type 2 diabetes mellitus, HbA1c levels between 6.5% and 12.0%, and either established or multiple risk factors for cardiovascular disease.
A total of 16,492 patients were randomized to receive either saxagliptin 5 mg daily (or 2.5 mg daily in patients with renal impairment) or matching placebo over a median follow-up of 2.1 years. Treatment with all other diabetes and cardiovascular medications was left to the discretion of the treating physician.
The primary endpoint of the study, a composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke occurred in 7.3% of the saxagliptin group compared with 7.2% of the placebo group (hazard ratio
1.00; P =0.99 for superiority and P <0.001 for non-inferiority).
The major secondary endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure, unstable angina or coronary revascularization was also balanced and occurred in 12.8% of the saxagliptin group and 12.4% of the placebo group (HR 1.02; P=0.66).
"The lack of any excess in heart attack risk is reassuring," commented Benjamin Scirica, MD MPH, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA, "though the neutral findings are in contrast to the benefit observed in pooled analyses from smaller, prior studies of saxagliptin, and highlight the importance of adequately powered outcome studies with sufficient follow-up to assess more fully cardiovascular effects of therapy."
In terms of blood sugar control, patients treated with saxagliptin were more likely to achieve a glycated hemoglobin less than 7% at the end of treatment (36.2% vs. 27.9%; P<0.001).
However, significantly more patients in the saxagliptin group reported at least one hypoglycemic event compared with placebo (15.3% vs 13.4%; p<0.001), though there was no significant excess in the rate of hospitalization for hypoglycemia.
Additionally, more patients in the saxagliptin group were hospitalized for heart failure compared with the placebo group (3.5% vs 2.8%; HR 1.27; P=0.007).
"The increase in hospitalization for heart failure was not expected and deserves further study," stated study chairman Eugene Braunwald, MD, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
"Few diabetes drugs have been studied as thoroughly as saxagliptin was in this trial. Our hope is that these data will help physicians guide future diabetes care in a more data-driven way and improve patient selection for different diabetes drugs," Dr. Bhatt said.
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Post by GodFather on Sept 5, 2013 22:12:43 GMT 5.5
Onglyza® (saxagliptin) achieves primary safety endpoint in SAVOR cardiovascular outcomes trial
AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced the full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. In this study, Onglyza® (saxagliptin) met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, when added to a patient's current standard of care (with or without other anti-diabetic therapies), as compared to placebo. Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the same composite endpoint. Patients treated with Onglyza experienced improved glycemic control and reduced development and progression of microalbuminuria over two years as assessed in exploratory analyses.
The major secondary composite endpoint of cardiovascular death, non-fatal MI, non-fatal ischemic stroke or hospitalization for heart failure, unstable angina or coronary revascularization was balanced across the two arms. One component of the composite secondary endpoint, hospitalization for heart failure, occurred more in the Onglyza group compared to placebo. Rates of pancreatitis were low and balanced between Onglyza and placebo. Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza group than in the placebo group. More patients in the Onglyza group reported at least one hypoglycemic event compared to placebo. Results were presented today during a Hot Line session at the ESC Congress 2013 in Amsterdam, Netherlands, and published in The New England Journal of Medicine.
In the past, questions have been raised about the safety of many diabetes treatments, in particular regarding their impact on the risk of cardiovascular death, heart attack or stroke. Led by the academic research organizations TIMI Study Group and Hadassah University Medical Center and conducted at more than 700 sites worldwide, SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) was a randomized, double-blind, placebo-controlled trial of 16,492 patients designed to evaluate the cardiovascular safety and efficacy of Onglyza (saxagliptin) in adults with type 2 diabetes at risk for cardiovascular death, heart attack and stroke, compared to placebo.
"Given the correlation between diabetes and cardiovascular complications, there is a need for thorough assessments of the cardiovascular risks among therapies that improve glycemic control," said Deepak L. Bhatt, MD, MPH, Senior Investigator of the TIMI Study Group, Brigham and Women's Hospital, and a Principal Investigator for the trial. "The results from SAVOR add important evidence to the overall body of data to further define the clinical profile of saxagliptin for the treatment of type 2 diabetes."
"No other DPP-4 inhibitor and few other anti-hyperglycemic agents have been studied as extensively as Onglyza to address the question of cardiovascular safety," said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. "Bristol-Myers Squibb and AstraZeneca are dedicated to meeting needs of physicians and patients in diabetes care and helping to ensure a better understanding of the value of our medications."
"SAVOR is an important contribution to our knowledge of the safety of Onglyza in type 2 diabetes patients at an increased risk for cardiovascular events similar to those found in a real-world population," said Briggs Morrison, MD, executive vice president, Global Medicines Development, AstraZeneca. "In addition, the data on pancreatitis and pancreatic cancer in a study of more than 16,000 patients provide important and timely scientific information from a robust, randomized trial for the diabetes community."
Study Results
In the study, the primary composite endpoint of cardiovascular death, non-fatal MI or non-fatal ischemic stroke occurred in 613 patients (7.3%) in the Onglyza group vs. 609 patients (7.2%) in the placebo group (Hazard Ratio
: 1.00; 95% Confidence Interval [CI]: 0.89, 1.12; non-inferiority p-value < 0.001; superiority p-value = 0.99). The major secondary endpoint, consisting of the primary composite endpoint and hospitalization for heart failure, unstable angina or coronary revascularization, occurred in 1,059 patients (12.8%) in the Onglyza (saxagliptin) group vs. 1,034 patients (12.4%) in the placebo group (HR: 1.02; 95% CI: 0.94, 1.11; p-value = 0.66). Hospitalization for heart failure, a component of this secondary composite endpoint, occurred at a greater rate in the Onglyza group (3.5%) than in the placebo group (2.8%) (HR: 1.27; 95% CI: 1.07, 1.51; p-value = 0.007). The pre-specified secondary endpoint of all-cause mortality occurred in 420 patients (4.9%) in the Onglyza group compared to 378 patients (4.2%) in the placebo group (HR: 1.11; 95% CI: 0.96, 1.27; p-value = 0.15).
Study physicians were allowed to actively manage patients’ glucose through concomitant use of other anti-diabetic drugs and dose titration. Fewer patients in the Onglyza group required the addition or increase of any new anti-diabetic medication compared to placebo (1,938 patients [23.7%] vs. 2,385 patients [29.3%], respectively; HR: 0.77; 95% CI: 0.73, 0.82; p-value < 0.001) or the initiation of insulin therapy for more than three months (454 patients [5.5%] vs. 634 patients [7.8%], respectively; HR: 0.70; 95% CI: 0.62, 0.79; p-value < 0.001). Patients in the Onglyza group had greater reductions in blood sugar levels both from baseline and compared to those in the placebo group, with mean reductions in glycosylated hemoglobin (HbA1c) levels of 0.5% at two years of treatment in the Onglyza group vs. 0.2% in the placebo group (p-value < 0.001). More patients in the Onglyza group achieved or maintained goal HbA1c of less than seven percent compared to those in the placebo group at two years (40.0% vs. 30.3%; p-value < 0.001).
A total of 1,264 patients (15.3%) in the Onglyza group reported at least one hypoglycemic event compared to 1,104 (13.4%) in the placebo group (p-value < 0.001), which included patients with both major (177 patients [2.1%] vs. 140 patients [1.7%]; p-value = 0.047) and minor (1,172 patients [14.2%] vs. 1,028 patients [12.5%]; p-value = 0.002) events for the Onglyza and placebo groups, respectively. Hospitalization for hypoglycemia was infrequent and similar between groups (0.6% vs. 0.5%; p-value = 0.33).
Patients in the Onglyza group experienced reduced development and progression of microalbuminuria, and were more likely to have an improved albumin:creatinine ratio at two years (372 patients [11.1%] in the Onglyza group vs. 295 patients [9.2%] in the placebo group), and less likely to have a worsening ratio (414 patients [12.4%] in the Onglyza group vs. 457 patients [14.2%] in the placebo group), compared to placebo.
A number of pre-specified safety endpoints for diabetes treatments were evaluated (pancreatitis, cancer, liver abnormalities, renal abnormalities, thrombocytopenia, lymphocytopenia, infections, hypersensitivity or skin reactions, bone fractures and hypoglycemia).
All suspected cases of pancreatitis were independently reviewed and adjudicated by a committee of medical experts external to the sponsors and investigators. Pancreatitis occurred infrequently and the number of patients with acute or chronic pancreatitis was similar between the treatment groups (24 [0.3%] in the Onglyza (saxagliptin) group vs. 21 [0.3%], in the placebo group; p-value = 0.77). Definite/possible acute pancreatitis occurred in 22 patients (0.3%) in the Onglyza group vs. 16 patients (0.2%) in the placebo group (p-value = 0.42); definite acute pancreatitis in 17 patients (0.2%) vs. nine patients (0.1%) (p-value = 0.17); and chronic pancreatitis in two patients (< 0.1%) vs. six patients (0.1%) (p-value = 0.18), respectively. There were five cases of pancreatic cancer in the Onglyza group and 12 cases in the placebo group (p-value = 0.095). Renal abnormalities were observed more frequently in the Onglyza group compared to the placebo group (5.8% vs. 5.1%, respectively; p-value = 0.04). The incidence of the other pre-specified safety endpoints was balanced between the two groups.
Study Design
The study included 16,492 adult patients with type 2 diabetes, 8,280 of whom were randomized to receive Onglyza and 8,212 of whom were randomized to receive placebo. Recruitment included patients with type 2 diabetes and baseline HbA1c levels of 6.5% to 12% on any diabetes treatment including diet, insulin and/or oral therapy (excluding GLP-1 agonists and DPP-4 inhibitors) who were at elevated risk for cardiovascular events according to two categories:
Patients ≥ 40 years of age with established cardiovascular disease, defined as ischemic heart disease, peripheral vascular disease or ischemic stroke.
Males ≥ 55 years of age and females ≥ 60 years of age with at least one of the following risk factors: dyslipidemia, hypertension or current smoking, but without established cardiovascular disease.
Further grouping was based on renal function, including patients with normal/mild (eGFR > 50 mL/min), moderate (30 - 50 mL/min) or severe (eGFR < 30 mL/min) renal impairment.
The primary safety objective was to establish that the upper bound of the 95% confidence interval for the estimated risk ratio comparing the incidence of the composite endpoint (cardiovascular death, non-fatal MI or non-fatal ischemic stroke) observed with Onglyza to that observed in the placebo group was less than 1.3. The primary efficacy objective was to determine, as a superiority assessment, whether treatment with Onglyza compared to placebo when added to current background therapy would result in a reduction in the composite endpoint of cardiovascular death, non-fatal MI or non-fatal ischemic stroke in patients with type 2 diabetes. Secondary efficacy objectives included a reduction in the primary composite endpoint together with hospitalization for heart failure, coronary revascularization or unstable angina pectoris, and reduction of all-cause mortality. Secondary safety objectives included the evaluation of safety and tolerability by assessment of overall adverse events and adverse events of special interest.
Patients were randomized between May 2010 and December 2011. The median follow-up was 2.1 years and maximum follow-up was 2.9 years.
About Onglyza® (saxagliptin)
As of September 2013, Onglyza is approved in 86 countries including those in the European Union, the United States, Canada, Mexico, India, Brazil and China.
About Diabetes
In 2012, diabetes was estimated to affect more than 370 million people worldwide. The prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterized by insulin resistance and dysfunction of beta cells in the pancreas, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to further progression of the disease. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.
The major cause of death and complications in patients with type 2 diabetes is cardiovascular disease. As many as 80% of patients with type 2 diabetes will develop and possibly die from a cardiovascular event.
About the AstraZeneca / Bristol-Myers Squibb Diabetes Alliance
Dedicated to addressing the global burden of diabetes by advancing individualized patient care, AstraZeneca and Bristol-Myers Squibb are working in collaboration to research, develop and commercialize a versatile portfolio of innovative treatment options for diabetes and related metabolic disorders that aim to provide treatment effects beyond glucose control.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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Post by GodFather on Sept 5, 2013 22:14:26 GMT 5.5
Scientists discover novel functions of platelets
A new finding could lead to novel treatments to reduce bleeding in trauma and severe infections. The research, from Oklahoma Medical Research Foundation (OMRF) scientists Lijun Xia, M.D., Ph.D., Jianxin Fu, M.D., Ph.D., and Brett Herzog, Ph.D., appears in the most recent issue of the journal Nature.
One way the immune system keeps a body healthy is through immune surveillance. Lymphocytes, a type of white blood cell, constantly exit the bloodstream and "check in" at the lymph nodes to learn about possible pathogens or abnormal cell growth. The function prepares the immune system to fight infections and dispose of pre-cancerous cells.
For years, scientists have wondered how lymphocytes exit the bloodstream at a large volume without causing bleeding. Xia and his team of researchers found that platelets, which normally stop blood loss by clumping and forming plugs in blood vessel holes after injuries, activate a screening process. And this process allows lymphocytes to exit into lymph nodes without letting red blood cells leave the blood vessel.
"Platelets are the smallest blood cells that work in clotting to heal cuts because they stick to the site of the injury," said Xia, a member of OMRF's Cardiovascular Biology Research Program. "This novel function requires platelets to dump a specific lipid content, but does not need intact platelets because it's not forming a clot. We never knew they could do this before."
Not only are platelets making it possible for lymphocytes to leave the blood vessel, they're doing so by going outside the vessel, themselves—another novel finding, he said.
When scientists interrupted the process by removing a protein called podoplanin, the screening process stopped working, allowing both lymphocytes and red blood cells to escape. The new study reveals a novel function of platelets independent of their hemostatic role. The findings could alter the ways in which doctors use platelets to treat traumatic injuries and serious infections.
Intact platelets that can clot usually only last 5 to 7 days in the blood and cannot be frozen, making storage a problem, Xia said. Since these new functions do not rely on intact platelets, it points to different uses for platelets, perhaps even some that have been frozen. If it works out, the discovery could be useful in stopping widespread internal bleeding caused by explosive traumas or severe infections.
"As the research continues, I think there's a possibility this will lead to new therapeutics that could slow or stop hemorrhaging in trauma and sepsis-related illnesses," Xia said.
The breakthrough has opened several avenues for further research, he said. One will be a better understanding of how platelets go outside the vessels to start the process. They will also be looking to see if platelets perform the same role in letting rapid-attack immune cells called neutrophils out of the bloodstream to fight infections.
"This is a prime example of the important research that the Institutional Development Award program makes possible in states that have historically had low levels of funding from the National Institutes of Health," said NIH grant program official María Teresa Canto, D.D.S., M.S., M.P.H. "Dr. Xia's study sheds light on a process that is key to vascular health as well as to the development of inflammation and associated diseases."
Contributing to the research were scientists Mark Kahn, M.D., of the Division of Cardiology at the University of Pennsylvania, Shaun Coughlin, M.D., Ph.D., of the Cardiovascular Research Institute at the University of California at San Francisco, and OMRF scientists Rodger McEver, M.D., Hong Chen, Ph.D., and Florea Lupu, Ph.D.
Funding for the research was provided by grants No. HL085607 and HL093242 from the National Heart Lung and Blood Institute, grant No. GM103441 from the National Institute of General Medical Sciences, a part of the National Institutes of Health, and the American Heart Association (11SDG7410022).
OMRF is an independent, nonprofit biomedical research institute dedicated to understanding and developing more effective treatments for human diseases. Its scientists focus on such critical research areas as cancer, lupus and cardiovascular disease.
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Post by GodFather on Sept 6, 2013 16:01:15 GMT 5.5
Pradaxa® (dabigatran etexilate) drives Boehringer Ingelheim's innovation promise in cardiovascular diseases
Boehringer Ingelheim announces new milestones for the novel oral anticoagulant Pradaxa® (dabigatran etexilate) with over two million patient-years of experience in all licensed indications globally.(1) In addition, the company confirms research currently underway for Pradaxa® in new cardiovascular patient populations, as well as robust plans to gather real-world evidence in patients with non-valvular atrial fibrillation (NVAF). These plans are the cornerstone of an initiative to expand the scientific knowledge of stroke prevention and interventional cardiology with Pradaxa®, and demonstrate Boehringer Ingelheim's leadership and commitment to innovative solutions for patients and healthcare providers.
Initiating new research will help strengthen understanding of the safety and efficacy profile of Pradaxa®, the longest studied novel oral anticoagulant (NOAC). Since its discovery 20 years ago, Pradaxa® has been evaluated through the extensive RE-VOLUTION® clinical trial programme, which includes 10 clinical trials involving more than 40,000 patients in over 100 countries globally.(2-12)
"We are building upon Pradaxa®'s strong foundation in clinical research and prescribing experience to deepen our understanding of the treatment's benefit/risk profile to address evolving patient needs and benefit the cardiovascular community as a whole," commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "Now, we are in discussions regarding plans for important new clinical trials where we see unmet patient need. Details of these plans will be announced in the near future."
The efficacy and safety of Pradaxa® to reduce risk of stroke and systemic embolism in patients with NVAF was established in the pivotal RE-LY® trial, one of the largest stroke prevention clinical studies ever conducted with NVAF patients.(9,10) To date, Pradaxa® has also been studied in the following areas:
Prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery (2-5)
Acute treatment of deep vein thrombosis (DVT) or primary embolism (PE) (6,7)
Prevention of recurrent DVT or PE8
The company recently announced it had submitted applications to U.S. and EU regulatory authorities to review Pradaxa® for use in patients with DVT and PE.
Current Pradaxa® Research Underway
Currently, there are 12 Boehringer Ingelheim-sponsored trials of Pradaxa® in progress. These include studies which investigate Pradaxa® in patients with impaired renal function, as well as paediatric patients, and studies which explore management strategies for gastrointestinal symptoms. An investigational antidote is progressing through phase I clinical research for the reversal of Pradaxa®-induced anticoagulation.(13)
Additionally, the company is collecting important data on the use of Pradaxa® in clinical practice with ongoing long-term study programmes and registries. The GLORIATM-AF Registry Program is set to become one of the largest worldwide registries with the objective of understanding the long-term use of oral antithrombotic therapies in the prevention of non-valvular AF-related strokes in a real-world setting. Currently, the GLORIATM-AF Registry Program actively recruiting in 35 countries, with a planned enrolment of up to 56,000 patients worldwide. In addition, Boehringer Ingelheim is working in close collaboration with leading hospitals, insurance, healthcare research and governmental organisations in the USA to further assess the real-world clinical usage of Pradaxa®.
Current Experience with Pradaxa®
Globally, Pradaxa® is currently approved in over 100 countries for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and primary prevention of VTE following total hip replacement or total knee replacement surgery.(1,14) The extensive in-market experience of over 2 million patient-years puts Pradaxa® first among the novel oral anticoagulants. Since its approval in NVAF, Pradaxa® is estimated to have prevented up to 93,000 strokes in NVAF patients compared to no treatment.(1) Combined experience from the clinical trials programme and real-world clinical practice establish Pradaxa® as the longest and most extensively studied novel oral anticoagulant.(1)
About Pradaxa® (dabigatran etexilate)
Prescribing experience with Pradaxa® continues to grow with over two million patient-years of experience in all licensed indications globally.(1)
Pradaxa® is approved in over 100 countries worldwide.(1) It is licensed for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolism in patients undergoing total hip replacement or total knee replacement surgery.(14)
Pradaxa®, a direct thrombin inhibitor (DTI),(15) was the first of a new generation of direct oral anticoagulants targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.
Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
1. Boehringer Ingelheim data on file
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5. Ginsberg JS. et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24(1)1–9.
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7. Schulman S. et al. A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II). Oral presentation from Session 332: Antithrombotic Therapy 1. Presented on 12 December at the American Society of Hematology (ASH) Annual Meeting 2011.
8. Schulman S. et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
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14. Pradaxa Summary of Product Characteristics, 2013
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Post by GodFather on Sept 7, 2013 16:34:07 GMT 5.5
Novartis announces an exclusive global licensing and research collaboration with Regenerex
Novartis today announced that it has entered into an exclusive global licensing and research collaboration agreement with Regenerex LLC, a biopharmaceutical company based in Louisville, Kentucky, for use of the company's novel Facilitating Cell Therapy (FCRx) platform. The hematopoietic stem cell-based FCRx platform has been investigated in kidney transplantation to induce stable immunological tolerance, resulting in graft survival without the need for lifelong immunosuppression. This collaboration reaffirms the Novartis commitment to transplant. Beyond transplant, Regenerex's novel platform potentially has curative potential for multiple underserved diseases and will be investigated in the rescue of serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies.
"As the field of biomedicine sits on the cusp of a new transformation, we are excited to announce this agreement which supports the Novartis leadership position in cell therapy," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "Thirty years ago, Novartis developed ciclosporin, which changed transplantation treatment paradigms and enabled countless lives to be saved. Now, this collaboration, along with our internal cell therapy assets, has the potential to transform medicine once again through innovation."
FCRx will broaden the current Novartis cell therapy portfolio, which includes two novel cell therapy platforms initially being investigated in hematological malignancies. HSC835 is a novel cell therapy approach that enables an expanded single umbilical cord blood derived hematopoietic stem cell transplant in patients with limited treatment options. HSC835 is currently in a Phase II trial in patients with high-risk hematological malignancies. A second cell therapy product, CTL019 is a chimeric antigen receptor T cell therapy currently in Phase II development in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).
About FCRx
FCRx is a novel allogeneic hematopoietic stem cell based therapy platform that also contains facilitating cells derived from a donor. The platform supports the development of tolerance, or "bone marrow chimerism," in transplant recipients, providing a better side effect profile than current human hematopoietic stem cell transplantation protocols. Chimerism may eventually render the recipient tolerant to cell, tissue or organ transplants from the same donor, thereby enabling transplant patients to discontinue immunosuppressive medications after building stable immunological tolerance. Results from a Phase II study in 15 kidney transplant recipients are extremely encouraging with six patients fully withdrawn from immunosuppression without loss of engraftment, and a further two with planned full withdrawal at 1 year[1]. Currently, solid organ transplant recipients must take immunosuppressive drugs for life to prevent rejection. This approach may also allow for treatment of inherited metabolic diseases like metachromatic leukodystrophy or sickle cell disease.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 full-time-equivalent associates and operate in more than 140 countries around the world.
1. Leventhal J, Abecassis M, Miller J. Gallon L, Ravindra K, Tollerud DJ, King B, Herzig G, Herzig R, Ildstad ST. Chimerism and tolerance without GVHD or engraftment syndrome in HLA-mismatched combined kidney and hematopoietic stem cell transplantation. Science Translational Medicine 2012 Mar 7; 4(124): 124ra28.
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Post by GodFather on Sept 9, 2013 21:32:00 GMT 5.5
Drug patch treatment sees new breakthrough
An assistant professor with the Virginia Tech - Wake Forest School of Biomedical Engineering has developed a flexible microneedle patch that allows drugs to be delivered directly and fully through the skin. The new patch can quicken drug delivery time while cutting waste, and can likely minimize side-effects in some cases, notable in vaccinations and cancer therapy.
News of the delivery technology was published in a recent issue of the scientific journal, Advanced Materials.
Leading development of the flexible patch was Lissett Bickford, now an assistant professor and researcher of biomedical engineering and the mechanical engineering, both part of the Virginia Tech College of Engineering. Work on the technology was completed while Bickford was a post-doctoral research associate at the University of North Carolina Chapel Hill.
Microneedle patch technology used on the skin has existed for several years, each patch containing an array of hundreds of micron-sized needles that pierce the skin and dissolve, delivering embedded therapeutics. However, because of their rigid chemical makeup, the patches proved difficult in fully piercing into the skin, creating a waste of drug material and a slowed delivery time. Additionally, the patches also have been difficult to produce in bulk; typical fabrication procedures have required centrifugation.
Bickford, with her research team, including Chapel Hill graduate student Katherine A. Moga, were able to develop a new flexible microneedle patch that forms to the skin directly - think a regular household bandage - and then fully pierces the skin and dissolves. Bickford said the softer, more malleable and water-soluble material also allows for more precise control over the shape, size, and composition of the patch, with little to no waste.
The nanoparticle, micro-molding patch is based on Particle Replication In Non-wetting Templates (PRINT for short) technology, developed by University of North Carolina researcher and professor Joseph DeSimone. Unlike other methods for making these patches, the new technology allows for quicker and greater wide-scale production, reducing related costs.
Research and work on the new patch was funded by the National Institutes of Health and Chapel Hill's University Cancer Research Fund. Advanced Materials wrote of the breakthrough in its July issue.
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Post by GodFather on Sept 10, 2013 19:44:15 GMT 5.5
Chemists find new way to put the brakes on cancer
While great strides have been achieved in cancer treatment, scientists are looking for the new targets and next generation of therapeutics to stop this second leading cause of death nationwide. A new platform for drug discovery has been developed through a collaborative effort linking chemists at NYU and pharmacologists at USC.
In a study appearing in Proceedings of the National Academy of Sciences, the research groups of Paramjit Arora, a professor in NYU's Department of Chemistry, and Bogdan Olenyuk from the USC School of Pharmacy have developed a synthetic molecule, "protein domain mimetic," which targets the interaction between two proteins, called transcription factor-coactivator complex at the point where intracellular signaling cascade converges resulting in an up-regulation of genes that promote tumor progression.
This approach presents a new frontier in cancer research and is different from the typical search for small molecules that target cellular kinases.
The synthetic molecule that the paper describes - HBS 1 - is based on chemically stabilized secondary structure of a protein that is mimicking specific fold, called α-helix ,- and shows outstanding potential for suppression of tumor growth. This compound was specifically designed to interrupt the type of molecular conversation within cell (called cell signaling) that promotes growth of cancer cells. Creation of HBS 1 required a method for locking correct helical shapes in synthetic strings of amino acids - a method previously developed at NYU.
The studies conducted at NYU and USC show that the molecule disrupted the cancer cell signaling network and reached the correct target in the cell to provide a rapid blockade of tumor growth. Importantly, the compounds did not show any signs of toxicity or negative impact in the test host.
While the in vivo experiments in this research were conducted using renal carcinoma cells, the principles of this design are applicable to many human conditions, including other cancers, cardiovascular diseases, and diabetic complications. The general concept of the study, the interruption of the connection between genes as they conspire to promote cancer growth, is general and applicable to the protein cell to protein cell "conversations" implicated in a host of human diseases.
This project required the interdisciplinary collaboration between chemists, biologists, pharmacologists and NMR spectroscopists both at NYU and USC. Contributors include Brooke Bullock Lao, Laura Henchey and Nathaniel Traaseth, and Paramjit Arora of NYU Chemistry Department and Swati Kushal, Ramin Dubey, Hanah Mesallati, and Bogdan Olenyuk from USC.
This research was supported by an NSF CAREER Award to Bogdan Olenyuk, and an NIH R01 grant to Paramjit Arora.
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Post by GodFather on Sept 11, 2013 20:07:12 GMT 5.5
Statins being overprescribed for growing number of kidney disease patients
A new analysis concludes that large numbers of patients in advanced stages of kidney disease are inappropriately being prescribed statins to lower their cholesterol - drugs that offer them no benefit and may increase other health risks such as diabetes, dementia or muscle pain. The findings, which were published in the American Journal of Cardiovascular Drugs as a review of multiple studies, raise serious questions about the value of cholesterol-lowering therapies in kidney disease.
The issue is important, the researchers say, because the incidence of chronic kidney disease is rising in the United States at what they called "an alarming rate." Also, kidney disease patients are 23 times more likely to get cardiovascular disease, and for them it's the leading cause of death.
But for these patients, the frequent decision to prescribe statin drugs to lower cholesterol in order to reduce the risk of cardiovascular disease is not supported by the wider body of research, experts say.
"There is very little benefit to statin drugs for patients in the early stages of kidney disease, and no benefit or possible toxicity for patients in later stages," said Ali Olyaei, a professor of pharmacotherapy in the College of Pharmacy at Oregon State University, and lead author on the new report.
"I believe the evidence shows that the majority of people with chronic kidney disease are taking statins inappropriately," Olyaei said. "They may help a little in early-stage disease, but those people are not the ones who generally die from cardiovascular diseases. And by the end stages the risks outweigh any benefit. More drugs are not always better."
Some of the particular risks posed by statin use, especially at higher doses, include severe muscle pain known as rhabdomyolysis, an increase in dementia and a significant increase in the risk of developing diabetes. The body of research also shows that statins do nothing to slow the progression of kidney disease, contrary to some reports that it might.
The impetus to use statin drugs - some of the most widely prescribed medications in the world to lower cholesterol - is obvious in end-stage kidney disease, because those patients have a mortality rate from coronary heart disease 15 times that of the general population. Unfortunately, evidence shows the drugs do not help prevent mortality in that situation. There is also no proven efficacy of the value of statins in patients using dialysis, researchers said.
If statins are prescribed in early-stage kidney disease, the study concluded that low dosages are more appropriate.
Collaborators on this report, which was supported by OSU, included researchers from the Oregon Health and Science University and the University of Illinois at Chicago.
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