BASEL: NOVARTIS INCREASING CANCER IMMUNOTHERAPY RESEARCH.

Novartis expands cancer immunotherapy research program with acquisition of CoStim Acquisition adds novel immune modulating targets and technology to accelerate Novartis cancer immunotherapy program Novartis and University of Pennsylvania CAR immunotherapy research combined with CoStim targets and technology strengthens Novartis' position in cancer immunotherapy discovery Basel, February 17, 2014 - Novartis announced today that it is broadening its cancer immunotherapy research program with the acquisition of CoStim Pharmaceuticals Inc., a Cambridge, MA-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer. Increasing evidence points to the role of the immune system in controlling cancer and to opportunities for creating effective oncology therapies for cancer patients by stimulating a targeted immune response. Already leading in cancer immunotherapy, with investigative chimeric antigen receptor (CAR) technology being developed in collaboration with the University of Pennsylvania, with this acquisition Novartis is adding late discovery stage immunotherapy programs directed to several targets, including PD-1. These medicines could benefit patients by circumventing cancer's ability to develop resistance against current single drugs. "Therapy for many types of cancers are expected to increasingly rely upon rational combinations of agents," said Dr. Mark Fishman, President of the Novartis Institutes for BioMedical Research. "Immunotherapy agents provide additional arrows in our quiver for such combinations. They complement our extensive portfolio of drugs that hit genetically-defined cancer-causing pathways, and also may be relevant to expansion of CAR therapies."

CLEAN CLOTHES PREVENT INFECTION

http://press.uchicago.edu/pressReleases/2014/January/1312_iche_bearman_guidance.html The University of Chicago Press Books About Contact News & Events [Journals]: Infectious Diseases Experts Issue Guidance on Healthcare Personnel Attire Recommendations to help prevent healthcare-associated infections transmitted through clothing Society for Healthcare Epidemiology of America Contact: Tamara Moore / tmoore@gymr.com/ 202-745-5114 Study contact: Gonzalo Bearman MD, MPH/ gbearman@mcvh-vcu.edu CHICAGO (January 20, 2014) – New guidance from the Society for Healthcare Epidemiology of America (SHEA) provides recommendations to prevent transmission of healthcare-associated infections through healthcare personnel (HCP) attire in non-operating room settings. The guidance was published online in the February issue of Infection Control and Hospital Epidemiology, the journal of the SHEA, along with a review of patient and healthcare provider perceptions of HCP attire and transmission risk, suggesting professionalism may not be contingent on the traditional white coat. “While studies have demonstrated the clothing of healthcare personnel may have a role in transmission of pathogens, the role of clothing in passing infectious pathogens to patients has not yet been well established,” said Gonzalo Bearman, MD, MPH, a lead author of the study and member of SHEA’s Guidelines Committee. “This document is an effort to analyze the available data, issue reasonable recommendations, define expert consensus, and describe the need for future studies to close the gaps in knowledge on infection prevention as it relates to HCP attire.” The authors outlined the following practices to be considered by individual facilities: “Bare below the elbows” (BBE): Facilities may consider adopting a BBE approach to inpatient care as a supplemental infection prevention policy; however, an optimal choice of alternate attire, such as scrub uniforms or other short sleeved personal attire, remains undefined. BBE is defined as wearing of short sleeves and no wristwatch, jewelry, or ties during clinical practice. White Coats: Facilities that mandate or strongly recommend use of a white coat for professional appearance should institute one or more of the following measures: HCP should have two or more white coats available and have access to a convenient and economical means to launder white coats (e.g. on site institution provided laundering at no cost or low cost). Institutions should provide coat hooks that would allow HCP to remove their white coat prior to contact with patients or a patient’s immediate environment. Laundering: Frequency: Optimally, any apparel worn at the bedside that comes in contact with the patient or patient environment should be laundered after daily use. Home laundering: If HCPs launder apparel at home, a hot water wash cycle (ideally with bleach) followed by a cycle in the dryer or ironing has been shown to eliminate bacteria. HCP footwear: All footwear should have closed toes, low heels, and non-skid soles. Shared equipment including stethoscopes should be cleaned between patients. No general guidance can be made for prohibiting items like lanyards, identification tags and sleeves, cell phones, pagers, and jewelry, but those items that come into direct contact with the patient or environment should be disinfected, replaced, or eliminated. If implemented, the authors recommend that all practices be voluntary and accompanied by a well-organized communication and education effort directed at both HCP and patients. In their review of the medical literature, the authors noted that while patients usually prefer formal attire, including a white coat, these preferences had little impact on patient satisfaction and confidence in HCPs. Patients did not tend to perceive the potential infection risks of white coats or other clothing, however when made aware of these risks, patients seemed willing to change their preferences of HCP attire. The authors developed the recommendations based on limited evidence, theoretical rationale, practical considerations, a survey of SHEA membership and SHEA Research Network, author expert opinion and consensus, and consideration of potential harm where applicable. The SHEA Research Network is a consortium of more than 200 hospitals collaborating on multi-center research projects. ### Bearman, G., Bryant, K., Leekha, S., Mayer, J., Munoz-Price, L.S., Murthy, R., Palmore, T., Rupp, M., White, J. “Expert Guidance: Healthcare Personnel Attire in Non-Operating Room Settings.” Infection Control and Hospital Epidemiology 35:2 (February 2014).

MINIMAL RESIDUAL DISEASE MONITORING: SWISS MED. WEEKLY www.smw.ch

Published 22 January 2014, doi:10.4414/smw.2014.13907 Cite this as: Swiss Med Wkly. 2014;144:w13907 Minimal residual disease monitoring: the new standard for treatment evaluation of haematological malignancies? Mathieu Hauwel, Thomas Matthes Swiss Flow Cytometry School, Haematology Service and Clinical Pathology Service, Geneva University Hospital, Switzerland SUMMARY of on-line paper. Abbreviations ALL acute lymphoblastic leukaemia AML acute myeloid leukaemia ASO-PCR allele-specific oligonucleotide-PCR BCR B-cell receptor CLL chronic lymphocytic lymphoma CML chronic myeloid leukaemia CR complete remission cytoCR flow cytometry CR DNA deoxyribonucleic acid FISH fluorescent in-situ hybridisation FL follicular lymphoma iCR immunofixation CR IgH immunoglobulin heavy chain LAIP leukaemia-associated immunophenotype LSCs leukaemic stem cells MCFC multicolour flow cytometry MRD minimal residual disease mRNA messenger RNA NGS new generation sequencing NMR nuclear magnetic resonance PCR polymerase chain-reaction PET positron emission tomography PFS progression-free survival Ph Philadelphia chromosome RNA ribonucleic acid RT-PCR reverse transcriptase-PCR sCR serum free light chain ratio CR TCR T-cell receptor Minimal residual disease (MRD) refers to the small number of malignant cells that remain after therapy when the patient is in remission and shows no symptoms or overt signs of disease. Current treatment protocols for haematological malignancies allow most patients to obtain some form of MRD state, but cure seldom follows and in most cases fatal relapses occur sooner or later, leaving a bitter impression of having won a battle yet lost the war. MRD detection and quantification are used for evaluation of treatment efficiency, patient risk stratification and long-term outcome prediction. Whereas multicolour flow cytometry (MCFC) and polymerase chain reaction (PCR) based methods constitute the two most commonly used techniques for MRD detection, next generation sequencing will certainly be widely employed in the future. As MRD reflects the nature of the malignant disease itself, including its sensitivity to the drug regimens applied, it constitutes the ideal method for surveillance and patient follow-up. The morphological examination of peripheral blood or bone marrow smears, although still an indispensable part of routine laboratory testing, is clearly insufficient for patient management, and clinicians should not ask themselves whether to look for MRD or not, but how and when. Key words: minimal residual disease; flow cytometry, next generation sequencing; PCR; acute lymphoblastic leukaemia; acute myeloid leukaemia; chronic myeloid leukaemia; multiple myeloma, lymphoid neoplasm

NY,NY: SILICONE NIPPLE PROSTHESIS

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SPIRONOLACTONE & EPLERENONE in PRIMARY ALDOSTERONISM (CONN SYNDROME)

Integr Blood Press Control. 2013 Oct 4;6:129-138. eCollection 2013. Mineralocorticoid receptor antagonists: emerging roles in cardiovascular medicine. AUSTRALIA: Melbourne. PROF J.W.FUNDER Spironolactone was first developed over 50 years ago as a potent mineralocorticoid receptor (MR) antagonist with undesirable side effects; it was followed a decade ago by eplerenone, which is less potent but much more MR-specific. From a marginal role as a potassium-sparing diuretic, spironolactone was shown to be an extraordinarily effective adjunctive agent in the treatment of progressive heart failure, as was eplerenone in subsequent heart failure trials. Neither acts as an aldosterone antagonist in the heart as the cardiac MR are occupied by cortisol, which becomes an aldosterone mimic in conditions of tissue damage. The accepted term "MR antagonist", (as opposed to "aldosterone antagonist" or, worse, "aldosterone blocker"), should be retained, despite the demonstration that they act not to deny agonist access but as inverse agonists. The prevalence of primary aldosteronism is now recognized as accounting for about 10% of hypertension, with recent evidence suggesting that this figure may be considerably higher: in over two thirds of cases of primary aldosteronism therapy including MR antagonists is standard of care. MR antagonists are safe and vasoprotective in uncomplicated essential hypertension, even in diabetics, and at low doses they also specifically lower blood pressure in patients with so-called resistant hypertension. Nowhere are more than 1% of patients with primary aldosteronism ever diagnosed and specifically treated. Given the higher risk profile in patients with primary aldosteronism than that of age, sex, and blood pressure matched essential hypertension, on public health grounds alone the guidelines for first-line treatment of all hypertension should mandate inclusion of a low-dose MR antagonist. KEYWORDS: eplerenone, inverse agonists, primary aldosteronism, public health, spironolactone PMID: 24133375 [PubMed - as supplied by publisher] PMCID: PMC3796852 Free PMC Article

UK CORK & LEATHER INSOLE

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USA CREUTZFELDT-JAKOB DISEASE

CREUTZFELDT-JAKOB DISEASE - USA (NORTH CAROLINA), POTENTIAL SURGICAL EXPOSURE ***************************************************************************** A ProMED-mail post ProMED-mail is a program of the International Society for Infectious Diseases Date: Tue 11 Feb 2014 Source: The Piedmont News Station [edited] Novant Health Forsyth Medical Center announced Monday [10 Feb 2014] they are reaching out to 18 neurosurgery patients exposed to Creutzfeldt-Jakob disease, a degenerative neurological disorder that is incurable and invariably fatal. "Today [11 Feb 2014], we are reaching out to 18 neurosurgery patients who were exposed to Creutzfeldt-Jakob disease over the last 3 weeks at Forsyth Medical Center," said Jeff Lindsay, President of Forsyth Medical Center. According to the National Institute of Neurological Disorders and Stroke, Creutzfeldt-Jakob disease (CJD) is a rare, degenerative, invariably fatal brain disorder. CJD affects about one person in every one million people per year worldwide. "While the CDC categorizes such risks as very low, any risk of transmission is simply unacceptable," said Lindsay. "On behalf of the entire team, I apologize to the patients and their families for this anxiety. We are committed to providing support to patients and their families." CJD [variant CJC] has been closely associated with mad cow disease (bovine spongiform encephalopathy), however Dr. Jim Lederer said this particular strain is not associated with mad cow disease. "The patient had sporadic CJD. This is important to note, because it is often incorrectly associated with mad cow disease [variant CJD]. It is not," said Dr. Jim Lederer. "On 18 Jan 2014, an operation was performed on a patient with symptoms that could have been attributed to CJD. There were reasons to suspect this patient may have CJD. As such, extra precautions to clean equipment should have been taken, but [were] not," said Dr. Jim Lederer. Forsyth Medical said the exposure occurred through surgical instruments that were not properly sterilized. The surgical instruments used during the surgery were sterilized using standard hospital procedures, however they were not subjected to the enhanced sterilization procedures necessary on instruments used in confirmed or suspected cases of CJD. A patient who had entered Forsyth Medical Center last month [January 2014] for back surgery said a hospital staff member contacted her on Monday [10 Feb 2014] saying she is one of 18 patients who may have been exposed to the disease. A [staff member] says that it's not the hospital's fault, but they are taking full responsibility." Doctors say it is rare that the exposed patients will develop the disease, but if the disease surfaces in patients, it likely won't happen for 20 to 30 years. Novant Health says they will keep tabs on the health of the 18 patients, watching for any signs of the disease for the rest of their lives. According to the CDC, prions, the infectious agents of CJD, may not be inactivated by means of routine surgical instrument sterilization procedures. The World Health Organization and the US Centers for Disease Control and Prevention recommend that instruments used in confirmed or suspected CJD cases be immediately destroyed after use; short of destruction, it is recommended that heat and chemical decontamination be used in combination to process instruments that come in contact with high-infectivity tissues. According to the CDC, no cases of iatrogenic transmission of CJD have been reported since 1976, when current sterilization procedures were adopted. "We believe the chances of transmission to another person [are] very, very low," said Dr. Jim Lederer. The operation at Forsyth Medical was performed on a patient who was "suspected and later confirmed" to have sporadic CJD. In a news conference, Forsyth Medical officials said the disease has no cure and may not show up in exposed patients for decades. CJD usually appears later in life and runs a rapid course. Typically, onset of symptoms occurs about age 60, and about 90 percent of individuals die within one year. In the early stages of disease, people may have failing memory, behavioral changes, lack of coordination, and visual disturbances. As the illness progresses, mental deterioration becomes pronounced, and involuntary movements, blindness, weakness of extremities, and coma may occur. The Department of Health and Human Services issued [the following] statement on Monday [10 Feb 2014]: "DHHS officials are aware of the incident at Novant Health Forsyth Medical Center and have been in contact with the facility. Our primary concern is the health, safety, and welfare of patients, and we will continue to closely monitor the situation," said Kevin Howell, DHHS spokesperson.