Monitoring Options Expand for Therapeutic Agents and Drugs of Abuse
...be used for large batches of samples. A number of single use devices incorporating immunoassays and designed to be used outside of the traditional laboratory have become available. These devices require FDA approval to be sold in the United States, and their use in non-medical environments such as workplac...Prothrombin Time Comes in Small (CLIA-Waived) Packages
... electromagnetic field kinetics to determine PT. A single drop (10 l) of capillary or venous whole blood is applied to a test strip containing thromboplastin, initiating the coagulation cascade. Alternating magnetic fields in the cocktail cause pre-incorporated iron particles in the strips reaction chamber ...Analyzers Offer Point-of-Care Lipid Panels
...or to perform a wide range of in-office tests on a single fingerstick whole blood sample. As with the Choles... strip selected. Options include a lipid panel and single testing for glucose, ketone, total cholesterol (100-400 mg/dl), HDL cholesterol (25-85 mg/dl), trigl...Hemoglobin Testing at the Point of Care
...emoglobin test cards that measures hemoglobin on a single drop of blood in seconds. Each package of reagent ...diabetes monitoring and -thalassemia testing on a single platform with selectable programs for fast HbA1c or HbA2/F/A1c reporting.The company says that the D...The Past, Present and Future of HLA Typing
...ity and specificity could be high enough to detect single nucleotide differences consistently. Several probes could be used to identify an array of HLA alleles. Today, radioactive probes are seldom used, and sequence specific oligonucleotides are now labeled with fluorescent dyes, biotin, digoxigenin, or...Testing for Human Papillomavirus
...ause HPVs cannot be cultured in vitro. There is a single diagnostic assay that is approved by the US FDA for the specific detection of high-risk HPV infection. The hc2 High-Risk HPV DNA Test (Digene Diagnostics, Gaithersburg) is designed to collectively detect one or more of 13 HPV genotypes (16/18/31/33/...New Quality Control Systems for Every Laboratory Application
...in communicable disease agents. For convenience, a single set of QC materials should contain several analyte...riety of current analytical methods, the days of a single lyophilized control, used throughout the chemistry laboratory, are long gone. Large medical laborato...Managing Preanalytical Processes for Patient Safety
...ther specimens. It helped us to simplify it into a single procedure. You can harm a patient with a wrong blood draw for a chemistry specimen just as you can for a blood bank specimen." To prevent these issues, a proper system is needed for the blood tube label. Some questions to ask are: Are the labels p...Diagnosing Diabetes: Immediate HbA1c Results Improve Glycemic Control
...es to GAD have been shown to be the most sensitive single marker for identifying people at risk of developing diabetes. Available HbA1c analyzers that produce results within minutes are important tools in the detection and management of diabetes. When results are reported during the patient's visit, health...Optimizing Quality Control Data Management
...pply the suggested rules in Unity Real Time with a single click. Fig 1 Westgard AdvisorTM in Unity Real Tim...l Time contains all the same basic features of the single Levey-Jennings chart, but allows users to select several tests to display on a single screen. This p...Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
...fractory to irinotecan-basedchemotherapy, and as a single agent for patients who are intolerantto irinotecan...h irinotecan, 2%in patients receiving ERBITUX as a single agent) and diarrhea (6%in patients receiving ERBITUX with irinotecan, 0.2% in patientsreceiving ERBI....... When patients were evaluated 12 weeks after a single treatmentwith BF-200 ALA, at least 60-70 % of the treated lesions werecompletely cured, depending on the weighting of the clinicalcenters and the area of the head. Relevant side effects did notoccur during the study, the cosmetic results were excelle......e inaggressive NHL patients, RAPID and a phase III single agent trial,known as EXTEND. The EXTEND trial explores the role of single-agenttreatment as a salvage regimen in patients with relapsed aggressiveNHL who have failed at least two prior treatment regimens. Patientsare randomized to receive either pixa......hritis on maintenanceHUMIRA were crossed-over to a single SC injection of HUMIRAco-injected with rHuPH20, and the two injections were compared withregard to PK and safety. HUMIRA is a registered trademark of AbbottLaboratories. The data from this clinical trial support the study hypothesisthat rHuPH20 incr...Protox Announces Positive Clinical Data from Prostate Cancer Study
...promising signsof therapeutic activity following a single intra-prostatictreatment. "The completion of the PRX302 Phase 1 trial is encouraging fromtwo perspectives," said Dr. Scott Coffield, PrincipalInvestigator from the lead site, Scott and White MemorialHospital. "First, there was therapeutic b...MediGene Announces Cancer-Fighting Virus Shows Promise in Early Clinical Trial
...otherapy. Previousclinical studies have shown that single doses of the oncolyticherpes simplex virus NV1020 administered regionally are welltolerated and suggest that it may induce tumor regression. Interimdata from a Phase I/II trial testing NV1020 on hepatic metastasesfrom CRC are encouraging. Methods: NV...Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
...costs exceeding $7 billionannually. Ragweed is the single most common seasonal allergen,affecting up to 75% of those with seasonal allergic rhinitis, or 30million Americans. Current treatment options are mainly limited tosymptomatic therapies to provide temporary relief and conventionalallergy immunotherapy...Rosetta Genomics and Weizmann Institute Scientists Identify Role of microRNA in Cancer Suppression
... The findings suggest the potential for aspecific, single microRNA (miR-34a) to be used as a drug candidatein cancer therapy to increase programmed cell-death (apoptosis) inthe context of the potent tumor suppressor p53. p53 has been widely accepted as a powerful tumor inhibitor thatcan prevent or slow the...Genzyme Announces Results of Clinical Trial of Hylastan
... regimen of Synvisc(R) (hylan G-F 20)provided in a single injection, which the company is currentlyseeking t...injections of hylastandelivered two weeks apart, a single injection of hylastan, or aninjection of a corticosteroid. Patients were evaluated for 26 weeksfollo...Ablynx Announces Interim Results of First Nanobody Phase I Study of ALX-0081 (ANTI-VWF)
...bo-controlled trial in healthymale volunteers at a single center in Europe. The study was initiated during ...development which is believed to be the first ever single domainantibody human trial. This is a significant milestone for Ablynxand demonstrates the success o......f the knee wererandomized to receive either: (I) a single injection of 1 mg ofAdlea (n=36) or (II) three ste...rovide pain relieffor weeks or months after just a single localized treatment. It isa non-opioid TRPV1 agonist with a unique mechanism of action thatprovides ......bust Phase I clinical developmentprogram including single ascending dose and multiple ascending dosestudies with the oral formulation and a single ascending dose studywith the IV formulation. Based on positive results from thesestudies, Portola in...Chi-Med Announces Positive Phase II Proof-of-Concept Data for HMPL-004 in Ulcerative Colitis
...hese compounds includesynthetic and semi-synthetic single chemical entities in additionto botanical and natu...semi-synthetic natural product drugs, andsynthetic single chemical entity drugs. It currently has twocandidates in clinical development in both the US and Ch...RTA 402 Shown to Protect Animals Against Toxicities of Standard Cancer Treatments
...ortfolio ofopportunities that can be advanced on a single management andphysical infrastructure, streamlining the route to human trials andapproval. Founded in 2002, Reata is based in the Dallas area. Formore information, visit www.reatapharma.com Contact Media: For Reata Pharmaceuticals, Inc. Kathryn M......with relapsed/refractory multiplemyeloma, and as a single agent in patients with relapsed/refractoryWaldenst...e and demonstratesperifosine's activity, both as a single agent and as part of acombination, in patients with multiple myeloma and Waldenstrom'smacroglobuline...Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib Combination Studies
...ing a double-blinded, randomized,Phase II study of single agent seliciclib versus best supportivecare in pat...ecurrently planning a randomized Phase II study of single agentseliciclib in patients with previously treated nasopharyngealcancer (NPC)", commented Dr. Judy ...Biotec Pharmacon Announces Preliminary Results from the Sloan-Kettering Clinical Study
...ered definitive. With a possible exception of one single incident, there are noadverse events reported from...in whether this isdrug related or not. Due to this single incident it has beendecided to extend the study with one additional dose level, i.e.140 mg/kg/day in......s since 2003 and in Europesince 2004. VELCADE as a single agent shows a median overallsurvival in this patient population of two and a half years (29.8months) with "robust response rates" regardless of age. VELCADE incombination with DOXIL(R) was approved in May 2007. Data from afollow-up to a Phase 3 multi......-Pacific and Latin andNorth America, making it the single largest cervical cancer vaccineefficacy trial to date. Cross protection In this clinical trial, the vaccine showed significantcross-protection against 6-month persistent infection caused byvirus types 45, 31 and 52. Together with virus types 16 and......rtezomib on days one, four, eight andeleven with a single dose of QUADRAMET administered on day three.By way...s aftereight weeks. QUADRAMET is administered as a single intravenousinjection, usually on an outpatient basis, and exhibits selectiveuptake in areas of bone ...Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
... the safety ofCTA018 Injection was evaluated after single doses of up to 180 mcg.Placebo and two strengths o...d dose administration. The trialwas conducted at a single Canadian center. Key safety evaluationsincluded adverse events, serum and urine calcium, serum ioniz......harmacyclics. "Along with the activity seen in our single agenttrial for second-line treatment of non-small cell lung cancerreported last month at ASCO, these data continue to supportXcytrin's potential role in this underserved cancer and furtherinform the design of our pivotal Phase 3 trial in this indicat......agonist (e.g., thiazolidinediones) when the single agent does not provide adequate glycemic co...R-gammaagonist (e.g., thiazolidinediones) when the single agent alone, withdiet and exercise, does not provide adequate glycemic control. 1.3 Important Lim......e inaggressive NHL patients, including a phase III single agent trial,known as EXTEND and a phase II/III com...own asRAPID. The EXTEND trial explores the role of single agent treatmentas a salvage regimen in patients with relapsed aggressive NHL whohave failed at least......ycemia. Additionally, as early as two hoursafter a single oral dose, there was a statistically significantreduction in plasma glucose levels in diabetic rats treated withdapagliflozin compared to untreated diabetic rats at doses of 0.1mg/kg and 1.0 mg/kg (-101 mg/dL and -128 mg/dL), respectively(p-value les......ese type 2 diabetes patients treated withdiet or a single oral anti-diabetic drug, discontinued any diabetesdrug for an eight- week period. Patients were then randomized toreceive one of four once-daily doses of liraglutide (0.1, 0.3, 0.6,and 0.9 mg) or placebo. Baseline A1c levels ranged between 8.1 to8.5%......amo'sPhase 1b study of SB-509. Subjects received a single treatment inboth legs of either placebo (6 subject...ved NCV during asix-month follow-up period after a single treatment with SB-509.This suggests that SB-509 may have a role in nerve regeneration,which is consi......cting dopamine D2 receptor agonist.When given as a single timed (morning) daily dose, Cycloset(TM) isbelieved to act on circadian neuronal activities within thehypothalamus to reset abnormally elevated hypothalamic drive forincreased plasma glucose, triglyceride, and free fatty acid levelsin fasting and pos......rcise, as add-on therapy to asulfonylurea when the single agent alone does not provide adequateglycemic cont...agonist (e.g., thiazolidinediones) when the single agent does not provide adequate glycemic control. (1.2) Important Limitations of Use: JANU......requirements, we will bepursuing Glufast both as a single agent and in combination withmetformin to meet their needs. We are working towards initiating afinal Phase III clinical study of Glufast in the U.S. thisyear." The first study detailed findings from a randomized,double-blind trial comparing Glufas......cent at the highest dosestudied. The prospect of a single therapeutic which has thepotential to address mult...loped for thetreatment of type 2 diabetes. It is a single enantiomer of racemicketoconazole which suppresses cortisol production by inhibiting the11 beta hydr...Advanced Cell Technology Develops First Human Embryonic Stem Cell Line without Destroying an Embryo
...ure Magazinedocumenting a technique for removing a single cell (known as ablastomere) from an eight-cell hum...is team have now reproduced the work of removing a single cellblastomere from a human embryo with the surviving embryocryo-preserved. Dr. Lanza noted at the m......vantageous in diseases known toinvolve more than a single causative factor. Moreover, bi- ormultivalent binding formats such as Duocalins(R) have significantpotential in targeting cell surface molecules in disease, mediatingagonistic effects on signal transduction pathways or inducingenhanced internalizatio...... Orexigen's novel formulation of naltrexoneSR in a single tri-layer tablet. In a Phase IIb multi-centerclinical trial, Contrave demonstrated statistically significantweight loss at 24 weeks compared to bupropion SR alone, naltrexoneIR (immediate release) alone, and placebo. Contrave is now beingstudied in t......udyevaluated the safety and efficacy of escalating single dosesof CJC-1134-PC in 58 patients who had discon...e levels, persisting for at least 7 days afterthe single injection. In a separate cohort of 16 patients (12active and 4 placebo) treated with either a sing......te during 2007. Phase II trials demonstrated thata single injection of FSH-CTP was able to provide the same clinicaleffect as 7 consecutive daily injections of commercial FSH. Thesetrials demonstrated that attaching the CTP did not affect thetherapeutic activity of FSH or cause a negative immune systemrespo...Array BioPharma Reports New Clinical Data on Its Anti-Inflammatory Drugs
...rmation on its MEK inhibitor,ARRY-162, from both a single ascending dose (SAD) and a multipleascending dose (MAD) Phase 1 clinical trial. In the SAD study, thedrug was given orally at doses of 5 to 80 mg. In blood samplestaken from these volunteers and stimulated ex vivo, ARRY-162 wasshown to inhibit the pr......elieves PDX has the potential to be delivered as a single agent orin combination therapy regimens. About PROPEL PROPEL is an international, multi-center, open-label, single-armpivotal Phase 2 clinical trial of PDX in patients with relapsed orrefractory PTCL. The trial will seek to enroll 100 evaluablepati...New Flu Vaccine from PepTcell Could Provide Immunity Against All Strains of Influenza Virus
... and HIV vaccines.PepTcell's lead product Flu-V, a single treatment flu vaccine isabout to enter clinical tr...ead product, Flu-v, has been developed to providea single treatment flu vaccine which is effective against allstrains of flu virus, including pandemic strains...Javelin Pharmaceuticals Announces Successful Pivotal Phase 3 Trial Data
...ormulation of morphine andChiSys(TM) packaged in a single unit-dose nasal spray. Worldwide,no comparable formulation of morphine is available. About Javelin Pharmaceuticals, Inc. With US corporate headquarters in Cambridge, MA, and a Europeanoffice in Cambridge, UK, Javelin applies innovative proprietaryt...... benefit demonstrated for an AI over tamoxifenin a single trial – LUTON, England, Friday 15 June 2007: Analysis of the entirepopulation of a single trial has demonstrated that survival inearly breast cancer can be significantly improved by switchin...BioCryst Presents Phase I Peramivir Data at the Options for the Control of Influenza Conference
... (17.7 to 24.3 hours) -- The bioavailability of single doses of i.m. peramivir is high (>98%) -- Peramivir was well-tolerated in both of these studies Jon P. Stonehouse, Chief Executive Officer of BioCryst said"these findings suggest an excellent safety profile of peramivirwhen given as an intr...New Flu Vaccine From PepTcell Could Provide Immunity Against All Strains of Influenza Virus
... and HIV vaccines.PepTcell's lead product Flu-V, a single treatment flu vaccine isabout to enter clinical tr...ead product, Flu-v, has been developed to providea single treatment flu vaccine which is effective against allstrains of flu virus, including pandemic strains......5 June 2007: Analysis of the entirepopulation of a single trial has demonstrated that survival inearly breast cancer can be significantly improved by switching fromtamoxifen to anastrozole (Arimidex). An analysis of the'Arimidex'-'Nolvadex 95' (ARNO 95) study, published online in TheJournal of Clinical Onco......ind,placebo-controlled, six-way crossover study of single oral doses ofNG2-73 administered to 19 healthy volunteers. Safety andtolerability were assessed, and kinetic-dynamic relationships weredetermined using plasma concentrations and multiple measures of PDincluding a visual analog scale of sedation (VAS)...CuraGen Presents Update on Clinical Development Program for Belinostat
...eatment of solid and hematologic cancers, bothas a single agent and in combination with other chemotherapeut...tal of 34patients. "We are very encouraged by the single agent activitydemonstrated in both CTCL and PTCL, and intrigued by the rapiditywith which most respo......noticdoses. The first-in-human studies included a single ascending dose anda five day multiple dose study i...ion of 5, 10 and 20 mg tablets ofNG2-73. In the single ascending dose study, 48 subjects were enrolled(38 male and 10 female); all 48 subjects completed th......s can be made from the safety data butthere was no single signal of safety observed. Safety evaluations also included ultrasound examinations ofendometrial thickness. The data from these examinations suggest aninverse dose dependent effect of Proellex on endometrial thicknessat three months. After three mo......versal of shallow neuromuscular blockadeinduced by single or multiple doses of either rocuronium(Esmeron(R)/Zemuron(R)) or vecuronium (Norcuron(R)). "Sugammadex has shown a rapid and complete reversal in thispivotal trial without evidence of PORC or re-occurrence ofneuromuscular blockade. Effective reversa......versal of shallow neuromuscular blockadeinduced by single or multiple doses of either rocuronium(Esmeron®/Zemuron®) or vecuronium (Norcuron®).“Sugammadex has shown a rapid and complete reversal in thispivotal trial without evidence of PORC or re-occurrence ofneuromuscular blockade. Effecti...