Single in Medical Technology

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... that compared the efficacy and safety of a single dose of peramivir (either 300 mg or 600 mg) and ... Korea:25; Taiwan:21). Both the 300 mg and 600 mg single dose peramivir groups demonstrated ... i.v. peramivir 300 mg and 600 mg in both single and multiple doses were generally safe and ...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

... study to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in ... the National Cancer Institute demonstrated that single agent perifosine not only induced tumor ... open-label, Phase 1 study is entitled "Study of single Agent Perifosine for Recurrent Pediatric Solid ...

Single Port Surgeries Now Performed at University Medical Center at Princeton

... now performing laparoscopic surgery by way of a single incision through the belly button -- becoming one ... the cosmetic issue of multiple scars. In single port laparoscopic surgery, only one incision is ... surgery, from multiple incisions to just a single incision in the belly button," said Henry ...

PARI Pharma Reports Successful Phase Ib Clinical Results for Inhaled Liposomal Cyclosporine A and Gains FDA Orphan Drug Designation for the Prevention and Treatment of Bronchiolitis Obliterans

... double lung transplants and seven patients had single lung transplants. Patients were given a single dose application of 10mg or 20mg of liposomal ... development of bronchiolitis obliterans is the single most important risk factor for five-year ...

Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401's Activity in the Treatment of Advanced Metastatic Renal Cell Cancer

... KRX-0401 Demonstrates Impressive single Agent Efficacy in Patients who Progressed after ... as a secondary endpoint. Best response to single agent perifosine was as follows: ... For this group, best response and median PFS to single agent perifosine was as follows: ...

Intercell AG Announces First Subject Enrolled in a Phase II Trial for the Further Development of Its Investigational Vaccine Enhancement Patch to Improve Pandemic Influenza Prevention in Collaboration With U.S. Department of Health and Human Services (HHS

... an H5N1 pandemic influenza outbreak with only a single dose vaccine application VIENNA and ... concomitantly, when combined with each other in a single dose regimen. The trial will be conducted in the ... our goal to achieve full protection with only a single dose plus patch this means an enormous logistical ...

New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)

... years. In the study, subjects were administered single oral doses of VYVANSE 50 mg and ADDERALL XR 20 mg ... Prilosec OTC once daily for 14 days. Alternate single doses of VYVANSE 50 mg and ADDERALL XR 20 mg were ... etiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate ...

Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles

... based on clinical data demonstrating that a single treatment with the high frequency radiowave ... Pelleve system, 83 women and 10 men were given a single treatment with the Pelleve handpiece. The ... of the Pelleve Skin Tightening System. With a single Pelleve treatment, over 87% of our patients ...

Intarcia Therapeutics, Inc. Announces Completion of Enrollment of ITCA 650 Phase 1b Study for the Treatment of Type 2 Diabetes

... for the full course of therapy with a single insertion of the DUROS device on day 1 and ... in which longer durations of treatment with a single ITCA 650 insertion will be evaluated. The DUROS ... can deliver up to a full year of therapy from a single ITCA 650 insertion. The goals of the ITCA 650 ...

Prometheus and Rosetta Genomics Announce License and Collaboration Agreement

... About miRview(TM) squamous Using a single microRNA, miRview(TM) squamous is designed to ... low accuracy. miRview(TM) squamous produces a single objective measure that indicates whether a sample ... diagnosis is critical. Currently there is no single diagnostic test that is conclusive for this ...

New Study Published in the Journal of Drugs in Dermatology Finds DOT Microablative CO2 Laser Optimum for Skin Rejuvenation

... in 4-5 treatments, the DOT technology can do in a single treatment and results have been far superior to ... patients desiring significant effects from a single treatment with minimal downtime. Additionally, ... 33-76 over a six-month period who underwent a single laser resurfacing procedure with the DOT ...

Scientists Discover Why Teeth Form in a Single Row

... genetic forces determines why mammals develop a single row of teeth, while sharks sport several, ... researchers discovered that turning off a single gene in mice resulted in development of extra ... this pathway to restrict teeth within a single row." One of the nation's top academic ...

Sequoia Pharmaceuticals Presents Proof of Clinical Concept of SPI-452, a Novel Pharmacokinetic Enhancer

... proof-of-clinical-concept study and a single ascending-dose, first-time-in-human study ... Before administering SPI-452, subjects received a single dose of darunavir (600 mg), atazanavir (300 mg) ... (SQV). In part 1 of the study, subjects received single doses of SPI-452 (25 mg, 50 mg, 100 mg, 200 mg, ...

New Study Proves Multiple Births From IVF Can Be Avoided

... Shady Grove Fertility Center Proves that elective single Embryo Transfer is Effective in Reducing Multiple ... ) The published study, " Elective single embryo tra n sfer: A 6-year progressive implementation of 784 single blastocyst transfers and the influence of payment ...

Medgenics Announces Positive Data From Phase I/II Clinical Trial of EPODURE Treatment of Anemia in Chronic Kidney Disease

... safety and efficacy for four months with single administration -- Institutional Review Board ... effectively for at least four months with a single EPODURE treatment without the need for additional ... of hemoglobin levels for months from a single treatment. Our results thus far appear to offer ...

Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile

... ABthrax (raxibacumab). The results showed that a single dose of raxibacumab, administered without ... multiple animal models, which demonstrated that a single dose of raxibacumab given prophylactically ... the anthrax vaccine, the protection afforded by a single dose of ABthrax would be immediate following the ...

Modigene Announces Positive Results of Pilot Toxicity Study of Its Long-Acting Human Growth Hormone hGH-CTP

... - single Injection in Primates Containing 1,000-Times the ... included a group of primates that received a single injection of hGH-CTP containing a dose that was ... by these first data in primates showing that huge single doses of hGH-CTP appear very safe," said Dr. Avri ...

Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Hernia Repair Presented at the Postgraduate Assembly in Anesthesiology (PGA)

... -- Pharmacokinetic findings showed that a single intraoperative infiltration of EXPAREL resulted ... and where the need for prolonged analgesia via a single administration can provide a significant ... Editor's Notes: -- "A single administration of DepoBupivacaine(TM) ...

USD 12.5 m Funding for the Development of Intercell's Vaccine Patch System for Pandemic Influenza From U.S. Department of Health and Human Services (HHS)

... under this HHS contract demonstrated that a single 45-microgram dose of an injected H5N1 influenza vaccine, coupled with a single 50-microgram Intercell patch was sufficient ... trial was one of the first to demonstrate that a single dose of Pandemic Influenza vaccine may meet the ...

New Keppra XR(TM) Data Highlight Its Role for Patients with Partial-Onset Seizures

... Emory University Hospital, USA single Dose Bioequivalence between Levetiracetam 2 x 750 ... to achieve a 1,500 mg dose. Results show that a single dose of 2 x 750 mg Keppra XR tablets was bioequivalent to a 3 x 500 mg single dose of Keppra XR in healthy adults, and that ...

Sunesis Pharmaceuticals Announces Presentation of Voreloxin Clinical Data in Patients with Acute Myeloid Leukemia at the 50th Annual Meeting of the American Society of Hematology

... below. Phase 2 Study of Voreloxin as single Agent Therapy (REVEAL-1 Trial) Interim data ... esponse E valuation of V or E loxin in A m L ) single agent Phase 2 trial show that voreloxin induces ... in the Phase 2 portion of this study. single agent cytarabine is the current treatment ...

Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress

... -- A Phase II dose escalation study of a single intraoperative administration of EXPAREL(TM) ... for prolonged postoperative analgesia. Either a single intraoperative administration of EXPAREL or ... (72 hours) postoperative pain relief in a single administration. Currently available local ...

Bayer Announces Upcoming Presentations of Campath(R) and Leukine(R) Data at the 50th Annual Meeting of the American Society of Hematology

... Campath is indicated in the United States as a single agent for the treatment of B-cell chronic ... anemia can occur in patients receiving Campath. single doses of Campath greater than 30mg or cumulative ... Campath is indicated as a single agent for the treatment of B-cell chronic ...

Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral Picoplatin

... solid tumor malignancies were randomized to a single dose of either intravenous (120 mg/m squared) or ... weeks later, they were crossed over to a second single picoplatin dose administered via the alternative ... part of the trial, patients received only a single oral dose of picoplatin (including doses of 50 ...

Sunesis Pharmaceuticals Presents Clinical Trial Data of Voreloxin in Patients with Acute Myeloid Leukemia and Ovarian Cancer at the Chemotherapy Foundation Symposium

... from an ongoing Phase 2 trial demonstrate single agent activity of voreloxin in advanced ... Phase 1 dose escalation trial of voreloxin as a single agent in acute leukemias (N=73) showed that ... oral mucositis. The researchers concluded that single agent activity in the relapsed/refractory AML ...

Sequoia Pharmaceuticals Presents In Vitro and First-in-Human Data Supporting Further Development of SPI-256, a Novel Investigational Protease Inhibitor

... presented on 59 healthy volunteers who took a single dose of SPI-256 (150mg, 450mg, 600mg, 900mg, or ... in combination with 100mg of RTV or received a single dose of 1200mg of SPI-256 with a high-fat meal. ... over the range of 150 to 1200mg. In addition, a single dose of SPI-256 achieved sufficient plasma ...

Rubicon Provides Genome Amplification for the Cancer Genome Atlas Project

... but enables difficult clinical samples such as single cells, plasma, serum and formalin-fixed tissue to ... clinicians to test for multiple analytes from a single small sample, producing more information from ... diagnostic applications, including analysis of single cells, formalin-fixed tissue and plasma. Rubicon ...

Despite Advances in the Accuracy of CT Colonography in Detecting Polyps, Digestive Health Experts Urge Patients to Consider Risks and Realities

... pre-cancerous growths and removing them in a single examination during colonoscopy," commented Dr. ... and breaking the sequence of polyp to cancer in a single diagnostic and therapeutic intervention, ... exposure, the ionizing radiation exposure from a single abdominal or chest CT may be associated with ...

Novare Announces Successful Series of Single Port Lap Band Procedures With RealHand(R) High Dexterity Instruments

... Hospital Center completes his 12th single Port Lap-Band(R) Procedure; Bariatric patients ... the successful completion of a series of single port Lap-Band procedures that results in reduced ... Teixeira. "By reducing the operative site to one single incision in the belly button we are also able to ...

Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin

... study was met. The study showed that even single doses of Alpharadin in patients with painful bone ... the palliative effects of four different single dose levels of Alpharadin in patients with bony ... has shown the beneficial palliative effect of a single dose of Alpharadin and that there is a ...

Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates

... in-clinic, multi-center randomized, double-blind, single administration, placebo controlled Phase 2a ... was to assess the safety and efficacy of a 1 mg single dose of AZ-002 in treating a ... 1 clinical trial of 40 healthy volunteers, at a single site, in a trial designed to assess the safety, ...

First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate

... multiple pathogens, both viral and bacterial in a single test. In less than four hours Tem-PCR can ... and community-acquired infections (CAI) in a single molecular test. Unlike hospital acquired MRSA ... both viral and bacterial, all in a single molecular test." Diatherix Laboratories Inc. is ...

Idenix Pharmaceuticals Advances HCV Discovery Program to Clinic

... healthy volunteers. This study will evaluate six single rising doses of IDX184, ranging from 5 mg to 100 ... pocket of HCV polymerase. IDX375 has exhibited single nanomolar in vitro potency against HCV genotype ... HCV protease. IDX136 and IDX316 have demonstrated single nanomolar potency against HCV genotype 1a and ...

Novare Announces Completion of First Pediatric Single Port Spleen Removal Using RealHand(R) HD Instruments

... becomes 4th surgical specialty to benefit from single port surgery with RealHand HD ... the successful completion of the first pediatric single port splenectomy, using RealHand HD instruments. ... in the patient's belly button. "It's called single port surgery," said Dr. Dutta, "and it's the ...

Anesiva Commences Phase 2 Trial of Adlea(TM) in Arthroscopic Shoulder Surgery

... tolerability, efficacy, and pharmacokinetics of a single dose of Adlea administered via ... provide pain relief for weeks to months after a single localized treatment. Its novel mechanism of ... Adlea has been shown to reduce pain after only a single administration for weeks to months in multiple ...

Proteolix Initiates Phase 1b Clinical Trial of Carfilzomib in a Combination Regimen for Patients With Relapsed Multiple Myeloma

... activity, causing apoptosis in cancer cells. In single agent Phase 1 studies carfilzomib has ... currently evaluating carfilzomib as a single agent for the treatment of multiple myeloma in ... that exhibits a high level of selectivity for a single active site in the proteasome with minimal cross ...

Eisai Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes

... on a North American, multi-center, open-label, single arm Phase II trial (DACO-020) in which patients ... than 30 ongoing trials with Dacogen either as a single agent or in combination with other therapies, ... DACO-020: This is a multi-center, open-label, single arm Phase II study of Dacogen in 99 patients with ...

Pressure Cycling Technology (PCT) Results in a Higher Yield of Proteins and in the Extraction of Proteins Not Previously Identified in Cancer, Stroke, and IVF Studies

... morbidity and mortality. To combat this, more single embryo transfers are needed. To this end, we ... selection and result in more live births from single embryo transfers. These are very exciting ... and may not result in more live births from single embryo transfers; that due to competitive ...

Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma

... this disease. The talactoferrin monotherapy single arm trial was conducted at six leading U.S. ... in patients with RCC are warranted either as a single agent or in combination with one of the newer ... monotherapy trial was an open label, 44-patient, single arm trial conducted at six leading U.S. sites. To ...

Trubion Pharmaceuticals Announces Presentation of Positive TRU-015 and SBI-087 Data at the 2008 Annual European Congress of Rheumatology Meeting

... data presented at the meeting demonstrated that a single dose of SBI-087, a next-generation Small Modular ... in a Phase I/IIa study. Patients treated with a single course of 5 mg/kg or higher in a previously ... for re-treatment. Patients who received a single infusion of 5 mg/kg received a single infusion of ...