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Edema in Medical Technology

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... Clinical Program for XERECEPT(R) in patients with edema associated with brain tumors and from preclinical ... of XERECEPT(R) in Patients with Cerebral edema Demonstrated Clinically Significant Reductions in ... standard of care in the treatment of cerebral edema associated with brain tumors, and an open-label ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and ... effusion or ascites; 3%; 8%) and superficial edema (6%; 5%), hemorrhage (6%; 11%), abdominal pain ... adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps ...

Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion

... a Phase 2 study in patients with Diabetic Macular edema (DME). Enrollment in the wet AMD and DME studies ... the underlying biology of CRVO is related to edema and the growth of abnormal new blood vessels that ... may help decrease vascular permeability and edema and prevent the growth of abnormal new blood ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... retention (e.g., pleural effusion, pulmonary edema and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%) and ... adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps ...

Early Data Show Potential for Imatinib Mesylate Tablets to Treat Life-Threatening Form of Pulmonary Artery Disease

... or ascites; 3%; 8%) and superficial edema (6%; 5%), hemorrhage (6%; 11%), abdominal pain ... adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle ... pain was less frequent (20.5%) and peripheral edema was not reported. Nausea and vomiting were the ...

DSMB Again Supports Continuation of the Phase III Clinical Trial of Medidur(TM) FA for the Treatment of DME

... Medidur FA for the treatment of diabetic macular edema (DME). FAME is two, duplicate, double-masked, ... years as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge injector ... diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. In ...

MacuSight(TM) Announces Positive Preliminary Results From Phase 1 Study of Sirolimus in Wet Age-Related Macular Degeneration

... patients with wet (exudative) age-related macular edema (wet AMD). Similar to its Phase 1 study in patients with diabetic macular edema (DME), preliminary results from this prospective ... (wet AMD) and the treatment of diabetic macular edema (DME), a manifestation of diabetic ...

MacuSight(TM) Announces Positive Initial Results From Phase 1 Study of Sirolimus in Diabetic Macular Edema

... chronic, clinically significant diabetic macular edema (DME). Results from this prospective study of 50 ... pathway rather than simply reversing macular edema in a more non-specific way," said Dr. ... compliance and safety. About Diabetic Macular edema Diabetic ...

Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial

... from the leading type 2 diabetic therapies include weight gain and edema as well as the potential for congestive heart failure and bone loss. ... patients from the adverse side effects of current treatments, including edema and weight gain. The company's scientific strategy is built on a ...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

... events. In this trial, occurrence of drug-related AEs included: peripheral edema (2.2 percent) and dizziness (1.1 percent). High blood pressure can ... (5/40 mg), 13.3 percent (10/20 mg), and 11.2 percent (10/40 mg). The edema incidence for placebo was 12.3 percent. Adverse reactions seen at ...

ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)

... microplasmin intravitreal injection for the treatment of Diabetic Macular edema (MIVI II DME). This trial is designed as the initial step in evaluating ... the leading cause of blindness in patients aged 20-60. Diabetic Macular edema (DME) is a condition where swelling of the retina occurs in patients with ...

Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma

... anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), ... vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), ...

Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia

... (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and musculoskeletal pain (2%-9%) were ... most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), ...

Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients

... anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), ... vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), ...

Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients

... anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), ... vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), ...

FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)

... only if clinically indicated. The type of treatment will depend on whether edema or hypotension is the primary clinical problem. Pre-existing low serum ... (64%), transaminase increase (61%), infection (48%), pain (48%), edema (47%), hypotension (36%), anorexia (36%), and rash (34%). ...

BioElectronics Announces Major Clinical Trials

... are starting to investigate the use of ActiPatch for post-surgical edema and pain control, but there has been little clinical data. We look forward ... drug administration (FDA) has cleared the use of the product for reducing edema (swelling) following blepharoplasty and the European Union has approved ...

Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions in Blood Pressure in Hypertensive Patients

... frequency in the three treatment groups. There was one case of peripheral edema in the placebo arm and one case of peripheral edema in one of the treated arms. There were no increases in liver enzymes above ...

InteKrin Therapeutics Announces Initiation of Phase 2b Study in Type 2 Diabetes with INT131

... studies, wherein an absence of recognized TZD adverse effects such as edema offers a genuine breakthrough for this target," said Linda Slanec Higgins, ... in humans and offers the opportunity for disease modification without the edema and weight gain of current TZD therapies," said Alex DePaoli, MD, ...

Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex

... HYLENEX-assisted arms, the HYLENEX arms demonstrated significantly less edema in all HYLENEX dose groups and all timepoints during infusions. Across the three HYLENEX dose cohorts, 94% of subjects had moderate or severe arm edema with placebo compared to 17% with HYLENEX (p < 0.0001). AEs occurring ...

ISTA Pharmaceuticals Presents Results from Two Phase III Clinical Trials of Xibrom(TM) QD (Once-daily) Formulation at the American Academy of Ophthalmology Annual Meeting

... times daily, when used for 3 months in the treatment of cystoid macular edema (CME) following uncomplicated cataract surgery. Poster Presentations at ... Versus Ketorolac in the Treatment of Acute Pseudophakic Cystoid Macular edema Contributing authors: David S. Rho, MD, Rochelle E. Tractenberg, ...

Ellex 2RT Study Demonstrates Clinical Efficacy in Treatment of Diabetic Macular Edema

... potential to improve and stabilize visual acuity and to reduce retinal edema in patients with diabetic maculopathy and macular edema without causing any damage to the photoreceptors. Peter Hamilton, MD, ...

USC Keck School of Medicine's Dr. Alan Epstein Receives Prestigious National Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic

... effects, especially that of capillary leak syndrome where leakage of fluid from the blood results in dangerously low blood pressure (hypotension), edema and multiple organ failure. Capillary leak syndrome affects as many as 65% of patients and can lead to the cessation of therapy. Dr. Epstein has ...

5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH

... withdrawal. The most common adverse events in the study were: upper respiratory tract infection (glargine 149 [29%], NPH 169 [33.6%]), peripheral edema (glargine 103 [20%], NPH 114 [22.7%]), and arthralgia (glargine 73 [14.2%], NPH 81 [16.1%]). About the study This long-term study was ...

New Study Showed Lantus(R) Plus One, Two or Three Shots of Apidra(R) Lowered Patients' Blood Sugar

... (AEs) were comparable among the 3 treatment arms. The most frequently reported AEs included upper respiratory tract infections (5.2%), peripheral edema (4.1%), pain in extremity (3.8%), nasopharyngitis (3.5%), sinusitis (3.2%), and back pain (3.2%). A greater but nonsignificant proportion of patients ...

Large, Long-Term Study Shows Avandia Has No Increased Overall Cardiovascular Risk Compared to Other Commonly Used Diabetes Medicines

... or for prevention of heart disease or stroke Take insulin or nitrate medicines Have a type of diabetic eye disease called macular edema Have liver problems or had liver problems while taking REZULIN(R) (troglitazone) Are pregnant or planning to become pregnant ...

PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)

... bacterium. The investigational antibody is designed to target a protein component known as the anthrax Protective Antigen (PA) of the lethal and edema toxin complexes produced by the bacterium. Preclinical studies suggest that Valortim(R) has the potential to provide significant protection against ...

ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting

... G.L. Torkildsen, J.I. Williams, P.J. Gomes, M.B. Abelson, T.R. McNamara Bromfenac for the Treatment of Chronic Pseudophakic Cystoid Macular edema Author: E.F. Kadrmas Stability of Vitrase(R) Solutions after Dilution in Anesthetics Authors: B.A. Aird, J.D. Dahlstrom, G.A. Baklayan, ....

ARVO, AOS: Large Study of Lacrisert(R) Dry Eye Insert;

... and included transient blurring of vision, ocular discomfort or irritation, matting or stickiness of eyelashes, photophobia, hypersensitivity, edema of the eyelids and hyperemia. Lacrisert should not be used by patients who are hypersensitive to hydroxypropyl cellulose. If improperly placed, ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema). Adverse reactions reported during post-approval use of PEGASYS therapy, ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema). Adverse reactions reported during post-approval use of PEGASYS therapy, with ...

Alimera Sciences' Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout

... Board (DSMB) has recommended the continuation of two pivotal Phase 3 clinical trials for the use of Iluvien(TM) in the treatment of diabetic macular edema (DME) under the current protocol, without change. The Board completed its final review of the currently available safety and efficacy data prior to ...

Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study

... reported adverse events among exenatide once weekly and sitagliptin users were nausea and diarrhea. Upper respiratory tract infection and peripheral edema were the most frequently reported events by patients receiving pioglitazone. Study Design The 26-week double-blind, superiority study ...

Changing Paradigms in Hereditary Angioedema: A Focus on Prompt Diagnosis and New Therapies

... (HAE) is estimated to afflict 10,000 people in the United States each year. Patients with HAE suffer from recurrent attacks of intense localized edema involving the skin, airway, and visceral organs. Left untreated, most patients will suffer at least one acute attack per month. Chronic therapy with ...

Alimera Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study

... first human pharmacokinetic study (PK Study) of Iluvien(TM). Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME). This 36-month, open-label, Phase 2 study, running concurrently with the pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in ...

Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports

... (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain ...

FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)

... group (greater than four hours). In the open label study of Cinryze as treatment for acute attacks of HAE, no patients who had acute laryngeal edema attacks required hospitalization or intubation. Cinryze was generally well tolerated. There were no deaths or serious adverse reactions related to ...

ESBATech's Antibody Fragment Enters Phase Ib/IIa in Ophthalmology

... but like any other surgery, problems may develop occasionally such as post-surgery inflammation. If poorly controlled, a condition called macular edema can be caused by inflammation, which when becoming chronic, leads to permanent damage to the retinal architecture and loss of visual acuity. ...

RAD001 Phase II Trial Results Positive in Patients with Advanced Gastric Cancer After Failure of One or More Prior Treatments

... The most commonly reported adverse events (all grades; >10% patients) in the study included, stomatitis, anorexia, fatigue, rash, nausea, edema peripheral, thrombocytopenia, diarrhea, pruritus, anemia, dysgeusia, vomiting, pyrexia, pneumonitis, constipation and insomnia. Serious adverse ...

Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function

... patients. Furthermore, our siRNA drug candidate, PF-4523655, has been advanced into two Phase II clinical trials -- one for diabetic macular edema and the other for age related macular degeneration -- by our licensee, Pfizer. In addition, we recently announced that our QPI-1007 drug candidate, ...
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