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Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

A new analysis of data from more than 12,000 people with cystic fibrosis (CF) and Pseudomonas aeruginosa (Pa) lung infection in the Cystic Fibrosis Foundation's Patient Registry shows that use of TOBI (Tobramycin Inhalation Solution, USP) was associated with a 21% reduction in mortality in the following year.

22 Oct 2010

AiCuris’ AIC246 inhibitor treats patient with multi-organ HCMV disease

AiCuris announced today that its novel HCMV inhibitor AIC246 has been used successfully to treat a patient with multi-organ HCMV disease caused by multi-resistant virus. Details will be presented at the 48th IDSA meeting on October 23, presentation number LB-38.

22 Oct 2010

Myrexis to present Phase 2 monotherapy study results of Azixa in patients with GBM

Myrexis, Inc., a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced it will present at the 2010 Society for Neuro-Oncology Scientific Meeting and Education Day, to be held November 18-21, 2010 in Montreal, Canada.

22 Oct 2010

Novartis releases study results on oral calcitonin for treatment of osteoarthritis: Unigene Laboratories

Unigene Laboratories, Inc. announced today that Novartis has released information on the first of two studies on oral calcitonin for the treatment of osteoarthritis conducted by its license partner Nordic Bioscience. The recently completed Study 2301, which assesses the safety and efficacy of oral calcitonin in the treatment of knee osteoarthritis, had three co-primary endpoints.

22 Oct 2010

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Idera Pharmaceuticals, Inc. today announced results from its single-dose, dose-escalation Phase 1 clinical trial evaluating the safety and mechanism of action of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for the treatment of autoimmune and inflammatory diseases.

22 Oct 2010

Advaxis completes patient recruitment in ADXS11-001 phase II study for cervical dysplasia

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, completes recruitment of the first group of patients in its US cervical dysplasia (CIN) phase II study of ADXS11-001 as required for the planned DMSB (safety board) meeting scheduled to be held January 11, 2011.

22 Oct 2010

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.

21 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).

21 Oct 2010

BioCryst to present intravenous peramivir data for influenza treatment at IDSA meeting

BioCryst Pharmaceuticals, Inc. announced the presentation of data related to intravenous (i.v.) peramivir for the treatment of influenza at the 48th Annual Infectious Diseases Society of America (IDSA) meeting being held in Vancouver, Canada.

21 Oct 2010

ISCTM to develop solutions for CNS clinical trial methodology

The International Society for CNS Clinical Trials and Methodology (ISCTM) met recently to develop solutions to challenges facing CNS clinical trial methodology.

21 Oct 2010

$OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS$

OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Today OptiNose Inc. announced the positive results of a study evaluating the efficacy of fluticasone when delivered by the Company's novel bi-directional technology in patients with refractory chronic rhinosinusitis (CRS). The results of the study have been published in an article in the September issue of Rhinology.

21 Oct 2010

Intercell and Romark announce IC41-nitazoxanide combination clinical trials for HCV

Intercell AG and Romark Laboratories L.C. today announced plans to commence clinical trials of Intercell's investigational therapeutic Hepatitis C virus (HCV) vaccine, IC41, in combination with Romark's antiviral drug, nitazoxanide, during the first half of 2011.

21 Oct 2010

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

MAP Pharmaceuticals, Inc. today announced that the Company will present nine analyses relating to its LEVADEX™ orally inhaled migraine therapy product candidate, including analysis from the FREEDOM-301 Phase 3 trial, at the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.

21 Oct 2010

Quark initiates dosing NAION patients in QPI-1007 Phase I study for ocular neuroprotection

Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced it has dosed the first patient with recent onset of non-arteritic anterior ischemic optic neuropathy (NAION) in its ongoing Phase I study of QPI-1007, the Company's proprietary synthetic siRNA drug candidate for ocular neuroprotection.

21 Oct 2010

Agensys and Seattle Genetics initiate ASG-5ME phase I clinical trial for castration-resistant prostate cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of castration-resistant prostate cancer. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by both companies for the treatment of solid tumors.

21 Oct 2010

Aastrom submits SPA for Phase 3 clinical development program in critical limb ischemia to FDA

Aastrom Biosciences, Inc., a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a special protocol assessment (SPA) describing the company's proposed Phase 3 clinical development program in critical limb ischemia (CLI).

21 Oct 2010

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

MacroGenics, Inc. and Eli Lilly and Company today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.

21 Oct 2010

Genzyme third quarter revenue increases to $1.0 billion

Genzyme Corp. today reported third-quarter earnings growth driven by increased shipments of Cerezyme® (imiglucerase for injection). Patients in the United States began returning to normal dosing levels last month, and patients globally are expected to be able to do so this quarter. Earnings growth in the third quarter was also driven by strong revenue from Lumizyme™ (alglucosidase alfa) and cost reduction measures.

21 Oct 2010

Drug Trial News

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

AiCuris’ AIC246 inhibitor treats patient with multi-organ HCMV disease

Myrexis to present Phase 2 monotherapy study results of Azixa in patients with GBM

Novartis releases study results on oral calcitonin for treatment of osteoarthritis: Unigene Laboratories

Idera announces IMO-3100 Phase 1 clinical trial results for autoimmune disease

Advaxis completes patient recruitment in ADXS11-001 phase II study for cervical dysplasia

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

BioCryst to present intravenous peramivir data for influenza treatment at IDSA meeting

ISCTM to develop solutions for CNS clinical trial methodology

OptiNose reports positive results from study of fluticasone delivered by novel device in refractory CRS

Intercell and Romark announce IC41-nitazoxanide combination clinical trials for HCV

MAP Pharmaceuticals to present nine analyses on LEVADEX for migraine therapy at 2010 EHMTIC congress

Quark initiates dosing NAION patients in QPI-1007 Phase I study for ocular neuroprotection

Agensys and Seattle Genetics initiate ASG-5ME phase I clinical trial for castration-resistant prostate cancer

Aastrom submits SPA for Phase 3 clinical development program in critical limb ischemia to FDA

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

Genzyme third quarter revenue increases to $1.0 billion

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