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Nottingham researchers undertake new clinical trial on hearing loss

Researchers at The University of Nottingham are embarking on a clinical trial that will help them to further understand the debilitating condition of hearing loss.

6 Jul 2010

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Neurim Pharmaceuticals confirmed today that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

6 Jul 2010

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.

2 Jul 2010

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease. The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

2 Jul 2010

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

Chelsea Therapeutics International, Ltd. announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

2 Jul 2010

QR Pharma to present clinical data from mechanism of action study in MCI patients at ICAD 2010

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that it has been accepted to present a poster on clinical data from its recent mechanism of action study in mild cognitive impaired (MCI) patients at the International Congress on Alzheimer's Disease (ICAD 2010).

2 Jul 2010

Compugen's CGEN-15001 recombinant fusion protein abolishes spontaneous relapses in animal model of MS

Compugen Ltd. announced today that administration of CGEN-15001 in an animal model of multiple sclerosis (MS) has been shown to completely abolish spontaneous relapses. In addition, administration of this novel molecule prior to disease onset demonstrated a pronounced delay of disease onset and a significant decrease in disease symptoms.

2 Jul 2010

Genentech's second Phase III ICON7 study of Avastin in ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group, announced today that a second large, Phase III, international study showed that the combination of Avastin® (bevacizumab) and chemotherapy, followed by the continued use of Avastin alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening (progression-free survival or PFS, the primary endpoint), compared to chemotherapy alone.

2 Jul 2010

ThromboGenics to present microplasmin Phase III trial data at 28th ASRS and 10th EURETINA Congress

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that data from the second Phase III trial of microplasmin (TG-MV-007) for the non-surgical treatment of vitreomacular adhesion (VMA), are to be presented at the 28th Annual Meeting of the American Society of Retina Specialists (ASRS) and the 10th EURETINA Congress.

1 Jul 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

Oxycyte PFCE decreases mortality after onset of decompression sickness in porcine model study

Oxygen Biotherapeutics, Inc. today announced that results from U.S. Navy studies demonstrated decreased mortality in porcine animal models that were given an intravenous dose of Oxycyte® perfluorocarbon emulsion (PFCE) after the onset of decompression sickness (DCS). These results showed a statistically significant decrease in mortality compared with the control group that did not receive Oxycyte PFCE. This data was published in the June issue of Aviation Space and Environmental Medicine.

1 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Sepracor Inc. announced today the preliminary results of a large-scale, 671-patient Phase III study of OMNARIS® (ciclesonide) HFA, an aerosol nasal formulation of ciclesonide, for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients. In this study, OMNARIS HFA met its primary efficacy endpoint by demonstrating a statistically significant reduction versus placebo in the reflective total nasal symptom score averaged over a two-week treatment period.

1 Jul 2010

Evotec commences EVT 101 proof-of-concept Phase II study in treatment-resistant depression

Evotec AG today announced the start of the proof-of-concept Phase II study in treatment-resistant depression with its NR2B subtype selective NMDA receptor antagonist EVT 101. This clinical development is part of an alliance between Evotec and Roche.

1 Jul 2010

CBio achieves recruitment milestone in XToll clinical trial

Australian drug development company CBio Limited today announced the achievement of a recruitment milestone in its clinical trial of XToll, the potential new-generation drug therapy which could provide safer and more effective treatment of autoimmune diseases such as rheumatoid arthritis.

1 Jul 2010

Biospherics acquires worldwide patent rights to Dtagatose from UKRF

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome, and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its wholly-owned subsidiary, Biospherics Incorporated, has signed a license agreement with the University of Kentucky Research Foundation (UKRF).

1 Jul 2010

XOMA reaches enrollment goal of 325 patients for Phase 2b clinical trial of XOMA 052

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that it has reached the enrollment goal of 325 patients for its Phase 2b dose-ranging clinical trial of XOMA 052, and that it expects patient enrollment to close in July 2010, with top-line results available in the first quarter of 2011. XOMA 052 is a therapeutic antibody candidate that inhibits the pro-inflammatory cytokine interleukin-1 beta (IL-1 beta) which drives the inflammatory cause of Type 2 diabetes.

1 Jul 2010

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced that it has initiated a multi-center, randomized, controlled, crossover Phase 2 clinical trial of TH-302 in combination with gemcitabine in patients with first line pancreatic cancer. TH-302 is a proprietary tumor selective Hypoxia-Activated Prodrug that specifically targets tumor hypoxia.

1 Jul 2010

Drug Trial News

Nottingham researchers undertake new clinical trial on hearing loss

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

QR Pharma to present clinical data from mechanism of action study in MCI patients at ICAD 2010

Compugen's CGEN-15001 recombinant fusion protein abolishes spontaneous relapses in animal model of MS

Genentech's second Phase III ICON7 study of Avastin in ovarian cancer meets primary endpoint

ThromboGenics to present microplasmin Phase III trial data at 28th ASRS and 10th EURETINA Congress

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Oxycyte PFCE decreases mortality after onset of decompression sickness in porcine model study

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Evotec commences EVT 101 proof-of-concept Phase II study in treatment-resistant depression

CBio achieves recruitment milestone in XToll clinical trial

Biospherics acquires worldwide patent rights to Dtagatose from UKRF

XOMA reaches enrollment goal of 325 patients for Phase 2b clinical trial of XOMA 052

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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