Clinical Trial News and Research

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Smoking cessation medication 46% effective in women

The most effective prescription drug used to quit smoking initially helps women more than men, according to a Yale School of Medicine study. The study, published Oct. 7 by the journal Nicotine and Tobacco Research, found that varenicline, marketed as Chantix, was more effective earlier in women, and equally effective in women and men after one year.

8 Oct 2015

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, has announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study.

7 Oct 2015

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Biogen (NASDAQ: BIIB) will, this week, present data at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, demonstrating the efficacy and safety of TECFIDERA® (dimethyl fumarate) across a broad range of people with relapsing-remitting multiple sclerosis (RRMS).

7 Oct 2015

Immune submits Bertilimumab IND application to FDA for treatment of Bullous Pemphigoid

Immune Pharmaceuticals, Inc. announced today that it has submitted an Investigational New Drug Application in the U.S. to expand recruiting for its first in class lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP).

7 Oct 2015

SCT, Thermo Fisher Scientific collaborate to advance development of cardiac disease models

Stem Cell Theranostics announced today that they have successfully completed a research collaboration with Thermo Fisher Scientific focused on advancing the development of cardiac disease models derived from induced pluripotent stem cells using Thermo Fisher Scientific's suite of work flow reagents and SCT's patient biobank and proprietary disease modeling methods.

7 Oct 2015

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

DBV Technologies, a clinical-stage specialty biopharmaceutical company, today announced that topline findings from the first 12 months of the OLFUS-VIPES study, or OLFUS, support the long-term safety and efficacy of Viaskin Peanut for the treatment of peanut allergy.

7 Oct 2015

Cabozantinib, nivolumab ‘bring hope’ for advanced RCC patients

Clinical trial results suggest significant benefits with the use of cabozantinib or nivolumab over everolimus for patients with advanced renal cell carcinoma, researchers reported at the European Cancer Congress in Vienna, Austria.

6 Oct 2015

First patients screened in Axovant's phase 3 study of RVT-101

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.

6 Oct 2015

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company's lead product candidate, ENV515 (travoprost XR).

6 Oct 2015

Flu vaccine significantly reduces stroke risk

The risk of suffering a stroke is significantly reduced for up to two months after receiving a flu vaccine, a major new study has shown.

6 Oct 2015

NIH-funded researchers test new gene therapy to improve visual function in mice

Researchers funded by the National Institutes of Health have developed a novel mouse model for the vision disorder Leber hereditary optic neuropathy (LHON), and found that they can use gene therapy to improve visual function in the mice. LHON is one of many diseases tied to gene mutations that damage the tiny energy factories that power our cells, called mitochondria.

6 Oct 2015

Anti-coagulant medications quickly resolve blood clots that could impair valve motion

Heart valve replacements made from tissue (bioprosthetic valves) have long been thought to be spared the complication of blood clot formation. Researchers have now found that about 15 percent of all bioprosthetic aortic heart valve patients develop blood clots on the leaflets affecting valve opening, regardless of whether the patient received the new valve via open-heart surgery or a minimally-invasive catheter procedure, a new study from the Cedars-Sinai Heart Institute shows.

6 Oct 2015

Allergan receives FDA approval to market JUVEDERM ULTRA XC for use in lips

Allergan plc, a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration to market JUVEDERM ULTRA XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. JUVEDERM ULTRA XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation.

1 Oct 2015

Plymouth University and Ingenza partner to develop efficient, scalable microbial production system for epidermicin

Ingenza is collaborating with researchers at Plymouth University to develop an efficient, scalable microbial production system for epidermicin, an exciting new antibiotic that rapidly kills methicillin-resistant Staphylococcus aureus and other harmful bacteria.

1 Oct 2015

Oraya therapy is effective in maintaining vision with reduced injections for wet AMD patients

The results show that Oraya Therapy is effective in maintaining vision with reduced injections for patients at different stages of their disease—from chronic patients in discontinuous treatment to treatment-naive patients with new diagnosis—and following different treatment pathways.

1 Oct 2015

Brodalumab therapy achieves 100% reduction in psoriasis symptoms

An experimental, biologic treatment, brodalumab, achieved 100 percent reduction in psoriasis symptoms in twice as many patients as a second, commonly used treatment, according to the results of a multicenter clinical trial led by Mount Sinai researchers and published online today in the New England Journal of Medicine.

1 Oct 2015

OncoGenex meets target enrollment in apatorsen Phase 2 trial

OncoGenex Pharmaceuticals, Inc. announced today that Borealis-2, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States.

30 Sep 2015

BiondVax to begin Phase IIb clinical trial of universal influenza vaccine in Europe

BiondVax Pharmaceuticals Ltd. announced today that it received regulatory clearance from the Hungarian Regulatory Authority (National Institute of Pharmacology and Nutrition, OGYEI) and the Central Ethics Committee in Budapest to initiate a Phase IIb clinical trial. The initiation meeting was scheduled for today, September 30, 2015, together with the partners from the UNISEC European Consortium.

30 Sep 2015

AMO Pharma raises $25 million in private equity financing

AMO Pharma Limited, a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment options, announced today that the company has raised $25 million in private equity financing from Woodford Investment Management.

30 Sep 2015

Survey: One-third of US women use compounded hormones at menopause

A third of US women who take hormones at menopause are using compounded hormones, shows a new national survey. These women commonly--and mistakenly--think these hormones are safer and offer more benefits than FDA-approved therapies.

30 Sep 2015

Clinical Trial News and Research

Smoking cessation medication 46% effective in women

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Immune submits Bertilimumab IND application to FDA for treatment of Bullous Pemphigoid

SCT, Thermo Fisher Scientific collaborate to advance development of cardiac disease models

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

Cabozantinib, nivolumab ‘bring hope’ for advanced RCC patients

First patients screened in Axovant's phase 3 study of RVT-101

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Flu vaccine significantly reduces stroke risk

NIH-funded researchers test new gene therapy to improve visual function in mice

Anti-coagulant medications quickly resolve blood clots that could impair valve motion

Allergan receives FDA approval to market JUVEDERM ULTRA XC for use in lips

Plymouth University and Ingenza partner to develop efficient, scalable microbial production system for epidermicin

Oraya therapy is effective in maintaining vision with reduced injections for wet AMD patients

Brodalumab therapy achieves 100% reduction in psoriasis symptoms

OncoGenex meets target enrollment in apatorsen Phase 2 trial

BiondVax to begin Phase IIb clinical trial of universal influenza vaccine in Europe

AMO Pharma raises $25 million in private equity financing

Survey: One-third of US women use compounded hormones at menopause

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