Efficacy News and Research

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70% of oncologists and 60% of ob-gyns disagree with Task Force's mammogram recommendations

Recent recommendations by the US Preventive Task Force on Breast Cancer advising that women under the age of 50 should not get routine mammograms have resulted in fierce debate within the medical community. According to a new oncology study from ORC, an Infogroup Company, 70 percent of oncologists and 60 percent of ob-gyns disagree with the assertion that women should not get mammograms before the age of 50.

20 May 2010

Recruitment of children and adults with type 1 diabetes commences in Protege Encore teplizumab trial

Dr. Barry Reiner announced that he is now recruiting children and adults with newly diagnosed type 1 diabetes for Protege Encore, a randomized, placebo-controlled Phase III clinical trial. This is the second of two Phase III studies testing the safety and efficacy of an investigational drug called teplizumab. The first study, known as Protege, has completed enrollment of more than 530 subjects with type 1 diabetes. There is currently no approved therapy to slow the progression of type 1 diabetes.

20 May 2010

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

Allergan, Inc. today announced that the United States Food and Drug Administration has approved ZYMAXID (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia.

20 May 2010

Targacept commences Phase 2 clinical proof of concept trial of TC-5619 in adults with ADHD

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in adults with attention deficit/hyperactivity disorder (ADHD). TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor, which Targacept refers to as NNR, and was discovered by Targacept scientists using Targacept's proprietary drug discovery platform known as Pentad (TM).

19 May 2010

Oncolytics Biotech initiates Phase I study of REOLYSIN and FOLFIRI in colorectal cancer patients

Oncolytics Biotech Inc. announced today that following submission to the U.S. Food and Drug Administration for review, the Company is initiating a U.S. Phase I study of REOLYSIN(R) in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer.

19 May 2010

eMedonline telemonitoring system developed to help patients transition from inpatient to outpatient setting

A clinical study is underway at Nyack Hospital to evaluate the use of cellphone-based technology to monitor medication adherence in discharged heart failure patients. The study is using the eMedonline telemonitoring system developed by Leap of Faith Technologies to help patients transition from the inpatient to outpatient setting.

19 May 2010

Discovery Labs revalidates optimized BAT in program to gain FDA approval of Surfaxin for RDS

Discovery Laboratories, Inc. announces today that the revalidation of its optimized fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test) has been completed, having met all pre-specified acceptance criteria.

19 May 2010

Flexible treatment delivery intervention in primary care reduces symptoms of anxiety: Study

An intervention in primary care settings that allowed a choice of cognitive behavior therapy, medication, or both, along with computer-assisted treatment support for patients with common anxiety disorders, resulted in greater improvement in anxiety symptoms and functional disability compared to usual care, according to a study in the May 19 issue of JAMA, a theme issue on mental health.

19 May 2010

Use of life-ending drugs without explicit patient request occurs in hospital, among elderly patients

Despite fears to the contrary, the use of drugs to end life without patient request has not increased since euthanasia was legalized in Belgium, states an article in CMAJ.

19 May 2010

Pearl Therapeutics presents data supporting development of PT003 combination bronchodilator product

Pearl Therapeutics Inc., a company developing clinically differentiated double and triple combination therapies for the treatment of highly prevalent chronic respiratory diseases, presented results from four studies that provide support for further development of PT003, the company's fixed dose combination of glycopyrrolate and formoterol delivered via a pressurized hydrofluoroalkane metered dose inhaler (HFA-MDI).

19 May 2010

PET scanning provides great insight into immune response

A commonly used probe for Positron Emission Tomography scanning and a new probe developed by researchers at UCLA reveal different functions in diverse cells of the immune system, providing a non-invasive and much clearer picture of an immune response in action.

19 May 2010

New multi-center follow-up study of NX-1207 for treatment of BPH to be completed

Nymox Pharmaceutical Corporation announced today that the Company is nearing completion of a new multi-center U.S. long-term follow-up study of NX-1207, its investigational drug for the treatment of benign prostatic hyperplasia.

19 May 2010

Generex Biotechnology's Phase I study data of AE37 for prostate cancer published

Generex Biotechnology Corporation announced today publication of results from the first Phase I study of its lead immunotherapeutic agent AE37 in patients with prostate cancer. At the end of 2009, the Company announced positive interim results from a Phase II trial being conducted with AE37 in patients with breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc.

19 May 2010

Roche, Biogen Idec discontinue ocrelizumab clinical development programme for RA

Roche and Biogen Idec today announced their decision to discontinue the ocrelizumab clinical development programme in patients with rheumatoid arthritis (RA).

19 May 2010

Causes and treatment options of mental disorders need to be reassessed: JAMA commentary

It is time to reassess mental disorders, recognizing that these are disorders of brain circuits likely caused by development processes, according to a commentary in the May 19 issue of JAMA, a theme issue on mental health.

19 May 2010

WPI, Cerus announce positive results from study of INTERCEPT Blood System to inactivate XMRV

The Whittemore Peterson Institute for Neuro-Immune Disease (WPI) and Cerus Corporation announced positive results from a study demonstrating the efficacy of the INTERCEPT Blood System to inactivate XMRV, a human retrovirus, in donated platelet components.

18 May 2010

Catalyst Pharmaceutical Partners first-quarter net loss decreases to $0.06 per basic and diluted share

Catalyst Pharmaceutical Partners, Inc. today announced its financial results for the three month period ended March 31, 2010. The Company reported a net loss of $1,045,043, or $0.06 per basic and diluted share, compared to a net loss of $3,031,201, or $0.22 per basic and diluted share, for the same period in 2009.

18 May 2010

Tengion reports net loss attributable to common stockholders of $14.33 per share for first-quarter 2010

Tengion Inc. today reported its financial results for the quarter ended March 31, 2010 and provided a corporate and clinical development update.

18 May 2010

Human stem cells restore alveolar epithelial tissue after E. coli endotoxin-induced ALI: Researchers

Human stem cells administered intravenously can restore alveolar epithelial tissue to a normal function in a novel ex vivo perfused human lung after E. coli endotoxin-induced acute lung injury, according to research from the University of California San Francisco.

18 May 2010

Adults with newly diagnosed type 1 diabetes recruited for Protege Encore clinical trial

Dr. Bruce Bode announced today that he is now recruiting adults with newly diagnosed type 1 diabetes for Protege Encore, a randomized, placebo-controlled Phase III clinical trial. This is the second of two Phase III studies testing the safety and efficacy of an investigational drug called teplizumab. The first study, known as Protege, has completed enrollment of more than 530 subjects with type 1 diabetes.

18 May 2010

Efficacy News and Research

70% of oncologists and 60% of ob-gyns disagree with Task Force's mammogram recommendations

Recruitment of children and adults with type 1 diabetes commences in Protege Encore teplizumab trial

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

Targacept commences Phase 2 clinical proof of concept trial of TC-5619 in adults with ADHD

Oncolytics Biotech initiates Phase I study of REOLYSIN and FOLFIRI in colorectal cancer patients

eMedonline telemonitoring system developed to help patients transition from inpatient to outpatient setting

Discovery Labs revalidates optimized BAT in program to gain FDA approval of Surfaxin for RDS

Flexible treatment delivery intervention in primary care reduces symptoms of anxiety: Study

Use of life-ending drugs without explicit patient request occurs in hospital, among elderly patients

Pearl Therapeutics presents data supporting development of PT003 combination bronchodilator product

PET scanning provides great insight into immune response

New multi-center follow-up study of NX-1207 for treatment of BPH to be completed

Generex Biotechnology's Phase I study data of AE37 for prostate cancer published

Roche, Biogen Idec discontinue ocrelizumab clinical development programme for RA

Causes and treatment options of mental disorders need to be reassessed: JAMA commentary

WPI, Cerus announce positive results from study of INTERCEPT Blood System to inactivate XMRV

Catalyst Pharmaceutical Partners first-quarter net loss decreases to $0.06 per basic and diluted share

Tengion reports net loss attributable to common stockholders of $14.33 per share for first-quarter 2010

Human stem cells restore alveolar epithelial tissue after E. coli endotoxin-induced ALI: Researchers

Adults with newly diagnosed type 1 diabetes recruited for Protege Encore clinical trial

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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