Clinical Trial News and Research

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Want to quit smoking? Try a nicotine patch plus a nicotine lozenge

In a comparison of five different smoking cessation medications, a nicotine patch plus a nicotine lozenge appears most effective at helping smokers quit, according to a report in the November issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

3 Nov 2009

Study reveals high risk of recurrence for early-stage breast cancer patients with HER2 positive tumors

Early-stage breast cancer patients with HER2 positive tumors one centimeter or smaller are at significant risk of recurrence of their disease, compared to those with early-stage disease who do not express the aggressive protein, according to a study led by researchers at The University of Texas M. D. Anderson Cancer Center.

3 Nov 2009

Crohn's disease drug market driven by TNF-alpha inhibitors Humira and Remicade

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the Crohn's disease drug market, the dominance of TNF-alpha inhibitors such as Abbott/Eisai's Humira and Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe's Remicade will continue over the next decade. Sales of Humira and Remicade, which accounted for more than three-quarters of the market in 2008, will continue to grow through 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

3 Nov 2009

Phase 1 study of STX107 for Fragile X syndrome begins

NIH-supported scientists at Seaside Therapeutics in Cambridge, Mass., are beginning a clinical trial of a potential medication designed to correct a central neurochemical defect underlying Fragile X syndrome, the most common inherited cause of intellectual disability. There has to date been no medication that could alter the disorder's neurologic abnormalities. The study will evaluate safety, tolerability, and optimal dosage in healthy volunteers.

3 Nov 2009

Pregnant women tolerate the 2009 H1N1 flu vaccine, mount strong immune response

Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

3 Nov 2009

Cancer Cell publishes a paper on ARIAD Pharmaceuticals' Pan-BCR-ABL inhibitor

ARIAD Pharmaceuticals, Inc. today announced that the scientific journal, Cancer Cell, has published a comprehensive paper describing the design and preclinical characterization of AP24534, ARIAD’s investigational, multi-targeted kinase inhibitor.

3 Nov 2009

NIA funds national Testosterone Trial, Penn Medicine to lead

Penn Medicine will lead a new national $45 million clinical trial to test whether testosterone therapy can favorably affect certain conditions affecting older men. Low serum testosterone may contribute to a number of problems affecting older men, including decreased ability to walk, loss of muscle mass and strength, decreased vitality, decreased sexual function, impaired cognition, cardiovascular disease and anemia. While testosterone normally decreases with age, in some men, low levels of testosterone may contribute to these debilitating conditions.

2 Nov 2009

Malaria conference begins in Nairobi, will highlight outlook for RTS,S experimental malaria vaccine

The 5th Multilateral Initiative on Malaria (MIM) Pan-African Conference "kicked off in Nairobi late Sunday with a call for substantial and sustained support for research to guide evidence-based policies and the development of new malaria tools, which together could save countless lives," Xinhua reports (11/2).

2 Nov 2009

Pico-Tesla commences pilot study of its Resonator system for treating type 2 diabetes patients

Pico-Tesla, The Magneceutical™ Therapy Company, announced today that it has commenced a randomized, double-blind, placebo-controlled Pilot Study of up to 165 persons who have type 2 diabetes, the most common form of diabetes.

2 Nov 2009

Enzo Biochem announces results of EGS21 clinical trial for treatment of non-alcoholic steatohepatitis

Enzo Biochem Inc. announced today that favorable results of the Company’s clinical trial for treatment of non-alcoholic steatohepatitis (NASH) were presented at the annual meeting of the American Association for the Study of Liver Diseases. The study was a randomized double blind placebo controlled format of EGS21, Enzo’s orally administered beta glucosylceramide formulation, designed to evaluate safety and efficacy of the study drug in patients with NASH and its associated metabolic syndrome.

2 Nov 2009

Study of combination therapy versus monotherapy for pulmonary arterial hypertension

Gilead Sciences, Inc., in collaboration with GlaxoSmithKline (GSK), today announced plans for an international, event-driven (morbidity and mortality) clinical trial to study combination therapy versus monotherapy in a first-line treatment setting for pulmonary arterial hypertension (PAH).

2 Nov 2009

EnzymeRx commences patient enrollment in Uricase-PEG 20 phase 1 study

EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, announced that it has launched its first clinical study of Uricase-PEG 20. Subjects have begun enrolling in a phase 1 safety, pharmacokinetic and pharmacodynamic study of single intravenous doses of Uricase-PEG 20.

2 Nov 2009

FDA issues a Complete Response Letter for GTx' toremifene NDA

GTx, Inc. today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

2 Nov 2009

Juvaris BioTherapeutics commences enrollment in its JVRS-100 influenza vaccine adjuvant study

Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines for infectious diseases, today announced that it has begun enrolling patients in a Phase 2 clinical trial of its lead compound, JVRS-100, as an adjuvant for seasonal influenza vaccines in the elderly population.

2 Nov 2009

Alnylam Pharmaceuticals presents new data from its transthyretin-mediated amyloidosis program

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it presented new pre-clinical research findings from its transthyretin (TTR)-mediated amyloidosis (ATTR) program at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (“The Liver Meeting”).

2 Nov 2009

Vanda Pharmaceuticals announces financial results for the third quarter of 2009

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the third quarter ended September 30, 2009.

2 Nov 2009

NIAID awards Pulmatrix $2.2M grant for developing novel influenza therapeutics

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the treatment and prevention of infectious and progressive respiratory diseases, today announced that it has been awarded a grant for $2.2 million from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), aimed at advancing the development of novel influenza therapeutics for the treatment of seasonal and pandemic influenza.

2 Nov 2009

ACM Global Central Laboratory celebrates landmark anniversary

ACM Global Central Laboratory, the global central lab that continually defines the customer-service standard with its flexible approach, is this week celebrating its 10th anniversary of providing central laboratory services throughout Europe.

2 Nov 2009

NOXXON Pharma commences human dosing in Spiegelmer NOX-A12 clinical trial

NOXXON Pharma AG, the biopharmaceutical company focusing on the development of novel drugs based on its unique proprietary Spiegelmer® technology, announced today the successful initial dosing of healthy volunteers in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12 is NOXXON’s second drug candidate entering the clinical stage of development within only five months.

2 Nov 2009

LRI and lupus organizations congratulate HGS and GlaxoSmithKline for achieving historical landmark

The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline for achieving an historical landmark - the second positive phase 3 clinical trial of Benlysta (belimumab), the first successfully tested new drug developed specifically for people with systemic lupus.

2 Nov 2009

Clinical Trial News and Research

Want to quit smoking? Try a nicotine patch plus a nicotine lozenge

Study reveals high risk of recurrence for early-stage breast cancer patients with HER2 positive tumors

Crohn's disease drug market driven by TNF-alpha inhibitors Humira and Remicade

Phase 1 study of STX107 for Fragile X syndrome begins

Pregnant women tolerate the 2009 H1N1 flu vaccine, mount strong immune response

Cancer Cell publishes a paper on ARIAD Pharmaceuticals' Pan-BCR-ABL inhibitor

NIA funds national Testosterone Trial, Penn Medicine to lead

Malaria conference begins in Nairobi, will highlight outlook for RTS,S experimental malaria vaccine

Pico-Tesla commences pilot study of its Resonator system for treating type 2 diabetes patients

Enzo Biochem announces results of EGS21 clinical trial for treatment of non-alcoholic steatohepatitis

Study of combination therapy versus monotherapy for pulmonary arterial hypertension

EnzymeRx commences patient enrollment in Uricase-PEG 20 phase 1 study

FDA issues a Complete Response Letter for GTx' toremifene NDA

Juvaris BioTherapeutics commences enrollment in its JVRS-100 influenza vaccine adjuvant study

Alnylam Pharmaceuticals presents new data from its transthyretin-mediated amyloidosis program

Vanda Pharmaceuticals announces financial results for the third quarter of 2009

NIAID awards Pulmatrix $2.2M grant for developing novel influenza therapeutics

ACM Global Central Laboratory celebrates landmark anniversary

NOXXON Pharma commences human dosing in Spiegelmer NOX-A12 clinical trial

LRI and lupus organizations congratulate HGS and GlaxoSmithKline for achieving historical landmark

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