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Tolerx presents otelixizumab preclinical research at 46th EASD

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the presentation of preclinical research describing the mechanism of action of otelixizumab at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD). In addition, Tolerx also announced that the first European patient was enrolled in DEFEND-2, a confirmatory Phase 3 clinical trial evaluating otelixizumab in autoimmune new-onset type 1 diabetes.

23 Sep 2010

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

New data from the linagliptin late stage clinical trial programme were presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD).

23 Sep 2010

Athersys presents MultiStem phase I study results at TCT Conference

Athersys, Inc. announced at its presentation at the Transvascular Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C., updated results from its phase I clinical trial of MultiStem, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI).

23 Sep 2010

SynCardia temporary Total Artificial Heart wins 2010 Kerrin Rennie Award

On Sept. 15, the SynCardia temporary Total Artificial Heart was awarded the 2010 Kerrin Rennie Award for Excellence in Medical Technology by the Medical Technology Association of Australia (MTAA).

23 Sep 2010

Vaxonco initiates Phase I clinical trial of novel DNA-based polyepitope vaccine against malaria

Vaxonco Inc., a Korean company specializing in peptide-based vaccines and Ichor Medical Systems (Ichor), whose advanced TriGrid™ Delivery System (TriGrid™) is being tested worldwide for its ability to enhance delivery of DNA drugs and vaccines, announced today the initiation of a Phase I clinical trial to evaluate a novel DNA-based polyepitope vaccine against malaria.

23 Sep 2010

TAVI procedure effective in patients unsuitable for surgical valve replacement: Study

One-year data from the PARTNER clinical trial, published today in the New England Journal of Medicine, demonstrate that transcatheter aortic-valve implantation, compared with standard therapy, resulted in significantly lower rates of death among patients who cannot undergo surgery for aortic stenosis. The results will be presented tomorrow as a Late Breaking Trial at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

23 Sep 2010

Phase II study: Fostamatinib improves outcomes in RA patients

AstraZeneca's new oral syk inhibitor, fostamatinib (R788), recently in-licensed from Rigel Pharmaceuticals, Inc., significantly improved outcomes of patients with rheumatoid arthritis who responded inadequately to ongoing treatment with methotrexate, according to phase II study data published in The New England Journal of Medicine today.

23 Sep 2010

Implantation of new bioprosthetic-tissue valve in patients with severe aortic stenosis saves lives

Implantation of a new bioprosthetic-tissue valve into the hearts of patients who have severe aortic stenosis and are too sick or too old for open-heart surgery has been found to both save lives and improve the quality of those lives, according to a new multicenter study, to be published online at 2 p.m. Pacific time today in the New England Journal of Medicine.

23 Sep 2010

FDA approves fingolimod drug for multiple sclerosis

The first oral medication for multiple sclerosis was approved today by the Food & Drug Administration. Physicians praised the decision to approve the drug, called fingolimod, saying it would give multiple sclerosis patients new options for treatment.

23 Sep 2010

Aeras Global TB Vaccine Foundation to initiate clinical trial of new investigational vaccine

At an international gathering of TB vaccine researchers in Tallinn today, the Aeras Global TB Vaccine Foundation announced it will initiate a clinical trial of an investigational live recombinant tuberculosis vaccine to be led by researchers at Saint Louis University in St. Louis, Missouri, USA. The announcement was made at the Second Global Forum on TB Vaccine Development.

23 Sep 2010

Northwestern Medicine participates in world's first human embryonic stem cell clinical trial for spinal cord injury

Northwestern Medicine is the first site open for enrollment in a national clinical research trial of a human embryonic stem cell-based therapy for participants with a subacute thoracic spinal cord injury. Following the procedure, participants will receive rehabilitation treatment at The Rehabilitation Institute of Chicago (RIC).

23 Sep 2010

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Intarcia Therapeutics, Inc. presented today final results of a 24-week phase 2 clinical study of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.

23 Sep 2010

Boston announces TAXUS ATLAS clinical trial data for complex lesions

Boston Scientific Corporation today announced comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the TAXUS Liberte Paclitaxel-Eluting Stent System in a variety of lesions and patient groups.

23 Sep 2010

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus.

22 Sep 2010

Patient follow-up complete in SANUWAVE's dermaPACE Phase III IDE trial for diabetic foot ulcers

SANUWAVE Health, Inc., an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in regenerative medicine, today announced the completion of patient follow-up in the Company's pivotal Phase III, Investigational Device Exemption (IDE) clinical trial with dermaPACE™ for the treatment of diabetic foot ulcers.

22 Sep 2010

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Apricus Biosciences, backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud's syndrome secondary to scleroderma.

22 Sep 2010

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Boston Scientific Corporation today announced data from its PLATINUM QCA study, which is designed to evaluate the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent. The results provided 30-day and nine-month clinical outcomes and nine-month quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) data supporting the safety and efficacy of the PROMUS Element Stent.

22 Sep 2010

Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Dutch biopharmaceutical company Crucell N.V. and the Aeras Global TB Vaccine Foundation today announced the start of a Phase II clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35.

22 Sep 2010

Study demonstrates why targeted therapies do not work in majority of people

In order for targeted therapies against cancer to be effective, scientists need to understand upfront what related proteins in a signaling "network" makes a cancer cell resistant to a drug and selectively target them as well, say researchers at Georgetown Lombardi Comprehensive Cancer Center and Fox Chase Cancer Center.

22 Sep 2010

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

Novartis Pharmaceuticals Corporation announced today that the results of a Phase III study of SOM230 (pasireotide) showed a reduction in cortisol levels in patients with Cushing's disease, a condition in which a benign (non-cancerous) pituitary tumor causes the adrenal glands to produce excess cortisol and can be fatal. Results will be presented at the 14th Congress of the European Neuroendocrine Association (ENEA).

22 Sep 2010

Clinical Trial News and Research

Tolerx presents otelixizumab preclinical research at 46th EASD

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

Athersys presents MultiStem phase I study results at TCT Conference

SynCardia temporary Total Artificial Heart wins 2010 Kerrin Rennie Award

Vaxonco initiates Phase I clinical trial of novel DNA-based polyepitope vaccine against malaria

TAVI procedure effective in patients unsuitable for surgical valve replacement: Study

Phase II study: Fostamatinib improves outcomes in RA patients

Implantation of new bioprosthetic-tissue valve in patients with severe aortic stenosis saves lives

FDA approves fingolimod drug for multiple sclerosis

Aeras Global TB Vaccine Foundation to initiate clinical trial of new investigational vaccine

Northwestern Medicine participates in world's first human embryonic stem cell clinical trial for spinal cord injury

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Boston announces TAXUS ATLAS clinical trial data for complex lesions

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Patient follow-up complete in SANUWAVE's dermaPACE Phase III IDE trial for diabetic foot ulcers

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Boston Scientific reports positive data from PLATINUM Element Stent quantitative coronary angiography study

Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Study demonstrates why targeted therapies do not work in majority of people

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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