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Cytheris initiates ORVACS Phase II clinical trial to study HIV infection

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of Phase II clinical trial of the company's investigative immunomodulatory agent, CYT107 (rhIL-7), in combination with two potent antiretroviral drugs represented by the integrase inhibitor raltegravir (ISENTRESS- Merck & Co.) and the CCR5 inhibitor, maraviroc (SELZENTRY- ViiV Healthcare).

19 Oct 2010

Amgen to review study results of ESA in chronic renal failure patients with FDA and CRDAC

Amgen will review the results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy) and will discuss how these results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) for chronic renal failure (CRF) patients at today's meeting of the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

19 Oct 2010

Positive results from Diamyd Medical's NP2 Enkephalin Phase I trial for chronic pain

Substantial and sustained reduction in pain scores were reported in the middle and high dose cohorts of Diamyd Medical's Phase I, open-label, dose escalation trial investigating NP2 Enkephalin as a potential therapy for chronic pain. No treatment related Serious Adverse Events have been observed in the study to date.

19 Oct 2010

UC awarded $2.1 million technology award to develop next generation brain monitors

The U.S. Department of Defense has awarded researchers at the University of Cincinnati (UC) a $2.1 million Advanced Technology/Therapeutic Development Award to develop the next generation of brain monitors.

19 Oct 2010

New research coalition to design first human trial of mosaic HIV vaccine candidate

Duke University Medical Center vaccine experts have assembled an international team of investigators to design and implement the first human trial of a mosaic HIV vaccine candidate, a novel strategy that attempts to counter one of the most daunting challenges in HIV vaccine design: the virus's extensive genetic diversity

19 Oct 2010

Annals of Vascular Surgery publishes Endologix's Powerlink System clinical trial results for AAA endovascular repair

Endologix, Inc. developer of minimally invasive treatments for aortic disorders, announced today the publication of results from its pivotal, multicenter, prospective clinical trial of the Company's Powerlink System for endovascular repair of abdominal aortic aneurysm (AAA) using an anatomical fixation technique with a suprarenal aortic extension.

19 Oct 2010

Medifocus receives two patents to expand IP portfolio

Medifocus, Inc. is pleased to announce that it has recently received notice of allowances for two additional international patents to expand its extensive Intellectual Properties (IP) portfolio in addition to the patents Medifocus has exclusively licensed from the Massachusetts Institute of Technology (MIT).

19 Oct 2010

Karmanos Cancer Institute awarded $3M NIH grant to study triple-negative breast cancer

Scientists at the Barbara Ann Karmanos Cancer Institute in Detroit have received a nearly $3 million, five-year research project (RO1) grant from the National Institutes of Health to study a potentially ground-breaking immunotherapy treatment for women with one of the deadliest forms of breast cancer – triple-negative breast cancer. The research is exclusive to the Karmanos Cancer Institute.

19 Oct 2010

Study finds IAP enzyme maintains normal microbial population in gastrointestinal system

An enzyme that keeps intestinal bacteria out of the bloodstream may also play an important role in maintaining the normal microbial population of the gastrointestinal system.

19 Oct 2010

New clinical trial to treat brain cancer launched

Cancer Research UK and Cancer Research Technology the charity's development and commercialisation arm together with immatics biotechnologies have launched the first clinical trial of a promising cancer vaccine to treat glioblastoma, one of the most common forms of brain cancer.

19 Oct 2010

CoAxia presents SENTIS clinical trial for ischemic stroke at 2010 Congress in Seoul

CoAxia Inc. of Maple Grove, MN, announced today that the results of the SENTIS clinical trial a worldwide, multi-center, randomized study of its NeuroFlo catheter were presented on Saturday, October 16th, by SENTIS Principal Investigator, Professor Ashfaq Shuaib at the 2010 World Stroke Congress in Seoul, South Korea.

19 Oct 2010

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

Findings from the PRECiSE 3 (P3) open label extension study for Cimzia, demonstrating the longest continuously running maintenance trial for an anti-TNF in Crohn's disease, will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology (ACG), taking place in San Antonio from October 15 – 20. Additionally, long-term efficacy data from the PRECiSE 4 (P4) clinical trial also will be presented at the meeting.

19 Oct 2010

Groundbreaking melanoma clinical trial initiated by Patrys

Patrys Limited (ASX: PAB), which is focused on developing revolutionary treatments for cancer, announced today the treatment of the first patient in a human clinical trial to evaluate PAT-SM6 as a therapy for melanoma.

18 Oct 2010

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) of Munich to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.

18 Oct 2010

Cmed debuts Timaeus 5 unified eClinical platform and Timaeus HotSpot regulatory-compliant eClinical suite

Cmed Technology, an eClinical technology provider, today unveiled two product previews at two major pharmaceutical conferences. It debuted Timaeus 5, Cmed's newest version of its unified eClinical platform to manage data from Study Design through Reporting. Timaeus 5 adds enhanced usability, extended operational capabilities, streamlined investigator and monitor interaction, and expanded reporting capabilities.

18 Oct 2010

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 2a clinical trial that will evaluate multiple combinations of VX-770 and VX-809, investigational oral cystic fibrosis transmembrane conductance regulator (CFTR) modulators for the treatment of cystic fibrosis (CF). The trial is designed to evaluate the safety and tolerability of VX-809 dosed alone for 14 days followed by dosing of VX-809 in combination with VX-770 for 7 days.

18 Oct 2010

Nanotope enters agreement with Smith & Nephew to develop cartilage regeneration product

Arrowhead Research Corporation today announced that its portfolio company, Nanotope, Inc., has entered into an agreement with Smith & Nephew, Inc., a member of the Smith & Nephew plc group to develop a cartilage regeneration product for human healthcare markets using a subset of its proprietary regenerative medicine technology.

18 Oct 2010

New Trident IWR platform launched at SCDM 2010 Conference

BioClinica, Inc., a leading global provider of clinical trial management services, today announced the launch of its new IVR/IWR (interactive voice response/interactive web response) platform, Trident IWR, at the 2010 Society for Clinical Data Management Annual Conference (SCDM).

From Clario 18 Oct 2010

St. Jude Medical to acquire AGA Medical

St. Jude Medical, Inc., a global medical device company, and AGA Medical Holdings, Inc., today announced that the Boards of Directors of both companies have approved a definitive agreement under which St. Jude Medical will acquire all of the outstanding shares of AGA Medical for $20.80 per share in a cash and stock transaction valued at approximately $1.3 billion, including the assumption of approximately $225 million in outstanding debt.

18 Oct 2010

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

NovaBay Pharmaceuticals, Inc. announced today that its development partner, Alcon Research, Ltd., has concluded its proof of concept clinical trial of NovaBay's patented lead Aganocide compound, NVC-422 for the treatment of viral conjunctivitis a highly contagious eye infection for which there are currently no marketed products.

18 Oct 2010

Clinical Trial News and Research

Cytheris initiates ORVACS Phase II clinical trial to study HIV infection

Amgen to review study results of ESA in chronic renal failure patients with FDA and CRDAC

Positive results from Diamyd Medical's NP2 Enkephalin Phase I trial for chronic pain

UC awarded $2.1 million technology award to develop next generation brain monitors

New research coalition to design first human trial of mosaic HIV vaccine candidate

Annals of Vascular Surgery publishes Endologix's Powerlink System clinical trial results for AAA endovascular repair

Medifocus receives two patents to expand IP portfolio

Karmanos Cancer Institute awarded $3M NIH grant to study triple-negative breast cancer

Study finds IAP enzyme maintains normal microbial population in gastrointestinal system

New clinical trial to treat brain cancer launched

CoAxia presents SENTIS clinical trial for ischemic stroke at 2010 Congress in Seoul

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

Groundbreaking melanoma clinical trial initiated by Patrys

Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Cmed debuts Timaeus 5 unified eClinical platform and Timaeus HotSpot regulatory-compliant eClinical suite

Vertex commences VX-770 and VX-809 combination Phase 2a clinical trial for cystic fibrosis

Nanotope enters agreement with Smith & Nephew to develop cartilage regeneration product

New Trident IWR platform launched at SCDM 2010 Conference

St. Jude Medical to acquire AGA Medical

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

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