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MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

MannKind Corporation today announced the first patient has been dosed in a phase 2 clinical trial of the novel, investigational cancer vaccine MKC1106-MT. As a part of MannKind's cancer immunotherapy program, this phase 2 study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma.

20 Oct 2010

Research paves way to understand the mechanism of leptin therapy to improve type 1 diabetes

New findings by UT Southwestern Medical Center researchers suggest a novel role for the brain in mediating beneficial actions of the hormone leptin in type 1 diabetes.

20 Oct 2010

European Commission grants orphan drug status to OBI-1 for hemophilia treatment

Inspiration Biopharmaceuticals, Inc. announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia.

20 Oct 2010

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

Ceregene, Inc., a biopharmaceutical company, announced today that enrollment has begun in a new double-blind sham surgery-controlled Phase 2b study evaluating CERE-120 in Parkinson's disease patients. CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons. Data from the first Phase 2 clinical trial of CERE-120 are being published later this year in Lancet Neurology (to appear online October 21, 2010).

20 Oct 2010

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

20 Oct 2010

BioMarin announces BMN-111 program for treatment of achondroplasia

BioMarin Pharmaceutical Inc. today announced its program for BMN-111, a peptide therapeutic for the treatment of achondroplasia. BioMarin plans to file an IND in the fourth quarter of 2011 and to initiate a Phase 1 clinical trial by the first quarter of 2012.

19 Oct 2010

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $1.00 in the second quarter of fiscal 2011.

19 Oct 2010

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

Clinical Trial News and Research

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

Research paves way to understand the mechanism of leptin therapy to improve type 1 diabetes

European Commission grants orphan drug status to OBI-1 for hemophilia treatment

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

BioMarin announces BMN-111 program for treatment of achondroplasia

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

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

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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