Clinical Trial News and Research

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Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Celldex Therapeutics, Inc. today announced the presentation of mature overall survival (OS) data for ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB).

21 Nov 2011

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive preliminary results from its Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

21 Nov 2011

Adeona to develop and commercialize DNA-based therapeutic for PAH using Intrexon technology

Adeona Pharmaceuticals, Inc., and the Human Therapeutics Division of Intrexon Corporation, announced today the formation of a global exclusive channel collaboration through which Adeona intends to develop and commercialize a DNA-based therapeutic using Intrexon's UltraVector platform and RheoSwitch Therapeutic System for the treatment of pulmonary arterial hypertension (PAH).

21 Nov 2011

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention.

21 Nov 2011

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Tasly Pharmaceuticals for the company's global Phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States.

21 Nov 2011

EMA validates Pfizer's Market Authorisation Application for tofacitinib to treat rheumatoid arthritis

Pfizer Inc. announced today that its Market Authorisation Application for tofacitinib (development code CP-690,550), a novel, oral JAK inhibitor being studied for the treatment of moderate-to-severe active rheumatoid arthritis (RA), has been validated by the European Medicines Agency (EMA).

21 Nov 2011

Retina Implant scientific advisory board approves multi-center phase of second human clinical trial

Retina Implant AG, the leading developer of subretinal implants for retinitis pigmentosa patients, today announced that its scientific advisory board is in full support of beginning the multi-center phase of the Company's second human clinical trial. The trial, which began in Tuebingen, Germany in 2010, will be expanded across Europe in five new sites, including two additional locations in Germany, Oxford, London and Budapest.

21 Nov 2011

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Almac, a leading provider of contract services to the global pharmaceutical and biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

21 Nov 2011

Promising results from dexpramipexole phase 2 trial on ALS

Treatment with dexpramipexole - a novel drug believed to prevent dysfunction of mitochondria, the subcellular structures that provide most of a cell's energy - appears to slow symptom progression in the neurodegenerative disease amyotrophic lateral sclerosis (ALS). Promising results of a phase 2 trial of dexpramipexole are receiving advance online publication in Nature Medicine.

20 Nov 2011

Cyberonics net sales increase 13% to $53.7M for second quarter 2012

Cyberonics, Inc. today announced results for the quarter ended October 28, 2011.

19 Nov 2011

Scientists identify novel gene mutation that causes glioblastoma

Scientists at the University of California, San Diego School of Medicine and UC San Diego Moores Cancer Center, in collaboration with colleagues in Boston and South Korea, say they have identified a novel gene mutation that causes at least one form of glioblastoma (GBM), the most common type of malignant brain tumor.

18 Nov 2011

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

Merrimack Pharmaceuticals, Inc. announced today that the first patient has been dosed in a Phase 2 clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with erlotinib, a small molecule directed at the epidermal growth factor receptor (EGFR), in three groups of patients with metastatic non-small cell lung cancer.

18 Nov 2011

Tikcro reports net loss of $1.0 million for third quarter 2011

Tikcro Technologies Ltd. today reported results for the third quarter and nine months ended September 30, 2011.

18 Nov 2011

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

The U.S. Food and Drug Administration today approved Erwinaze to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

18 Nov 2011

Tonix to initiate TNX-102 PK and BA study for fibromyalgia

Tonix Pharmaceuticals Holding Corp., a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system, including fibromyalgia syndrome and post-traumatic stress disorder, will initiate a comparative pharmacokinetic and bioavailability study of TNX-102, a novel dosage oral formulation of cyclobenzaprine for the treatment of FM, following the U.S. Food and Drug Administration clearance of the Company's initial Investigational New Drug Application.

18 Nov 2011

IRCI to design and fund clinical trials for rare cancers

Cancer Research UK will join forces with international research groups from the UK, Europe and the US to launch an initiative to boost the development of new treatments for patients with rare cancers. The announcement will be made by Dr Harpal Kumar, chief executive of Cancer Research UK, at the 2011 World Cancer Leaders' Summit taking place today in Dublin.

18 Nov 2011

Scientists discover family of chemical compounds that could prevent malaria

A international team led by scientists from the Genomics Institute of the Novartis Research Foundation (GNF) and The Scripps Research Institute has discovered a family of chemical compounds that could lead to a new generation of antimalarial drugs capable of not only alleviating symptoms but also preventing the deadly disease.

17 Nov 2011

EC approves Pfizer's Vyndaqel to treat Transthyretin Familial Amyloid Polyneuropathy

Pfizer announced today that the European Commission has approved Vyndaqel (tafamidis) for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with stage 1 symptomatic polyneuropathy.

17 Nov 2011

Hemoglobin levels, blood pressure and male gender linked to higher risk of silent strokes in SCA children

Factors such as low hemoglobin levels, increased systolic blood pressure, and male gender are linked to a higher risk of silent cerebral infarcts (SCIs), or silent strokes, in children with sickle cell anemia (SCA), according to results from a large, first-of-its-kind study published online today in Blood, the Journal of the American Society of Hematology (ASH).

17 Nov 2011

Biothera completes enrollment in Imprime PGG Phase II combination study on NSCLC

EBiothera's Phase II non-small cell lung cancer (NSCLC) clinical trial evaluating Imprime PGG administered in combination with cetuximab (Erbitux), carboplatin and paclitaxel has met its goal of 90 patients and is fully enrolled, the company announced today.

17 Nov 2011

Clinical Trial News and Research

Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Adeona to develop and commercialize DNA-based therapeutic for PAH using Intrexon technology

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

EMA validates Pfizer's Market Authorisation Application for tofacitinib to treat rheumatoid arthritis

Retina Implant scientific advisory board approves multi-center phase of second human clinical trial

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Promising results from dexpramipexole phase 2 trial on ALS

Cyberonics net sales increase 13% to $53.7M for second quarter 2012

Scientists identify novel gene mutation that causes glioblastoma

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

Tikcro reports net loss of $1.0 million for third quarter 2011

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

Tonix to initiate TNX-102 PK and BA study for fibromyalgia

IRCI to design and fund clinical trials for rare cancers

Scientists discover family of chemical compounds that could prevent malaria

EC approves Pfizer's Vyndaqel to treat Transthyretin Familial Amyloid Polyneuropathy

Hemoglobin levels, blood pressure and male gender linked to higher risk of silent strokes in SCA children

Biothera completes enrollment in Imprime PGG Phase II combination study on NSCLC

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