Clinical Trial News and Research

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Abraxis BioScience to present updated survival findings from ABRAXANE Phase I/II trial at 101st AACR meeting

Abraxis BioScience, Inc., a fully integrated biotechnology company, announced that the updated survival findings from a Phase I/II clinical trial evaluating the chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for first-line treatment of patients with metastatic pancreatic cancer will be discussed during a keynote address on April 20 at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.

9 Apr 2010

Idera Pharmaceuticals' TLR antagonists exert anti atherogenic effects in preclinical model of atherosclerosis

Idera Pharmaceuticals, Inc. today presented data from a preclinical study evaluating the mechanism of action of a Toll-like Receptor (TLR) antagonist in a preclinical model of atherosclerosis. The presentation entitled "A novel antagonist of TLR7 and TLR9 exerts anti atherogenic effects in ApoE-/- mouse model of atherosclerosis" (abstract P259) was made by Idera scientists at the American Heart Association conference "Arteriosclerosis, Thrombosis and Vascular Biology 2010 Scientific Sessions" being held April 8-10 in San Francisco, CA.

9 Apr 2010

Dangerous agitations: Nicotine replacement therapy needs to be tested in ICU setting

Nicotine withdrawal can cause dangerous agitation in intensive care patients. Researchers writing in BioMed Central's open access journal Critical Care found that, compared to non-smokers, agitated smokers were more likely to accidentally remove tubes and catheters, require supplemental sedative, analgesic or anti-psychotic medications, or need physical restraints.

9 Apr 2010

Keryx Biopharmaceuticals commences Phase 3 registration clinical trial for perifosine

Keryx Biopharmaceuticals, Inc. announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer.

9 Apr 2010

University of Southampton, Synairgen Research scientists commence Phase II trial of interferon beta for asthma

Scientists from the University of Southampton and Synairgen Research Ltd, a respiratory drug development company spun out from the University, have begun a Phase II study into the effectiveness of the drug interferon beta for asthma patients.

9 Apr 2010

Fate Therapeutics to acquire Ottawa biotechnology company Verio Therapeutics

Fate Therapeutics, Inc. announced today a definitive agreement to acquire Verio Therapeutics Inc., a privately held biotechnology company based in Ottawa, Ontario, which is developing drug candidates targeting the activation of endogenous stem cells. Verio Therapeutics is advancing the work of several of Canada's leading stem cell scientists, including Michael Rudnicki, Ph.D., FRSC, and Lynn Arthur Megeney, Ph.D., who have made breakthrough discoveries relating to muscle and pancreatic regeneration.

9 Apr 2010

Cell Therapeutics receives FDA Complete Response Letter for Pixuvri NDA

Cell Therapeutics, Inc. today announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Pixuvri™ (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").

9 Apr 2010

ReVision Optics initiates US clinical trial of PresbyLens corneal inlay

ReVision Optics, a leading company in the research, development and manufacture of custom optical products to correct and maintain vision, announced today that it has begun its US clinical trial of the PresbyLens® corneal inlay. The clinical trial will evaluate the PresbyLens® corneal inlay for the correction of presbyopia, the age-related loss of near vision. The study began on April 6th with the treatment of three subjects by clinical investigator Dr. Stephen Slade of the Slade & Baker Vision Center in Houston, Texas.

9 Apr 2010

Æterna Zentaris commences perifosine Phase 3 registration trial

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced the initiation of a Phase 3 registration clinical trial with perifosine (KRX-0401) ), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.

9 Apr 2010

BioClinica WebSend system that accelerates image collection for clinical studies released

BioClinica, Inc., a global provider of clinical trial management services, today announced the release of BioClinica WebSend, a system that simplifies and accelerates image collection for clinical studies. WebSend transfers and tracks medical images in real-time, offering key benefits over the standard manual transport methods commonly used in imaging trials, including faster delivery of image data, enhanced data quality with fewer site queries, and reduced cost.

From Clario 8 Apr 2010

Study shows benefits of oxytocin nasal spray in children with ASD

Autism spectrum disorders are developmental disorders usually diagnosed in childhood. Children with ASDs have impairments in social interactions and communication, and a tendency towards repetitive behaviors. A hallmark of autism is a difficulty in understanding and reciprocating the emotion of others.

8 Apr 2010

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

In a clinical trial known as PROVE 3 published in this week's New England Journal of Medicine, treatment with telaprevir-based regimens significantly increased rates of sustained viral response (SVR) in patients with genotype 1 hepatitis C virus (HCV) infection who did not achieve SVR with at least one prior course of pegylated-interferon and ribavirin therapy.

8 Apr 2010

Phase III trial of brentuximab vedotin for post-transplant Hodgkin lymphoma initiated

Seattle Genetics, Inc., Takeda Pharmaceutical Company Limited and its wholly owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of a phase III clinical trial of brentuximab vedotin (SGN-35) for post-transplant Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, which is expressed on malignant Hodgkin lymphoma cells.

8 Apr 2010

Single vaccine for anthrax and plague: iBio confirms grant of rights

iBio, Inc. confirmed today the grant of rights to use iBio's proprietary technology, the iBioLaunch™ platform, in support of a $5.3 million government-funded project for the development of a single vaccine to protect against both anthrax and plague. The project will be managed by Fraunhofer USA Center for Molecular Biotechnology (CMB) pursuant to the long-term agreement between iBio and CMB for advancement of the iBio technology.

8 Apr 2010

Results of M118 EMINENCE clinical trial published in Circulation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex mixture drugs, today announced that the results of the M118 EMINENCE clinical trial have published in Circulation.

8 Apr 2010

Secretary of Health announces five health research grants to improve health of Pennsylvanians

Secretary of Health Everette James today announced five health research grants totaling approximately $20 million will be awarded from Pennsylvania's share of the national tobacco settlement for 2009-2010.

8 Apr 2010

HeartWare's ADVANCE bridge-to-transplant clinical trial: FDA approves additional enrollment under CAP

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration has approved an IDE Supplement that allows HeartWare to enroll up to an additional 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

8 Apr 2010

Phase II clinical trial of Avastin and Tarceva in patients with glioblastoma multiforme

Patients suffering from recently diagnosed malignant brain tumors called glioblastoma multiforme or a rare variant called gliosarcoma may be eligible to participate in a Phase II clinical trial at Cedars-Sinai Medical Center that combines two innovative drugs.

8 Apr 2010

Avid Radiopharmaceuticals, PETNET Solutions collaborate in manufacture of Florbetapir F 18

Avid Radiopharmaceuticals, Inc. and PETNET Solutions, Inc., a wholly-owned subsidiary of Siemens Medical Solutions, USA, Inc., marked the first dose shipped from a PETNET Solutions manufacturing facility as part of its collaboration with Avid on Florbetapir F 18 (18F-AV-45 or Florbetapir), Avid's molecular imaging agent for positron emission tomography (PET) imaging of β-amyloid deposits in the brain, a key pathological component of Alzheimer's disease.

8 Apr 2010

King Pharmaceuticals commences Phase IIb clinical trial of ELADUR for chronic low back pain

DURECT Corporation announced today that its licensee, King Pharmaceuticals, has begun a Phase IIb clinical trial to evaluate ELADUR™ (TRANSDUR™-Bupivacaine) for the treatment of chronic low back pain. ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.

7 Apr 2010

Clinical Trial News and Research

Abraxis BioScience to present updated survival findings from ABRAXANE Phase I/II trial at 101st AACR meeting

Idera Pharmaceuticals' TLR antagonists exert anti atherogenic effects in preclinical model of atherosclerosis

Dangerous agitations: Nicotine replacement therapy needs to be tested in ICU setting

Keryx Biopharmaceuticals commences Phase 3 registration clinical trial for perifosine

University of Southampton, Synairgen Research scientists commence Phase II trial of interferon beta for asthma

Fate Therapeutics to acquire Ottawa biotechnology company Verio Therapeutics

Cell Therapeutics receives FDA Complete Response Letter for Pixuvri NDA

ReVision Optics initiates US clinical trial of PresbyLens corneal inlay

Æterna Zentaris commences perifosine Phase 3 registration trial

BioClinica WebSend system that accelerates image collection for clinical studies released

Study shows benefits of oxytocin nasal spray in children with ASD

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

Phase III trial of brentuximab vedotin for post-transplant Hodgkin lymphoma initiated

Single vaccine for anthrax and plague: iBio confirms grant of rights

Results of M118 EMINENCE clinical trial published in Circulation

Secretary of Health announces five health research grants to improve health of Pennsylvanians

HeartWare's ADVANCE bridge-to-transplant clinical trial: FDA approves additional enrollment under CAP

Phase II clinical trial of Avastin and Tarceva in patients with glioblastoma multiforme

Avid Radiopharmaceuticals, PETNET Solutions collaborate in manufacture of Florbetapir F 18

King Pharmaceuticals commences Phase IIb clinical trial of ELADUR for chronic low back pain

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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