Clinical Trial News and Research

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Acceleron commences ACE-536 Phase 1 clinical trial in anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases today announced that it has initiated a Phase 1 clinical study of ACE-536.

14 Sep 2011

New drug combination may treat two aggressive cancers

Researchers at Brigham and Women's Hospital (BWH) have identified a new combination of targeted therapies that, together, may treat two aggressive tumor types that until now have not had effective treatments. These findings are published in Cancer Cell on September 13, 2011.

13 Sep 2011

Delcath announces updated Phase 2 trial results from metastatic neuroendocrine tumor cohort

Delcath Systems, Inc. announced that updated results from the metastatic neuroendocrine tumor (mNET) cohort of the Company's recently completed Phase 2 clinical trial were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress held this week in Munich, Germany.

13 Sep 2011

ImmunoCellular announces updated long-term data from ICT-107 Phase I trial on GBM

ImmunoCellular Therapeutics, Ltd., a biotechnology company focused on the development of novel immune-based cancer therapies, today announced updated long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

13 Sep 2011

Clinical trial planned in Australia and the USA to help patients with ‘orphan’ disease

Prana Biotechnology Limited announced today that researchers are planning recruitment for a phase II clinical trial of the experimental drug PBT2 in Huntington’s patients. There are currently no treatments for the genetic, neurodegenerative disease; Australia is increasingly seen as a leader in the development of therapies for neurologic disorders. Huntington’s often affects young adults and progressively impacts the body, mind and emotions. The disease causes incapacitation and death about 15-25 years after onset.

12 Sep 2011

Frontage, Spaulding Clinical enter strategic partnership

Frontage Laboratories, Inc., a global full-service Clinical Research Organization with facilities in the US and China, and Spaulding Clinical Research, LLC, a US-based, leading-edge Clinical Pharmacology Unit, ECG Core Lab, and Medical Device Manufacturer have entered into a strategic partnership agreement.

12 Sep 2011

Oncothyreon commences enrollment in PX-866 Phase 2 trial for metastatic castration-resistant prostate cancer

Oncothyreon Inc. today announced enrollment of the first patient in a Phase 2 trial of PX-866 in patients with recurrent or metastatic castration-resistant prostate cancer. PX-866 is a small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.

12 Sep 2011

BioClinica releases Express EDC solution for clinical trials

BioClinica, Inc., a global provider of clinical trial management solutions, announced the latest release of BioClinica Express EDC. This modern, web-based platform is a comprehensive electronic data capture (EDC) solution that adds speed and quality to every part of the clinical trial process.

From Clario 12 Sep 2011

PHT announces availability of eDHP-18 QoL questionnaire on all ePRO collection modalities

PHT Corporation announced today the availability of the electronic version of the DHP-18 (Diabetes Health Profile) Quality of Life (QoL) questionnaire on all of its electronic patient reported outcome (ePRO) collection modalities - smartphone, tablet and Web. PHT is the global pacesetter in PRO and ePRO solutions that maximize the collection of high-quality data from clinical trial patients to improve clinical trial efficiencies.

12 Sep 2011

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

Two independent advisory panels to the Food and Drug Administration (FDA) on Friday recommended increasing the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States. They did not however mention the exact words of the safety warnings and did not recommend limiting use of the drugs to a proposed five years. About 11 percent of women 55 and older take the drugs to prevent bone fractures.

12 Sep 2011

Roche initiates Phase 1 clinical trial of investigational drug for Down syndrome

Roche today announced the initiation of its first Phase 1 clinical trial to investigate the safety and tolerability of a molecule designed to address the cognitive and behavioral deficits associated with Down syndrome.

12 Sep 2011

Human gliomas release excess levels of glutamate and trigger seizures

Glioma, one of the most deadly and common types of brain tumor, is often associated with seizures, but the origins of these seizures and effective treatments for them have been elusive. Now a team funded by the National Institutes of Health has found that human gliomas implanted in mice release excess levels of the brain chemical glutamate, overstimulating neurons near the tumor and triggering seizures.

12 Sep 2011

Candidate malaria vaccine represents 'potentially encouraging anti-malaria strategy,' researchers say

A team of researchers led by Stephen Hoffman of Sanaria Inc. has created a candidate malaria vaccine against Plasmodium falciparum, the most deadly of the malaria parasites, using live but weakened parasites that "represents a potentially encouraging anti-malaria strategy," an NIH/National Institute of Allergy and Infectious Diseases press release reports.

12 Sep 2011

UMSOM to receive FDA approval for whole parasite malaria vaccine clinical trials

For the first time, a malaria vaccine that uses the entire malaria parasite has proven safe and shown promise to produce a strong immune response in a clinical trial, according to a new study co-authored by researchers at the University of Maryland School of Medicine Center for Vaccine Development.

12 Sep 2011

Study pinpoints relationship between primary brain tumors and onset of epileptic seizures

New research from the University of Alabama at Birmingham pinpoints the relationship between primary brain tumors and the onset of epileptic seizures and reveals that a drug used to treat Crohn's disease inhibits those seizures and may be able to slow a tumor's growth.

12 Sep 2011

FDA panel votes 9-2 in favor of new blood thinner drug

A new stroke preventer from Bayer and Johnson & Johnson – Xarelto moved one step closer to U.S. approval, but questions remained about restrictions on labeling and the need for more studies.

9 Sep 2011

NIH awards $12.8 million renewal grant for Louisville adult stem cell research project

At the time when Dr. Roberto Bolli received word that he was awarded a $12.8 million grant renewal from the National Institutes of Health for one research project, five patients in another of his clinical trials at the University of Louisville have reached the successful endpoint of their participation.

9 Sep 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

Weight Watchers more effective alternative to primary care for obese adults

A new, one-year global study published today in The Lancet indicates that overweight and obese adults referred to Weight Watchers, a community based provider of weight-loss services, lost more than twice as much weight when compared with those who received standard care.

9 Sep 2011

Positive results from Sanaria PfSPZ Vaccine initial Phase 1 trial on malaria

Positive results from the initial Phase 1 clinical trial in 80 healthy volunteers and complementary pre-clinical studies of the Sanaria PfSPZ Vaccine are published today in the online issue of Science.

9 Sep 2011

Clinical Trial News and Research

Acceleron commences ACE-536 Phase 1 clinical trial in anemia

New drug combination may treat two aggressive cancers

Delcath announces updated Phase 2 trial results from metastatic neuroendocrine tumor cohort

ImmunoCellular announces updated long-term data from ICT-107 Phase I trial on GBM

Clinical trial planned in Australia and the USA to help patients with ‘orphan’ disease

Frontage, Spaulding Clinical enter strategic partnership

Oncothyreon commences enrollment in PX-866 Phase 2 trial for metastatic castration-resistant prostate cancer

BioClinica releases Express EDC solution for clinical trials

PHT announces availability of eDHP-18 QoL questionnaire on all ePRO collection modalities

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

Roche initiates Phase 1 clinical trial of investigational drug for Down syndrome

Human gliomas release excess levels of glutamate and trigger seizures

Candidate malaria vaccine represents 'potentially encouraging anti-malaria strategy,' researchers say

UMSOM to receive FDA approval for whole parasite malaria vaccine clinical trials

Study pinpoints relationship between primary brain tumors and onset of epileptic seizures

FDA panel votes 9-2 in favor of new blood thinner drug

NIH awards $12.8 million renewal grant for Louisville adult stem cell research project

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Weight Watchers more effective alternative to primary care for obese adults

Positive results from Sanaria PfSPZ Vaccine initial Phase 1 trial on malaria

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