Clinical Trial News and Research

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Genome sequencing of tumors biopsied from women with invasive breast cancer

Tumors biopsied from women with invasive breast cancer are having their genomes sequenced in an attempt to develop a DNA profile that one day may identify ahead of time the patients who will most likely respond to chemotherapy with an aromatase inhibitor. Aromatase inhibitors are a class of chemotherapeutic agents that block the production of estrogen in postmenopausal women.

27 Mar 2010

READ 3 study for DME begins enrolling participants

A Phase II clinical trial for a promising treatment for diabetic eye disease has begun enrolling participants.

27 Mar 2010

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing.

26 Mar 2010

Neurologix reports net loss of $13.5M for year ended December 31, 2009

Neurologix, Inc., a biotechnology company engaged in the development of innovative therapies for the brain and central nervous system, today announced its financial results for the year ended December 31, 2009.

26 Mar 2010

NCMHD announces $3.8M grant for research on minority recruitment in cancer clinical trials

The University of Minnesota Medical School today announced the details of a $3.8 million grant by the National Institutes of Health's National Center on Minority Health and Health Disparities for research focused on minority recruitment and retention in cancer clinical trials.

26 Mar 2010

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

Currently, Alzheimer's disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer's, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. and Cardinal Health are working together to change that.

26 Mar 2010

CTMS solutions provider TranSenda International acquired by BioClinica

BioClinica™, Inc.,, a global provider of clinical trial management services, today announced its acquisition of substantially all of the assets of privately held TranSenda International, LLC. Headquartered in Bellevue, WA, TranSenda is a provider of clinical trial management software (CTMS) solutions and is a Microsoft Gold Certified Partner.

From Clario 26 Mar 2010

Muscular dystrophy: $1M grant for study of erectile dysfunction drugs in improving muscle blood flow

A Cedars-Sinai Heart Institute cardiologist has been awarded a three-year, nearly $1 million grant from the Muscular Dystrophy Association (MDA) to study whether drugs used to treat erectile dysfunction could also be used to improve muscle blood flow and reduce fatigue in muscular dystrophy patients.

26 Mar 2010

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

New topical drug may help treat diabetic eye disease

Early-stage human clinical trials showed that a new topical drug was safe and had biological effects in a type of diabetic eye disease, and may offer researchers a new approach to prevent and treat diabetic macular edema.

26 Mar 2010

Eli Lilly supports SNM's initiative to advance innovative therapies

SNM is pleased to announce that biopharmaceutical company, Eli Lilly and Company, has joined SNM's Clinical Trials Network-making it the third major company to formally support this initiative to facilitate the development of promising therapeutic medicines.

26 Mar 2010

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

Oramed Pharmaceuticals Inc. announced today the completion of its' pivotal Phase 2b clinical study of its oral insulin capsule, ORMD-0801. The Company expects to report results from this study within the coming weeks.

26 Mar 2010

SMA Foundation completes biomarker study for Spinal Muscular Atrophy

The Spinal Muscular Atrophy (SMA) Foundation, a nonprofit organization dedicated to accelerating the development of a treatment for SMA, is pleased to announce the completion of a pilot study to identify Biomarkers for Spinal Muscular Atrophy (BforSMA) and the discovery of over 400 candidate biomarkers.

26 Mar 2010

Interim results from ZALBIN Phase 2B trial in chronic hepatitis C patients announced

Human Genome Sciences, Inc. today announced interim results through Week 12 following the end of treatment in a Phase 2b clinical trial conducted by Novartis to evaluate the safety and efficacy of ZALBIN™ (albinterferon alfa-2b), an investigational agent, administered monthly in combination with ribavirin in 391 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C virus. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).

26 Mar 2010

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

26 Mar 2010

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Novavax, Inc. announced today positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine.

26 Mar 2010

Hana Biosciences reports net loss of $5M for fourth quarter 2009

Hana Biosciences Inc., a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the fourth quarter and year ended December 31, 2009, and provided a corporate update.

26 Mar 2010

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Aastrom Biosciences, Inc., a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported that the final patient has been treated in the company's ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. This patient received intramuscular injections of either Aastrom's tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease.

26 Mar 2010

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Arena Pharmaceuticals, Inc. announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.

25 Mar 2010

Venn Life Sciences completes $3 mn funding, acquires Dutch CRO UpToYou

Venn Life Sciences has just completed a significant funding round of over $3 million, to enable it to further accelerate the growth of its business.

25 Mar 2010

Clinical Trial News and Research

Genome sequencing of tumors biopsied from women with invasive breast cancer

READ 3 study for DME begins enrolling participants

ARCA biopharma granted patent for methods of treating heart failure patients with bucindolol based on genetic testing

Neurologix reports net loss of $13.5M for year ended December 31, 2009

NCMHD announces $3.8M grant for research on minority recruitment in cancer clinical trials

Avid, Cardinal Health partner to detect Alzheimer's disease in living patients

CTMS solutions provider TranSenda International acquired by BioClinica

Muscular dystrophy: $1M grant for study of erectile dysfunction drugs in improving muscle blood flow

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

New topical drug may help treat diabetic eye disease

Eli Lilly supports SNM's initiative to advance innovative therapies

Oramed Pharmaceuticals completes Phase 2b study of ORMD-0801 oral insulin capsule

SMA Foundation completes biomarker study for Spinal Muscular Atrophy

Interim results from ZALBIN Phase 2B trial in chronic hepatitis C patients announced

FDA approves Mirapex ER tablets for signs and symptoms of idiopathic PD

Positive results from Stage A pivotal study of 2009 A/H1N1 VLP pandemic influenza vaccine

Hana Biosciences reports net loss of $5M for fourth quarter 2009

Aastrom Biosciences' RESTORE-CLI trial: Final patient treated

Arena Pharmaceuticals initiates patient screening for phase 1 clinical trial of APD916

Venn Life Sciences completes $3 mn funding, acquires Dutch CRO UpToYou

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