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PPD introduces new centralized computing platform for analysis and reporting of clinical trial data

PPD, Inc. today announced it has launched a new global information technology infrastructure for analysis and reporting of clinical trial data. The biostatistics technology infrastructure (BTI) is a centralized computing platform that enhances the company’s ability to deliver secure, quality reporting and data analysis to meet client timelines.

2 Dec 2009

GammaL c device provides accurate lesion localization and facilitates needle-guided biopsy

Breast-Specific Gamma Imaging (BSGI) is a molecular breast imaging technique increasingly being used in the diagnostic workup of patients with indeterminate mammograms and has demonstrated the ability to detect cancers missed by mammography and ultrasound.

2 Dec 2009

Patient enrollment complete in Peregrine Pharmaceuticals' Cotara trial

Peregrine Pharmaceuticals, Inc. today reported completion of patient enrollment in a dose confirmation and dosimetry trial of Cotara® in patients with relapsed glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for GBM.

2 Dec 2009

Phosphagenics commences Phase 1B clinical trial of its oxycodone/TPM transdermal patch systems

Phosphagenics Limited today announced the initiation of a Phase 1B clinical trial for its patented oxycodone/TPM (Targeted Penetration Matrix) transdermal patch systems.

2 Dec 2009

Sorin Group includes the first patient in its Clepsydra clinical trial

Sorin Group announced today the first inclusion of a patient in the Clepsydra clinical trial. The study will investigate the sensitivity to changes in heart failure status of PhD™, a unique diagnostic feature using the dual sensor technology of minute ventilation and accelerometer to monitor patient’s breathing and activity levels every day.

2 Dec 2009

FDA approves revised clinical trial protocol for CytRx' arimoclomol

CytRx Corporation, a biopharmaceutical company, is permitted to re-enter the clinic with its orally administered molecular chaperone drug candidate arimoclomol as a therapeutic treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), following the U.S. Food and Drug Administration’s (FDA) acceptance of a revised clinical trial protocol.

2 Dec 2009

FDA grants Fast Track designation for AEterna Zentaris' perifosine

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

2 Dec 2009

Genta to supply Ganite for new CF clinical trial

Genta Incorporated announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

2 Dec 2009

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Sepracor Inc. today announced that clinical study data for STEDESA™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST.

2 Dec 2009

Positive results from DermaGen's Phase I/IIa AMP study of atopic dermatitis

DermaGen AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" - announced that Dermagen AB has received promising results from a clinical Phase I/IIa study. DermaGen AB is developing a novel antimicrobial peptide (AMP) treatment for atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin disease where dry skin and the skin's weakened barrier function make patients susceptible to colonization by microorganisms, a triggering or exacerbating factor of the disease.

2 Dec 2009

NHLBI awards stimulus funds for hemophilia drug research

PTC Therapeutics, Inc. (PTC) today announced the receipt of a $1 million Challenge Grant award from the National Heart, Lung, and Blood Institute (NHLBI) as part of the National Institutes of Health (NIH).

2 Dec 2009

Protein marker may hold the key against pancreatic cancer

Pancreatic tumors can be identified by a readily detectable marker that shows promise as a basis for immune therapy against the disease, according to research at Washington University School of Medicine in St. Louis.

2 Dec 2009

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

Roche announced today that the United States Food & Drug Administration (FDA) approved an additional intended use for its licensed nucleic acid test, to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas® TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA), hepatitis C virus RNA and hepatitis B virus DNA in human plasma.

From Roche Sequencing and Life Science 2 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

RSNA: Dec. 2, 2009 briefing and presentations

A special press briefing will be held Wednesday, Dec. 2, at 10:45 a.m. CT (11:45 a.m. ET), featuring a panel of top experts who will discuss the recent U.S. Preventive Services Task Force (USPSTF) release of revised screening mammography guidelines. Many patients, breast cancer survivors, medical experts and government authorities dispute the guidelines as being without scientific evidence.

2 Dec 2009

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Stemline Therapeutics, Inc., a private clinical stage biopharmaceutical company and leading developer of oncology compounds directed to cancer stem cells, today announced that The University of Texas M.D. Anderson Cancer Center (Houston, TX) and Stemline have entered into a research collaboration.

2 Dec 2009

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard(®) were presented at the American Heart Association (AHA) Scientific Sessions 2009, on Sunday, November 15 in Orlando, Florida.

2 Dec 2009

nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

nContact Surgical, Inc. ("nContact"), a leader in the investigation of devices for minimally-invasive treatment for heart conditions, today announced the initiation of a feasibility clinical trial designed to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF). This prospective, feasibility study will enroll patients at study sites across the United States.

2 Dec 2009

Harvest Technologies' BMAC System exhibits potential as an effective treatment for CLI

Harvest Technologies Corp. announced today results from the company sponsored 60-patient clinical trial conducted at Sri Ramachandra Medical Center in Chennai, India using the company's BMAC System to treat patients with non-reconstructable Critical Limb Ischemia (CLI). Sri Ramachandra Medical Center is a Harvard Medical international-associated institution based in Chennai, India and one of the largest private healthcare facilities in South Asia.

2 Dec 2009

ImThera Medical implants its aura6000 neurostimulation device in two OSA patients

ImThera Medical, Inc. today announced that two patients have been surgically implanted with ImThera’s aura6000™ neurostimulation device for treating tongue-based Obstructive Sleep Apnea (OSA). Patients are being enrolled in ImThera’s pilot clinical investigation in Belgium with the first results expected to be published in the first half of 2010.

2 Dec 2009

Clinical Trial News and Research

PPD introduces new centralized computing platform for analysis and reporting of clinical trial data

GammaL c device provides accurate lesion localization and facilitates needle-guided biopsy

Patient enrollment complete in Peregrine Pharmaceuticals' Cotara trial

Phosphagenics commences Phase 1B clinical trial of its oxycodone/TPM transdermal patch systems

Sorin Group includes the first patient in its Clepsydra clinical trial

FDA approves revised clinical trial protocol for CytRx' arimoclomol

FDA grants Fast Track designation for AEterna Zentaris' perifosine

Genta to supply Ganite for new CF clinical trial

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Positive results from DermaGen's Phase I/IIa AMP study of atopic dermatitis

NHLBI awards stimulus funds for hemophilia drug research

Protein marker may hold the key against pancreatic cancer

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

New data demonstrating the strength of Novartis' hematology portfolio to be presented

RSNA: Dec. 2, 2009 briefing and presentations

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

Harvest Technologies' BMAC System exhibits potential as an effective treatment for CLI

ImThera Medical implants its aura6000 neurostimulation device in two OSA patients

Achieving and maintaining ISO 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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