Clinical Intelligence

BIND Bioscience releases promising anti-tumor results

Wednesday, April 11, 2012 02:52 PM

BIND Biosciences, a clinical-stage biopharmaceutical company, has releases promising data from an ongoing phase I study of BIND-014, the company’s lead drug candidate within a new class of targeted therapeutics, Accurins, that are programmed to concentrate at tumors.

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Syndax initiates phase I/II study in metastatic breast cancer

Monday, April 9, 2012 04:42 PM

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company based in Waltham, Mass., has initiated a phase I/II study combining its lead product entinostat with lapatinib ditosylate (Tykerb) in patients with locally recurrent or distant relapsed metastatic breast cancer previously treated with trastuzumab (Herceptin).

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CureFAKtor drug inhibits pancreatic tumor growth

Friday, April 6, 2012 04:14 PM

CureFAKtor Pharmaceuticals, a privately-held biopharmaceutical company, has reported data demonstrating analogs of novel focal adhesion kinase (FAK) inhibitor CFAK-C4 disrupted FAK-vascular endothelial growth factor receptor 3 (FAK-VEGFR3) interaction and inhibited pancreatic tumor growth.

Data showed that oral small molecule FAK inhibitor C4 analogs disrupt FAK-VEGFR3 interaction and dramatically inhibit pancreatic tumor growth at low concentrations as single agents, as well as in combination with gemcitabine, demonstrating synergistic effect. In vivo, 30-day treatment with low doses of the four analogs led to massive reduction in tumor growth when treated as single agents (60%) and in combination with gemcitabine (80%) (P<0.05). The C4 analogs displayed enhanced potency, minimum toxicity and high specificity for the target site.

A previous CureFAKtor study pinpointed the site of interaction of VEGFR-3 and FAK to create the small molecule drug capable of disrupting signaling and causing death of many types of cancer cells.

CureFAKtor is planning a phase I clinical study of CFAK-C4 in combination with gemcitabine chemotherapy in 2012, which received Orphan Drug Designation by the FDA.

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UCB, Amgen begin phase III postmenopausal osteoporosis program

Friday, April 6, 2012 03:47 PM

UCB, a global biopharmaceutical based in Brussels, Belgium, and biotech Amgen have initiated their sclerostin antibody (CDP7851/AMG785) phase III clinical trial program for the treatment of postmenopausal osteoporosis.

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Novartis phase III COPD studies meet primary endpoints

Friday, April 6, 2012 03:08 PM

The first three Novartis Pharmaceuticals QVA149 phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints.

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Abbott touts promising results in phase II Hep C trial

Thursday, April 5, 2012 08:00 AM

Abbott has released promising data from two different interferon-free phase II studies for hepatitis C (HCV), suggesting that a 12-week regimen of two Abbott medicines, and no peginterferon, can achieve high cure rates for treatment-naïve, genotype 1 patients.

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Synta releases data on ganetespib across range of malignancies

Wednesday, April 4, 2012 09:00 AM

Lexington, Mass.-based Synta Pharmaceuticals has released results on the use of ganetespib, the most advanced heat shock protein 90 (Hsp90) inhibitor in clinical development, in melanoma and colorectal cancer.

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The CenterWatch Monthly, April 2012

Sunday, April 1, 2012 06:30 AM

Global sites see growth in trials, revenue, staffing

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Alzheimer’s plasma biomarker study yields potential for diagnostic blood tests

Friday, March 30, 2012 09:10 AM

Proteome Sciences, in collaboration with the National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health and Merck Millipore, has completed its 1,000-sample Alzheimer’s disease (AD) biomarker validation study.

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Paratek, FDA agrees on Special Protocol Assessment for pneumonia study

Wednesday, March 28, 2012 12:51 PM

Paratek Pharmaceuticals has reached agreement with the FDA on its second Special Protocol Assessment (SPA) related to the phase III program design for the company's lead antibiotic candidate, omadacycline (formerly PTK 0796), this time for community-acquired bacterial pneumonia (CABP).

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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