Theorem Clinical Research

Clinical Intelligence

Parkinson's Biomarker Initiative expands genetic study

Friday, March 27, 2015 01:26 PM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by the Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with a mutation of the GBA (glucosidase beta acid) gene. Participants will include people with or at increased risk to develop Parkinson's disease. Researchers hope that a greater understanding of the biology and clinical features of these participants will lead to therapies benefiting all Parkinson's patients and ultimately provide strategies to prevent disease onset.

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Quest Diagnostics

Mast to develop Vepoloxamer (MST-188) in chronic heart failure

Friday, March 27, 2015 01:15 PM

Mast Therapeutics, a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. Encouraged by recently reported nonclinical results and input from experts in the field, the company expects to begin dosing in a phase II study of vepoloxamer in patients with chronic heart failure in the third quarter of this year.

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FDA approves treatment for inhalation anthrax

Thursday, March 26, 2015 02:31 PM

The FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

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Selten Pharma receives FDA Orphan Drug designation for PAH

Thursday, March 19, 2015 01:13 PM

Selten Pharma, a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, has announced its lead compound tacrolimus (SPI-026) has been granted Orphan Drug designation by the FDA for the treatment of pulmonary arterial hypertension (PAH).

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Can-Fite completes commercial biomarker test to predict patients' drug response

Thursday, March 19, 2015 01:09 PM

Can-Fite BioPharma, a Israel-based biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite's drugs, which currently are in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

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XBiotech launches cancer patient directed web site and call center

Monday, March 16, 2015 09:00 AM

XBiotech, an Austin, Texas-based developer of next generation therapeutic antibodies, has launched a web site and call center to help patients with metastatic colorectal cancer learn about its U.S. pivotal phase III clinical trial. The phase III study, Xilonix Colorectal cancer Immunotherapy Treatment Evaluation (XCITE), assesses XBiotech's True Human monoclonal antibody (Xilonix) for the treatment of metastatic colon cancer.

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NIH-led study to assess community-based Hepatitis C treatment in Washington, D.C.

Thursday, March 12, 2015 12:52 PM

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.

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CardioCell adds Stony Brook University to sites conducting phase IIa trial

Thursday, March 12, 2015 12:31 PM

CardioCell, a Stemedica Cell Technologies subsidiary that designs allogeneic stem-cell therapies for cardiovascular indications, has expanded patient recruitment to Stony Brook University’s Heart Institute for its phase IIa clinical trial for chronic heart failure (HF). Recruitment for 20 qualified patients currently is underway at only Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia.

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One World Cannabis, Sheba Academic Medical Center ink trial agreement

Thursday, March 12, 2015 12:13 PM

OWC Pharmaceutical Research's wholly owned subsidiary One World Cannabis, an Israel-based company focused on medical cannabis treatment and medical cannabis regulatory affairs, has signed a collaboration agreement with Sheba Academic Medical Center, the largest hospital in Israel and in the Middle East.

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FDA expands approved use of Opdivo to treat lung cancer

Thursday, March 5, 2015 01:42 PM

The FDA has expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly


Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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