Clinical Intelligence

Zafgen initiates phase I trial of ZGN-1061

Wednesday, September 21, 2016

Zafgen, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has announced that the company has recently initiated dosing in the multiple ascending dose (MAD) cohorts of its ongoing phase I clinical trial of ZGN-1061. The initiation of the MAD portion was triggered following a review of the initial safety and tolerability data from the first two cohorts of the single ascending dose (SAD) portion of the clinical trial. ZGN-1061 is a second-generation, differentiated MetAP2 inhibitor in development for severe and complicated obesity indications.  

[Read More]

Janssen completes WHO submission for EUAL for Ebola vaccine regimen

Wednesday, September 14, 2016

Bavarian Nordic has announced that Janssen Vaccines & Prevention has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic’s MVA-BN Filo vaccine. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.

[Read More]

GenSight to add teenage patients in Leber’s hereditary optic neuropathy trial

Tuesday, September 13, 2016

GenSight Biologics, a biopharma company that discovers and develops innovative gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, has announced that regulatory agencies and ethics committees in the U.S., France and the U.K., have authorized a protocol amendment to include teenage patients (15-18 years) in RESCUE and REVERSE, two ongoing phase III clinical trials of GS010 in the treatment of Leber’s Hereditary Optic Neuropathy (LHON).

[Read More]

NIH award expands landmark Alzheimer’s biomarker study

Tuesday, September 13, 2016

The Alzheimer’s Disease Neuroimaging Initiative (ADNI)—the long-running NIH-supported study investigating brain and fluid biomarkers of the disease—enters a new phase of discovery with the launch of ADNI3. With the recent NIH award of approximately $40 million over the next five years—coupled with anticipated private sector contributions of $20 million through the Foundation for the National Institutes of Health (FNIH)—ADNI3 will use cutting-edge technologies in brain imaging as it recruits hundreds of new volunteers. Expansion of the groundbreaking study, now in its 12th year, will further develop ways to speed clinical trials by providing researchers the biomarkers needed to detect the onset and track the progression of Alzheimer’s disease.

[Read More]