News Briefs 

Regulus Therapeutics initiated its ATHENA natural history of disease study in patients with Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. The ATHENA study is designed to characterize the natural decline of renal function markers such as Glomerular Filtration Rate, creatinine, proteinuria and β-2 microglobulin, in Alport syndrome patients over time. Regulus aims to enroll up to 120 Alport syndrome patients in the ATHENA study to inform future clinical development plans of Regulus’ RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, currently in development to treat renal dysfunction in Alport syndrome. Study home 

WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for clinical research, announced that ePharmaSolutions has joined its group of companies. Based near Philadelphia, ePharmaSolutions provides eClinical solutions and services, including a cloud-based enterprise Clinical Trial Portal (CTP) and Electronic Trial Master File (eTMF). Its products are used by 350,000 clinical research professionals in 130 countries. Like the other companies within WCG, ePharmaSolutions will continue to operate independently at its current locations, and will retain both its leadership and brand. Press release 

A Veeva Systems survey on industry approaches to electronic Trial Master Files (eTMFs) found that more than 32% of TMF owners will grant auditors remote access to their eTMF by early 2015, versus the 16% who provide them access today. Veeva Systems’ survey comes just months after the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidelines on TMF accessibility. Repeated inspection delays due to inaccessible and incomplete sponsor TMFs prompted the MHRA to update its definition of a critical Good Clinical Practice inspection finding to include TMF accessibility and availability. Press release   

PHT Corporation, a provider of technologies used to collect patient-driven eData for clinical research, announced that its LogPad System has been selected by Agile Therapeutics for use in the SECURE Phase 3 trial for its investigational product candidate, Twirla. PHT’s LogPad System is an electronic patient reported outcome eDiary for patient-focused eClinical research. Twirla is an investigational once weekly contraceptive patch, designed to offer convenience and promote enhanced patient compliance. Press release 

Transparency Life Sciences (TLS) received a $1.4 million Small Business Innovation Research grant from the NIH for a Phase 2a proof-of-concept study of the ACE inhibitor lisinopril as an adjunctive therapy for multiple sclerosis (MS). TLS developed the clinical protocol for the lisinopril study with crowdsourced input from MS researchers, physicians and patients. The trial is also designed to minimize the need for patient site visits by relying primarily on telemonitoring and video interactions with subjects, through a partnership with AMC Health, which will deploy its mobile technology to enable video study visits in patients' homes, collect biometric data and enable remote assessment of a primary endpoint. Press release 

Rockland Immunochemicals received a $224,473 Small Business Innovation Research (SBIR) grant from the NIH to develop an antibody-based point of care device for the diagnosis of Sickle Cell Disease (SCD). Early detection of SCD can help reduce the risk of life-threatening infections, but currently, there are no simple and cost effective screening tests that can differentiate patients with the sickle cell trait (HbAS) from sickle cell disease conditions (HbSS, HbSC and HbS β-thalassemias). Press release 

Caris Life Sciences has adopted IBM technical computing and storage technology to accelerate its molecular profiling services for cancer patients. These services help oncologists develop tailored therapeutic plans for each patient’s unique cancer. Caris has tested more than 65,000 cancer patients for 70 different molecular markers, which are then correlated with 55 FDA-approved cancer therapies and hundreds of clinical trials agents.  Working with IBM and premier IBM Business Partner Re-Store, Caris has developed a scalable infrastructure to profile both genomic and proteomic data, expanding the range of molecular targets it can use to recommend therapies. Press release  

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, announced that its CSM platform has been used to assess the quality and integrity of data in a Phase III study of gastric cancer. The Stomach Cancer Adjuvant Multi-Institutional Group Trial (SAMIT), sponsored by the Epidemiological and Clinical Research Information Network (ECRIN) at Nagoya University School of Medicine, Nagoya, Japan, implemented the solution to check the quality of the data collated during the eight year study of 1,495 patients across 230 hospitals in Japan. The SAMIT trial is the largest ever adjuvant trial for gastric cancer. Press release  

New Products 

The non-profit tranSMART Foundation released Version 1.2 of its open source tranSMART knowledge management platfor, offering extensions in analytics and analysis, data loading, search and retrieval, as well as improved developer tools and interfaces that facilitate the addition of new features in the future. Community and member organizations contributed new features such as genome-wide association studies (GWAS), integration with the R statistical platform, cross study analysis, new data types, and new search and browse tools. This release, for the first time, provides the capability to integrate a number of different profiling data, such as mRNA, microRNA, and metabolomic, with genetic data based on individual patients. Press release 

Tute Genomics announced the launch of MyGene, a patient portal that offers individual access to genome sequencing results. MyGene is an extension of Tute’s cloud-based clinical report builder, allowing healthcare organizations to select and share validated clinical genetics findings with patients in a mobile format. Doctors, labs and diagnostic companies can use MyGene to create customized clinical reports, including pre-built, drag-and-drop modules for various gene panels, ACMG incidental findings, pharmacogenetics, and more. Press release 

EMC Information Intelligence Group added EMC Documentum SSV to its Life Sciences Solution Suite for regulatory management.  EMC Documentum SSV is used to store, search and retrieve submission documentation and all associated correspondence, linking these documents to submission files. It also automatically stores electronic common technical documents (eCTD), non-eCTD electronic submissions and paper submissions into a Documentum repository with security, audit trail, metadata and indexing capabilities. Product page