Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
DiaVacs, Inc., a clinical stage biotechnology company focused on developing cell-based therapy for treatment of type 1 diabetes, and Profil® Institute for Clinical Research, Inc., an early phase clinical research organization focused on diabetes and obesity, announced today a strategic collaboration to conduct DiaVacs' phase Ib/IIa clinical trial. This clinical trial will study the safety and preliminary efficacy of DiaVacs' novel dendritic cell therapy for treatment of type 1 diabetes in patients who are newly diagnosed.
DiaVacs' proprietary technology is based on dendritic cell therapy. DiaVacs has perfected the immunology and technology to take a patient's own dendritic cells from their blood, modify them through the use of small interfering oligonucleotides, and then vaccinate the patient by simple injection of these modified cells under the skin using a small needle. The cells are taken up and trafficked to the pancreatic lymph nodes where they take up residence and induce tolerance. This cell-based therapy has been shown to be safe in phase I human trials and effective at halting disease progression in preclinical models of disease.
The double-blind, placebo-controlled study will begin by first enrolling 10 subjects who are at least 18 years of age with newly diagnosed type 1 diabetes (< 6 months from diagnosis). A fifteen month commitment will be required of all study participants, including multiple visits to Profil Institute's San Diego clinical facility. Thereafter, the study will expand the inclusion criteria to include younger participants who are newly diagnosed. The primary efficacy endpoint of the study is evidence of the return of insulin secretion by the pancreas. Additionally, various immune markers will be assessed for evidence that the autoimmune process responsible for type 1 diabetes has been altered.