Sernova Receives US FDA IND Allowance to Initiate a US Clinical Trial of Its Cell Pouch for the Treatment of Type 1 Diabetes
Sernova Corp., a clinical stage company developing regenerative medicine technologies for the long-term treatment of diseases including diabetes and hemophilia, is pleased to announce it has received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (TM) (CPS) in the United States.Sernova Provides Company Outlook on Corporate and Clinical Developments
Sernova Corp., a clinical stage company developing medical technologies for the long-term treatment of chronic metabolic diseases including diabetes, blood disorders such as hemophilia and other diseases, today provided a brief company outlook on corporate and clinical developments.Sernova and CTI Clinical Trial Announce Regulatory Collaboration
Sernova Corp., a clinical stage company developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia and CTI Clinical Trial and Consulting Services (CTI), are pleased to announce their collaboration on regulatory matters respecting Sernova's Cell Pouch System(TM), a novel implantable and scalable medical device that when combined with therapeutic cells, may provide a convenient, safe and effective long-term therapeutic option for patients with chronic diseases such as insulin-dependent diabetes who seek to improve their quality of life.Sernova Announces Agreement with CCRM to Produce Specialized Cells for the Treatment of Diabetes
Sernova Corp., a clinical stage company developing medical technologies for the long-term treatment of chronic diseases including diabetes and hemophilia, announced today it has entered into a service agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) to establish, optimize and validate Sernova's licensed technology for creating stem cell derived therapeutic cells that produce insulin and are glucose responsive.New Funding Allows for the Clinical Development of Novel Cell Based Hemophilia Therapy
People with hemophilia have prolonged abnormal bleeding as a result of trauma. Hemophilia A, also called factor VIII (FVIII) deficiency, is the most common form of the genetic disorder caused by missing or defective blood clotting protein called factor VIII. Severe hemophilia occurs in about 60% of cases where the deficiency of Factor VIII is less than 1% of normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene.