Please wait while we load the requested 10-K report or click the link below:
The initial database lock for VTI-208 was July 31, 2015. At that time the Company had a range of between six and 27 months of follow up data. The subjects are being followed in the VTI-208E extension study with periodic contacts to assess long term survival and the incidence of cancer, liver transplant and to assess quality of life. The Company has now updated the survival data as of December 31, 2015, providing an additional five months of follow up data. These additional data show:
Three additional deaths in control subjects and one in ELAD-treated subjects. One additional subject withdrew consent and two were lost to follow-up.
No significant changes to conclusions from the data as of July 31, 2015.
The overall survival data for the primary end point of intent-to-treat Kaplan Meier analysis continued to show no difference between treated and control groups.
Pre-specified and post-hoc subgroup analyses maintained the previously observed differences between the ELAD-treated and control groups.
The Kaplan Meier analysis of the post hoc subset of 60 subjects that is the basis for the new VTL-308 trial maintained its p value of <0.01 (p=0.006) and a hazard ratio of 0.28 and is shown in Figure 1. Survival at 180 days was 90% in ELAD-treated subjects and 48% in control subjects. There is no guarantee that these results can be replicated in the VTL-308 trial.
Received written responses from the FDA regarding the Type C briefing document that included a draft of the VTL-308 trial protocol. Subsequently, the final protocol was submitted to the FDA. The Company is proceeding with the trial and continues to anticipate that the first subject will be enrolled in the first half of 2016. Clinical sites are in the process of opening in the U.S. and should begin to open in the EU soon.
Presented posters and continued the laboratory R&D work to help characterize ELAD’s mechanism of action:
A poster presented at the annual meeting of the American Association for the Study of Liver Disease (AASLD) in November described eleven factors secreted by VTL C3A cells that have been associated with liver regeneration. This poster also described what the Company believes is a very exciting finding that the media from growing the VTL C3A cells reduces the rate of apoptosis, or cell death, of primary human hepatocytes in cell culture. This is significant because it could explain how ELAD stabilizes the liver and allows for its regeneration through preventing further hepatocyte cell death.
The following information was filed by Vital Therapies Inc (VTL) on Tuesday, March 8, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one year to another to evaluate Vital Therapies Inc's financial trajectory
Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Vital Therapies Inc.