Full Press Release Details
Vital Therapies provides corporate
update and announces date of third quarter 2015 financial results
SAN DIEGO, October 16, 2015 (GLOBE NEWSWIRE)
-- Vital Therapies, Inc. (Nasdaq: VTL), a biotherapeutic company developing ELAD , a cell-based therapy targeting the treatment
of liver failure, today provided an update on its clinical development program. The Company also announced an employee retention
program and the date of its upcoming third quarter 2015 financial results conference call and webcast.
Briefing Document for Proposed VTL-308
Phase 3 Trial Submitted to FDA
The Company has submitted a briefing document
including a draft trial protocol to the Food and Drug Administration (FDA) for the upcoming Type C written response meeting, from
which the Company expects feedback by year end. This trial, to be known as VTL-308, is similar to the failed VTI-208 trial, but
incorporates changes based on the promising subset data from VTI-208.
The proposed design excludes subjects aged
50 years or older and those with a MELD of 30 or higher. Considering the three components of MELD, subjects are also excluded with
creatinine of 1.3 mg/dL or above, which limits kidney dysfunction, and international normalized ratio (INR) above 2.5, which limits
blood coagulopathy. The third MELD component, bilirubin, has been raised to a minimum of 16 mg/dL to ensure that liver dysfunction
is a major contributor to MELD. An intent-to-treat (ITT) post-hoc analysis of VTI-208 incorporating these parameters is shown below
(this subset has a median MELD of 26.0 and a mean MELD of 25.6):
Figure 1. Kaplan Meier Curve of the Post
Hoc VTI-208 Subset: age <50 years, MELD <30 and specific restrictions on MELD components (Creatinine < 1.3 mg/dL, INR
2.5, Bilirubin 16 mg/dL). Overall survival up to at least study day 91 (N=60; p<0.01. hazard ratio = 0.28).
15010 Avenue of Science, San Diego, California, USA 92128
Tel 858.673.6840 - Fax 858-673-6843
91-day survival in this post hoc analysis was
93% for the ELAD group versus 61% for those treated only with standard-of-care (Pearson's Chi-squared p<0.01). Moreover, the
survival benefit appeared durable with survival at the end of 180 days of 89% for the ELAD group versus 48% in those treated only
with standard-of-care (Pearson's Chi-squared p<0.01).
Although the result of this post hoc analysis
showed statistical significance, it was not pre-specified and there is no guarantee that the results of the planned VTL-308 phase
3 trial will replicate the results of this subset.
VTL-308 is designed to enroll approximately
150 subjects and to be conducted at approximately 40 sites in the U.S., U.K., Ireland, Germany and Spain, comprised mostly of high
enrolling sites from VTI-208. The Company has begun the process of opening clinical sites for VTL-308 and anticipates enrolling
the trial's first subject in the first half of 2016.
The Company is not requesting a Special Protocol
Assessment (SPA) from FDA due to the open label design of the trial. The Company plans to submit a briefing package to the European
Medicines Agency (EMA) to request scientific advice on VTL-308. The Company also plans to submit Clinical Trial Authorizations
(CTAs) to each EU country expected to participate in the trial.
Presentation of VTI-208 Results at AASLD
Results of the VTI-208 trial have been accepted
for oral presentation by the American Association for the Study of Liver Disease (AASLD) at some time between 3:00 and 4:30 PM
Pacific time in the late breaking session at The Liver Meeting in San Francisco, CA on November 16, 2015. The presentation will
be given by Principal Investigator David J. Reich, MD, professor and vice chairman of the Department of Surgery at Drexel University
College of Medicine.
Employee Retention Program
The Board of Directors has approved an employee
retention program that grants up to a total of 742,168 stock options (2.7% of total shares and options outstanding prior to these
grants) to all employees and certain consultants. The key feature of this program is that the new stock options only vest after
three years provided the VTL-308 trial is completed with a statistically significant result.
"VTL is fortunate to have outstanding
employees who are motivated by participating in the development of an innovative lifesaving therapy. The Board considers it to
be in the interests of all shareholders to provide additional incentives to retain those employees who devote the next few years
of their careers to the completion of the VTL-308 clinical trial," said Muneer Satter, Co-Chairman of Vital Therapies.
of the option awards can be found in a concurrently filed Form 8-K. This program is being implemented out of existing available
options. The Form 8-K will also include the Company's updated investor presentation, which can also be found at the Company's
investor relations web site: http://ir.vitaltherapies.com/.
Upcoming Third Quarter Conference Call
The Company will release its third quarter
2015 financial results after the market closes on Thursday, November 5, 2015. The press release will be followed by a conference
call at 4:30 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will
review financial results and discuss other business matters.
The conference call dial-in numbers are (855)
765-5682 for domestic callers and (919) 825-3204 for international callers. The conference ID number for the call is 57542661.
Participants may access the live webcast via a link on the Vital Therapies website in the Investor Relations section under "Events"
For those unable to dial in at the designated
time, a conference call replay will be available for one week following the conference call, from approximately 7:30 p.m. ET on
November 5, 2015 to 11:59 p.m. ET on November 12, 2015. The conference call replay numbers for domestic and international callers
are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 57542661. Additionally, an archive
of the webcast will be available on the Company's website for 90 days.
MELD (Model of End-Stage Liver
Disease) was developed by clinicians at Mayo Clinic in Rochester, MN as an algorithm of three clinical laboratory measurements
to yield a single uniformly accepted score to predict the probability of 90-day survival of chronic liver disease patients and
thereby prioritize them for liver transplant. After rigorous empirical evaluation of hundreds of such patients, the clinicians
concluded that no single laboratory measurement predicted survival in chronic liver disease, but that a complex algorithm of bilirubin,
creatinine and INR gave a reliable estimate of survival probability.
MELD score has since been validated for predicting
90-day survival in other types of liver disease including acute alcoholic hepatitis. Details on MELD score can be found in a paper
published in Hepatology (2005) titled "MELD Accurately Predicts Mortality in Patients With Alcoholic Hepatitis"
(Winston Dunn, Laith H. Jamil, Larry S. Brown, Russell H. Wiesner, W. Ray Kim, K. V. Narayanan Menon, Michael Malinchoc, Patrick
S. Kamath, and Vijay Shah). For reference, normal people with no liver disease have MELD scores of about 6 and the average MELD
at liver transplant in the U.S. is about 24. High MELD scores are associated with high mortality. For example, at a MELD score
of 26 (median MELD of the 60-subject post-hoc subset population), the Dunn et al paper would predict that the patient has a 47%
probability of death within 90 days. At a MELD score of 30, the upper limit in the proposed VTL-308 trial, the Dunn et al paper
would predict that the patient has a 62% probability of death within 90 days.
About VTI-208 and VTI-208E
VTI-208 was a phase 3 randomized, controlled,
open-label trial, evaluating the ELAD System in subjects with AILD. The primary endpoint was overall survival through at least
91 days assessed using the Kaplan Meier statistical method, and the secondary endpoint was proportion of survivors at study days
28 and 91. The trial enrolled 203 subjects over 22 months with 96 subjects randomized to the treated group and 107 randomized to
the control group. VTI-208E, an extension study, assesses subject outcomes for five years after enrollment in VTI-208. Results
of the VTI-208 clinical trial, incorporating VTI-208E survival data through July 30, 2015, showed that the trial failed to reach
its primary or secondary endpoints.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic Company developing a cell-based
therapy targeting the treatment of liver failure. The Company's ELAD System is an extracorporeal human allogeneic cellular
liver therapy. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies and ELAD are trademarks of Vital
Forward-Looking Statements
This press release contains forward-looking statements within the