Vital Therapies (NSDQ:VTL) said today that the phase 3 clinical trial of its Elad cell-based therapy treatment for liver failure did not meet primary or secondary endpoints and the company is shutting down 2 other clinical trials of Elad.
The randomized, controlled, 203-patient trial examined the efficacy of the cell-based therapy in treating subjects with alcohol-induced liver decomposition.
The study found no difference between the control group and those treated with Elad in regards to its primary endpoint of overall survvial of at least 91 days, according to the San Diego, Calif.-based company.
The trial’s secondary survival endpoints at 28 and 91 days also showed no difference between groups, the company reported. Serious adverse events were also similar between the treated and control groups.
Vital Therapies said that while it it is still in the process of analyzing the data set, it is canceling the VTI-210 and VTI-212 clinical trials of its Elad system. The trials were actively enrolling patients in the U.S. and European Union, according to the company’s website.
Though the company said the results were ‘disappointing’, it added that a pre-specified subset of 120 subjects with Model for End-stage Liver Disease scores of less than 28 had showed promising results with the therapy.
Vital Therapies said it expected the $62 million in cash it had would allow the company to complete a new trial without needing to raise additional capital, but hinges on discussions with regulatory authorities.
Vital Therapies shares have plummeted in after-hours trading on the news, dropping over 70% as of 5:25 p.m. EDT.
The post Vital Therapies trial fails to meet endpoints appeared first on MassDevice.
from MassDevice http://ift.tt/1hykxcq
Cap comentari:
Publica un comentari a l'entrada