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The first patient was dosed in the PROTECT study in December 2017. More than 1,600 adults have now been enrolled in the study at 27 sites across the US, Europe, and Canada.
Data from the PROTECT Study will Inform Positioning and Differentiation of Sci-B-Vac®
Jeff Baxter, President and Chief Executive Officer of VBI Vaccines, stated that the completion of enrollment in the PROTECT study is a significant milestone in this pivotal Phase-III program. According to him, Data from this head-to-head immunogenicity study will inform the positioning and differentiation of Sci-B-Vac®.
Jeff added that the Company looks forward to reporting the topline data and remain dedicated to advancing Sci-B-Vac® through phase-3 development as quickly as possible.
Top-line Data from the PROTECT Study are Expected Mid-Year 2019
PROTECT is a double-blind, two-arm, randomized, controlled study, and is one of two ongoing global studies that form the Phase-3 program for Sci-B-Vac®. It is designed to evaluate the safety and immunogenicity of Sci-B-Vac® compared to the control vaccine, Engerix-B®, in support of future regulatory filings in the US, Europe, and Canada. More than 1,600 subjects, 18 years of age and older, have been randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac® 10μg or a three-dose course of the control vaccine, Engerix-B® 20μg.
The co-primary objective of the study is to demonstrate non-inferiority of the seroprotection rate induced by Sci-B-Vac® versus Engerix-B® four weeks after the third vaccination in adults age 18 and older. The other co-primary objective is to demonstrate superiority of the seroprotection rate induced by Sci-B-Vac® versus Engerix-B® four weeks after the third vaccination in adults older than 45 years of age. Top-line data from the PROTECT study are expected mid-year 2019.
FDA Accepted Investigational New Drug Application for Sci-B-Vac® Phase-3 Clinical Program
On August 30, 2017, the US Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug Application (IND) for a Phase-3 clinical program evaluating Sci-B-Vac®. VBI Vaccines had previously received a No Objection Letter (NOL) from Health Canada in response to its Clinical Trial Application (CTA) as well. Acceptance of the IND and CTA enabled the Company to initiate the Phase-3 clinical study in both the US and Canada.
About Hepatitis B Infection
Hepatitis B is an infectious disease caused by the hepatitis B virus (HBV) that affects the liver. It can cause both acute and chronic infections. Many people have no symptoms during the initial infection, some develop a rapid onset of sickness with vomiting, yellowish skin, tiredness, dark urine, and abdominal pain. It may take 30 to 180 days for symptoms to begin. Most of those with chronic disease have no symptoms; however, cirrhosis and liver cancer may eventually develop. These complications result in the death of 15% to 25% of those with chronic disease. The virus is transmitted by exposure to infectious blood or body fluids.