IVIG
The product has entered a Phase I/II/III study in US for treatment
in primary immunodeficiency. The study is currently recruiting patients.
A safety protocol is planned for recruitment of patients who cannot
be enrolled into the current clinical study.
HBIG
HBIG is an antibody-based product that contains antibodies specific
to hepatitis B, or HBV. HBV can cause lifelong infection, scarring
of the liver, liver cancer, liver failure and death. Many patients
with chronic HBV infection require a liver transplant. After liver
transplant surgery, there is a high risk that these transplant patients
will be reinfected with HBV, which destroys the transplanted liver.
To prevent reinfection, these patients require life long treatment
for HBV. HBIG is one of the treatments used to prevent reinfection
of the transplanted liver. The Company recently submitted a regulatory
filing for Omri-Hep-B product in Sweden and anticipates obtaining
approval for this product by the second quarter of 2008 (2Q08).
WNIG
WNIG is an antibody-based product that will treat severe infection
with West Nile virus. WNIG has received orphan drug designation
from the FDA for this indication. A multi-center Phase I/II clinical
study has been conducted together with the NIH with this product
in patients with severe West Nile virus infection. Enrollment of
patients into this study has been completed, with 62 patients recruited.
HT-VIG
HT-VIG is a more concentrated form of VIG and is intended to be
used in smaller volumes than existing VIG preparations for the same
indication. In addition, we believe our HT-VIG product may be effective
alone or in combination with vaccination for the treatment of smallpox
and in first line protection. VIG must be administered intravenously
due to the large volume of VIG that is required for effective treatment.
As a result, it must only be given by specialized personnel in a
clinic and can take up to an hour. The smaller volume of HT-VIG
is designed to be used in a single injection, intravenously or intramuscularly,
allowing non-specialized medical personnel to treat more patients
in urgent situations.
Pre-clinical studies have been conducted in animals evaluating
the efficacy of our HT-VIG product in the treatment of smallpox
and smallpox vaccine related complications. Results collected to
date show high efficacy of this product when compared to marketed
VIG regular products.
The development of this product has been supported by the NIH by
a three year grant of approximately $3.0 million.
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