Soligenix (OTCBB:SNGX) said Tuesday that it has been given a new grant from the National Institute of Allergy and Infectious Diseases (NIAID) to further support the preclinical development of OrbeShield as a treatment for gastrointestinal acute radiation syndrome.
The small business innovation research grant will provide Soligenix with around $600,000 over a two-year period to conduct the study.
acute radiation syndrome is a potentially life-threatening consequence
of exposure to high doses of radiation following a serious nuclear
There is currently no effective therapy approved for the treatment of the condition.
a recent study in beagle dogs, statistically significant survival was
seen in dogs that received OrbeShield therapy starting both 2 and 24
hours following exposure to total body irradiation (TBI).
program is designed to simulate real world situations in which people
exposed to various levels of radiation would not be able to reach care
centers immediately after a nuclear event.
Untreated dogs died
at a median time of 8 days when exposed to high dose radiation, even if
the dogs were given intensive supportive care such as antibiotics,
intravenous fluids and anti-emetics, Soligenix noted.
Transplant of autologous bone marrow cells also had no effect on the rate of death of the exposed animals.
the observation period, the company noticed that the survival of dogs
was "strongly correlated" to the recovery from acute radiation damage to
the GI tract.
These studies were conducted by Dr. George E.
Georges at the Fred Hutchinson Cancer Research Center (FHCRC) under an
NIAID funded grant.
This latest grant will further support the
testing of OrbeShield in the prevention of the acute radiation syndrome
in a beagle dog model.
These studies will once again be conducted in conjunction with Dr. Georges at FHCRC, Soligenix said.
are encouraged with the promising survival results observed to date
with OrbeShield in the beagle model as a post-exposure therapy for the
treatment of GI ARS," said president and CEO of Soligenix, Christopher J. Schaber, PhD.
renewed support from NIAID, we look forward to working with Dr. Georges
to continue development of OrbeShield with the aim of addressing this
critical unmet medical need."
Gastrointestinal acute radiation
syndrome occurs after toxic radiation exposure and involves several
organ systems, notably the bone marrow and the GI tract. Substantial GI
injury after radiation exposure can result in death.
contains BDP, a highly potent, topically active corticosteroid that has a
local effect on inflamed tissue. The treatment is formulated for oral
BDP has been marketed in the United States and
worldwide since the early 1970s as the active pharmaceutical ingredient
in inhalation products for patients with allergic rhinitis and asthma.
BDP could potentially also be used in treating other GI disorders
characterized by severe inflammation such as Crohn's disease and
radiation enteritis, Soligenix said.
biopharmaceutical company develops products to treat life-threatening
side effects of cancer treatments and gastrointestinal diseases, as well
as vaccines against bioterrorism agents.
Its lead product,
orBec, is a locally acting corticosteroid that has been initially
developed for the treatment of acute gastrointestinal Graft-versus-Host
disease, a potentially life-threatening complication of hematopoietic