Soligenix secures new grant for development of acute radiation treatment

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. 

Gastrointestinal acute radiation syndrome is a potentially life-threatening consequence of exposure to high doses of radiation following a serious nuclear event.

There is currently no effective therapy approved for the treatment of the condition.

In 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).

The 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. 

During 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.

"We 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.

"With 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.

OrbeShield contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. The treatment is formulated for oral administration.

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.

Oral 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.

The 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 cell transplantation.