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Soligenix unveils positive survival results in preclinical radiation injury study

Proactive Investors
Tuesday, 21 February 2012

Biopharmaceutical company Soligenix (OTCBB:SNGXD) unveiled Tuesday further positive preliminary results from its ongoing pre-clinical study of SGX202, a treatment for gastrointestinal acute radiation syndrome.

The new study results showed that dogs treated with SGX202 24 hours after lethal exposure demonstrated "statistically significant" improvement in survival when compared to dogs in the control group, Soligenix said.

The trial builds upon previous results that showed statistically significant survival in dogs when dosing of SGX202 was initiated two hours after lethal doses of total body irradiation (TBI), the company added.

The latest results show again that SGX202 has the potential to reduce the inflammatory cytokine storm induced by the radiation-damaged gastrointestinal (GI) tract, which is typically very sensitive to radiation injury.

GI damage is the major cause of rapid mortality during high dose radiation exposure, such as that encountered during nuclear accidents or with the use of dirty bombs.

Gut injury from high dose radiation is associated with epithelial cell damage and hypoperfusion of the intestine, which stimulates local and systemic inflammation in the body.

The aim of the study was to determine whether SGX202 could improve survival and GI recovery beginning 24 hours after TBI.

Six dogs were exposed to TBI and then given autologous bone marrow and SGX202 with supportive care, while four dogs were used as controls and not treated with SGX202.

SGX202 was administered 24 hours after TBI and daily until GI recovery, or up to day 100 post exposure. 

Median survival post-TBI exposure in the control group was eight days, compared to over 87 days in the SGX202-treated group, Soligenix said.  

Analysis of the full dataset from this study remains ongoing, and is anticipated to be published in a peer reviewed journal, the company added.

"We are very pleased with the results to date with SGX202 in GI ARS," said CEO, Christopher J. Schaber, PhD.

"Based on these data and our positive preliminary interactions with both the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), it is our intent to continue to seek additional funding for the continued development of SGX202."  

The preclinical study was supported by a $1 million grant from the NIAID.

Principal investigator for the study, George Georges, MD, added: "SGX202 may potentially inhibit the cellular and innate immune mechanisms within the gut mucosa that exaggerate mucosal damage, and improve GI recovery after radiation.

"In the challenging area of radiation injury, the second study also met its primary objective in protecting dogs from GI ARS and extending their survival. We are completing our analysis of the data so that we may extend our investigations of SGX202 in GI recovery after radiation exposure and build upon these promising results."

SGX202 contains BDP, a topically active corticosteroid that has a local effect on inflamed tissue. The drug is formulated for oral administration as a single product consisting of two tablets.  BDP has been marketed in the United States and worldwide since the early 1970s, as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.

Oral BDP can also be applied in treating other GI disorders characterized by severe inflammation, such as Crohn's Disease and radiation enteritis.

Soligenix is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, as well as vaccines for certain 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.
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