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Soligenix Receives IND Clearance from FDA to Initiate Clinical Program to Evaluate SGX942 for the Treatment of Oral Mucositis
Date:3/27/2013

ltaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy.  SGX942 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections.  SGX942 was developed pursuant to discoveries made by Professors B. Brett Finlay , PhD and Robert Hancock , PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development inclusive of government grants. 

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies (e.g., radiation or chemotherapy).  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. Mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.  The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, ra
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