Preclinical Melioidosis Results Presented at the 2015 ASM Biodefense and Emerging Diseases Research Meeting in Washington, DC

SGX943 in combination with antibiotics increases survival in an acute, lethal pneumonic model

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Feb 11, 2015, 07:00 ET

PRINCETON, N.J., Feb. 11, 2015 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it presented data from its recent preclinical study that demonstrated statistically significant efficacy of SGX943 in a mouse model of acute, lethal pneumonic melioidosis. The data was presented in an oral presentation at the American Society of Microbiology (ASM) Biodefense and Emerging Diseases Research meeting on Tuesday, February 10, 2015 at Washington Marriott Wardman Park, 2660 Woodley Rd. NW in Washington, DC.

The Company's proprietary innate defense regulator (IDR) technology, including SGX943, have been specifically developed to target the host response to infection (not the bacteria) making them broadly applicable to many bacterial infections. Soligenix has been investigating the efficacy of SGX943 against B. pseudomallei infection, the causative agent of melioidosis. B. pseudomallei is a Tier 1 biothreat, a National Institute of Allergy and Infectious Diseases (NIAID) category B priority pathogen and a top 5 priority in the most recent Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy document.

Soligenix has demonstrated preliminary efficacy of SGX943, in combination with standard of care antibiotics, resulting in a statistically significant (p<0.001) increase in survival relative to the use of antibiotics alone.

The IDR technology has been specifically designed to modulate the host innate immune system, making them broadly applicable to diseases where the innate immune system is dysfunctional, such as in oral mucositis (SGX942), or responding to an attack, such as in the event of a bacterial infection (SGX943). Previous preclinical work has also demonstrated the ability to treat tissue and skin infections, to aid in bacterial clearance as well as increasing overall survival and to function in a complementary manner to antibiotics. In particular, IDRs, which can target antibiotic resistant bacteria (such as methicillin-resistant S. aureus and B. pseudomallei), are effective against both extracellular and intracellular bacteria and against both Gram-positive and Gram-negative bacteria. This broad spectrum activity uniquely positions IDRs to address the problems of emerging infectious diseases and antibiotic resistance.

Previous work with the SGX94 technology has also demonstrated its safety in both preclinical toxicology studies and a comprehensive Phase 1 clinical study in healthy volunteers.

About Melioidosis

Melioidosis is a potentially fatal infection caused by the Gram-negative bacillus, Burkholderia pseudomallei (Bps). Highly resistant to many antibiotics, Bps can cause an acute disease characterized by a fulminant pneumonia and a chronic condition that can recrudesce. There is no preventive vaccine or effective immunotherapy for melioidosis. Therefore, there is a significant medical need for improved prevention and therapy.

Bps and the closely-related Burkholderia mallei (Bm) are considered possible biological warfare agents by the Department of Health and Human Services (DHHS) because of the potential for widespread dissemination through aerosol. Bps is classified as a Tier 1 biothreat and a category B priority pathogen by the NIAID and is a top 5 priority in the most recent Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy document.

Bps infection (melioidosis) is a major public health concern in the endemic regions of Southeast Asia and Northern Australia. Moreover, the organism has a worldwide distribution and the full extent of global spread is likely underestimated. Bps activity is seen in Southeast Asia, South America, Africa, the Middle East, India, and Northern Australia. The highest pockets of disease activity occur in Northern Australia and Northeast Thailand, Burma and Vietnam, and is likely under-reported in China. In Northeast Thailand, the mortality rate associated with Bps infection is over 40%, making it the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.

About SGX943

SGX943 is the drug product designation for the active ingredient SGX94 in the treatment of melioidosis. SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous 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. SGX94 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. SGX94 and related analogs have a strong intellectual property position, including composition of matter. SGX94 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 to date, inclusive of government grants. SGX94, the active ingredient in SGX942, is also in clinical development for the treatment of oral mucositis.

The testing of SGX943 in melioidosis is currently being supported by a NIAID Small Business Innovation Research (SBIR) grant valued at approximately $300,000 over one year.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of SGX101 for the treatment for melioidosis.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.