Soligenix Inc (OTCBB:SNGX) continues to move higher on huge volume after hitting an all-time low of $0.91 in December of last year. Investors love these ex big board stocks with built in exposure and volume like SNGX for the ability to make big moves once on a lower exchange.
On March 3 SNGX said it has received a positive recommendation from the Data Review Committee (DRC) to continue enrolling into the company’s Phase 2 study evaluating SGX942, a first-in-class innate defense regulator (IDR), as a treatment for oral mucositis in patients undergoing chemoradiation (CRT) therapy for head and neck cancer. Following DRC review of available data on the subjects enrolled in the trial, the committee recommended that enrollment include an additional 20 subjects randomized into either a single SGX942 dose group or the placebo group to allow for a more targeted assessment of the drug’s potential effect and to inform final dose selection in this patient population.
This Phase 2 study is a randomized, double-blind, dose-ranging, placebo-controlled trial, initially set to enroll approximately 75 subjects across 3 SGX942 dose groups and placebo, focused on demonstrating the safety and biologic activity of SGX942 in patients with tumors of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of tumor treatment with CRT.
Soligenix Inc (OTCBB:SNGX) is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. SNGX has two distinctive programs under development for melioidosis including SGX943 and SGX101 as well as their novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
The Company’s Vaccines/BioDefense business segment includes active development programs for RiVax™, their ricin toxin vaccine candidate, VeloThrax™, their anthrax vaccine candidate, OrbeShield™, their GI acute radiation syndrome therapeutic candidate. The development vaccine programs incorporates the use of SNGX proprietary heat stabilization platform technology, known as ThermoVax™.
Back in November 2014 SNGX signed a stock purchase agreement with Lincoln Park Capital Fund, LLC (LPC), providing an initial investment in Soligenix of $600,000 and the availability of additional periodic investments up to $10.0 million over a 36-month term. At its sole discretion, Soligenix has the right to sell to LPC up to an additional $10.0 million of its common stock. With this flexible financing vehicle, Soligenix should be able to focus on advancing its clinical programs.
Melioidosis is an infectious disease caused by a Gram-negative bacterium, Burkholderia pseudomallei, found in soil and water. It is of public health importance in endemic areas, particularly in Thailand and northern Australia. It exists in acute and chronic forms. Signs and symptoms may include pain in chest, bones, or joints; cough; skin infections, lung nodules and pneumonia.
Often referred to as Whitmore’s disease, Melioidosis is of great public health importance in endemic areas. Once a melioidosis is diagnosed, the disease can be treated with the use of appropriate antibiotics.
Melioidosis was in the news recently after the US Centers for Disease Control and Prevention (CDC) launched on inquiry into melioidosis illness at Tulane National Research Center (TNPRC). This has raised the visibility and awareness of melioidosis among healthcare professionals and the general public.
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Current treatments for Melioidosis is insufficient; treatments can reduce mortality rate to 10% for uncomplicated cases, but still up to 80% for cases with bacteraemia or severe sepsis using antibiotics.
SNGX has two distinctive programs for Melioidosis: SGX943 and SGX101; SGX943 is being developed to treat infections and tissue damages, belongs to a new class of compounds called Innate Defense Regulators (IDRs).
The Company has specifically developed SGX943 to target the host response to infection 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.
This month SNGX presented at the ASM Biodefense and Emerging Infectious Diseases Meeting, preclinical animal data showing that SGX943 is efficacious in Gram-positive methicillin resistant Staphylococcus aureus (MRSA) infection as well as with other Gram-negative pathogens infection
Soligenix also presented preclinical animal data showing that SGX943, either alone or in combination with antibiotic Doxycycline, was effective to increase survival after Bps infection.
The 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 XON, -1.38% focused on the joint development of SGX101 for the treatment for melioidosis.
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Currently trading at a $34 million market valuation SNGX has transformed itself in recent months from illiquid to one of the top traded stocks on the entire bb’s. The Company is fully funded moving forward with $4.2 million in the treasury although they do have $10 million in short term debt. The excitement on SNGX is all about the two distinctive programs under development for melioidosis including SGX943 and SGX101 and the positive data coming back from the trials. SNGX is a stock to watch.
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Disclosure: we hold no position in SNGX either long or short and we have not been compensated for this article.