Soligenix and the Creation of Rare Cancer Drugs

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is currently an unmet medical need. Soligenix is a biotherapeutic business segment dedicated to the development of products for orphan diseases and areas where there are currently no drug therapies approved, such as Cutaneous T-Cell Lymphoma, oral mucositis, and pediatric Crohn’s disease. They are now conducting two Phase 3 clinical trials with multiple data reads through 2019 and early 2020.

Their first Phase 3 trial, for cutaneous T-cell Lymphoma (or CTCL), used a novel photodynamic therapy for the first-line treatment of this rare cancer. In treating this disease, which consists of cancerous lesions or tumors on the skin, they apply a proprietary topical drug called synthetic hypericin to the cancerous lesions, then activate the drug with a short course of safe visible fluorescent light from a specialized light device; this drug-light therapy combination is referred to by its research name, SGX301. The primary outcome in this trial is to shrink the size of the lesions by 50% or greater. In October of last year, they announced the result of a positive interim efficacy analysis, and anticipate top-line final results in the 1Q 2020.

Their second Phase 3 study uses a new class of drugs, referred to as Innate Defense Regulators, which modulate the body’s own innate immune system to treat disease. Their first in class drug called Dusquetide, research name SGX942, and it treats oral mucositis, which are painful ulcerations in the mouth and throat caused by chemo-radiation therapy in patients being treated for their head and neck cancers, which results in the inability to eat and drink, as well as, an increase in opioid treatment dosage. By administrating a short four-minute IV infusion of SGX942 periodically, it should reduce the duration of severe oral mucositis, as well as, the impact of infections and survival.

Additionally, Soligenix have a separate vaccine biodefense business segment, funded entirely by the US government, focused on developing vaccines and therapeutics for civilian and military applications, in areas such as ricin exposure and emerging and antibiotic resistant infectious diseases. They have secured in excess of $50 million to date of non-dilutive government funding to advance their studies of rare diseases. Soligenix is now seeking financing and investors, to get involved, go to their corporate website.

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