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Soligenix Announces Japanese Patent Allowance for Use of Dusquetide in Oral Mucositis
Specific therapeutic use claims in oral mucositis adds to existing composition of matter claims PRINCETON, N.J., Feb. 3, 2020 /PRNewswire/ -- Soligenix, Inc.
About this update from Soligenix, Inc.
[{"type":"text","content":"Specific therapeutic use claims in oral mucositis adds to existing composition of matter claims\n\n\nPRINCETON, N.J., Feb. 3, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Japanese Patent Office has granted the patent titled \"Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis.\" This allowance builds on similar intellectual property in the United States (US), New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide. The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide. Dusquetide previously demonstrated positive results in a Phase 2 oral mucositis clinical trial and a pivotal Phase 3 study is ongoing, with a positive interim analysis completed in August 2019 and final topline results expected in Q2 2020. \nBased on the positive and previously published Phase 2 results, the pivotal Phase 3 clinical trial is a highly powered, double-blind, randomized, placebo-controlled, multinational trial. The study, called DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), is enrolling approximately 260 subjects with head and neck cancer (HNC) undergoing standard chemoradiation therapy (CRT) and who are therefore at high risk of developing severe oral mucositis. Enrollment is ongoing in the US and across Europe with enrollment completion expected in Q1 2020 and final topline primary endpoint results anticipated in Q2 2020. \n\"Soligenix continues to pursue broad patent coverage for its IDR technology, including dusquetide, first with composition of matter claims followed by therapeutic use claims in oral mucositis,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"Having successfully pursued composition of matter claims in jurisdictions worldwide, we continue to pursue therapeutic use claims like those issued in the US previously and in Japan with this most recent patent. The therapeutic use claims are...