Soligenix CEO issues update letter to shareholders
Soligenix issued an update letter from its president and CEO, Christopher Schaber. The letter reads: "I wanted to take this opportunity to provide a mid-year update, as well as to provide some further guidance on our development programs. Our focus remains, first and foremost, on the quality execution of our two pivotal Phase 3 clinical trials, including SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer and SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). In addition, we continue to advance the development of our heat stable ricin toxin vaccine (RiVax(R)) with the financial support of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), while we also continue to actively pursue non-dilutive funding to support our rare disease pipeline. We are actively enrolling patients in our pivotal Phase 3 study in CTCL with SGX301 (synthetic hypericin) with interim results still anticipated in the October timeframe and final topline results targeted for the first half of 2019. We remain encouraged by this development program as a potential front line treatment where there is currently an unmet medical need. You may recall that this trial, referred to as the "FLASH" study (Fluorescent Light Activated Synthetic Hypericin), aims to evaluate the response to SGX301 as a skin directed therapy to treat early stage CTCL. SGX301 has received Orphan Drug designation as well as Fast Track designation from the United States (US) Food and Drug Administration (FDA). Additionally, SGX301 was granted Orphan Drug designation from the European Medicines Agency (EMA) and Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). We are also actively enrolling patients in a pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (CRT). Current guidance on timing of study completion continues to be 2019, with the interim analysis for the trial occurring in the first half of 2019 and final topline results targeted for the second half of 2019. We are advancing the development of our thermostabilized ricin toxin vaccine, RiVax(R), with the support of up to $24.7 million over six years awarded by NIAID, where we have announced that biomarkers for RiVax(R) testing have been successfully identified, facilitating potential approval under the FDA Animal Rule. The FDA Animal Rule is applied to products where testing in human clinical trials would be unethical, and in the case of ricin toxin, fatal. The Animal Rule combines safety studies in humans and efficacy testing in animals to facilitate approval. Key to the application of the Animal Rule is the requirement to establish a correlation between the immune response observed in clinical trials in healthy volunteers with the immune response demonstrated in animal efficacy studies..."