Long-term follow-up data from a Phase 2 study assessing Soligenix's (OTCQB:SNGX) dusquetide (SGX942) for the treatment of oral mucositis (OM) head and neck cancer patients undergoing chemoradiation therapy (CRT) showed dusquetide to be safe and well-tolerated. The observations in the 12-month period were consistent with those made in the four-week acute phase of the trial. In addition, dusquetide did not interfere with CRT as evidenced by improved survival and tumor resolution over the period. No drug-toxicities were reported.
Results first announced in December 2015 showed treatment with dusquetide reduced the median duration of severe OM by 50% in all patients compared to placebo. In those at high risk of developing severe OM, the median reduction was 67%.
A pivotal Phase 2b/3 is the next step.
Dusquetide is a member of a class of peptides called an innate defense regulator (IDR) which has no direct antibiotic activity but modulates host responses, increasing survival and accelerating the resolution of tissue damage following exposure to pathogens.
OM usually occurs in the mouth of patents undergoing anticancer treatments. Almost all head and neck cancer patients receiving chemo develop OM.
The company will host an investor webcast on December 16 at 8:30 am ET to discuss the clinical environment related to OM, IDRs and the study data.
Shares are up 6% on light volume.
Subscribe for full text news in your inbox