A couple of weeks ago, Soligenix Inc (OTCBB:SNGX) reported that it completed patient enrollment as suggested by the Data Review Committee earlier in 2015, into its Phase II trial for SGX942. This drug is a first-in-class IDR and is being assessed as a potential treatment for oral mucositis in people undergoing chemo-radiation therapy for neck and head cancer. Consistent with previous guidance, the company expects releasing preliminary data in the fourth quarter of 2015.
Soligenix’s Phase 2 trial of SGX942 is a randomized, double-blind, placebo-controlled, dose-ranging study, initially set to enroll nearly 75 patients across three SGX942 dose groups and one placebo group, focused on assessing the biologic and safety activity of drug in patients with mouth and oropharynx cancer. These patients often suffer from debilitating oral mucositis as a result of CRT treatment.
Following the Data Review Committee assessment of available data on the patients enrolled in the study, the committee suggested that enrollment should have at least additional twenty subjects randomized into either a ‘SGX942’ dose group or the placebo group. It was meant to help a more targeted evaluation of the drug’s potential impact and to know final dose selection in respective patient population.
The management view
The efficacy evaluation is the comparison of the duration and/or incidence of both severe and ulcerative oral mucositis throughout the enrollments’ seven week course of CRT treatment and for an additional four weeks thereafter. Christopher J. Schaber, PhD, the CEO of Soligenix stated that they are delighted to report the significant achievement of enrollment completion in this trial targeting unmet medical need. They appreciate the initiatives of the clinicians involved as well as the patient’s participation in the study.
Soligenix Inc (OTCBB:SNGX) ended the last trading session with a loss of 5.83% and it also broke the short term support area of $1.20 levels. The volume surged to 532,000, a massive spike compared to the daily average of 96,000, indicating a strong bout of selloff. The stock can still bounce from the lows as it is testing the intermediate support area around $1.10 levels now but to reverse the long term trend, it must manage the supply area in the band of $1.50-$1.60. The investors can attempt some aggressive bottom fishing at the current levels after calculating the risk.