Date: 2017-07-27
Type of
information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Soligenix (USA - NJ)
Product: dusquetide (SGX942)
Action
mechanism:
- peptide. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. This peptide is an Innate Defense Regulator (IDR), a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.
Disease: oral mucositis in head and neck cancer patients being treated with chemoradiation
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- DOM-INNATE study (Dusquetide treatment in Oral Mucositis - by modulating INNATE immunity) is a double-blind, randomized, placebo-controlled, multinational trial that will seek to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects will be randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study will be the median duration of severe oral mucositis, which will be assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis will be evaluated using the WHO Grading system. Severe oral mucositis is defined as a WHO Grade of ?3. Subjects will be followed for an additional 12 months after the completion of treatment.
The study design incorporates feedback from the FDA as well as from the EMA via the Scientific Advice process. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study, if successful, in conjunction with results from the Phase 2 dose-ranging study, generally will be considered sufficient to support a marketing authorization application for potential licensure in Europe. (NCT03237325)
Latest
news:
- • On July 27, 2017, Soligenix announced that patient enrollment has been opened for its Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluating SGX942 (dusquetide) as a treatment for severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.
Soligenix has been working with leading oncology centers, a number of which participated in the Phase 2 study, to advance this Phase 3 clinical trial referred to as the "DOM-INNATE" study (Dusquetide treatment in Oral Mucositis - by modulating INNATE immunity).
- • On May 3, 2017, Soligenix announced that it has received FDA clearance to advance a pivotal Phase 3 clinical trial evaluating SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer (HNC) patients being treated with chemoradiation (CRT). Soligenix plans to begin this study in the second quarter of 2017. Based on positive Phase 2 results (Study IDR-OM-01), the upcoming pivotal Phase 3 clinical trial (Study IDR-OM-02) will be a highly powered, double-blind, randomized, placebo-controlled, multinational trial that will seek to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects will be randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for 2 weeks following completion of CRT. The primary endpoint for the study will be the median duration of severe oral mucositis, which will be assessed by oral examination at each treatment visit and then through 6 weeks following completion of CRT. Oral mucositis will be evaluated using the WHO Grading system. Severe oral mucositis is defined as a WHO Grade of ?3. Subjects will be followed for an additional 12 months after the completion of treatment.
- The study design incorporates feedback from the FDA as well as from the European Medicines Agency (EMA) via the Scientific Advice process. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study, if successful, in conjunction with results from the Phase 2 dose-ranging study, generally will be considered sufficient to support a marketing authorization application (MAA) for potential licensure in Europe.
Is
general: Yes
