The Data Review Committee evaluated the Phase 2 Clinical Trial of SGX942 of Soligenix Inc (OTCBB:SNGX) and provided positive recommendations. The drug candidate is meant for cure of ‘Oral Mucositis’ in Head and Neck Cancer patients. The study will enroll twenty more subjects in near term.
Soligenix’s SGX942 is an effective innate defense regulator, a new class of synthetic peptides that has an innovative feature of action in that it has immediate anti-infective and anti-inflammatory reaction. IDRs do not feature direct antibiotic reaction but modulate host responses. It increases survival rate after infections with a wide range of bacterial Gram-positive and Gram-negative pathogens. It also accelerates resolution of tissue damage that occurs due to several factors including bacterial pathogens, radiation therapy, trauma, and chemotherapy.
Soligenix drug candidate SGX942 has confirmed safety in a Phase 1 clinical trial in healthy enrollments and effectiveness in several animal disease models including colitis, mucositis, skin infection and many other bacterial infections. The candidate SGX942 and related analogs reflect a strong property position, including the composition of matter. It was formulated pursuant to discoveries made by several Professors including Robert Hancock, Ph.D. and B. Brett Finlay, Ph.D. Till this time, more than $40 million has been invested in development plan, inclusive of government grants.
Fast track designation
Soligenix’s SGX942 has acquired fast-track designation from the FDA for cure of oral mucositis that occurs due to the chemotherapy and/or radiation treatment in neck and head cancer patients. The designation is granted to those drugs that promise to cure a severe, life-threatening disease. Also, it is offered to the drug candidate that has potential to address an unmet medical need. It fastens the development and reviews of new drug candidates. With the new status, Soligenix Inc (OTCBB:SNGX) will be able to submit an NDA for SGX942 on a rolling basis.