Dec. 3, 2015, 12:40 PM
- Thinly traded nano cap Soligenix (OTCQB:SNGX -27.5%) slumps again today on a 5x surge in volume. Shares are down over 40% over the past two days on no particular news.
- The company is sponsoring one ongoing clinical trial, a Phase 2 evaluating Fast Track-tagged SGX942, a 5-amino acid peptide, for the treatment of oral mucositis (OM) in head and neck cancer patients undergoing chemo and/or radiation treatment. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint, improvement in OM symptoms four weeks after the end of therapy, is December 2015. The estimated study completion date is August 2016.
- On November 25, the FDA designated Cellceutix's (OTCPK:CTIX) Phase 2-stage oral rinse, Brilacidin-OM, for Fast Track review for OM. The oral rinse formulation presents a distinct advantage over SGX942's intravenous route of administration.
- A Phase 3 study evaluating SGX301, photoactivated hypericin, for the treatment of cutaneous T-cell lymphoma is set to begin shortly. The primary endpoint is the response in three treated lesions defined as at least a 50% improvement in CAILS score (a composite measurement) compared to placebo. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is October 2017. SGX301 is designated an Orphan Drug in both the U.S. and Europe for the indication.
- Previously: Cellceutix's Brilacidin-OM Fast Track'd for oral mucositis (Nov. 25)
Sep. 19, 2013, 12:05 PM
- Soligenix (SNGX.OB +11.2%) jumps after announcing it has received a contract from the Biomedical Advanced Research and Development Authority for the "preclinical and manufacturing development" of the GI ARS treatment OrbeShield.
- The initial deal is for two years and can be extended for up to five total years.
- The contract is valued at up to $26.3M and will help the company "successfully navigate and complete the FDA approval process." (PR)
We are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. We maintain two active business segments: BioTherapeutics and Vaccines/BioDefense. Our BioTherapeutics business segment is developing a... More
Industry: Drug Manufacturers - Other
Country: United States