Proactive Investors - Soligenix shares more than doubled on Thursday after the biopharmaceutical company announced positive results from a compatibility study of its investigational therapeutic HyBryte in cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device.
The company is developing and moving toward the potential commercialization of HyBryte (synthetic hypericin sodium) for the treatment of CTCL, a class of non-Hodgkin’s lymphoma.
The study, led by principal investigator Dr Brian Poligone at the Rochester Skin Lymphoma Medical Group, enrolled nine patients to receive eight weeks of HyBryte treatment of their cancerous lesions, with the response assessed after 10 weeks using the Composite Assessment of Index Lesion Severity (CAILS) score.
The company said the study achieved its purpose of establishing that any light device capable of producing visible light of an appropriate and consistent wavelength of 500 to 650 nm is suitable for use with HyBryte and extends the pharmacokinetic profile using a recently developed, more sensitive hypericin assay.
Soligenix (NASDAQ:SNGX) added that the study outcomes also confirmed the results of the recently published Phase 3 FLASH trial for CTCL patients which found 16% of the participants receiving HyBryte achieved at least a 50% reduction in their lesions compared to 4% of patients in the placebo group at eight weeks.
“Important corporate objectives for the study were to replicate results previously observed in the FLASH study, while using finished drug product manufactured by our proposed commercial contract manufacturer and activated using a commercially viable light device," said Soligenix CEO Dr Christopher J Schaber in a statement.
"We look forward to continuing to work with Dr Poligone and all of our committed clinical investigators to make HyBryte available to this underserved orphan patient population."
Soligenix shares were up 138.7% at US$3.39 on Thursday morning.