Soligenix, Inc. (NASDAQ: SNGX) plummets over 32% in today pre session after positive clinical data from a compatibility study testing HyBryte (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) utilizing the commercially available Daavlin Series 7 visible light device, which recently gained FDA 510(k) approval, are released by the company.
The open-label trial involved 9 patients who were treated with HyBryte for 8 weeks for malignant lesions, with treatment response assessed at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. Brian Poligone, MD, PhD, of the Rochester Skin Lymphoma Medical Group, enrolled all participants.
The study’s goal was to determine if any light device capable of producing visible light of an acceptable and consistent wavelength (500 to 650 nm) could be used with HyBryteTM and to expand the pharmacokinetic profile using a recently developed, more sensitive hypericin test. Aside from accomplishing these goals, the effectiveness revealed substantially supports the findings of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) research. Despite the fact that patients in the present research were purposefully chosen to have more severe illness compatible with its future commercial application, the treatment response data of 22% after 8 weeks of twice weekly HyBryteTM therapy recapitulates the results of the FLASH trial.
“We were thrilled to have the opportunity to collaborate with Soligenix and bring HyBryteTM to our patients,” said Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group in Fairport, NY, and Principal Investigator for the compatibility study as well as Leading Enrolling Investigator in the FLASH study. “Since the Phase 3 FLASH study, I’ve had a number of patients inquire about possible access to this promising therapy.” We were fortunate to be chosen to conduct this study, and the patients’ enthusiasm for the product was clear by their desire to participate in the trial, allowing it to be completed quickly. I look forward to continuing to collaborate with Soligenix to progress the HyBryteTM initiative so that my patients can benefit from this much-needed medicine.
The President and CEO of Soligenix, Christopher J. Schaber stated these findings support the positive HyBryteTM data from the FLASH study. Important corporate objectives for the study included replicating FLASH study results while using finished drug product manufactured by their proposed commercial contract manufacturer and activated using a commercially viable light device. They look forward to working with Dr. Poligone and all of their dedicated clinical investigators to bring HyBryteTM to this underserved orphan patient population.
