The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), awarded Soligenix a Small Business Innovation Research (SBIR) grant of nearly $1.5 million to support the company’s pivotal Phase 3 clinical trial testing SGX301 (synthetic hypericin) as a therapy for cutaneous T-cell lymphoma (CTCL).
“We are appreciative of the financial support provided by NCI for our pivotal Phase 3 clinical study of SGX301 in the treatment of CTCL,” Christopher J. Schaber, PhD, president and CEO of Soligenix, said in a press release.
“With the assistance of NCI, as well as important collaborators such as the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation, we look forward to completing this study in order to potentially address the unmet medical need that currently exists in this patient population,” he said.
The Phase 3 FLASH trial (NCT02448381), a randomized, double-blind, placebo-controlled study, is based on positive results from a Phase 2 study of SGX301. The FLASH trial, still recruiting participants, is scheduled to enroll 120 patients.
SGX301 will be evaluated in three treatment cycles, each eight weeks long. In the first cycle, patients will be randomly assigned to either SGX301 (80 patients) or a placebo (40 patients) for their index lesions. In the second cycle, SGX301 treatment will be administered to all participants for their index lesions. Finally, in the third cycle, all patients will receive SGX301 in all their lesions.
After completing the treatment, all trial participants will be followed for an additional six months.
The study’s primary objective is to determine the percentage of patients achieving a partial or complete response of the treated lesions. The response is defined as a 50 percent or higher reduction in lesion size for three index lesions, assessed at week eight.
SGX301 is a novel, first-in-class, photodynamic therapy, meaning it uses light-sensitive medication and a light source to destroy abnormal cells. The drug, being developed by the Soligenix, is a synthetic form of the potent photosensitizer hypericin. Used as a topical gel, the drug is applied to the cancerous skin lesions and is activated using a brief treatment with safe fluorescent light.
In contrast to other photodynamic therapies, which are activated with ultraviolet light, the use of visible light makes SGX301 safer and prevents other secondary malignancies, including melanoma.
“We would like to thank NIH for its continued support and for its recognition of the merits of the important work we are doing in orphan diseases and areas of unmet medical need, as demonstrated by the approximate $6 million of additional non-dilutive funding it has awarded to Soligenix in 2017 across both our biotherapeutics and biodefense business segments,” Schaber said.
“We will continue to be aggressive in our pursuit of government grants and contracts across our entire pipeline as a way to secure non-dilutive funding to support multiple development programs, while effectively managing our cash position,” he added.