March 19, 2020
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SGX301 induces response in cutaneous T-cell lymphoma

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A phase 3 trial designed to evaluate SGX301 for treatment of cutaneous T-cell lymphoma met its primary endpoint, according to the agent’s manufacturer.

The FLASH trial included 169 patients with early-stage cutaneous T-cell lymphoma, a rare and heterogenous group of non-Hodgkin lymphomas.

Researchers randomly assigned them 2:1 to SGX301 (Soligenix) — a photodynamic therapy using synthetically manufactured hypericin in an ointment combined with visible fluorescent light — or placebo.

Composite Assessment of Index Lesion Score (CAILS) served as the primary endpoint.

Results showed a significant improvement in CAILS among patients assigned SGX301 at 8 weeks (P = .04). A preliminary assessment of results after 12 weeks also suggested a significantly more robust response with SGX301.

“This is an important outcome for patients [with] cutaneous T-cell lymphoma,” Ellen Kim, MD, director of the dermatology clinic at Perelman Center for Advanced Medicine and lead investigator of the FLASH study, said in a Soligenix-issued press release. “SGX301 has successfully demonstrated efficacy in this challenging chronic cancer, with no safety concerns, making it a potentially preferred first-line option for the treatment of early-stage [disease].”

Researchers observed a statistically significant improvement in response after 6 weeks of treatment, Kim said.

“This successfully proves that the drug has biologic activity in combating this disease in a relatively short time window, with preliminary data suggesting that the improvement continues to increase with extended treatment,” Kim said. “In addition to the efficacy demonstrated, SGX301 was well-tolerated and its mechanism of action is not associated with DNA damage like other currently available therapies.”

Complete data are expected to be released in June.

“We are extremely pleased with the results, which demonstrate successful treatment with SGX301 and reinforce its potential to be an important new treatment for early-stage cutaneous T-cell lymphoma,” Christopher J. Schaber, PhD, president and CEO of Soligenix, said in the release. “We will now look to move as quickly as possible to complete a full analysis of the data for publication, as well as begin preparations for a robust discussion with the FDA regarding this important data set.”

The FDA previously granted fast track designation to SGX301 for this indication.