Continued Treatment with SGX301 Increases Efficacy in Patients with Cutaneous T-Cell Lymphoma
In patients with cutaneous T-cell lymphoma (CTCL), SGX301 (synthetic hypericin) demonstrated strong clinical activity, according to updated data from the pivotal phase 3 FLASH trial.
In the first 6-week double-blind treatment cycle of this study, the primary endpoint was achieved. In Cycle 2, patients were treated continuously with SGX301 twice weekly for 12 weeks and the response rate was 40%.
“As anticipated, the data continues to become more compelling with extended SGX301 treatment,” stated Ellen Kim, MD, Director of the Dermatology Clinic, Perelman Center for Advanced Medicine and Lead Investigator of the FLASH study, in a press release. “This treatment response is comparable to other, less safe, treatment alternatives, showing a statistically significant response at just 6 weeks, which continues to significantly increase with more treatment. The response rate at 12 weeks is similar to other therapies, some of which patients must take for more than a year. In addition to the efficacy demonstrated, SGX301 remains well tolerated with a unique mechanism of action that is not associated with DNA damage like other currently available therapies. I look forward to working with Soligenix to move this important new therapy forward with US Food and Drug Administration (FDA) so that patients may access it as soon as possible.”
Read the full press release here.
