Soligenix must enroll more people in Phase 3 test to treat lymphoma, prompting shares to tumble

Soligenix Inc (NASDAQ:SGNX) said on Monday it has received a positive recommendation from the Data Monitoring Committee (DMC) to incrrease the enrollment in the company’s Phase 3 study to possibly treat cutaneous T-cell lymphoma (CTCL), but the delay in top-line results to early in 2020 caused shares to slide as a result.

The company said the DMC recommended that about 40 additional subjects be randomized into the trial to maintain the assumption of 90% statistical power for the primary efficacy endpoint in the study.

“With this new level of clarity from the DMC’s analysis of the interim Phase 3 study data and given our current enrollment status of approximately 120 subjects, we anticipate completing the study before the end of 2019 with topline results coming no later than the first quarter of 2020,” said Soligenix president and CEO Christopher Schaber.

“Given our current cash resources, we anticipate that the available funds are sufficient to cover the additional study patients needed,” he said.

Shares of the company declined 18.7% to trade at $1.17 on Monday, having fallen as much as 22.75% to a session low of $1.12.

READ: Maxim Group lowers price target for Soligenix on dilution worries

Schaber said the company believes its drug, SGX301, has the potential “to successfully treat the CTCL index lesions using a combination therapy.”

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. 

Unlike most NHLs which generally involve B-cell lymphocytes involved in producing antibodies, CTCL is caused by an expansion of malignant T-cell lymphocytes involved in cell-mediated immunity normally programmed to migrate to the skin. 

These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses, the company said. 

Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is no cure for CTCL.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.

Reporting by Rene Pastor, contactable through [email protected]

Story by ProactiveInvestors