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FAQ on Soligenix Inc.'s HyBryte(TM) Trial Results for Cutaneous T-Cell Lymphoma

FaqStaq News - Just the FAQs July 18, 2025
By FAQstaq Staff
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FAQ on Soligenix Inc.'s HyBryte(TM) Trial Results for Cutaneous T-Cell Lymphoma

Summary

Soligenix Inc. reports promising interim results from a real-world trial of HyBryte(TM) for early-stage cutaneous T-cell lymphoma, highlighting its potential as a much-needed treatment option in a field with limited advancements.

What is HyBryte(TM) and what condition does it treat?

HyBryte(TM) is a synthetic hypericin treatment developed by Soligenix Inc. for early-stage cutaneous T-cell lymphoma (CTCL), a type of skin cancer.

Why are the results of the HyBryte(TM) trial significant?

The results are significant because they show promising treatment success in CTCL, a condition with limited treatment options and no new FDA-approved skin-directed therapies introduced in over a decade.

Who is leading the HyBryte(TM) trial?

The trial is under the direction of Ellen Kim, MD, director of the Penn Cutaneous Lymphoma Program, who is also a leading enroller in Soligenix’s phase 3 FLASH study.

What are the interim results of the HyBryte(TM) trial?

At the 18-week evaluation point, six out of patients showed promising treatment success, indicating potential effectiveness of extended HyBryte(TM) therapy in early-stage mycosis fungoides.

How does HyBryte(TM) compare to conventional treatment options for CTCL?

HyBryte(TM) offers a promising alternative to conventional options, which carry risks and have seen no significant advancements in over a decade.

Where can I find more information about Soligenix and the HyBryte(TM) trial?

More information is available in the company’s newsroom at https://ibn.fm/SNGX and through the Cutaneous Lymphoma Foundation.

What is the next step for HyBryte(TM) following these interim results?

The next steps include continuing the investigator-initiated study and advancing through the confirmatory phase 3 FLASH2 trial to further evaluate HyBryte(TM)’s efficacy and safety.

Who is affected by cutaneous T-cell lymphoma and why is new treatment important?

Patients with early-stage CTCL are affected, and new treatments are crucial due to the limited options available and the risks associated with conventional therapies.

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