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Some rare diseases or rare cancers are exceedingly difficult to treat. For example, for patients with early-stage cutaneous T-cell lymphoma (CTCL), treatment involves topical steroids or chemotherapeutics alongside UV light. But this can be further damaging to the skin. Because there are no other first-line treatment solutions available, there is a huge unmet need to fill within this patient population. According to IPS News, a Phase 3 clinical trial showed HyBryte (SGX301 / synthetic hypericin / hypericin ointment 0.25%) as a promising treatment for patients with CTCL.

HyBryte

So what exactly is HyBryte? According to drug developer Soligenix, HyBryte is:

a photodynamic therapy using synthetically manufactured hypericin in an ointment combined with visible fluorescent light. Hypericin…is easily activated with relatively low energy light, [making] it ideal for photodynamic therapy because it can be activated with fluorescent light, instead of UV A or UV B light, which are associated with increased cancer risks.

Within the Phase 3 FLASH clinical trial, researchers found that 18 weeks of HyBryte treatment reduced skin lesions by up to 50% in 49% of treated patients. The therapy was also found to be relatively safe and well-tolerated. In fact, researchers believe that HyBryte is most likely safer than the current care options in terms of long term use. Interested in learning more about the study and its findings? Check out this comprehensive overview from Soligenix.

Moving forward, Soligenix hopes to file a New Drug Application (NDA) near the start of 2022.

Cutaneous T-Cell Lymphoma (CTCL)

There are multiple forms of cutaneous T-cell lymphoma, a subset of non-Hodgkin’s lymphoma (NHL). For example, lymphomatoid papulosis, subcutaneous panniculitic T-cell lymphoma, and mycosis fungoides are all forms of CTCL. Mycosis fungoides is slow-growing and the most common form of CTCL. In each case, the condition is characterized by abnormal and malignant T-cells in the skin, which manifest in rashes, lesions, tumors, or other related forms.

Symptoms vary based on the specific CTCL subtype. Itching is often seen across all subtypes. Patients with mycosis fungoides experience:

• Patch (atrophic or non atrophic) stage: In this stage, patients often see nonspecific dermatitis (a red rash, scaly looking skin) on areas which typically do not get a lot of sun. These include the lower buttocks, stomach, and groin. The patch stage may also manifest as light skin spots.
• Plaque stage: In the plaque stage, mycosis fungoides progresses to include thick, raised, and often itchy plaques.
• Tumor stage: In the final stage, patients experience patches, plaques, and tumors across their skin. Tumors can break open and form ulcers or open sores.

Alternately, patients with Sézary syndrome may have symptoms such as:

• Inability to control body temperature
• Widespread skin redness and itchiness
• Swollen or peeling skin
• Hair loss
• Thickened toenails and fingernails
• Swollen lymph nodes
• Drooping eyelids
• Enlarged spleen