New York, New York–(Newsfile Corp. – July 6, 2021) – PCG Digital — A rare form of non-Hodgkin’s lymphoma, cutaneous T-cell lymphoma (CTCL) has no current FDA-approved first-line therapies. There are roughly 3,000 new CTCL cases in the United States each year, with more than 20,000 patients living with CTCL.
Small cap biotech Soligenix (NASDAQ: SNGX) is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel first in class photodynamic therapy utilizing safe visible light for the treatment of early stage CTCL.
Recently Dr. Ellen Kim, Medical Director of the Dermatology Clinic for the Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for Soligenix’s positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in CTCL, recently presented key details of HyBryte’s™ efficacy and safety profile at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting.
We caught up with Dr. Kim shortly after the meeting to discuss the HyBryte™ data and the current treatment landscape for CTCL.
- How does HyBryte™ stack up to other treatments that you’ve been using in your practice? If it gains FDA-approval, how will that affect your approach to treating Cutaneous T-Cell Lymphoma (CTCL)?
- HyBryte™ is as effective, and has better short term, and possibly long term, safety profile than current skin directed therapies. It is also effective for CTCL plaques which are traditionally more refractory to many skin directed treatments. Given this, it will be used both as first line therapy for my early stage patients and for patients who can’t continue other therapies due to side effects or loss of response.
- HyBryte™ uses visible light as opposed to ultraviolet (UV) light. Penn Medicine, as well as most centers treating this disease, is currently using UV treatments for CTCL. Is HyBryte™, in your opinion, a safer option?
- HyBryte™ has a definite advantage over phototherapy long term – it’s mechanism of action is distinct from ultraviolet phototherapy and is non-mutagenic so the risk of developing actinic skin damage and skin cancers is lower. Short term side effects were also less common and milder than what we see in traditional phototherapy.
- Dr. Kim, on the Penn Medicine website, it lists Photopheresis and T-Cell Lymphoma Phototherapy as two different treatments. Can you describe the difference between the two? Is one more effective than the other? Where would you classify HyBryte™?
- Phototherapy is a skin-directed treatment utilizing either ultraviolet A or B light and is used primarily in early stage CTCL.
Photopheresis is a systemic treatment where a patient’s peripheral white blood cells are treated ex vivo with UVA-based phototherapy in a machine and is indicated for primarily CTCL patients with blood involvement, most of whom have more advanced stage disease. Early stage CTCL patients without blood involvement are not typically treated with photopheresis at most centers.
Because they are used in different types of patients/stages of disease, and there are no randomized controlled trials that examined phototherapy vs photopheresis, one cannot compare the response rates between phototherapy and photopheresis to each other.
HyBryte™, a skin-directed therapy, is similar to phototherapy with a primary focus on treating early stage disease. Again, targeted as a potential first line therapy.
- Can you describe the process of Photopheresis and phototherapy from a patient’s perspective? How invasive is it for early stage patients? What can the patient expect as far as a timeline and level of discomfort? Does HyBryte™ provide a faster and more comfortable process?
- Traditional phototherapy and HyBryte™ have similar logistics from the patient perspective – they do require in office visits twice or three times weekly for a period of several months. Phototherapy treats the entire skin surface area exposed to the light, whereas HyBryte™ can be used for selective treatment if desired (though multiple lesions can be treated if desired as well). We don’t have direct trial data comparing phototherapy vs HyBryte™ regarding time to response. When I counsel patients starting traditional phototherapy, I counsel that initial response is seen at 4-6 weeks, but full response can take 4-12 months. We do know time to response is similar between HyBryte™ and topical bexarotene gel, topical nitrogen mustard gel, oral bexarotene in early stage disease; however, as I noted earlier, the safety profile of HyBryte™ compared to these other DNA-damaging therapies longer term is potentially much different given the mild side-effects we’ve seen in the Phase 3 FLASH study.
Photopheresis requires 2 outpatient treatments every 4 weeks, and a peripheral IV is placed each visit since the peripheral blood is removed from the patient temporarily during the treatment, so is considered a more invasive procedure. Time to response is slow – first response is seen at 3 months, full response takes 6-24 months. Again, the focus here is mostly later stage or for more advanced disease.
- Can you share any knowledge or experience you have with synthetic hypericin? Is it safe? Have you ever encountered any negative side effects from its use?
- After participating in the FLASH study as the overall study PI, I’ve been impressed with the efficacy and tolerability of HyBryte™ – any localized skin application side effects have been very mild and manageable compared to other current skin directed therapies.
- When will the public receive more details about the positive Phase 3 FLASH study and HyBryte™?
- This year, I’ve had the pleasure to present some of the high level positive results at three prestigious conferences in this disease space. The American Academy of Dermatology, the Society of Investigative Dermatology and the US Cutaneous Lymphoma Consortium; however, we currently anticipate having the full manuscript for the FLASH study (and HyBryte™) published in a peer reviewed medical journal and made available later this year.
- One final question, Dr. Kim. Can you definitively say that you will use HyBryte™ as a treatment option for CTCL in your practice, provided it gains FDA approval?
- Yes, most definitely. This will be a valuable, safer option for our patients who must utilize multiple different skin directed therapies to manage their chronic CTCL over many years and sometimes decades.
To learn more about Hybryte visit https://www.hybryte.com
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