Strong Clinical Momentum for Soligenix's HyBryte™ in Treating Cutaneous T-Cell Lymphoma; PCG Digital Exclusive with Dr. Brian Poligone
01 August 2024 - 11:00PM
PCG Digital -- Soligenix, Inc. (NASDAQ: SNGX), a late-stage
biopharmaceutical company, is making significant strides in the
treatment of Cutaneous T-Cell Lymphoma (CTCL) with its
investigational drug, HyBryte™. In an exclusive interview, PCG
Digital speaks with Dr. Brian Poligone, Director of the Rochester
Skin Lymphoma Medical Group and Principal Investigator for
Soligenix’s comparative study, who shares insights on the promising
advancements.
Key Highlights from the Interview:
- Need for
Rapid and Safe Treatments: Given that CTCL is incurable
but manageable with chronic treatment, there is a critical need for
therapies that can induce rapid remission and be safely used over
long periods.
- Comparative
Study Findings: Dr. Poligone discusses the HPN-CTCL-04
study, which compared HyBryte™ to Valchlor®. Preliminary results
indicate that HyBryte™ is both safe and effective. The study used
standard CTCL measurements to compare the safety and efficacy of
these two therapies. Initial findings suggest that HyBryte™ was
safe and effective relative to the FDA-approved, gold-standard
Valchlor®. Dr. Poligone noted, “Valchlor® is one of our most
commonly used drugs in the clinic. It's a topical chemotherapy
applied once daily, and some patients will react to it,
experiencing an allergy or reaction that makes it intolerable.
Additionally, some patients do not respond to it, even after
extended use. Due to these issues and others, Valchlor® is not the
only drug we need. We need alternative treatments for those
cases."
- Patient
Experience and Clinician Feedback: The Phase 3 FLASH
study, published in JAMA Dermatology, showed that HyBryte™ provides
a quick response and is well-tolerated by patients. Higher doses
used in subsequent studies were also well-received, with adverse
events comparable to or better than those in previous studies. Dr.
Poligone remarked, “From my standpoint as a clinician who sees
patients with this lymphoma every day, they're eager to get this
drug. They're excited about what they're hearing, and since it's
been available in my clinic, they have been asking for it, which I
think is a good sign. Similarly, among my colleagues treating
lymphoma patients, there is a lot of eagerness to know when this
will be approved and available outside of a clinical trial
setting.”
- Safety
Profile: The recent HPN-CTCL-02 examined the safety
characteristics of HyBryte™ while extending observations of its
effect in CTCL. Very low doses of HyBryte™ were found in the blood
after application to large body surface areas, with no effects on
the heart, liver, kidneys, or bone marrow. These findings will be
presented at the upcoming EORTC CTCL meeting in Switzerland this
October.
- Future
Trials: Dr. Poligone also shared his optimism about the
upcoming confirmatory Phase 3 FLASH2 trial, which will build on the
strong data from previous studies. Recruitment for FLASH2 will be
driven by the positive safety and efficacy data, making it easier
to enroll both new and previous patients eager to access
HyBryte™.
Soligenix plans to initiate patient enrollment in the
confirmatory FLASH 2 study with HyBryte™ by the end of 2024. The
company continues to explore the potential of HyBryte™ in treating
other dermatological conditions such as psoriasis, where it has a
Phase 2 study ongoing, demonstrating its commitment to expanding
treatment options for patients with skin diseases.
For the full interview, watch the video here:
https://youtu.be/R8khcNmj9ZQ?si=fXPpQrgPhTJVL1Hx
Read the latest interview with Dr. Ellen Kim on Soligenix’s
promising Phase 3 FLASH trial here:
https://prismmarketview.com/soligenixs-hybryte-lighting-the-way-towards-commercial-success-with-promising-flash-study-results/
About SoligenixSoligenix is a late-stage
biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical
need. Our Specialized BioTherapeutics business segment is
developing and moving toward potential commercialization of
HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel
photodynamic therapy utilizing safe visible light for the treatment
of cutaneous T-cell lymphoma (CTCL). With successful completion of
the second Phase 3 study, regulatory approvals will be sought to
support potential commercialization worldwide. Development programs
in this business segment also include expansion of synthetic
hypericin (SGX302) into psoriasis, our first-in-class innate
defense regulator (IDR) technology, dusquetide (SGX942) for the
treatment of inflammatory diseases, including oral mucositis in
head and neck cancer, and (SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes
development programs for RiVax®, our ricin toxin vaccine candidate,
as well as our vaccine programs targeting filoviruses (such as
Marburg and Ebola) and CiVax™, our vaccine candidate for the
prevention of COVID-19 (caused by SARS-CoV-2). The development of
our vaccine programs incorporates the use of our proprietary heat
stabilization platform technology, known as ThermoVax®. To date,
this business segment has been supported with government grant and
contract funding from the National Institute of Allergy and
Infectious Diseases (NIAID), the Defense Threat Reduction Agency
(DTRA) and the Biomedical Advanced Research and Development
Authority (BARDA).
DisclaimerThis communication was produced by
PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc.,
(together "PCG"). PCG is not a registered or licensed broker-dealer
nor investment adviser. No information contained in this
communication constitutes an offer to sell, a solicitation of an
offer to buy, or a recommendation of any security. PCG may be
compensated by respective clients for publicizing information
relating to its client's securities.
See www.pcgadvisory.com/disclosures.
PCG Digitalinfo@pcgadvisory.com646-863-6341
A video accompanying this announcement is available
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