[ad_1]
Soligenix Demonstrates Clinical Success in First-in-Class Treatment for Cutaneous T-Cell Lymphoma
New York, NY – 
Soligenix, (NASDAQ: SNGX) a biopharmaceutical company specializing in treatments for rare diseases, is addressing this unmet need for those living with CTCL.
HyBryte™ (synthetic hypericin) offers a less invasive photodynamic therapy, using safe, visible light to treat early-stage CTCL. Soligenix recently conducted a Phase 3 FLASH trial of HyBryte™, demonstrating safety, tolerability and efficacy and positioning HyBryte™ as a safer short- and long-term treatment option for CTCL patients.
Dr. Ellen Kim, the Lead Principal Investigator for the study and Medical Director of the Dermatology Clinic for the Perelman Center for Advanced Medicine, presented at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting this month, summarizing the HyBryte™ FLASH trial.
Dr. Kim said, “We’re looking for treatment options with efficacy, but also short-term and long-term safety. Because there are no curable treatment options for CTCL, we manage this disease like we manage other chronic conditions. HyBryte™ is a safe and effective option for that.
“The response rate peaked at 49 percent which is quite typical for the sort of response for many skin-directed therapies currently approved for CTCL. What’s gratifying is that HyBryte™ has a really great safety profile.”
About the Phase 3 FLASH study for HyBryte:
· The HyBryte study was a multi-center randomized control blinded trial held in the US.
· HyBryte is a synthetic hypericin ointment that can be combined with visible light to treat early-stage mycosis fungoides CTCL.
· The study was conducted in three cycles, with the first cycle randomizing patients in a blinded manner between placebo and the active drug. Cycle 2 was the crossover cycle where all patients received HyBryte™ and Cycle 3 was optional to treat all lesions. Response rate was measured at the end of each cycle.
· Each cycle was six weeks long, with two treatments per week, followed by a two-week rest period before results were measured. 169 patients were enrolled in the study.
o Cycle 1 produced a 16% response rate in active drug recipients
o Cycle 2 produced a 40% response rate from patients who received two cycles of HyBryte™ (Cycle 1 and Cycle 2).
o Cycle 3 produced a 49% response rate
· The response rate is comparable to other skin-directed therapies studied and the safety profile was excellent, with responses seen in both patch and deeper plaque lesions. Other therapies have limitations with regards to short-term and long-term side effects.
· Minimal adverse effects were seen in 16% of patients. 1.7% discontinued the trial due to adverse side effects, which included erythema, hyperpigmentation, and itching.
· Due to the use of visible light that penetrates deeper versus traditional ultraviolet A or B phototherapy, there was no difference in response rate between dark and light-skinned patients.
Watch the full presentation here : HERE
To find out more, visit HyBryte.com
Disclaimer
This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together “PCG”). PCG is an integrated investor relations, communications and strategic advisory firm. The information contained on this may be ‘Paid Advertising’ for purposes of Section 17(b) of the Securities Act of 1933, as amended (together with the rules and regulations there under, the “Securities Act”). PCG may be compensated by respective clients for publicizing information relating to its client’s securities. For more information in terms of compensation received for services provided by PCG, see the pertinent advertising materials relating to the respective client. By accessing this Site and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy.
PCG is not a registered or licensed broker, dealer, broker-dealer, investment adviser nor investment manager, nor does PCG engage in any activities that would require such registrations. PCG does not provide investment advice, endorsement, analysis or recommendations with respect to any securities, and its services to or statements about its clients should never be construed as any endorsement of or opinion about any security of any client. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security or any other similar product or service regardless of whether such security, product, or service is referenced in this communication. Further, nothing in this communication is intended to provide tax, legal, or investment advice and nothing in this communication should be construed as a recommendation to buy, sell or hold any investment or security or to engage in any investment strategy or transaction. For full disclaimers, including compensation received for professional services, please visit www.pcgadvisory.com/disclosures.
Contact: info@pcgadvisory.com
[ad_2]