Soligenix Announces Positive Top-line Results for its Pivotal Phase 3 FLASH Trial Evaluating SGX301 in Treatment of Cutaneous T-Cell Lymphoma
Soligenix, Inc. (SNGX)
NASDAQ:AMEX Investor Relations:
soligenix.com/investors
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Source: PR Newswire
PRINCETON, N.J., March 19, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020. "This is an important outcome for
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News
- SNGX: Phase 3 FLASH2 Trial of HyBryte in CTCL Underway… [Yahoo! Finance]Yahoo! Finance
- Soligenix Initiates Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell LymphomaPR Newswire
- EXCLUSIVE: Soligenix Starts Confirmatory Late-Stage Trial For HyBryte For Type Of Blood Cancer [Yahoo! Finance]Yahoo! Finance
- HyBryte™ Clinical Results Demonstrate Continued Improvement Post-Treatment [Yahoo! Finance]Yahoo! Finance
- HyBryte™ Clinical Results Demonstrate Continued Improvement Post-TreatmentPR Newswire
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Sec Filings
- 12/13/24 - Form 4
- 12/13/24 - Form 4
- 12/13/24 - Form 4
- SNGX's page on the SEC website