Thursday, January 05, 2017 7:36:42 AM
PRINCETON, N.J., Jan. 5, 2017 /PRNewswire/ -- Soligenix, Inc. (SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the company had received positive Scientific Advice from the European Medicines Agency (EMA) for the development of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study (IDR-OM-02), if successful, in conjunction with the Phase 2 dose-ranging study IDR-OM-01, is generally considered sufficient to support a marketing authorization application (MAA) to the EMA for potential licensure in Europe. The advice also provides several constructive suggestions to strengthen the study design and data collection that will be integrated into the final protocol.
"We are pleased that the EMA agrees that the proposed Phase 3 clinical study, if positive, is sufficient to establish the efficacy of SGX942 and support an MAA filing," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe that this positive Scientific Advice outcome represents a significant step forward in our oral mucositis development program and has the potential to accelerate the registration timetable in Europe. We look forward to incorporating the EMA's protocol suggestions with those from the US Food and Drug Administration. Given the current timeline, we anticipate initiating this pivotal Phase 3 clinical trial in the first half of 2017."
Recent SNGX News
- Join Soligenix's Exclusive Live Investor Webinar and Q&A Session on September 18, 2024 • PR Newswire (US) • 09/16/2024 11:30:00 AM
- Soligenix Receives European Patent for Improved Production of Synthetic Hypericin • PR Newswire (US) • 09/03/2024 11:30:00 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/16/2024 08:19:57 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 08:13:45 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/09/2024 08:09:14 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/09/2024 08:07:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 08:05:32 PM
- Soligenix Announces Recent Accomplishments And Second Quarter 2024 Financial Results • PR Newswire (US) • 08/09/2024 11:30:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/05/2024 04:15:07 AM
- Strong Clinical Momentum for Soligenix's HyBryte™ in Treating Cutaneous T-Cell Lymphoma; PCG Digital Exclusive with Dr. Brian Poligone • GlobeNewswire Inc. • 08/01/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/25/2024 11:30:14 AM
- PRISM MarketView Features Q&A with Dr. Ellen Kim: Soligenix's HyBryte™— Lighting the Way Towards Commercial Success with Promising FLASH Study Results • GlobeNewswire Inc. • 07/15/2024 02:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 05:28:54 PM
- Expanded HyBryte™ Treatment Demonstrating Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma • PR Newswire (US) • 07/09/2024 11:30:00 AM
- Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma • PR Newswire (US) • 06/25/2024 11:30:00 AM
- A Comparison of Vaccine Technologies to be Presented at the ASM Microbe Conference • PR Newswire (US) • 06/14/2024 11:30:00 AM
- Setting the Stage for Success: PRISM MarketView Highlights Soligenix's Promising HyBryte™ Replication Trial • GlobeNewswire Inc. • 06/05/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 12:00:25 PM
- Soligenix Announces Reverse Stock Split • PR Newswire (US) • 05/31/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/29/2024 08:05:07 PM
- Soligenix Encourages Stockholders to Vote their Shares at the Annual Meeting • PR Newswire (US) • 05/29/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/28/2024 08:08:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 08:05:27 PM
- Soligenix, Inc. Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting • PR Newswire (US) • 05/24/2024 11:30:00 AM
- Soligenix Encourages Stockholders to Vote "FOR" Reverse Stock Split • PR Newswire (US) • 05/23/2024 11:30:00 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM