![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
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
- 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
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/22/2024 08:05:06 PM
- PRISM MarketView Highlights Soligenix, Inc. as it Builds on Compelling Phase 3 Data with Key Catalysts on the Horizon • GlobeNewswire Inc. • 05/21/2024 04:35:16 PM
- SuVax™ and MarVax™ Thermostable Vaccine Platform to be Presented at the Vaccine Technology IX Conference • PR Newswire (US) • 05/21/2024 11:30:00 AM
- Soligenix Encourages Stockholders to Vote Prior to Annual Meeting • PR Newswire (US) • 05/20/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/17/2024 08:25:40 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/17/2024 08:09:20 PM
- Positive Clinical Results from HyBryte™ Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma Published in JEADV Clinical Practice • PR Newswire (US) • 05/16/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/15/2024 08:05:38 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/10/2024 08:16:03 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 08:05:50 PM
- Soligenix Announces Recent Accomplishments And First Quarter 2024 Financial Results • PR Newswire (US) • 05/10/2024 11:30:00 AM
- Soligenix to Present at Upcoming Conferences • PR Newswire (US) • 05/06/2024 11:30:00 AM
- Soligenix Extends Patent Protection for its Filovirus Vaccine Platform to the United Kingdom and South Africa • PR Newswire (US) • 04/25/2024 11:30:00 AM
- Soligenix Announces Pricing of $4.75 Million Public Offering • PR Newswire (US) • 04/18/2024 12:30:00 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM