Sunday, January 28, 2018 10:31:15 AM
Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, “We requested this protocol modification to improve patient access to this important clinical trial for appropriately selected and managed patients. In an ultra-orphan indication like ocular melanoma, striking the appropriate balance between eligibility criteria and patient access can be a challenge. We are pleased that the FDA agreed to this modification, and hope that once approved by the institutional review boards of our participating clinical trial sites, that this modification will help accelerate enrollment in this registrational trial.”
PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT®. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.
Recent DCTH News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/29/2024 08:06:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:32:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:31:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:30:44 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:30:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/28/2024 08:28:10 PM
- Delcath Systems Announces Appointment of Bridget Martell, MA, MD to Delcath’s Board of Directors • Business Wire • 05/28/2024 01:30:00 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 05/17/2024 04:48:32 PM
- Form 4/A - Statement of changes in beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 05/16/2024 06:05:35 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 05:09:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 04:56:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 04:45:15 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 01:14:39 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 12:05:15 PM
- Delcath Systems Reports First Quarter 2024 Results and Business Highlights • PR Newswire (US) • 05/14/2024 11:30:00 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/09/2024 09:12:20 PM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 05/08/2024 08:02:02 PM
- Delcath Systems to Host First Quarter 2024 Earnings Call • PR Newswire (US) • 05/07/2024 12:30:00 PM
- Publication of Results from Pivotal FOCUS Study in Metastatic Uveal Melanoma Patients treated with HEPZATO KIT • PR Newswire (US) • 05/06/2024 01:00:00 PM
- Delcath Systems Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 05/03/2024 09:15:00 PM
- Delcath Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 04/04/2024 12:35:00 PM
- Delcath Systems Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update • PR Newswire (US) • 03/26/2024 11:30:00 AM
FEATURED DaBaby and Stunna 4 Vegas's "NO DRIBBLE" Joins Music Licensing, Inc.'s Portfolio • Jun 7, 2024 10:15 AM
Mushrooms Inc. (OTC: MSRM) Announces Significant Share Buy Back by the Board Director and New Strategic Initiatives. • MSRM • Jun 5, 2024 1:32 PM
Hydromer Announces Launch of HydroThrombX Medical Device Coating Technology • HYDI • Jun 5, 2024 10:24 AM
Dr. Michael Dent Finances $1 Million to Drive HealthLynked's Healthcare Transformation • HLYK • Jun 5, 2024 8:00 AM
Avant Technologies Enters Binding LOI to Purchase Dozens of High-Performance, Immersible, AI-Powered Servers • AVAI • Jun 5, 2024 8:00 AM
IQST - iQSTEL Announces $290 Million 2024 Annual Revenue Forecast • IQST • Jun 4, 2024 1:43 PM