Wednesday, July 03, 2013 9:15:16 PM
Author Block: Adam Yopp, Yull Arriega, Amit Singal, John Mansour, Glen Balch, Phillip Thorpe. UT Southwestern Medical Center, Dallas, TX
Abstract Body: Background: HCC is the fastest growing cause of cancer-related deaths in the US, with the majority of patients presenting with advanced stage disease. Despite sorafenib being the only systemic therapy with proven efficacy in advanced HCC, the median survival for these patients is still less than one year. Sorafenib, in pre-clinical HCC models, upregulates phosphatidylserine (PS) exposure on tumor vascular endothelium. The phosphatidylserine (PS)-targeting antibody, bavituximab, given in combination with sorafenib has greater efficacy in pre-clinical HCC models than either therapy alone. Bavituximab acts by directing immune cells to destroy the PS-expressing tumor vasculature, and by reactivating tumor immunity.The aim of our study was to evaluate the maximum tolerated dose (MTD) of bavituximab in combination with 400 mg bid of sorafenib in patients with advanced HCC.
Methods: In this single institution, phase I study (NCT01264705), sorafenib-naive adult patients with measurable, advanced HCC, ECOG PS = 2, and Child-Pugh (CP) class A cirrhosis received escalating doses of bavituximab weekly (0.3, 1.0, and 3.0 mg/kg) and sorafenib 400 mg bid for 28 days.
Results: Median age of patients was 61(range 43-76) years and seven patients were male. Five patients had CP A5 and 4 patients had CP A6 cirrhosis. The majority of patients had underlying HCV (7/9), one patient had HBV and one patient had NASH. Five patients (4 TACE, 1 resection) received prior treatment. Four patients had metastatic disease at initiation of treatment. No dose limiting toxicities were seen at any dose level. No grade 3/4 treatment-related events in the first 28 days were noted. Common toxicities at all grades were related to sorafenib and included hand-foot syndrome (33% grade I, 22% grade II), fatigue (33% grade I) and anorexia (22% grade I).
Conclusions: Bavituximab and sorafenib can be given safely in patients with advanced HCC at 3.0 mg/kg weekly and 400 mg bid, respectively. Hand-foot syndrome, fatigue and anorexia were the most common adverse events and are consistent with known adverse events with sorafenib therapy. These doses are currently being evaluated in an ongoing phase II study in this population.
Recent CDMO News
- Avid Bioservices to Report Financial Results for First Quarter of Fiscal Year 2025 After Market Close on September 9, 2024 • GlobeNewswire Inc. • 09/03/2024 08:05:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/29/2024 08:30:10 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 08/28/2024 08:34:04 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/28/2024 08:32:18 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/28/2024 08:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:50:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:48:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/15/2024 08:40:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 08:30:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:02:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:02:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:01:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:01:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:00:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:00:45 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/11/2024 12:23:26 AM
- Avid Bioservices Reports Financial Results for Fourth Quarter and Fiscal Year Ended April 30, 2024 • GlobeNewswire Inc. • 07/02/2024 08:05:04 PM
- Avid Bioservices to Report Financial Results for Quarter and Fiscal Year Ended April 30, 2024, After Market Close on July 2, 2024 • GlobeNewswire Inc. • 07/01/2024 11:00:21 AM
- Avid Bioservices Earns Committed Badge from EcoVadis for Sustainability Performance • GlobeNewswire Inc. • 05/23/2024 12:05:46 PM
- Avid Bioservices to Participate at Upcoming Investor Conferences • GlobeNewswire Inc. • 05/07/2024 08:05:11 PM
- Avid Bioservices Reports Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 04/24/2024 09:25:33 PM
- Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q • GlobeNewswire Inc. • 03/20/2024 11:00:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
Reliant Coffee Debuts at #271 on the Inc. 5000 List of Fastest Growing Companies - Coffee Service Industry Disruptor Brews Up Exponential Growth Sep 5, 2024 11:51 AM
VAYK Confirms Receiving Revenue from First Airbnb Property with 1.4 Million Annual Revenue Goal • VAYK • Sep 4, 2024 9:34 AM
Mawson Finland Limited Expands Known Mineralized Zones at Rajapalot: New Lens Intercepts 21.75 m at 5.25 g/t Gold & 515 ppm Cobalt • MFL • Sep 4, 2024 9:02 AM
Integrated Ventures Acquires 51% Stake In GetTrim.Com (TM), Telemedicine Platform With Focus On Expansion Into Booming GLP-1 Powered Weight Loss Market • INTV • Sep 4, 2024 8:45 AM
Avant Technologies Announces Strategic Review Process Intended to Maximize Shareholder Value • AVAI • Sep 4, 2024 8:00 AM
PickleJar Launches National "Get on the Bus" Campaign, Unveils Thompson Square Tour Bus Wrap • PKLE • Sep 4, 2024 7:17 AM