Wednesday, May 18, 2016 5:09:13 PM
Background: Ofranergene obadenovec (VB-111) is a gene therapeutic consisting of a non-replicating adenovirus vector (Ad-5) with a modified murine pre-proendothelin promoter leading to apoptosis of tumor vasculature by expressing a Fas-chimera transgene in angiogenic endothelial cells. Over 170 patients have been treated with VB-111 across different cancer indications with evidence of anti-tumor activity with no significant safety issues. We report results of the phase II study of VB-111 in combination with paclitaxel in patients with recurrent müllerian cancers.
Methods: VB-111 was administered as intravenous infusion at escalating doses from 3x1012 (DL1&2) to 1x1013 viral particles (VPs) (DL3, therapeutic dose) every 2 months. Paclitaxel was given at 40 mg/m2 (DL1), and 80mg/m2 weekly (DL2-3). A phase 2 expansion cohort commenced at DL3 (therapeutic dose). Assessments included safety, tumor response (CA-125 and RECIST), histopathology, progression free survival (PFS) and overall survival (OS).
Results: Nineteen patients at 2 US centers received up to 7 repeat doses of VB-111, 15/19 received the therapeutic dose. Median age was 65 (41-79) with a median of 3 prior lines of therapy. No DLTs were observed. VB-111 was associated with flu-like symptoms and mild infusion reactions; the drug was safe and well tolerated. In the therapeutic dose cohort, a 60% response rate (RR) was seen by the GCIG criteria (more than 50% reduction in CA-125), 93% had clinical benefit. The median OS was not reached, mean OS was 19.9 months. A dose-response was seen. Within the therapeutic dose cohort (n = 15), responses seen in 3 of the 5 patients who had received prior bevacizumab (RR 60%) and in 5 of the 9 pts with platinum refractory disease or progressive disease within 3 months of platinum (RR 55%). On study biopsies suggest that further to the anti-angiogenic mechanism of action VB-111 induced antitumor immune reaction.
Conclusions: VB-111 in combination with weekly paclitaxel was safe and well tolerated in ovarian cancer patients. Anticipated toxicities were observed. Tumor responses were seen and survival data is encouraging. Clinical trial information: NCT01711970
http://abstracts.asco.org/176/AbstView_176_167022.html
Recent VBLT News
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 06/20/2024 09:01:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 09:18:35 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 09:17:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 09:12:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 09:07:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 09:06:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/10/2024 09:04:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 08:30:44 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 04/19/2024 08:56:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/12/2024 12:44:49 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 04/11/2024 09:00:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/09/2024 09:20:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/08/2024 04:15:14 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 04/01/2024 08:30:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2024 01:00:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/22/2024 01:15:22 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 02/16/2024 02:00:13 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/05/2024 10:00:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/02/2024 09:05:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2024 04:05:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2024 04:05:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2024 04:04:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2024 04:04:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/26/2024 04:02:17 PM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM