Concluding on ovarian, some skeptics felt the survival benefit between low and high cohorts for ovarian was not due to VB-111 but due to platinum. The low dose arm was 40mg weekly platinum versus 80 mg weekly platinum for the high dose arm. But I can't see how this is relevant since half of the patients were primary platinum resistant and all of the them were platinum refractory!
A final confounding point(my own)... from my reading of ovarian cancer, RECIST data is not the be and end all as many of the patients have metastatic disease that is more diffusely spread with ascites and microscopic seeding. This may make CA-125 reduction a more important surrogate marker for survival than RECIST in ovarian, despite what the shorts/skeptics argue. From my read on survival benefits, RECIST criteria is not the gold standard in examining or predicting overall survival(neither is CA-125 reduction although it is in terms of a clinical response to therapy). Both have their advocates and detractors. I found several articles on CA-125 response as being correlated with overall survival. In defense of the company here, this was a small scale run by Harvard(Harvard paid for the study to be run--not VBLT). Neither Harvard nor the company had/put up the needed funds to perform a randomized, double-blinded, adequately powered trial here. This was a phase I, turned into a phase II by definition. Ovarian was not initially on the companies radar.
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
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