(The Peregrine bavi combo trial (most likely) used carboplatin/paclitaxel plus bavituximab in lung cancer patients.)
underwriter,
There's a lot of Bevacizumab (Avastin) trial data out there for you to explore, and I think you'll be very pleased when you compare. You should have a look around..
Here's a phase 2 trial, (what's typically termed an "efficacy trial", as opposed to a phase 1 "safety" trial), using avastin in combo w/carboplatin/paclitaxel, compared to carboplatin/paclitaxel alone, in Advanced or Metastatic Non-Small-Cell Lung Cancer.
NOTE: While this patient population was advanced/metastatic/recurrent, they had NOT grown resistant (yet) to carboplatin/palitaxel, as the patient pool in the Indian bavi combo trial had. (BIG difference).
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RESULTS: Compared with the control arm, treatment with carboplatin and paclitaxel plus bevacizumab (15 mg/kg) resulted in a higher response rate (31.5% v 18.8%), longer median time to progression (7.4 v 4.2 months) and a modest increase in survival (17.7 v 14.9 months). Of the 19 control patients that crossed over to single-agent bevacizumab, five experienced stable disease, and 1-year survival was 47%. Bleeding was the most prominent adverse event and was manifested in two distinct clinical patterns; minor mucocutaneous hemorrhage and major hemoptysis. Major hemoptysis was associated with squamous cell histology, tumor necrosis and cavitation, and disease location close to major blood vessels.
(The Peregrine bavi combo trial (most likely) used Docetaxel plus bavituximab in breast cancer patients.)
Here's a phase 2 trial, (what's typically termed an "efficacy trial", as opposed to a phase 1 "safety" trial), using avastin in combo w/Docetaxel
Purpose: To evaluate the safety and efficacy of bevacizumab and weekly docetaxel as first- or second-line therapy in patients with metastatic breast cancer (MBC).
(These patients were not nearly "as far gone" as the PPHM Indian trial. As a first or second-line therapy, docetaxel can really accomplish something, statistically speaking ...)
Anyway..........
Get a load of the toxicities! (Serious- grade 3 & 4). (7%)—pulmonary embolus! Yeouch! Look at those percentages....
and note the overall response, (complete + partial + stable), in folks who were NOT resistant to the chemo, they had NOT failed chemo...
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Results: One-hundred fifty-eight treatment cycles were administered with a median of six cycles (range 1-15 cycles) per patient. The most common grade 4 toxicities per patient were as follows: 2 (7%)—pulmonary embolus, 1 (4%)—febrile neutropenia, and 1 (4%)—infection; grade 3 toxicities were 4 (15%)—neutropenia, 4 (15%)—fatigue, 2 (7%)—neuropathy, 2 (7%)—athralgias, 2 (7%)—stomatitis, 1 (7%)—pleural effusion, and 1 (4%)—hypertension. The overall response rate was 52% [95% confidence interval (95% CI), 32-71%], median response duration was 6.0 months (95% CI, 4.6-6.5 months), and the median progression-free survival was 7.5 months (95% CI, 6.2-8.3 months). In hypothesis-generating univariate and limited multivariate analyses, E-selectin was statistically significantly associated with response to the combination.
What you see there is similar ORR to the glimpse we got today, but the Avastin was in a way easier trial- first & second-line therapy, and Avastin had really scary side effects...
BY THE WAY - Those results are not that different to Docetaxel alone.....
LOL - and then there's Cetuximab (Erbitux)!....
Don't get me started. talk about scary side effects........
Bavi should use the Guiness slogan, "Bavi is good for you" :)
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