Replies to post #268006 on Avid Bioservices Inc (CDMO)

[entdoc]

BioBS...thank you for the May, 2016 article eb0783. check it out. Bavi side-effects. I will study the data and see which side-effects can be teased out of the data as attributable to Bavi. Cheers! .

[eb0783]

Good find BioBS! This should answer entdoc's request for info. I particularly liked this part:

In this trial, there was a
lower incidence of vascular events in the docetaxel with bavituximab
3 mg/kg arm (n ¼ 1; DVT) than in the combined docetaxel
with placebo/bavituximab 1 mg/kg arm (n ¼ 5; DVT, PE, CVA).
There were no instances of clinically significant, treatmentemergent
bleeding, proteinuria, hypertension, or visceral perforation.
Further, vascular events in both arms of this trial did not
exceed those expected with docetaxel monotherapy or in the
general context of progressive advanced malignancy.30-33 Separately,
immune checkpoint inhibitors targeting CTLA4, PD1, and
PDL1 have been associated with numerous immune-related AEs,
including pneumonitis, colitis, hepatitis, hypophysitis, dermatitis,
and nephritis.1,34-37 In contrast, overt immune-related toxicities
have not been observed with bavituximab.

So in contrast to CTLA4, PD1, PDL1, "overt immune-related toxicities
have not been observed with bavituximab." Sounds kinda like a repeat of what Dr Thorpe was saying back in 2005.

[exwannabe]

AEs, P2 NSCLC table

One has to look closely. Note that you must go by percents (as the combined arm was twice as many N as 3Mg) and also the table is orderd by control arm AEs, thus if one just looks at the top AEs they miss some real data.

Below is the chart simplified to % and ordered by the sum of the % ARs.

It certainly looks like Bavi does have some side effects, and with bavi also on the comparator arm (it was blended) which confounds the data somewhat.

They certainly were mainly grade 1-2, so I would not argue with PPHM saying they were minor and well tolerated. But the question raised by entdoc was if there were none, which would be very stange, and is not well supported by this data.

AE 3MG 1+0mg
Nausea 37.5 27.8 *
Neutropenia 32.5 24.1 *
Cough 25.0 21.5 *
Asthemia 30.0 16.5 *
Anemia 25.0 17.7 *
Anorexia 27.0 15.2 *
Diarhia 17.5 20.3 X
Alopecia 20.0 17.7 X
Fatague 35.0 29.1 *
Pyrexia 20.0 16.5 *
Edema 15.0 20.3 *
Constipatiom 17.5 15.2 *
Ayrthralgia 20.0 10.1 *
Chest Pain 20.0 10.1 *
Back Pain 10.0 10.1
Dyspnea 12.5 13.9
Vomiting 15.0 11.4 *
Pro. Cough 17.5 8.9 *
Leukopenia 10.0 15.2 X
Hypotension 15.0 5.1 *
Pain Extremity 12.5 10.1 *
Per Neuropothy 10.0 8.9 X
Headach 7.5 10.1 X
Dizziness 10.0 7.6 *
Weight Loss 10.0 6.3 *
Dyspnea 10.0 6.3 *
Abd. Pain 12.5 3.9 *
Dehydration 10.0 5.1 *
Stammaitis 10.0 5.1 *
Mucosol Inflam. 12.5 2.5 *

* indicates more than a 2% diff with 3mg worse, X = combined arms 2% worse