Replies to post #3035 on Avid Bioservices Inc (CDMO)

[seamoss58]

dia76ca, correct take and good point.

Remember, this is a Phase I study and safety is the primary
endpoint - efficacy comes later. However, I'm a bit concerned
as well that they may have "bit off more than they can chew"
given the poor health their volunteers may be in. The upside
is that this IS being tested on "stricken" patients so some
Phase II applicable data will be forthcoming.

cmos

[eb0783]

I might assume that is why only half of the Tarvacin animals survived the lassa fever. They were very sick and weak before they started.

Paul

[terrygd]

dia, yes, the immune system plays an important part and that is why there is a minimum acceptable guideline.
Inclusion Criteria:



Adequate hematologic function (absolute neutrophil count [ANC] greater than or equal to 1,500 cells/uL,

hemoglobin [Hgb] greater than or equal to 12 g/dL in females and greater than or equal to 13 g/dL in males,

platelet count greater than or equal to 100,000/uL and less than or equal to 500,000/uL)

Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min)

Normal coagulation profile (PT/INR and aPTT within institutional normal limits)

D-dimer within institutional limits

[mskatiescarletohara]

+++ In both cases isn't it possible that their immune systems have been damaged.

Yes, because both sets of patients, i.e. cancer and HEP-C refractory have tried all available medical treatments and their systems have become "immune" to current available treatments, which is why PPHM is treating solid tumor/Hep-C refractory patients. The goal is to determine safety dosing and hopefully, some in the patient population will demonstrate some sort of efficacy.

katie....