Avid Bioservices Inc (CDMO)

[edcpf]

wwtmm, disease stage and patient ECOG status are different things.

SUNRISE is stage IIIB and IV. Same as preceding Phase II trial.

Stage III

Stage three (III) lung cancers are classified as either stage IIIA or IIIB. For many stage IIIA cancers and nearly all stage IIIB cancers, the tumor is difficult, and sometimes impossible, to remove. For example, the lung cancer may have spread to the lymph nodes located in the center of the chest, which is outside the lung. Or, the tumor may have grown into nearby structures in the lung. In either situation, it is less likely that the surgeon can completely remove the cancer because removal of the cancer must be performed bit by bit.

Stage IV

Stage four (IV) means the lung cancer has spread to more than one area in the other lung, the fluid surrounding the lung or the heart, or distant parts of the body through the bloodstream. Once released in the blood, cancer can spread anywhere in the body, but it is more likely to spread to the brain, bones, liver, and adrenal glands. It is called stage IVA when the cancer has spread within the chest or IVB when it has spread outside of the chest.

SUNRISE recruits patients with ECOG 0 or 1. In preceding Phase II trial, ECOG 2 were also recruited. This is the difference here. Bavituximab does not seem to help those sicker patients as much as it helps healthier ones.

GRADE ECOG PERFORMANCE STATUS
0 Fully active, able to carry on all pre-disease performance without restriction
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5 Dead