The subjects in this clinical trial had a long treatment period before their initial diagnosis
until enrollment in this clinical trial as well as they received many kinds of anti-cancer drugs.
50% of the patients underwent more than one and a half years of treatment. Some of them
were treated more than 13 years until this enrollment. Long-time treatment before enrollment
in these clinical trials means that there were many patients with sharply decreased immunity.
Nonetheless, when they took the SB Injections, they had neither neutropenia nor anemia,
which are the serious adverse events shown in general chemotherapy; nor did they suffer hair
loss. All recovered from the adverse events, if any, and there were no complications or death.
Therefore, it is expected that the SB Injection will the best treatment for those who cannot
overcome the adverse events of chemotherapy.
Based on the above findings, it is evaluated that the trial drug, the SB Injection, is efficacious.
Also, it is a stable drug and it is proper to plan phase-3 clinical trials.