Escalation to any of the next planned dose level will require the approval from an informal cohort review meeting. The cohort review group will comprise of the Principal Investigator, contract research organization's (CRO's) Medical Monitor and Project Manager (to facilitate meetings and writing minutes), and the Sponsor's Chief Scientific Officer, President, or designee. The review meetings will be held after all patients complete the 4-week observational period for that dose group. The Investigators whose patients will be reviewed at the meeting must participate in the meeting. The rest of the Investigators of the study will be invited to participate on an optional basis. The cohort review group will review all safety data to date including adverse events (AEs), clinically significant laboratory abnormalities, and Dose Limiting Toxicities (DLTs) (as defined later in the synopsis) to decide whether the study will advance unaltered, the protocol requires an amendment, to halt recruitment until the resolution of a specific issue, or to terminate the study.