07.15.15
Actinium Pharmaceuticals, a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, has submitted a request for a pre-IND (Investigative New Drug) meeting to the U.S. Food and Drug Administration (FDA) for the company's Iomab-B drug candidate currently preparing to commence the pivotal Phase 3 trial. During the early development of a new drug, manufacturers are required to apply for and obtain IND designation.
"We are optimistic that we will move through the meeting and application process successfully and obtain approval from the FDA that will allow us to move into the critical Phase 3 phase for Iomab-B,” said Kaushik J. Dave, president and chief executive officer, Actinium Pharmaceuticals. “We have also begun to establish the infrastructure necessary to enable speedy Phase 3 development of Iomab-B, if and when we receive IND status."
Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S.
"We are optimistic that we will move through the meeting and application process successfully and obtain approval from the FDA that will allow us to move into the critical Phase 3 phase for Iomab-B,” said Kaushik J. Dave, president and chief executive officer, Actinium Pharmaceuticals. “We have also begun to establish the infrastructure necessary to enable speedy Phase 3 development of Iomab-B, if and when we receive IND status."
Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S.
