“We worked extremely diligently to identify the right specialist CRO partner for the pivotal Phase 3 Iomab-B clinical trial and we are delighted to announce that we have selected Medpace,” said Felix Garzon, senior vice president, head of clinical development, Actinium Pharmaceuticals. “Medpace is full service CRO with a global reach, demonstrated track record of successfully managing clinical trials and medical and clinical expertise in the field of bone marrow transplantation. With this major milestone now complete and with Medpace as our partner, we are excited to move into the next chapter of Iomab-B’s clinical development of bringing clinical sites online and enrolling patients.”
The company established an agreement with the FDA that the path to a Biologics License Application submission for Iomab-B could include a single, pivotal Phase 3 clinical study if it is successful.
“Since receiving clearance of our IND for Iomab-B in December, we have focused on the execution of our clinical milestones,” said Sandesh Seth, executive chairman, Actinium Pharmaceuticals. “The selection of Medpace as our CRO is a significant milestone as it greatly expands our clinical and operational capacities for the Phase 3 Iomab-B pivotal trial. Iomab-B is the only therapy of its kind and addresses a patient population with significant unmet needs, we remain steadfastly focused on the execution of this trial with the goal of delivering this much needed therapy to patients in need of a bone marrow transplant and we welcome the addition of Medpace as our partner.”