Actinium Partners With IBA Molecular To Manufacture Iomab TM-B

Biopharmaceutical company Actinium has announced that is partnering with IBA Molecular North America in order to ensure current good manufacturing practice (cGMP) of its leading drug candidate Iomab-B. Actinium has stated that IBA Molecular will be able to scale up the production of Iomab-B under cGMPs, as well as further develop and test the quality of the drug product. This manufacturing development is leading up to the start of the pivotal phase III trial.

Iomab-B is a drug designed to allow patients suffering with relapsed and refractory acute myeloid leukemia, or AML, to receive bone marrow transplants. This two arm, randomized, controlled, multicenter trial will be centered around refractory and relapsed AML patients over the age of 55. There will be 75 patients in each arm of the trial, for a total enrollment of 150 patients. There are currently no FDA approved treatments AML in the study’s patient population.

This phase III trial is following in the footsteps of an earlier phase I/II trial that demonstrated disease free survival for six months for 60 percent of older AML patients. If the drug is approved by the FDA, Actinium will begin the process of commercialization.

Actinium is focused on developing new, innovative treatments by using immunotherapeutics for advanced cancers. IBA Molecular North America is a global developer and drug manufacturer that primarilydistributes radiopharmaceutical products as well as services that are used in molecular imaging. The agreement between the two companies will further the development of the Iomab-B and allow for Actinium to begin the process of commercialization.

Dr. Kaushik J. Dave, the President and CEO of Actinium, commented on the partnership with IBA Molecular. “As we are progressing with clinical development of this important drug candidate, we are working on manufacturing development at the same time,” said Dave. “We want to ensure the highest quality and consistency of our drug candidate and meet regulatory requirements for successful clearance and commercialization.”

Lee Karras, president of IBA Molecular North America, also released a statement saying that his company was pleased to be selected to manufacture the Iomab-B drug. “IBA Molecular has a proven track record of radiopharmaceutical development and manufacturing and we look forward to adding this important product to our manufacturing portfolio,” Karras said.