Sandesh Seth, Chairman of Actinium Pharmaceuticals Inc (ATNM), says the company is poised to achieve fast-track status with the FDA.
“We are not the fifth me-too drug candidate for a chronic disease. Rather, Iomab-B and Actimab-A — if approved — would have life-extending benefits, and in so doing, Actinium Pharmaceuticals can make a difference,” Seth says. “That really motivates us.”
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Seth says Iomab-B, Actinium’s drug for patients who cannot withstand chemotherapy, is preparing to enter a Phase III pivotal trial. So far, he says, the drug has demonstrated strong results.
“Iomab-B has shown strong clinical trials results in more than 250 patients to date. In the Phase I/II clinical trials, it has shown that 100% of these patients were able to move to a bone marrow transplant with one-year survival of approximately 30% and two-year survival of approximately 19%, which compares to 10% and 0%, respectively,” Seth says.
Meanwhile, Seth says Actinium expects to have early results in December for its second drug candidate, Actimab-A, which is for elderly patients who are newly diagnosed with AML. Seth says that as a second-generation product, he believes Actimab-A is derisked.
“The first-generation product, Bismab-A, had proof of concept in a Phase I/II study in a tougher patient population, which are relapsed and refractory patients, whereas these are newly diagnosed AML patients…The first-generation product was commercially unviable because it cost $98,000 a dose and had a 46-minute half-life,” Seth says. “We can make the second-generation drug, Actimab-A, which is 500 times more potent for under $10,000, and it is commercially viable with a half-life of 10.5 days, so the logistics work.”
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