Actinium Pharmaceuticals Inc., a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced it has filed an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for Actimab-A, a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. The company expects to provide interim results for the Actimab-A trial around the same time as the American Society of Hematology (ASH) meeting in December 2014.
Patients over age 60 comprise the majority of those diagnosed with acute myeloid leukemia (AML), but treatment approaches in this population are limited because a majority of these individuals are judged too frail and unable to tolerate standard induction chemotherapy. Orphan drug designation is granted to treatments that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients per year. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity.
Kaushik Dave, president and CEO of Actinium, stated: “Acute myeloid leukemia is the most common acute leukemia affecting adults and accounts for the largest number of annual deaths due to leukemia. With limited treatment options for a majority of AML patients over age 60 who cannot tolerate standard induction chemotherapy, we are confident that Actimab-A may offer a new potential treatment paradigm by utilizing alpha emitters which we believe should provide more efficient leukemia cell killing without the toxicity of intensive chemotherapy. We believe that Actimab-A meets the criteria for orphan drug designation, and represents a significant potential therapeutic advance over currently available treatments options for newly diagnosed elderly AML patients. We remain committed to addressing significant unmet medical needs for AML patients and are moving steadfastly to advance our Phase 1/2 Actimab-A clinical trial and look forward to releasing interim data later this year.”
Date: September 3, 2014
Source: Actinium Pharmaceuticals