actinium pharmaceuticals inc (ATNM) Key Developments
Actinium Pharmaceuticals, Inc. Appoints Felix Garzon as Senior Vice President, Head of Clinical Development
Aug 18 15
Actinium Pharmaceuticals, Inc. announced the appointment of Felix Garzon, MD, Ph.D. to the position of Senior Vice President, Head of Clinical Development effective August 17, 2015. Dr. Garzon brings with him 28 years of pertinent pharmaceutical and biotechnology experience in increasingly senior roles, most recently at Eisai and Bristol-Myers Squibb, having worked on both later and earlier stages of drug development. Dr. Garzon has more than 28 years of robust international experience working in positions of increasing responsibility in the development of new oncology and hematology drugs in several successful companies in the United States and Europe. Dr. Garzon was previously Senior Director, Oncology Product Creation Unit at Eisai, and Director, Oncology Global Clinical Research at Bristol-Myers Squibb.
Actinium Pharmaceuticals, Inc. Advances Iomab b Towards Phase 3 with Pre ind Meeting Request
Jul 15 15
Actinium Pharmaceuticals, Inc. announced that it 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. Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fast growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers, including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.
Actinium Pharmaceuticals, Inc.(AMEX:ATNM) dropped from Russell 2000 Index
Jun 29 15
Actinium Pharmaceuticals, Inc. will be removed from Russell 2000 Index
Actinium Pharmaceuticals, Inc.(AMEX:ATNM) dropped from Russell 3000 Index
Jun 29 15
Actinium Pharmaceuticals, Inc. will be removed from the Russell 3000 Index.
Actinium Pharmaceuticals, Inc. Announces Clinical Update on Actimab A at Upcoming 2015 ASCO Annual Meeting
May 20 15
Actinium Pharmaceuticals, Inc. announced the upcoming poster and abstract at ASCO 2015, the 51st Annual Meeting of American Society of Clinical Oncology, to be held in Chicago on May 29 - June 2. Data will be presented from the Company's ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients. Clinical data from the first three cohorts will be discussed. Cohort 3, which included 3 additional patients, demonstrated no dose limiting toxicities in patients older than 60 and up to 87 years of age who were not eligible for currently approved therapies. Two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 88% in the bone marrow. In the previous cohort treated at a lower dose level of Actimab-A, one patient achieved CRi. The Company also recently announced that it began the fourth and last cohort (2.0 Ci/kg per dose) in the Phase I portion of this trial. //st Title: Phase I trial of a-particle therapy with actinium-225 (225Ac)-lintuzumab (anti-CD33) &low-dose cytarabine (LDAC) in older patients with untreated acute myeloid leukemia (AML).