Strategic additions in key areas will support later stage clinical trials for Iomab-B and Actimab-A
New York, NY -- (SBWIRE) -- 01/27/2016 -- Actinium Pharmaceuticals, Inc.("Actinium"), is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium announced today the appointment of Rowena Choudrie, M.S. to the position of Senior Director, Pharmaceutical Product Development and Kevin Zikaras to the position of Senior Clinical Scientist. These hires will report to Kaushik J. Dave, Ph.D., MBA Chief Executive Officer and Felix Garzon, M.D., Ph.D., Senior Vice President, Head of Clinical Development, respectively.
"Actinium has strategically added to our team in recent months reflecting the progress we have made with our Iomab-B and Actimab-A programs, which will both be in later stage clinical trials this year" said Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. "The hiring of Rowena and Kevin is a display of our ability to attract top talent and I look forward to their contributions to our goal of developing and commercializing best in class therapies for diseases with unmet needs."
Ms. Choudrie has over 20 years of pharmaceutical industry experience with roles of increasing responsibility in product development. At Actinium, Ms. Choudrie will be responsible for clinical trial material supply, drug product process scale-up to support commercial supply and final product formulation. In addition, she will support Actinium's regulatory efforts particularly in the area of Chemistry, Manufacturing and Control (CMC). Most Recently, Ms. Choudrie worked at NPS Pharmaceuticals as Senior Director, Pharmaceutical Development, Global Technical Operations where she directed formulation development, process development and clinical manufacturing while managing Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). From 2004 until 2009, Ms. Choudrie worked at Palatin Technologies, Inc. serving as Director, Formulation Development and Manufacturing where she was responsible for clinical manufacturing and supply and served as CMC working group leader to coordinate phase 1, 2 and 3 trial activities with an array of multi-disciplinary groups within the organization. From 1990 until 2004, Ms. Choudrie worked at Schering-Plough Research Institute as a Principal Engineer and Chair of the Product Development Team. At Schering-Plough, Ms. Choudrie led process development, process improvement and formulation improvement for multiple drugs. In addition, she managed internal and external technology transfers on a global basis. Finally, she contributed to multiple New Drug Applications (NDAs) and Biologics License Applications (BLAs) that received approval by the U.S. FDA and European Medicines Agency.
Ms. Choudrie received her Bachelor of Science and Master of Science degrees in Mechanical Engineering from the New Jersey Institute of Technology.
"Rowena is a proven pharmaceutical product development professional with a track record of driving process development and scale-up, managing both clinical trial and commercial product supply and executing CMC sections for numerous regulatory filings. I welcome her to our team and am delighted to have the benefit of her product development knowledge and experience" said Kaushik J. Dave, Ph.D., Chief Executive Officer of Actinium Pharmaceuticals.
Mr. Zikaras joins Actinium from Bristol-Myers Squibb where he was a Clinical Protocol Manager in the Immuno-Oncology group since 2014. There he served as global clinical operations lead for the phase 3 registration trial for the lead asset indication in immuno-oncology and supported operations and regulatory filings for numerous immuno-oncology indications. From 2013 until 2014 he was Clinical Research Manager at Columbia University Medical Center where he managed Hematologic Malignancies clinical research including 8 FTEs. Also at Columbia, Mr. Zikaras managed multi-center and investigator initiated trials where his responsibilities included clinical trial development, budget creation and Investigational Review Board (IRB) submissions through completion. From 2011 until 2013, Mr. Zikaras was a Research Study Specialist at Memorial-Sloan Kettering Cancer Center where he was involved in 12 phase 1 – 3 clinical trials in hematologic malignancies including Actinium's Actimab-A program. Mr. Zikaras received his Bachelor of Arts degree with a major in biology from Bowdoin College and is an author on five publications.
Dr. Garzon, Actinium's Senior Vice President, Head of Clinical Development said, "Throughout his career Kevin has worked with leading researchers in the area of hematology and has developed strong skills in the areas of clinical trial management and operations. His experience in hematology clinical research and working experience with Actimab-A make him a valuable addition to the Actinium team."
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (http://www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.