New Personnel Bolster Clinical and Regulatory Teams Ahead of Planned Phase 3 and Phase 2 Trials
NEW YORK, NY--(November 04, 2015) - Actinium Pharmaceuticals, Inc. ($ATNM) ("Actinium" or "the Company"), is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium announced today the appointment of Dr. Xin Du, Ph.D., to the position of Executive Director, Regulatory Affairs and Dr. Sri Srivastava, Ph.D., PMP, to the position of Associate Director of Project Management. Dr. Srivastava will have operational responsibilities for Actinium's Actimab-A program including the planned Phase 2 trial, planning and process optimization, management of external vendors and the coordination of all clinical trial related matters. Dr. Du will be responsible for managing Actinium's regulatory submissions, CMC efforts, interacting with regulatory agencies and developing the Company's regulatory strategy as pertains to both Iomab-B, Actimab-A and all future programs. Both hires are especially timely given the planned transformation of Actinium into a later stage product development company in 2016.
"Actinium is pleased to announce the continued expansion of our team and the key hiring of Dr. Du and Dr. Srivastava," said Kaushik Dave, Ph.D., MBA, CEO of Actinium. "We are focused on progressing Iomab-B and Actimab-A in the clinic and we view Dr. Du's FDA and regulatory background as a major asset as we prepare Iomab-B for its single, Pivotal Phase 3 trial and believe Dr. Srivastava's CRO and project management background will be integral to our anticipated Phase 2 trial for Actimab-A."
"I am excited to be part of the Actinium team and to have the opportunity to work on promising products which could provide significant benefits to patients. I am glad that I could bring my regulatory and biological knowledge and experience in helping the transformation of Actinium into a later stage product development company and in bringing high quality products to patients," Dr. Du said.
Dr. Xin Du, Ph.D., is a senior regulatory professional with over 15 years of industry experience and a proven track record of product approvals, regulatory strategy and efficient regulatory submission management. Dr. Du began his career at the FDA as Staff Fellow at the Center for Biologics Evaluation and Research. At the FDA, Dr. Du focused on the regulation of drug production, particularly Chemistry, Manufacturing and Control (CMC) and reviewed IND and BLA submissions. Following the FDA, he has worked for several global biopharmaceutical companies such as Aventis (acquired by Sanofi), Wyeth (acquired by Pfizer), Novartis, Bristol-Myers Squibb and NPS Pharmaceuticals (acquired by Shire) in regulatory affairs and CMC positions with increasing responsibility. Most Recently, Dr. Du was Senior Director and Global Regulatory CMC Head at NPS Pharmaceuticals, until the Company's acquisition by Shire, where he was instrumental in receiving approval for the Company's first BLA submission and in the successful launch of the Company's first product in Europe. Throughout his career, Dr. Du has been successful in preparing regulatory filings, managing interactions with regulatory agencies on a global basis and obtaining regulatory approvals for various drug products.
"I am delighted to join Actinium at such a transformational time for the Company. Actimab- A is an exciting radioimmunotherapeutic and I look forward to applying my clinical trial operations knowledge and experience to its development while working with the team as we guide Actimab-A through its planned Phase 2 trial," Dr. Srivastava said.
Dr. Sri Srivastava, Ph.D., PMP, has nearly two decades of successful project management and clinical operations experience with both large biopharmaceutical companies and as a consultant to emerging biopharmaceutical companies. His career includes tenures at Parke-Davis (now Pfizer), Purdue Pharma, Organon Pharmaceutical, Aestus Therapeutics, Janssen R&D and ClinTech Research. Dr. Srivastava spent a decade at ClinTech Research where he provided consulting services focused on clinical operations for emerging biopharmaceuticals including Aestus Therapeutics where he managed a randomized Phase 2 clinical trial. Dr. Srivastava has significant experience in clinical trial site and vendor oversight, developing study related documentation, designing clinical trial protocols, reviewing data management & monitoring plans, monitoring reports CSR. In addition, Dr. Srivastava has been invited speaker at clinical conferences to present multiple aspect of study management from virtual management and project optimization as it relates to clinical trials.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (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.
Senior Director, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
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