NEW YORK, Sept. 6, 2018 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) today announced the appointment of Robert N. Daly, M.S., Ph.D., to the position of Vice President, Head of Clinical Operations, effective immediately. In this role, Dr. Daly will oversee all clinical operations, with a focus on executing Actinium's progressing pivotal Phase 3 trial for Iomab-B as a targeted conditioning agent, driving forward the Company's growing CD33 program including its advancement in targeted conditioning, as well as future clinical trial expansion for the entire pipeline. He will be supervised by Dr. Mark Berger, Actinium's Chief Medical Officer and will report to Actinium's Chairman and CEO, Sandesh Seth, for strategic and organizational related matters.
"Dr. Daly is a seasoned industry veteran with more than 20 years of relevant experience in clinical operations, clinical research and product development, having worked for pharmaceutical, biotechnology and contract research organizations, worldwide," stated Dr. Berger. "He has considerable experience in successfully managing clinical operations of large, global clinical trials as evidenced by the 7,000 patient, 450-site Phase 3 trial he led across 30 countries while at Portola that resulted in the approval of Betrixaban. Dr. Daly's clinical operations expertise, as well as his experience in the field of hematologic malignancies, makes Dr. Daly a perfect fit for this position. I look forward to working with Dr. Daly in continuing to establish Actinium as the leader in targeted conditioning for bone marrow transplant."
Dr. Daly stated, "Throughout my career I have managed and progressed large, multi-center, international clinical trials including those that have supported approvals in areas of high unmet patient need. I was struck by the pedigree of Actinium's drug candidates and the breadth of clinical evidence supporting their use in targeting conditioning for bone marrow transplant and hematologic indications. I am excited to join Actinium now, given the positive momentum of the SIERRA trial for Iomab-B following the positive DMC safety analysis and the recent expansion of our CD33 program to targeted conditioning for high-risk MDS patients, multiple myeloma and in novel combinations for difficult to treat patient populations. I look forward to working with my colleagues at Actinium to successfully complete the SIERRA trial, prepare for a BLA submission and continue to build a best-in-class CD33 program. This is clearly an exciting and critical time for Actinium and I am honored to be on board and to contribute to the Company's mission."
Sandesh Seth, Actinium's Chairman and CEO said, "Actinium has evolved to a highly differentiated biotechnology company with a multi-target clinical pipeline focused on targeted conditioning to provide more patients with access to potentially curative bone marrow transplant and improving patient outcomes from BMT. Utilizing our antibody radio-conjugate approach, our clinical development team has found multiple ways to drive synergy and expansion across our pipeline as evidenced by first-in-class initiatives such as our Actimab-MDS trial, the first CD33 targeted conditioning trial for this patient population, and Actimab-M, the first CD33 targeting program and alpha-particle in patients with multiple myeloma. We are confident that additional opportunities exist that our ARC approach is ideally suited for and the addition of Dr. Daly to the Actinium team will allow us to efficiently and effectively capitalize on these opportunities. I am confident that Dr. Daly will make an immediate impact on our pivotal Phase 3 SIERRA trial and lasting contributions to Actinium's growth."
Prior to joining Actinium, Dr. Daly served as Vice President, Clinical, at CTI BioPharma, where he led research and development activities for Clinical Operations supporting the company's two Phase 3 programs for Pacritinib, a JAK2/FLT3 inhibitor for patients with Myelofibrosis. Previously, Dr. Daly was Vice President, Development Operations at Durata Therapeutics, Inc., until its acquisition by Actavis, plc. At Durata, Dr. Daly managed multiple departments including all R&D, Clinical Monitoring and Operations, Project Management, Biostatistics and Data Management supporting Dalbavancin, a lipoglycopeptide antibiotic approved for patients infected with methicillin-resistance Staphylococcus aureus. Dr. Daly served as Executive Director, Clinical Operations and Head, Global Medical Sciences and Medical Affairs for Portola Pharmaceuticals, Inc. While at Portola, Dr. Daly managed a 7,000 patient, 450-site Phase 3 trial in 30 countries that led to the approval of the Factor Xa Inhibitor Betrixaban for patients with venous thrombosis. Dr. Daly also directed Portola's activities in oncology for an orally available kinase inhibitor aimed at hematologic cancers and inflammatory disorders. During Dr. Daly's career, he also gained valuable clinical research, clinical operations and product experience at companies including KAI Pharmaceuticals, Inc., Artisan Pharma, Inc., Theravance Biopharma, Inc., Millennium Pharmaceuticals, Inc., DuPont Pharmaceuticals Company and KOS Pharmaceuticals, Solvay Pharmaceuticals and SmithKline Beecham Pharmaceuticals.
Dr. Daly received his Ph.D. in pharmacology from the Medical College of Pennsylvania (now Drexel University School of Medicine), a Master of Science in biology from Drexel University and a Bachelor of Arts degree in biology from Glassboro State College (now Rowan University). He has authored more than 30 publications and has been a frequent presenter at major medical meetings.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for potentially superior targeted conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. The Company's targeted Antibody Radio-Conjugates (ARCs), combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium is developing a pipeline of clinical-stage ARCs targeting CD45 and CD33 for patients with a broad range of hematologic malignancies.
Iomab-B, Actinium's lead product candidate, is currently enrolling patients in a pivotal Phase 3 trial. Iomab-B combines the anti-CD45 monoclonal antibody BC8 labeled with iodine-131 and is designed to condition the bone marrow prior to a bone marrow transplant without the need for intense chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) of age 55 or older. Actinium's pipeline also includes a potentially best-in-class CD33 program with our ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in Phase 2 and Phase 1 clinical trials for patients with AML, myelodysplastic syndrome (MDS) and multiple myeloma.
Actinium is also developing its proprietary Actinium Warhead Enabling (AWE) technology platform to utilize the highly differentiated radioisotope actinium-225 with a wide range of targets. AWE is being utilized in a collaborative research partnership with Astellas Pharma, Inc.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
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