Actinium Pharmaceuticals Strengthens Targeted Myeloablation Focused Clinical Development Team with New Hires Including Experienced Bone Marrow Transplant Physician and Drug Developer Vijay Reddy, M.D., Ph.D. as Vice President, Clinical Development
- Dr. Vijay Reddy joins Actinium with over 20 years of bone marrow transplant clinical experience including extensive product development experience at Pharmacyclics, an AbbVie Company, Medimmune and Johnson & Johnson
- Dr. Reddy will be focused on Actinium’s targeted myeloablation programs including the Pivotal Phase 3 SIERRA trial for Iomab-B and the planned Phase 2 Actimab-MDS trial
- Dr. Farnoush Safavi appointed Director of Clinical Development and Kathleen McNamara, R.N appointed Clinical Education Support Specialist will also focus on Iomab-B, Actimab-MDS and other planned myeloablation trials
NEW YORK, April 18, 2018 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) ("Actinium" or "the Company"), announced today that it has expanded its clinical development team with hiring of Vijay Reddy, M.D., Ph.D. as Vice President, Clinical Development, who will focus on Actinium’s clinical programs centered on targeted myeloablation. Actinium is differentiating itself by developing the only multi-disease, multi-target pipeline of drug candidates focused on improving bone marrow transplant access and outcomes through improved myeloablation which includes the Company’s lead program, Iomab-B, that is being studied in the Pivotal Phase 3 SIERRA study and its planned Phase 2 Actimab-MDS trial.
Dr. Mark Berger, Actinium’s Chief Medical Officer said, “I am incredibly excited to welcome Dr. Reddy, Dr. Safavi and Ms. McNamara to Actinium’s clinical development team. Vijay brings extensive clinical experience in the field of bone marrow transplant along with hematology focused drug development experience. His deep domain expertise and knowledge will allow us to capitalize on the many opportunities in myeloablation, for which our drug candidates and Actinium Warhead Enabling technology are ideally suited. Farnoush has a strong background in clinical trial execution and a proven ability to drive clinical trial enrollment, which will be of great benefit as we work to complete the SIERRA trial and launch new trials such as Actimab-MDS. Kathleen possesses a strong clinical nursing background, drug development experience and significant experience in the administration of complex therapies that will be well received by the SIERRA sites she supports. I am confident that collectively and individually, Dr. Reddy, Dr. Safavi and Ms. McNamara will make invaluable contributions that will allow us to continue to build on Actinium’s leadership position in myeloablation.”
Dr. Reddy said, “As a transplant physician I am keenly aware of Iomab-B and its value proposition for patients, so it is incredibly exciting to have the opportunity to help bring this important targeted therapy against acute myeloid leukemia to patients with a clear need that can benefit from a BM. Actinium has done a fantastic job in the execution of the SIERRA trial thus far, as evidenced by participation of many of the leading BMT centers. In addition, expansion of the myeloablation programs with the planned Actimab-MDS trial represents a compelling opportunity. I am incredibly excited by the opportunities that lie ahead for Actinium and look forward to working with Dr. Berger and my new colleagues to build the leading myeloablation company.”
Sandesh Seth, Actinium’s Chairman and CEO said, “Actinium is committed to being the leading company focused on myeloablation that improves access to and outcomes from potentially lifesaving bone marrow transplants. What started as a single asset in Iomab-B has evolved into a myeloablation franchise with the only multi-disease multitarget pipeline in myeloablation. The addition of Dr. Reddy, Dr. Safavi and Ms. McNamara will allow us to execute on the critical milestones for our pivotal Phase 3 trial for Iomab-B, efficiently launch our planned Phase 2 Actimab-MDS trial and capitalize on other opportunities in the field. We are incredibly excited for the talent we have assembled within Actinium and are motivated to make great advances with our drug candidates and technologies to better outcomes for patients.”
Dr. Reddy has specialized in hematologic oncology with a Ph.D. in cancer immunology who focused his clinical practice in the area of bone marrow transplantation. Dr. Reddy was attending physician at Shands Hospital, University of Florida, and the Medical Director for adult BMT program in Orlando, prior to his starting in industry. He has served as inspector for the Foundation of Accreditation of Cellular Therapies (FACT). He is currently an Editorial Board Member for Biology of Blood and Marrow Transplantation and has authored over 50 publications in hematology/oncology and BMT journals.
Dr. Reddy joins Actinium from Pharmacyclics LLC, an Abbvie company, where he was Senior Medical Director, Oncology Medical Affairs. In this role, Dr. Reddy worked on the Ibrutinib program in CLL, MCL and chronic graft versus host disease (GVHD), along with additional indications. Previously, he worked at Medimmune (AstraZeneca) as Medical Director, Early clinical development, Immuno-Oncology R&D. Prior to Medimmune, Dr. Reddy worked at Janssen, a Johnson & Johnson company as Medical Director, Oncology. Prior to his experience in the pharmaceutical industry, Dr. Reddy was Professor of Medicine at the University of Central Florida. As a practicing clinician, Dr. Reddy participated in several clinical trials for BMT as an investigator, physician advisor or advisory board member.
Dr. Reddy received his M.B., B.S. (M.D. equivalent) from the Madras Medical College in India and his Ph.D. in cancer immunology from Memorial University of Newfoundland in Canada. He completed fellowships in hematology at The Princess Margaret Hospital and in Blood and Marrow Transplantation at the University of Toronto. He also was a Research Associate at the Dana Farber Cancer Institute.
Dr. Safavi joined Actinium from Progenics Pharmaceuticals, Inc., where she focused on oncology clinical studies. Prior to Progenics, Dr. Safavi had clinical roles of increasing responsibility at Stealth Bio Therapeutics, Verastem Inc. and New England Research Institute, Inc. Before her work in industry, Dr. Safavi supported academic clinical research at Massachusetts General Hospital, Emory University, Memorial Sloan Kettering Cancer Center, Montefiore Medical Center – Albert Einstein School of Medicine and MD Anderson Cancer Center.
Dr. Safavi received her M.D. from Xavier University School of Medicine, West Indies, Master of Health Services Administration from St. Joseph’s College of Maine and her Bachelor of Science degree in Biology from the University of Houston.
Kathleen McNamara is a Registered Nurse and Oncology Certified Nurse with significant clinical experience in the care of oncology patients. Most recently, Ms. McNamara was the Nurse Manager at a large infusion center where she oversaw patient care and trained the nursing staff in oncology therapy administration. Kathleen gained valuable experience in drug developing where she worked at Celgene Corporation as a Clinical Research Scientist on leukemia focused clinical trials and at Quintiles as an Oncology Nurse Educator. The majority of Kathleen’s career has been focused on the clinical care of oncology patients where she gained valuable experience in the administration of complex oncology therapies including biologics, bone marrow transplants and clinical trials. In addition, Kathleen has successfully managed, led and helped educate nursing staffs in a number of hospitals and infusion centers.
Kathleen earned her Bachelor of Science degree in Nursing from Niagara University and her Master of Arts degree in Education from Long Island University. She is a Registered Nurse with a certificate in Pediatric Nurse Practitioner in Ambulatory Pediatrics from the State University of New York.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for potentially superior myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. Our targeted therapies have demonstrated the potential to result in significantly improved access to bone marrow transplant with better outcomes, namely increased marrow engraftment and survival. Our targeted therapies are ARC’s or Antibody Radio-Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. We have four clinical trials based on our AWE or Actinium Warhead Enabling Technology Platform that utilizes the isotope Actinium-225 (Ac225) which emits alpha particles. In addition, our most advanced product candidate, Iomab-B, an ARC developed by the Fred Hutchinson Cancer Research Center, is comprised of an anti-CD45 monoclonal antibody labeled with iodine-131. We are currently conducting a pivotal Phase 3 trial of Iomab-B for myeloablation and conditioning of the bone marrow prior to a bone marrow transplant for patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow transplant is a potentially curative treatment for patients with AML and other blood cancers including leukemias, lymphomas and multiple myeloma as well as certain blood disorders. Iomab-B has been tested in several of these other cancers with over five hundred patients treated in several Phase 1 and 2 trials with promising results. Upon successful completion of our Phase 3 clinical trial for Iomab-B we intend to submit this candidate for marketing approval in the U.S. and European Union where it has been designated as an Orphan Drug. We are also developing a potentially best in class CD33 program using an ARC comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Our most advanced CD33 program candidate, Actimab-A, is currently in a Phase 2 clinical trial for patients advanced over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy. Actimab-A also has Orphan Drug designation in the US and EU. Actimab-M, our second CD33 program ARC, is being studied in a Phase 1 trial for patients with refractory multiple myeloma. Actinium is also planning a Phase 2 trial for Actimab-MDS, our third CD33 program candidate, as a conditioning regimen prior to a bone marrow transplant for patients with MDS that have a p53 genetic mutation. Our Phase 1 trial studying Actimab-A with CLAG-M is our fourth CD33 program clinical trial for patients with relapsed or refractory AML. Our AWE or Actinium Warhead Enabling Technology Platform, originally developed in conjunction with Memorial Sloan Kettering Cancer Center, is focused on leveraging Actinium’s know how and intellectual property to create additional ARC drug candidates by labeling Ac225 to targeting moieties that we will either progress in clinical trials ourselves or out-license.
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.
Actinium Pharmaceuticals, Inc.
Principal Financial Officer
Marek Ciszewski, J.D.
Released April 18, 2018