SOURCE: Actinium Pharmaceuticals
Hillard Lazarus, MD, Pioneer Transplanter and Roland Turck, MD,
Radiopharmaceutical Commercialization Veteran Detailed Unmet Medical
Need and Development Path for Iomab-B
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM)
("Actinium" or "the Company"), a biopharmaceutical Company developing
innovative targeted payload immunotherapeutics for the treatment of
advanced cancers, recently hosted a Key Opinion Leader (KOL) Breakfast
for healthcare investors and industry professionals at the NY Palace
Hotel. A complete video of this event, as well as brief highlights from
the presentations are available and posted for viewing at http://www.actiniumpharma.com/investors/media-content/.
The
panelists discussed the dire need for new therapies for older patients
with hematologic malignancies including acute myeloid leukemia (AML),
and the curative role of bone marrow transplant. Iomab-B was described
as having efficacy and safety superior to that of traditional
myeloablative regimens, and likely to markedly increase the number of
patients eligible for transplant. An update on the upcoming Phase 3
clinical trial of Iomab-B, plus clinical positioning and positive
commercial prospects were also provided, and can be viewed online.
The
meeting featured bone marrow transplant and hematology specialist
Hillard M. Lazarus, MD, a Professor of Medicine at Case Western Reserve
University (CWRU) School of Medicine, as well as Disease Team Leader and
Director of Novel Cell Therapy at University Hospitals, Case Medical
Center, and Company Scientific Advisory Board Member. Also featured was
radiopharmaceutical industry veteran Roland U. Turck, MD, Managing
Partner at TurckBio and recently-appointed Senior Advisor to the
Actinium Board of Directors. Dr. Turck has extensive, unparalleled
experience in the launch and commercialization of radiopharmaceuticals.
Dr.
Lazarus performed the first bone marrow transplant in Ohio in 1976, and
has had a seminal impact on multiple aspects of transplantation He now
heads several clinical trials at the National Center for Regenerative
Medicine (CWRU). He has over 500 publications and has won a variety of
lifetime achievement, distinguished alumnus, and cancer research awards,
in addition to fellowships sponsored by the Leukemia Society of America
and the American Cancer Society.
Dr. Turck was formerly the
head of Bayer's Global Specialty Medicine business, where he helped lead
the commercialization of Xofigo, the first alpha particle-emitting
radioactive agent, whose launch has been the most commercially
successful of any radiopharmaceutical product to date. He is an expert
in biopharmaceutical specialty medicine with more than 20 years of
pharmaceutical industry experience at Bayer, Berlex, and Schering,
having developed and commercialized several major oncology products on a
global scale, including Xofigo, Stivarga, Nexavar, and Campath.
Those
interested in learning more about Iomab-B or bone marrow
transplantation are encouraged to view filmed highlights, or the
full-length video of the presentations, which are available in the media
section of the Company's website, at http://www.actiniumpharma.com/investors/media-content/.
About Bone Marrow Transplant:Bone
marrow transplants (BMT) are most commonly used to treat leukemia and
lymphoma, conditions incurred when a blood or immune cell, respectively,
becomes cancerous and proliferates. Together, these diseases account
for some 50,000 to 75,000 new cases annually in the United States. BMT
involves first clearing a patient's body of his or her own immune cells
and then transplanting bone marrow, the source of all blood- and
immune-forming cells, from a tissue-matched donor. The new cells, which
are free of cancer, repopulate the patient's bone marrow and eventually
give rise to a functioning set of blood and immune cells, providing a
lifelong cure. BMT offers the chance of a "curative" outcome (2+ year
survival), and therefore can play a central role in the treatment of
AML. The impact of BMT on AML continues to increase with AML being the
most common and fastest growing indication for allogeneic BMT,
comprising 25% to 30% of all BMT recipients. There are currently over
100,000 BMT survivors across all indications and this number is expected
to increase to 250,000 by 2020 and 500,000 by 2030, with 25% of them
over age 60.
About Iomab-BIomab-B™ is being
developed to prepare patients for hematopoietic stem cell
transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical
study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate
consisting of BC8, a novel murine monoclonal antibody, and iodine-131
radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research
Center to target CD45, a pan-leukocytic antigen widely expressed on
white blood cells. This antigen makes BC8 potentially useful in
targeting white blood cells in preparation for hematopoietic stem cell
transplantation in a number of blood cancer indications, including acute
myeloid leukemia (AML), chronic myeloid leukemia (CML), acute
lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL),
Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma
(MM).
About Actinium PharmaceuticalsActinium 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.
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