SOURCE: Actinium Pharmaceuticals
Company Gearing Up for Pivotal, Phase 3 Clinical Trial
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM)
("Actinium" or "the Company"), is a biopharmaceutical company
developing innovative targeted payload immunotherapeutics for the
treatment of advanced cancers. Actinium announced today that it has
submitted an Investigational New Drug (IND) application with the U.S.
Food and Drug Administration (FDA) for Iomab-B, a radioimmunotherapeutic
that conditions Acute Myeloid Leukemia (AML) patients for a
Hematopoietic Stem Cell Transplant (HSCT), commonly referred to as a
Bone Marrow Transplant (BMT). Pending the FDA's acceptance of the IND
filing, Actinium will initiate a single, pivotal Phase 3 clinical study
in refractory and relapsed AML patients over the age 55.
"We are
excited to have submitted the Iomab-B IND application to the FDA," said
Kaushik J. Dave, Ph.D., MBA, CEO of Actinium. "We focused heavily on
Iomab-B in 2015 and overcame our previous manufacturing hurdles, which
gave us great confidence when we met with the FDA for our pre-IND
meeting. Our filing, well ahead of our year end guidance, is a great
milestone for Actinium."
Sandesh Seth, Actinium's Executive
Chairman commented, "This much anticipated regulatory filing is an
important one that marks the first step in Actinium's transition to a
later development stage biopharmaceutical company. As we prepare for the
pivotal Phase 3 clinical trial for Iomab-B in 2016, we have added key
members to our executive, regulatory and clinical operations teams and
will continue to add selectively. This strengthening of the company will
enable us to meet our goals of efficient execution of not only the
Iomab-B program but also of the Actimab-A Phase 2 trial planned for
early 2016, as well as other pre-clinical and clinical programs expected
for next year."
About the Iomab-B Pivotal, Clinical Trial
Iomab-B
will be used in preparing patients for hematopoietic stem cell
transplantation (HSCT), the fastest growing hospital procedure in the
U.S. The Company established an agreement with the FDA that the path to a
Biologics License Application (BLA) submission could include a single,
pivotal Phase 3 clinical study, if it is successful. The population in
this two arm, randomized, controlled, multicenter trial will be
refractory and relapsed Acute Myeloid Leukemia (AML) patients over the
age of 55. The trial size was set at 150 patients with 75 patients per
arm. The primary endpoint in the pivotal Phase 3 trial is durable
complete remission, defined as a complete remission lasting at least 6
months and the secondary endpoint will be overall survival at one year.
There are currently no effective treatments approved by the FDA for AML
in this patient population and there is no defined standard of care.
Iomab-B has completed several physician sponsored clinical trials
examining its potential as a conditioning regimen prior to HSCT in
various blood cancers, including the Phase 1/2 study in relapsed and/or
refractory AML patients. The results of these studies in over 300
patients have demonstrated the potential of Iomab-B to create a new
treatment paradigm for bone marrow transplants by: expanding the pool to
ineligible patients who do not have any viable treatment options
currently; enabling a shorter and safer preparatory interval for HSCT;
reducing post-transplant complications; and showing a clear survival
benefit including curative potential.
About Iomab-B
Iomab-B
is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal
antibody, and iodine-131 radioisotope. BC8 has been developed by the
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). When labeled with radioactive isotopes, BC8
carries radioactivity directly to the site of cancerous growth and bone
marrow while avoiding effects of radiation on most healthy tissues.
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.
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