Breaking News

Tweet TWEET

Actinium to Host Advisory Meeting at the 2014 ASBMT and CIBMTR Conference

Actinium to Host Advisory Meeting at the 2014 ASBMT and CIBMTR Conference 
Leading Transplant Experts to Review Preparations for Pivotal Phase
III Trial of Actinium's Iomab(TM)-B Drug Candidate 
NEW YORK, NY -- (Marketwired) -- 02/26/14 --  Actinium
Pharmaceuticals, Inc. (OTCBB: ATNM) ("Actinium" or "the Company"), a
biopharmaceutical Company developing innovative targeted payload
immunotherapeutics for the treatment of advanced cancers, will host
an advisory meeting with leading bone marrow transplant experts
during the combined annual meetings of the American Society for Blood
and Marrow Transplantation (ASBMT) and the Center for International
Blood & Marrow Transplant Research (CIBMTR) in Grapevine, Texas on
Saturday, March 1, 2014. The Company will present an agreement
reached with the Food and Drug Administration (FDA) on the design of
a single pivotal Phase III trial for approval of Iomab(TM)-B,
Actinium's leading drug candidate. The advisory group will discuss
the Iomab(TM)-B Phase III trial design, formation of a Scientific
Advisory Board for Iomab(TM)-B and logistics of the Phase III trial.  
"Having such a prominent group of transplant experts working with us
on this trial will go a long way toward ensuring the best possible
trial," said Dragan Cicic, MD, Chief Medical Officer of Actinium
Pharmaceuticals. "We are not only developing a new drug but an
entirely new paradigm in treatment of this patient population, and
having people who in many ways define new treatment paradigms
actively participate in the process is of enormous value to us." 
Attendees of the meeting will include Richard Champlin, MD, Chair,
Department of Stem Cell Transplantation and Cellular Therapy, MD
Anderson Cancer Center, Houston, TX; Sergio Giralt, MD, Chief Adult
Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer
Center; Hillard Lazarus, MD, Disease Team Leader and Director, Novel
Cell Therapy, University Hospitals Case Medical Center; Peter
McSweeney, MD, Clinical Director and Laboratory Medical Director,
Blood and Marrow Transplant Program, Colorado Blood Cancer Institute
and Primary Investigator for Iomab(TM)-B trials; and John Pagel, MD,
PhD, Associate Member, Clinical Research Division, Fred Hutchinson
Cancer Research Center.  
"I am thrilled that we are moving closer to the final trial before
potential approval for Iomab(TM)-B," said John Pagel, MD, Primary
Investigator for Iomab(TM)-B. "This drug candidate has a potential to
change the way we approach bone marrow transplants and expand their
use to patients who would benefit from them the most but currently
have very limited access to this lifesaving procedure." 
About Iomab(TM)-B 
Iomab(TM)-B will be used in preparing patients for hematopoietic stem
cell transplant, commonly referred to as bone marrow transplant which
is 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 will include a single, pivotal
Phase 3 clinical study if it is successful. The trial 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 study design of the pivotal trial is based on
results of an earlier Phase 1/2 trial in which sixty percent of the
older patients with refractory and relapsed AML exhibited disease
free survival estimated at six months. The primary endpoint in the
pivotal Phase 3 trial is durable complete remission, defined as a
complete remission lasting at least 6 months. There are currently no
treatments approved by the FDA for AML in this patient population and
there is no defined standard of care. Iomab(TM)-B has completed
several physician sponsored clinical trials examining its potential
as a conditioning regimen prior to a bone marrow transplant 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(TM)-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.  
Iomab(TM)-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 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. (OTCBB: ATNM) is a New York-based
biopharmaceutical company developing innovative targeted payload
immunotherapeutics for the treatment of advanced cancers. Actinium's
targeted radiotherapy is 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 Iomab(TM)-B will be used in preparing patients
for hematopoietic stem cell transplant, commonly referred to as bone
marrow transplant. The Company is conducting a single, pivotal,
multicenter Phase 3 clinical study of Iomab(TM)-B in refractory and
relapsed Acute Myeloid Leukemia (AML) patients over the age of 55
with a primary endpoint of durable complete remission. The company's
second program, 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. For more information, please visit
www.actiniumpharmaceuticals.com. 
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.  
Contact:
Actinium Pharmaceuticals, Inc.
Investor/Media Relations: 
Corey Sohmer
(646) 459-4201
Email: csohmer@actiniumpharmaceuticals.com 
 
 
Press spacebar to pause and continue. Press esc to stop.