NEW YORK, Feb. 5, 2019 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the
Company") announced today that its novel Phase 1/2 combination
trial of Actimab-A and venetoclax has been initiated. Gary Schiller, MD, Professor,
Hematology-Oncology and Director, Hematologic Malignancy/Stem Cell
Transplant Program at the UCLA Medical Center will serve as
Principal Investigator for this study. The Phase 1/2 combination
trial will enroll patients with relapsed or refractory AML or Acute
Myeloid Leukemia that have been previously treated with venetoclax
and patients that have never received venetoclax.
Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor that is
jointly developed and marketed by AbbVie and Genentech. BCL-2 is
one of several proteins encoded by the BCL2 gene family, which
regulates apoptosis or programmed cell death. MCL-1 is another
protein encoded by the BCL2 gene family that is also overexpressed
in cancers, including relapsed or refractory AML, that prevents
apoptosis and promotes resistance to venetoclax, which does not
bind to MCL-1. It has been demonstrated that MCL-1 levels can be
depleted with radiation, but only external radiation was used in
these studies. Actinium believes that the targeted radiation from
Actimab-A can more effectively deplete MCL-1 levels thereby
removing the AML cells' resistance mechanism and rendering them
more susceptible to venetoclax. In preclinical studies, Actinium
demonstrated this synergistic effect when combining Actimab-A with
venetoclax that led to increased cancer cell death, the results of
which were highlighted in a webinar hosted by Actinium that can be
accessed here.
Dr. Dale Ludwig, Actinium's Chief
Scientific Officer said, "The ability to deplete MCL-1, a known
resistance mechanism to venetoclax, by selectively targeting AML
cells that express CD33 with Actimab-A and hitting them with potent
alpha radiation from Actinium-225 is very compelling. I am excited
to see this study enter the clinic as I believe Actimab-A's
targeted radiation will prove to be synergistic with venetoclax as
we have shown in our preclinical work. With our powerful Antibody
Warhead Enabling technology platform we are excited to deploy
targeted radiation as a weapon against cancer cells by exploiting
their susceptibility to radiation and leveraging potential
synergies with other therapeutic modalities."
Dr. Mark Berger, Chief Medical
Officer of Actinium said' "Despite advancements and recent
approvals of AML therapies including venetoclax, there is a real
need to improve their incremental benefits and produce more durable
responses as well as curative outcomes for patients with relapsed
and refractory disease. We are excited about this trial as our
recent phase 2 study with Actimab-A demonstrated an ability to
produce complete responses in difficult to treat AML
patients. We attribute this efficacy to ARCs being agnostic
to cytogenetic factors, the ubiquitous expression of CD33 in AML
and potency of the Actinium-225 warhead. We are hopeful that the
combination of Actimab-A and venetoclax will in the clinic will
validate our preclinical studies showing synergy and result in
improved patient outcomes."
About Actinium Pharmaceuticals, Inc.
Actinium
Pharmaceuticals Inc. is focused on improving patient access and
outcomes to cellular therapies such as bone marrow transplant (BMT)
and CAR-T with its proprietary, chemotherapy free, targeted
conditioning technology. Actinium is the only company with a
multi-disease, multi-target, drug development pipeline focused on
targeted conditioning. Its targeted conditioning technology is
enabled by ARCs or Antibody Radio-Conjugates that combine the
targeting ability of monoclonal antibodies with the cell killing
ability of radioisotopes. Actinium's pipeline of clinical-stage
targeted conditioning ARCs target the antigens CD45 and CD33 for
patients with a broad range of hematologic malignancies including
acute myeloid leukemia (AML) and myelodysplastic syndrome
(MDS).
Iomab-B, Actinium's lead targeted conditioning product
candidate, is currently enrolling patients in the pivotal Phase 3
SIERRA trial in patients age 55 or older, with active, relapsed or
refractory AML. Iodine-131 apamistamab (Iomab-B), combines the
anti-CD45 monoclonal antibody labeled with iodine-131 for
myeloablation prior to a bone marrow transplant. CD45 is expressed
on leukemia, lymphoma and normal immune cells. Iomab-B has been
studied in over 500 patients in 10 clinical trials in numerous
hematologic diseases. Actinium's Iomab-ACT program is an expansion
of its CD45 program that is intended to be a universal, chemo-free
solution for targeted lymphodepletion prior to CAR-T. Through
targeted lymphodepletion, the Iomab-ACT program is expected to
improve CAR-T cell expansion, reduce CAR-T related toxicities and
expand patient access to CAR-T treatment and potentially other
adoptive cell therapies. Due to its lower payload dose,
lymphodepletion with the Iomab-ACT program can be accomplished
through a single outpatient infusion. Actinium intends to advance
its Iomab-ACT program with CAR-T focused collaborators from
academia and industry.
Actinium's pipeline also includes a potentially best-in-class
CD33 program with its ARC comprised of the anti-CD33 antibody
lintuzumab labeled with the alpha-particle emitter actinium-225.
Its CD33 program is currently being studied in multiple Phase 1
clinical trials for targeting conditioning, in combinations and as
a therapeutic in multiple diseases and indications including AML,
MDS and MM.
Actinium is also developing its proprietary AWE or Antibody
Warhead Enabling technology platform which utilizes radioisotopes
including iodine-131 and the highly differentiated actinium-225
coupled with antibodies to target a variety of antigens that are
expressed in hematological and solid tumor cancers. The AWE
technology enables Actinium's internal pipeline and with the
radioisotope Actinium-225 is being utilized in a collaborative
research partnership with Astellas Pharma, Inc. Actinium's clinical
programs and AWE technology platform are covered by a portfolio of
over 75 patents covering composition of matter, formulations,
methods of use and also methods of manufacturing the radioisotope
Actinium-225 in a cyclotron.
More information is available at www.actiniumpharma.com and our
Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
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.
Contact:
Actinium Pharmaceuticals, Inc.
Steve O'Loughlin
Principal Financial Officer
soloughlin@actiniumpharma.com
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SOURCE Actinium Pharmaceuticals, Inc.