NEW YORK, Feb. 4, 2019 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or
the "Company") announced today that the Medical College of Wisconsin (MCW) has started
dosing patients in the second cohort of its novel trial of
Actimab-A in combination with CLAG-M in patients with relapsed or
refractory AML or Acute Myeloid Leukemia. This trial is evaluating
the impact that the addition of targeted internalized radiation via
Actimab-A to the salvage chemotherapy regimen CLAG-M will have on
safety and tolerability, response rates, rates of BMT or bone
marrow transplant, PFS or progression-free survival, and OS or
overall survival.
Dr. Mark Berger, Chief Medical
Officer of Actinium, said, "This trial represents an exciting
advancement of our CD33 program that is aligned with our clinical
strategy to pursue combinations utilizing our ARC drug candidates.
We are pleased to be moving ahead with MCW to the second cohort of
this trial and we are optimistic that our ARC combination strategy
will have a positive impact on patient outcomes by improving
response rates, duration of responses and/or increasing the rate of
patients receiving a bone marrow transplant. Chemotherapy and
external radiation are routinely used in combination in several
cancers but despite being radiation sensitive, AML is not treated
with external radiation given its diffuse nature. Therefore, the
ability to deliver radiation internally in a targeted fashion to
AML cells with potency and tolerability gives us great confidence
in our ARC approach. In addition, this trial is particularly
important as AML patients with relapsed or refractory disease face
a poor prognosis with limited treatment options."
In this Phase 1 combination trial patients are administered the
salvage chemotherapy regimen CLAG-M, which consists of cladribine,
cytarabine, filgrastim, and mitoxantrone, followed by a single dose
of Actimab-A. Actimab-A is an ARC or Antibody Radiation-Conjugate
that consists or the CD33 targeting monoclonal antibody lintuzumab
labelled with the alpha-particle emitting isotope Ac-225 or
Actinium-225. In the first dose cohort, patients received 0.25
uCi/kg of Actimab-A. This combination trial is designed as a 3+3
dose escalation study. No dose limiting toxicities (DLTs) were
reported in the first patient cohort. As a result, and per the
study protocol, the Institutional Review Board (IRB) at MCW has
authorized the initiation of the second dosing cohort, in which
patients will receive 0.50 uCi/kg of Actimab-A. Assuming no DLTs
are observed in the second cohort, three patients will be treated
and the study will progress to the third and final cohort will
study Actimab-A at a dose of 0.75 uCi/kg.
Sandesh Seth, Actinium's Chairman
and Chief Executive Officer of Actinium, said, "In recent months,
Actinium's R&D and clinical teams have worked together to
identify opportunities to further utilize our ARCs in combination
with other therapeutic modalities. As a result, we are exploring
multiple R&D and clinical initiatives with ARC based
combination therapies. With the ARC combination strategy solidified
as a corporate focus, we are delighted to see this positive
progress from our first Actimab-A combination trial with CLAG-M. We
are confident that the use of targeted radiation will prove
synergistic with multiple modalities and open several therapeutic
opportunities that are not possible with any other technology. We
look forward to making continued progress on this front including
the planned clinical trials with Actimab-A and venetoclax."
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), myelodysplastic syndrome (MDS) and
multiple myeloma (MM).
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.