NEW YORK, Dec. 4, 2018 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) announced
today that additional data from an updated analysis of the pivotal
Iomab-B Phase 3 SIERRA trial were highlighted last night in an oral
presentation at the 60th American Society of Hematology
(ASH) Annual Meeting. The SIERRA trial is the only ongoing Phase 3
trial offering a bone marrow transplant (BMT) to patients 55 years
of age or older with active, relapsed or refractory acute myeloid
leukemia (AML). Data in the table below were presented in the oral
session and are updated from those at the time of abstract
submission. Preliminary data strongly support the feasibility and
safety of re-induction and targeted conditioning with Iomab-B prior
to a BMT.
Preliminary
Feasibility and Safety Data
|
|
Randomized to
Iomab-B Study Arm
(N=19)
|
Randomized to
Conventional Care
(N=19)
|
Randomized to
Conventional Care,
No Remission, and
Crossed Over (N=10)
|
Number of
Patients
Receiving BMT after
receiving therapy
|
100%
(18/18)
(1 patient did
not
receive therapeutic
Iomab-B dose)
|
21% (4/19)
|
100%
(10/10)
|
Blast % at
Randomization
|
Median:
30%
Range: 4*
-74
|
Median:
26%
Range:
6-97
|
At Randomization
24% (6-70) At Crossover 45%
(10-70)
|
Days to
BMT
(post-randomization)
|
Median: 28
Range:
23-38
|
Median: 67
Range:
66-86
|
Median: 66
Range:
57-161
|
Days to Absolute
Neutrophil
Engraftment
|
Median:13
Range: 9 –
22
|
Not
entered
|
Median:13
Range: 9 -
20
|
Days to Platelet
Engraftment
|
Median: 16
Range: 13 –
26
|
Not
entered
|
Median:17
Range: 10 –
20
|
100-Day Non-
Relapse Mortality
|
0% (0/18)
|
25% (1/4 – septic
shock)
|
10% (1/10 –
diffuse
alveolar hemorrhage)
|
*1 patient with 4%
blasts in the marrow had circulating AML blasts
|
Other Key Highlights:
- 15 of 19 (79%) patients in the control arm failed to achieve a
complete response
- 67% (10/15) of patients eligible for crossover successfully
transplanted with Iomab-B
- All patients receiving Iomab-B engrafted despite active disease
with high blast count (median 30%, or median 45% for crossover
patients)
- Patients receiving Iomab-B received a BMT more quickly
post-randomization (28 days) than patients receiving conventional
care (67 days)
- In the conventional care arm, there was no difference in time
to BMT for patients that crossed over to Iomab-B (66 days) compared
to those achieving complete remission with conventional care (67
days)
- No Grade 3 or 4 Iomab-B infusion related reactions with all
Iomab-B infusions completed
- No non-relapse mortality in patients randomized to Iomab-B
arm
Abstract #1017: Targeted Conditioning of Iomab-B
(131I-anti-CD45) Prior to Allogeneic Hematopoietic Cell
Transplantation Versus Conventional Care in Relapsed or Refractory
Acute Myeloid Leukemia (AML): Preliminary Feasibility and Safety
Results from the Prospective, Randomized Phase 3 Sierra Trial
Dr. Edward Agura, Medical
Director of Bone Marrow Transplantation at Baylor University Medical Center said, "Given that
more than two thirds of patients who are diagnosed with AML are 55
years of age or older, there exists a significant unmet medical
need to broaden transplant access and improve outcomes for these
patients. The data from the SIERRA trial thus far are highly
encouraging as they demonstrate that Iomab-B can enable a
potentially curative transplant in patients with active disease,
including those patients with progressing disease who did not
achieve a response on conventional care. The nearly universal and
rapid engraftment of patients receiving Iomab-B, together with no
100-day non-relapse mortality, is particularly compelling as these
results have not been achieved with conventional care."
The 150 patient SIERRA study is a multi-center randomized trial
that will compare outcomes of patients who receive Iomab-B and a
BMT to those patients receiving physician's choice of salvage
chemotherapy, defined as conventional care, as no standard of care
exists for this patient population. AML patients with active,
relapsed or refractory AML have dismal prognoses and are typically
not offered curative transplant as an option. This is largely
because salvage treatments have a limited ability to produce a
complete remission, which is necessary prior to BMT if conventional
BMT is to be successful. However, with Iomab-B targeted
conditioning, a complete remission prior to starting the Iomab-B
conditioning is not necessary for a successful transplant.
Dr. Mark Berger, Actinium's Chief
Medical Officer said, "We believe that Iomab-B represents a
potentially disruptive modality for targeted conditioning. The
preliminary data from the SIERRA trial presented at ASH exceeded
our expectations regarding feasibility and safety, which adds to
the already extensive body of research and data demonstrating the
utility of Iomab-B for targeted conditioning in multiple
hematologic indications. With this data in hand we are highly
motivated to complete the SIERRA trial, which will serve as the
beachhead for our multi-target, multi-disease pipeline for targeted
conditioning, where we are committed to expanding our leadership
position."
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
or sparing, 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 ARC's or Antibody Radiation
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), acute
lymphoblastic leukemia (ALL), Hodgkin's lymphoma and Non-Hodgkin's
lymphoma. Actinium's Iomab-ACT program is designed to be a
universal lymphodepletion technology intended to eliminate the need
for chemotherapy-based conditioning prior to CAR-T or other
adoptive cellular therapies.
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,
chemotherapy-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 clinical
trials for targeting conditioning and as a therapeutic in multiple
diseases and indications including AML, MDS and MM. Actinium
applies its CD33 program at high doses to target CD33+ cells of the
myeloid lineage in combination with reduced intensity conditioning
(RIC), which together are intended to result in myeloablative
outcomes with a more benign and well tolerated profile than high
intensity chemotherapy myeloablation. Actinium is focused on
applying its CD33 program at low doses in combination with other
therapeutic modalities including chemotherapy, targeted agents and
immunotherapies.
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
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
Investor Relations
Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com
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SOURCE Actinium Pharmaceuticals, Inc.