NEW YORK, Nov. 1, 2018
/PRNewswire/ -- Actinium Pharmaceuticals,
Inc. (NYSE American: ATNM) announced today that multiple
abstracts highlighting its Antibody Radiation Conjugates (ARCs)
have been accepted for presentation at the 59th American
Society of Hematology (ASH) Annual Meeting and Exposition,
including an oral presentation of preliminary feasibility and
safety results from its pivotal Phase 3 SIERRA trial of Iomab-B.
The ASH Annual Meeting is being held December 1 – 4, 2018 in San Diego, California. Data presented will
highlight Actinium's lead product candidate, Iomab-B, that is
intended to be a targeted conditioning agent prior to a bone marrow
transplant for patients with active relapsed or refractory Acute
Myeloid Leukemia (AML) who are over the age of 55. Patients with
active relapsed or refractory AML do not routinely undergo
allogeneic bone marrow transplant due to a lack of efficacy using
standard approaches and typically the survival of such patients
without a transplant is less than six months.
Iomab-B Oral Presentation Details
Abstract # 1017
Title: 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
Session Name: 721. Clinical Allogeneic Transplantation:
Conditioning Regimens, Engraftment, and Acute Transplant
Toxicities: Conditioning Intensity and Novel Approaches with
Targeted therapy
Session Date: Monday, December 3,
2018
Presentation Time: 6:45 PM
Room: Manchester Grand Hyatt San Diego, Seaport Ballroom A
Presenter: Dr. Agura, Baylor University
Medical Center
Results as of July 5, 2018
Dr. Mark Berger, Actinium's Chief
Medical Officer said, "We are honored that results from our ongoing
Phase 3 trial have been accepted for an oral presentation at this
year's ASH annual meeting as approximately just ten percent of
accepted abstracts receive this designation. Most importantly,
patients with active, relapsed or refractory AML have severely
restricted access to bone marrow transplant, the only potentially
curative treatment option, so we are we are elated that the initial
feasibility and safety data from SIERRA has demonstrated the
ability to enable transplant and engraftment for not only all
patients initially randomized to Iomab-B but also all those that
crossed-over from the control arm when salvage chemotherapy failed
to produce a complete response. Importantly, this occurred in
patients with high blast counts as the median blast count was 30%
and 47% in the Iomab-B arm and cross-over patients, respectively.
We look forward to having our data presented at ASH,
providing additional updates on this important trial as it
progresses and completing the SIERRA trial with the goal of
bringing this important targeted conditioning agent to patients
with a significant unmet need."
Sandesh Seth, Actinium's Chairman
and Chief Executive Officer said, "We are delighted that data
representing an important cross-section of our Antibody Radiation
Conjugate pipeline will be featured at this year's ASH,
particularly the presentation highlighting preliminary results from
the SIERRA trial for our lead targeted conditioning asset, Iomab-B.
Recognizing that a bone marrow transplant is a potentially curative
treatment option for many hematologic diseases, Actinium is focused
on improving bone marrow transplant access and outcomes through
improved targeted conditioning, which is currently underserved by
chemotherapy. We are excited that the data presented in the various
forums at ASH will demonstrate the capabilities of our highly
differentiated ARC approach for targeted conditioning that we
believe is unmatched by other technologies or approaches. We are
committed to continuing to expand our targeted conditioning
pipeline as we have done with Actimab-MDS with the goal of building
an independent fully integrated company."
Data from the Company's CD33 program ARC, Ac-225 – Lintuzumab,
and the recently completed Actimab-A Phase 2 trial from for
patients newly diagnosed with AML who are unfit for intensive
chemotherapy has been accepted for poster presentation. Actinium
recently announced in a CD33 program update that, based on the
results of the Phase 2 Actimab-A trial, Actinium is continuing to
develop Ac-225 – Lintuzumab in two combination trials for patients
with relapsed or refractory AML, one being with Venetoclax and the
other being with Venetoclax and Hypomethylating agents. Ac-225 –
Lintuzumab is also being studied in patients with multiple myeloma
and as a targeted conditioning agent to enable a bone marrow
transplant for patients with high-risk Myelodysplastic
Syndrome.
Actimab-A Abstract Details
Abstract # 1457
TITLE: A Phase 2 Study of Actinium-225 (225Ac)-Lintuzumab in Older
Patients with Untreated Acute Myeloid Leukemia (AML) - Interim
Analysis of 1.5 µci/Kg/Dose
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Poster I
Date: Saturday, December 1, 2018
Presentation Time: 6:15 PM - 8:15
PM
Location: San Diego Convention
Center, Hall GH
Actinium also submitted preliminary data from its Iomab-ACT
program for next generation targeted lymphodepletion prior to CAR-T
therapy. This data will be published online coinciding with the
start of the 2018 ASH Annual Meeting.
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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