- The SIERRA results demonstrate Iomab-B's
ability to overcome the negative impact of a TP53 mutation in
patients who otherwise would have limited treatment options and
dismal prognosis
- Represents the eleventh oral presentation
of the Phase 3 SIERRA results demonstrating continued recognition
of the high potential for Iomab-B led allogeneic bone marrow
transplant by the bone marrow transplant community
NEW
YORK, April 1, 2024 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a leader in the development of Antibody Radiation
Conjugates (ARCs) and other targeted radiotherapies, today
announced that results from the Phase 3 SIERRA trial of Iomab-B in
patients with a TP53 mutation have been accepted for oral
presentation at the 50th Annual meeting of the European
Bone Marrow Transplant Society (EBMT) being held April 14 – 17, 2024, in Glasgow, Scotland. Iomab-B is a targeted
radiotherapy conditioning agent comprised of an anti-CD45
monoclonal antibody and Iodine-131 radioisotope payload. The Phase
3 SIERRA trial enrolled 153 patients with active relapsed or
refractory acute myeloid leukemia (r/r AML) and compared outcomes
of patients receiving Iomab-B and a bone marrow transplant (BMT) to
those of patients receiving physician's choice of care in the
control arm. In total, 24% of patients (37/153) in the SIERRA trial
had a TP53 mutation, which is associated with poor outcomes, and 27
of the TP53 positive patients received Iomab-B. Iomab-B met the
primary endpoint of durable Complete Remission (dCR) in the SIERRA
trial with high-statistical significance (p<0.0001) and 100% of
patients receiving a therapeutic dose of Iomab-B achieved BMT
access and engagement.
Dr. Hannah Choe, Assistant
Professor of Medicine at Ohio State
University and SIERRA trial investigator will present the
SIERRA results. Details of the oral presentation are as
follows:
Title: I-131-Apamistamab-Led Allogeneic Hematopoietic
Cell Transplant Demonstrates Survival Benefit and Overcomes
High-Risk TP53 Mutations in Patients with R/R AML
Date and Time: Wednesday, April
17, 2024, 12:39 PM GMT
Session: OS17-02
Location: Scottish Event Campus (SEC Centre)
Dr. Avinash Desai, Actinium's
Chief Medical Officer, said, "In addition to demonstrating
unprecedented 100% access to BMT in Iomab-B treated patients with
active r/r AML and achieving the primary endpoint of dCR with high
statistical significance, we are excited by the compelling outcomes
in patients with a TP53 mutation in the SIERRA trial. We look
forward to returning to EBMT and once again highlighting the
positive results from the Phase 3 SIERRA trial to the European bone
marrow transplant community. We are particularly focused on
Europe as it represents the
largest bone marrow transplant market performing 40% of the BMT
transplants globally. We also look forward to continuing to work
with our European, Middle East and
North African commercial partner, Immedica Pharma Ab, to bring
Iomab-B to patients globally."
About the EBMT Annual Meeting
The Annual Meeting of the EBMT is attended by more than 5,500
participants, including physicians, nurses, data managers,
statisticians, quality managers, cell therapists, paediatricians,
pharmacists, psychologists, psychiatrists and psychoanalysts,
transplant coordinators, lab scientists, trainees, patients. This
important congress ensures and encourages dialogues and information
exchange, education and scientific productivity.
The full annual meeting program is available online at:
https://ebmt2024.abstractserver.com/program/#/program/2/horizontal.
About Actinium Pharmaceuticals, Inc.
Actinium develops targeted radiotherapies to meaningfully
improve survival for people who have failed existing oncology
therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA
(EU)), an induction and conditioning agent prior to bone marrow
transplant, and Actimab-A (National Cancer Institute CRADA pivotal
development path), a therapeutic agent, have demonstrated potential
to extend survival outcomes for people with relapsed and refractory
acute myeloid leukemia. Actinium plans to advance Iomab-B for other
blood cancers and next generation conditioning candidate Iomab-ACT
to improve cell and gene therapy outcomes. Actinium holds more than
230 patents and patent applications including several patents
related to the manufacture of the isotope Ac-225 in a
cyclotron.
For more information, please
visit: https://www.actiniumpharma.com/
Forward-Looking Statements
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.
Investors:
investorrelations@actiniumpharma.com
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SOURCE Actinium Pharmaceuticals, Inc.
