- 24 leading bone marrow transplant
(BMT) centers that perform over 30% of transplants in the U.S.
participated in the SIERRA trial that enrolled patients with active
relapsed or refractory acute myeloid leukemia
- Demonstration of rapid ability and
ease of adoption for Iomab-B infusions at SIERRA sites
NEW YORK,
April 28,
2023 /PRNewswire/ -- Actinium Pharmaceuticals,
Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a
leader in the development of targeted radiotherapies, today
announced that two posters detailing positive clinical experiences
of sites in the pivotal Phase 3 SIERRA trial of Iomab-B, including
the ease of Iomab-B administration, the rapid proficiency of sites
and minimal radiation exposure to personnel are being presented at
the 48th Annual Oncology Nursing Society (ONS) Congress,
which is being held on April 26–30, 2023, in San Antonio, Texas. The SIERRA trial is the
first randomized Phase 3 trial intended to take patients with
active, relapsed or refractory (r/r) acute myeloid leukemia (AML)
to a BMT, which is only feasible due to Iomab-B's targeted
radiotherapy approach that enables these patients who are
considered unfit and transplant ineligible in current routine
clinical practice to access BMT without first achieving a
remission.
Actinium's ONS posters demonstrate that Iomab-B
can be adopted across a wide variety of BMT centers, evidenced by
the 24 sites, which perform over 30% of all allogeneic BMT
procedures in the United States,
that participated in the SIERRA trial. Through education and
utilizing Actinium-developed shielding solutions, site personnel
became rapidly adept at Iomab-B administration. Importantly,
treating nursing site personnel had minimal average radiation
exposure of 0.009 millisievert (mSv), which is similar to the
exposure from a roundtrip cross country flight, less than
1/10th the general public exposure limit of 1 mSv and
significantly below the occupational radiation exposure limit for
nursing staff of 50 mSv, clearly demonstrating no increased risk to
nursing staff caring for Iomab-B patients.
Dr. Avinash Desai,
Actinium's Chief Medical Officer, commented, "Throughout the SIERRA
trial, Actinium had a great partnership approach with BMT clinical
trial sites, which has provided us with valuable insights for the
potential commercial adoption and utilization of Iomab-B. Through
our education efforts and shielding solutions, we have optimized
administration of Iomab-B across a wide range of BMT centers. BMT
centers are large, integrated hospitals that are accustomed to
dealing with more complex procedures, such as surgeries or CAR-T
cell therapy, and can administer single-infusion Iomab-B with
relative ease compared to other complex cell therapies. The 24 BMT
centers that participated in the SIERRA trial established a strong
base that we will now look to build on in anticipation of Iomab-B
commercial launch, assuming approval. On behalf of Actinium, I
would like to thank all the nursing personnel at the SIERRA sites
that made this first-of-its-kind trial possible."
Sandesh Seth,
Actinium's Chairman and CEO, added, "Our team's commitment to
operational excellence at the point of care was integral to our
execution of the SIERRA trial and has positioned Iomab-B well for
future success. Through our SIERRA experience, we have established
a playbook for implementing Iomab-B at BMT centers that is scalable
and efficient. In addition to our educational efforts and shielding
solutions, we take great pride in the fact that we did not miss a
single patient dose in the SIERRA trial and our end-to-end supply
chain delivered a just-in-time personalized therapy to patients
treated at the top BMT centers. Our positive experiences in the 24
SIERRA trial sites give us great confidence in our ability to
expand to the top 50 BMT centers that perform approximately 75% of
the BMT procedures at the time of launch. We are grateful for the
opportunity to highlight Iomab-B and SIERRA at ONS and look forward
to additional opportunities to highlight the positive trial results
and site experiences at future medical conferences globally to
increase awareness for Iomab-B's practice changing potential."
ONS Poster Details:
Successful Interdisciplinary Approach to Treat
Patients With R/R AML with Iomab-B Prior to HCT: The SIERRA Trial
Experience
- SIERRA site staff became rapidly adept to administering Iomab-B
and caring for patients via Actinium led educational efforts
focused on nursing, radiation safety and nuclear medicine
- All SIERRA sites operated fully independently after treating
their initial Iomab-B patient
- SIERRA sites were able to establish tailormade individual
approaches for their site and quickly established a cadence for
subsequent Iomab-B patients
Exposure Rates of Staff Caring for SIERRA
Trial Patients Receiving Iomab-B: Experiences at Five Sites
- Data was collected from 105 personnel from 5 SIERRA trial sites
who were monitored while providing care for Iomab-B treated
patients
- The average radiation exposure was 0.009 mSv, which is
approximately 1/10th of the annual exposure limit for
the general public of 1 mSv
- The average SIERRA treating nursing staff exposure of 0.009 mSv
is approximately equal to the exposure on a roundtrip flight across
the U.S.
- For hospital personnel such as nurses, the occupational dose
limit is increased to 50 mSv
- These results indicate that Iomab-B radiation exposure to
caregivers from Iomab-B is minimal
About Oncology Nursing Society
The Oncology Nursing Society
(ONS) is a professional association that represents
100,000 nurses and is the professional home to more than 35,000
members. ONS is committed to promoting excellence in oncology
nursing and the transformation of cancer care. Since 1975, ONS has
provided a professional community for oncology nurses, developed
evidence-based education programs and treatment information, and
advocated for patient care, all in an effort to improve the quality
of life and outcomes for patients with cancer and their families.
https://www.ons.org/.
About Iomab-B and the Phase 3 SIERRA
Trial
Iomab-B is a first-in-class targeted radiotherapy
intended to enable a potentially curative bone marrow transplant
(BMT) for patients who are considered unfit and ineligible for BMT
with current routine treatment either due to the inability to
tolerate non-targeted therapies or the inability for these
therapies to produce a necessary remission. The SIERRA trial is the
first randomized Phase 3 trial intended to take patients with
active, relapsed or refractory acute myeloid leukemia (r/r AML) age
55 and above to a BMT without the patient first achieving
remission. In February 2023, Actinium
reported that Iomab-B enabled unprecedented 100% BMT access and
engraftment, achieved the primary endpoint of the SIERRA trial,
durable Complete Remission of 6-months after initial remission
post-BMT, with high statistical significance (p<0.0001), had a
favorable safety profile compared to control arm therapies,
significantly improved event-free survival and doubled median
overall survival. Based on these positive results, Actinium intends
to file a Biologics License Application by the end of 2023 to seek
approval for Iomab-B from the FDA.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a
clinical-stage biopharmaceutical company developing targeted
radiotherapies to deliver cancer-killing radiation with cellular
level precision to treat patients with high unmet needs. Actinium's
clinical pipeline is led by targeted radiotherapies that are being
applied to targeted conditioning, which is intended to selectively
deplete a patient's disease or cancer cells and certain immune
cells prior to a bone marrow transplant (BMT), gene therapy or
adoptive cell therapy, such as CAR-T, to enable engraftment of
these transplanted cells with minimal toxicities. Our lead product
candidate, Iomab-B (I-131 apamistamab) has been studied in over
four hundred patients, including the pivotal Phase 3 Study of
Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia
(SIERRA) trial for BMT conditioning. The SIERRA trial was positive
with Iomab-B meeting the primary endpoint of durable Complete
Remission of 6-months with high statistical significance
(p<0.0001). Iomab-B enabled 100% of patients to access a BMT and
produced higher rates of post-BMT CR. Iomab-B produced positive
results for the secondary endpoints of the SIERRA trial including
reducing the probability of an event by 78% resulting in an
Event-Free Survival (EFS) Hazard Ratio of 0.22 (p<0.0001),
doubled 1-year overall survival and median overall survival.
Iomab-ACT, low dose I-131 apamistamab, is being studied as a
targeted conditioning agent in a Phase 1 study with a CD19 CAR
T-cell Therapy with Memorial Sloan Kettering Cancer Center with NIH
funding. Actimab-A, our second most advanced product candidate has
been studied in approximately 150 patients with Acute Myeloid
Leukemia or AML, including in combination trials with the
chemotherapy regimen CLAG-M and with venetoclax, a targeted
therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based
antibody radiation conjugate targeting CD33, a validated target in
AML. Actinium has entered into a Cooperative Research and
Development Agreement (CRADA) with the National Cancer Institute
(NCI) to develop Actimab-A as a single agent or combination with
chemotherapy, targeted agents or immunotherapy in Phase 1, 2 or 3
trials. The NCI will fund clinical trial expenses under the CRADA
while Actinium will supply Actimab-A. The NCI is currently
accepting proposals for non-clinical and clinical studies with
Actimab-A. Actinium is a pioneer and leader in the field of
Actinium-225 alpha therapies with an industry leading technology
platform comprising over 200 patents and patent applications
including methods of producing the radioisotope AC-225. Our
technology and expertise have enabled collaborative research
partnerships with Astellas Pharma, Inc. for solid tumor
theranostics, with AVEO Oncology Inc. to create an Actinium-225
HER3 targeting radiotherapy for solid tumors, and with EpicentRx,
Inc. to create targeted radiotherapy combinations with their novel,
clinical stage small molecule CD47-SIRPα inhibitor. More
information is available on Actinium's website:
https://www.actiniumpharma.com/.
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.
Investor Contact:
investorrelations@actiniumpharma.com
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SOURCE Actinium Pharmaceuticals, Inc.