Source: Actinium Pharmaceuticals, Inc. 7/11/19
- Studies observed minimal cumulative radiation exposure to clinical
staff providing care to patients treated with Iomab-B in the SIERRA
trial of 0.09 mSv, contributing minimal exposure to the 50 mSv annual
occupational dose limit
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today highlighted its presence at the Health Physics Society ("HPS") 64th Annual Meeting that is being held July 7th – 11th in Orlando, Florida.
During HPS, Actinium presented the findings of two studies that support
the safety of healthcare professionals who provide care to patients
treated with Iomab-B, Actinium's lead product candidate, which is being
studied in the pivotal Phase 3 SIERRA trial. The studies evaluated
radiation exposure to healthcare professionals who cared for patients
treated with Iomab-B and the exposure from handling blood samples from
patients following Iomab-B infusion. Both studies reported minimal
radiation exposure to the respective healthcare professionals. One study
of 105 healthcare professionals from 5 SIERRA sites that provided care
to patients receiving Iomab-B observed a mean cumulative radiation
exposure of 0.09 mSv or millisieverts, which is significantly less than
the 50 mSv annual occupational dose limit for staff. Iomab-B is an ARC
or Antibody Radiation-Conjugate comprised of the CD45 targeting
antibody, apamistamab, and the radioisotope iodine-131 that is intended
to be a re-induction and conditioning agent prior to a BMT or Bone
Marrow Transplant. The SIERRA trial is a multicenter, 150 patient study
for patients with active, relapsed or refractory AML or Acute Myeloid
Leukemia that is the only randomized Phase 3 trial to offer a
potentially curative BMT to this patient population for which there is
no standard of care.
Details of the HPS presentations on Iomab-B are as follows:
Title: Occupational Radiation Exposures to Clinical Staff Working With 131I – Iomab-B
Summary: Data from 105 healthcare professionals from five
SIERRA sites was analyzed. Staff monitored when only providing care to
Iomab-B treated patients had a mean cumulative exposure of 0.07 mSv
despite high levels of radiation being administered with targeted
Iomab-B while staff who provided care for multiple patients, including
those receiving other forms or radiation therapy, had a mean cumulative
exposure of 0.11 mSv. Radiation exposure levels to all staff were found
to be minimal, with mean cumulative exposure of 0.09 mSv, contributing
minimal exposure to the 50 mSv annual occupational limit. The study
sited training, education, customized physical shielding and more
advanced safety procedures as leading to minimal additional radiation
exposure.
Title: Iomab-B Study Blood Sample Handling and Occupational Radiation Extremity Exposure
Summary: Radiation exposure levels were minimal and not a
safety concern to clinical staff involved in blood specimen collecting
and handling.
Dr. Qing Liang, Actinium's Vice President, Head of Radiation
Sciences, said, "The safety of patients and site staff is our number one
concern, so I am excited that the data from these studies demonstrated
minimal radiation exposure to staff caring for patients in the Iomab-B
SIERRA trial. I am confident that our collective efforts, together with
the supportive data presented here at the Health Physics Society
Meeting, will have a positive impact on the SIERRA trial, Iomab-B and
our other ARC therapeutic candidates."
"Staff at clinical sites are often surprised to learn that they can
be exposed to higher amounts of radiation when flying on an airplane
than compared to providing care to patients treated with Iomab-B. These
study data solidly support this fact with the 0.09 mSv mean exposure to
staff significantly lower than the 50 mSv annual occupational limit and
even lower than the annual radiation 3 mSv, we all receive from natural
background. Since joining Actinium, I have focused on building
relationships with the radiation safety and nuclear medicine caregivers
at existing and prospective sites for our SIERRA trial, educating site
staff and working with my clinical colleagues to further optimize the
SIERRA trial for patients and site staff. I believe that such efforts
bode well not only for the SIERRA trail but also for Iomab-B in a
commercial setting, assuming its approval," Concluded Dr. Liang."
The Health Physics Society has nearly 4,000 members including
scientists, safety professionals, physicists, engineers and other
professionals from academia, industry, the federal government and
national laboratories.
Dr. Mark Berger, Actinium's Chief
Medical Officer, said, "The SIERRA trial is a complex study involving
multiple stakeholders at sites, including transplant physicians,
radiation safety officers, nuclear medicine physicians and the nursing
staff who provide care that is critical for these patients. Our team has
worked intensely to address the needs of each of these stakeholders and
I am proud that our efforts have taken Iomab-B from the single center
where it was originally studied at to 19 clinical trials sites in the
SIERRA trial thus far. The two studies presented at HPS which
demonstrated that staff can safely provide care to patients with minimal
radiation exposure are important and augment the promising interim
feasibility and safety data that we have presented from the SIERRA
trial. We are focused on continuing to generate positive data from the
SIERRA trial for Iomab-B as we see a tremendous opportunity to improve
outcomes for a significant number of patients with our ARC's focused on
targeted conditioning for BMT and cell therapies."
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company focused on improving patient access and outcomes to cellular
therapies such as BMT or Bone Marrow Transplant and CAR-T with its
proprietary ARC or Antibody Radiation-Conjugate targeted conditioning
technology. 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 indications. It is developing a
multi-disease, multi-target pipeline of clinical-stage ARC's targeting
the antigens CD45 and CD33 for targeting conditioning and as a
therapeutic either in combination with other therapeutic modalities or
as a single agent for patients with a broad range of hematologic
malignancies including Acute Myeloid Leukemia (AML), Myelodysplastic
Syndrome (MDS) and Multiple Myeloma (MM). Actinium's lead product
candidate, Iomab-B, is in a pivotal Phase 3 trial for re-induction and
conditioning prior to a BMT for patients with active relapsed or
refractory AML or Acute Myeloid Leukemia. BMT is the only curative
treatment option for this patient population and currently no standard
of care exists. Actimab-MDS is its second pivotal program for targeted
conditioning that will study the ARC comprised of the anti-CD33
monoclonal antibody lintuzumab linked to the radioisotope actinium-225
in patients with high-risk MDS in combination with RIC or Reduced
Intensity Conditioning prior to a BMT. Its ACT or Adoptive Cell Therapy
program targets CD45 and utilizes a lower dose of iodine-131 than
Iomab-B or lutetium-177 and is intended to be used for targeted
conditioning or lymphodepletion prior to CAR-T and adoptive cell
therapies as a replacement to non-optimized chemotherapies, such a
Flu/Cy or fludarabine and cyclophosphamide, that is used in standard
practice today. Actinium also has multiple clinical trials ongoing, in
startup phase, or in planning, to use its CD33 ARC in combination with
other therapeutic modalities such as chemotherapy, targeted agents or
immunotherapy. It has initiated several combination trials, including a
doublet combination trial with its CD33 ARC and venetoclax, a BCL-2
inhibitor, for patients with relapsed or refractory AML, a triplet
combination trial with venetoclax and an HMA or hypomethylating agent
and in combination with the salvage chemotherapy regimen CLAG-M
(cladribine, cytarabine, filgrastim and mitoxantrone) for patients with
relapsed or refractory AML. Actinium is also studying its CD33 ARC as
single agent for patients with penta-refractory multiple myeloma. Its
AWE technology platform 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
100 patents covering composition of matter, formulations, methods of
use, the DOTA linker technology for actinium-225 applications and
methods of manufacturing the actinium-225 radioisotope in a cyclotron.
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