Source: Actinium Pharmaceuticals, Inc.
- Actimab-A plus CLAG-M further expands Actinium’s CD33 program and addressable patient population of Actimab-A
-
Combination aligns with Actinium’s focus on improving bone marrow
transplant access and outcomes through improved myeloablation
- Conference call to be held on Tuesday, February 13, 2018 at 4:30 PM ET
Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"),
announced today that the Company is initiating a new clinical trial
that will study Actimab-A in combination with CLAG-M for patients with
relapsed or refractory acute myeloid leukemia (AML). CLAG-M is a
salvage chemotherapy regimen that consists of cladribine, cytarabine,
and filgrastim with mitoxantrone for patients with relapsed or
refractory AML. The combination trial will be a Phase 1,
dose-escalation study that will be conducted at the Medical College of
Wisconsin by principal investigator Dr. Ehab Atallah.
Dr.
Mark Berger, Actinium’s Chief Medical Officer said, “Relapsed and
refractory AML patients unfortunately have limited treatment options
that have little clinical benefit for patients. Actimab-A is ideally
suited to be studied in combination with other therapeutic modalities
like CLAG-M given its potency and minimal extramedullary toxicities. We
are optimistic that this novel combination will demonstrate Actimab-A’ s
key strengths through higher response rates, a greater number of
patients successfully receiving a bone marrow transplant and ultimately,
survival. Further, it will demonstrate the value of using Actimab-A in
combinations as we believe that combination therapies will be the next
wave in the treatment of patients with AML just as combinations of
regimen’s approved in multiple myeloma over the past three or four years
have become for patients with that disease.”
Actinium
will host a conference call on Tuesday, February 13, 2018 at 4:30 PM ET
that will be led by Dr. Mark Berger, Actinium’s Chief Medical Officer
and Dr. Atallah.
Webcast Registration: https://onecast.thinkpragmatic.com/ses/d4PAnC1sn4SzZZdJjklZQA~~
U.S. Participant Dial-in: (646) 402-9440
U.S./Canada Toll Free Dial-in: (855) 698-6739
Conference ID: 2540
U.S. Participant Dial-in: (646) 402-9440
U.S./Canada Toll Free Dial-in: (855) 698-6739
Conference ID: 2540
Sandesh
Seth, Actinium’s Chairman and CEO said, “This latest clinical
initiative is especially exciting as it further demonstrates that we are
building the industry leading CD33 Program. We the only company with
multi-disease, multi-indication clinical trials with our ongoing
Actimab-A, Actimab-M and planned Actimab-MDS studies and this latest
initiative has the potential of extending the addressable patient
population for Actimab-A. This is a viable approach for Actimab-A as we
begin to strategize and implement the next phase of Actimab-A’s
development. In doing so, we expect to maximize the value of our CD33
program and increase its synergies for potential partners and
collaborators. Further, this initiative is aligned with Actinium’s core
strategy of improving access and outcomes to transplants and one we are
excited to embark on.”
Actimab-A is Actinium’s
lead drug candidate from its CD33 program and is an Antibody
Radio-Conjugate (ARC) that is comprised of the CD33 targeting antibody
lintuzumab and actinium-225, an alpha-emitting radioisotope. Actimab-A
is currently being studied in Phase 2 clinical trial in patients that
are newly diagnosed with AML who are over the age of 60 that are
ineligible for intense chemotherapy, also known as unfit patients. The
Company expects to complete patient enrollment of the Phase 2 trial in
the first half of 2018 and report top line data results in the second
half of 2018. The Company is also developing Actimab-M and Actimab-MDS,
which are also CD33 actinium-225 ARCs. Actimab-M is being studied in a
Phase 1 investigator-initiated trial for patients with refractory
multiple myeloma. The Phase 1 Actimab-M trial is expected to complete
enrollment and report top like data in the second half of 2018.
Actimab-MDS is expected to begin a Phase 2 clinical trial in the second
half of 2018 following a pre-IND meeting with the FDA in the first half
of 2018. Actimab-MDS is intended to bridge patients with high-risk
myelodysplastic syndrome (MDS) that have a p53 genetic mutation to a
bone marrow transplant via targeted myeloablation.
About Actinium Pharmaceuticals, Inc.
Actinium
Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company
focused on developing and commercializing targeted therapies for
potentially superior myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant and for the targeting and killing of
cancer cells. Our targeted therapies have demonstrated the potential to
result in significantly improved access to bone marrow transplant with
better outcomes, namely increased marrow engraftment and survival. Our
targeted therapies are ARC’s or Antibody Radio-Conjugates that combine
the targeting ability of monoclonal antibodies with the cell killing
ability of radioisotopes. Three of our four ARC drug candidates are
based on our AWE or Actinium Warhead Enabling Technology Platform that
utilizes the isotope Actinium-225 (Ac225) that emits alpha
particles. We are currently conducting clinical trials for our four
product candidates; Iomab-B, Actimab-A Actimab-M and Actimab-MDS, as
well as performing research on other potential drug candidates utilizing
our proprietary AWE Technology Platform. Our most advanced product
candidate, Iomab-B, an ARC developed by the Fred Hutchinson Cancer
Research Center, is comprised of an anti-CD45 monoclonal antibody
labeled with iodine-131. We are currently conducting a pivotal Phase 3
trial of Iomab-B for myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant for patients with relapsed or
refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow
transplant is a potentially curative treatment for patients with AML
and other blood cancers including leukemias, lymphomas and multiple
myeloma as well as certain blood disorders. Iomab-B has been tested in
several of these other cancers with over five hundred patients treated
in several Phase 1 and 2 trials with promising results. Upon successful
completion of our Phase 3 clinical trial for Iomab-B we intend to
submit this candidate for marketing approval in the U.S. and European
Union where it has been designated as an Orphan Drug. We are also
developing a potentially best in class CD33 program using an ARC
comprised of the anti-CD33 monoclonal antibody lintuzumab labeled with
the alpha-particle emitter actinium-225. Our most advanced CD33 program
candidate, Actimab-A, is currently in a Phase 2 clinical trial for
patients advanced over the age of 60 who are newly diagnosed with AML
and ineligible for standard induction chemotherapy. Actimab-A also has
Orphan Drug designation in the US and EU. Actimab-M, our second CD33
targeting ARC, is being studied in a Phase 1 trial for patients with
refractory multiple myeloma. Actinium is also planning a Phase 2 trial
for Actimab-MDS, our third CD33 program candidate, as a conditioning
regimen prior to a bone marrow transplant for patients with MDS that
have a p53 genetic mutation. Our AWE or Actinium Warhead Enabling
Technology Platform, originally developed in conjunction with Memorial
Sloan Kettering Cancer Center, is focused on leveraging Actinium’s know
how and intellectual property to create additional ARC drug candidates
by labeling Ac225 to targeting moieties that we will either progress in clinical trials ourselves or out-license.
More information is available at www.actiniumpharma.com
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