Actinium Pharmaceuticals
(NYSE: $ATNM) Selects Vector Oncology as its Clinical Research Organization for
Actimab-A Phase 2 Trial
NEW
YORK - September 20, 2016 (Investorideas.com Newswire) Actinium
Pharmaceuticals, Inc. (NYSE: ATNM)
("Actinium" or "the Company"), a biopharmaceutical Company
developing innovative targeted payload immunotherapeutics for the treatment of
advanced cancers, announced today that the Company has selected Vector Oncology
as its Clinical Research Organization (CRO) for its anticipated Actimab-A Phase
2 clinical trial.
"We
are delighted to be working with Vector Oncology for our upcoming Phase 2
clinical trial," stated Dragan Cicic, M.D., Actinium’s Chief Medical
Officer. "Vector Oncology displayed an expertise in hematology clinical
trials with an emphasis on Phase 2 studies, which gives us great confidence in
our selection. We look forward to working with Vector Oncology and to benefiting
from their robust clinical capabilities."
Sean
L. Hart, Executive Vice President and Managing Director at Vector Oncology
said, "Vector Oncology is excited to be working with Actinium as a member
of this important team. Since our first interaction with Actinium, all team
members involved have committed to getting this important product in the hands
of oncology professionals as soon as possible to advance the research efforts.
We very much look forward to an exciting future together."
The
Company recently completed a Phase 1 trial with Actimab-A in 18 patients newly
diagnosed with Acute Myeloid Leukemia (AML) who are above the age of 60. The
Phase 1 trial was a dose escalation study with fractionated dosing levels of
Actimab-A ranging from 0.5 µCi/kg/fractionated dose to 2.0 µCi/kg/fractionated
dose. Actinium announced that the dose for the Phase 2 clinical trial will be
two doses of Actimab-A at 2.0 µCi/kg/fractionated dose one week apart, the
highest dose level from the Phase 1 trial.
The
Actimab-A Phase 2 clinical trial is expected to begin in 2016 and will enroll
53 patients bringing the total number of patients in this Phase 1/2 Actimab-A
trial to 71. This multi-center, open-label, single-arm Phase 2 trial will
enroll patients newly diagnosed with AML who are over the age of 60.The Company
will also be incorporating into the Phase 2 trial protocol changes including
the removal of low dose cytarabine, the mandated use of granulocyte
colony-stimulating factors (GCSF) and the mandated use of Hydroxyurea based on
the findings from its peripheral blast (PB) burden hypothesis which was derived
from the two Phase 1 clinical trials conducted with Actimab-A in its
Hum195-Alpha clinical program.
Based
on evidence that suggests that peripheral blasts prevent Actimab-A from
reaching the bone marrow at optimal doses, the Company has mandated the use of
Hydroxyurea to reduce the PB burden in patients above a certain key threshold.
PB burden will serve as an inclusion criteria for the Phase 2 trial but it is
not expected to exclude patients due to the ability of Hydroxyurea to reduce
peripheral blasts. The end point of the Phase 2 trial will be complete response
rate at up to 42 days after Actimab-A administration, where complete response
is defined as complete remission (CR) or complete remission with incomplete
platelet recovery (CRp). A formal interim analysis is expected to occur in
mid-2017.
Sandesh
Seth, Actinium’s Executive Chairman said, "The selection of Vector
Oncology as our CRO marks an important step in the development of Actimab-A.
The Phase 2 Actimab-A trial is the second Phase 2 trial from our HuM195-Alpha
program, albeit with a second generation, much superior product candidate and
tantalizing results from the Phase 1 portion that should bode well for the progress
of this trial. With the revised protocol, PB burden hypothesis and strengthened
clinical development team we look forward to the Phase 2 trial of Actimab-A and
working with Vector Oncology to ensure efficient and timely trial
execution."
About Vector Oncology
Vector
Oncology is a leader in the design and delivery of care based oncology research
and data analytics. Utilizing our comprehensive Oncology Data Warehouse and
proprietary Patient Care Monitor (PCM) patient engagement and outcomes
platform, our experienced project teams, medical experts and health economics and
outcomes scientists design and deliver high-quality projects generating real
world evidence and insight. With some of the most experienced medical,
scientific, operational, and executive teams in late stage research, Vector
Oncology is uniquely positioned to meet the demand to demonstrate product value
in terms of economic impact, clinical effectiveness and tolerability, and
patient reported outcomes (PRO). For more information, please visit www.vectoroncology.com.
About Actimab-A
Actimab-A,
Actinium's most advanced alpha particle immunotherapy (APIT) program, is being
prepared for a Phase 2 clinical trial for patients newly diagnosed with AML
over the age of 60. Actimab-A is being developed as a first-line therapy and it
has attracted support from some of the leading experts at the most prestigious
cancer treatment hospitals due to the potential of its safety and efficacy
profile. Actimab-A consists of the monoclonal antibody, HuM195, and the
radioisotope, actinium-225. Actinium-225 decays by giving off high-energy alpha
particles, which kill cancer cells. When actinium decays, it produces a series
of daughter atoms, each of which gives off its own alpha particle, increasing
the chances that the cancer cell will be destroyed. HuM195 is the humanized
version of M195 and is a monoclonal antibody that targets CD33, which is
abundantly found on myeloid leukemia cells. Both the alpha particle technology
and HuM195 were initially developed at Memorial Sloan Kettering Cancer Center.
Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha
program, which has now been studied in almost 90 patients in four clinical
trials.
About Actinium Pharmaceuticals
Actinium
Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical
company developing innovative targeted payload immunotherapeutics for the
treatment of advanced cancers. Actinium's targeted radioimmunotherapy products
are based on its proprietary delivery platform for the therapeutic utilization
of alpha-emitting Actinium-225 and Bismuth-213 and certain beta emitting
radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's
lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon
approval, in preparing patients for hematopoietic stem cell transplant,
commonly referred to as bone marrow transplant. The Company is conducting a
single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory or
relapsed AML patients over the age of 55 with a primary endpoint of durable
complete remission. The Company's second product candidate, Actimab-A, is
continuing its clinical development in a Phase 1/2 trial for patients newly diagnosed
with AML over the age of 60 in a single-arm multicenter trial.
Forward-Looking
Statements for Actinium Pharmaceuticals, Inc.
This
news release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and uncertainties, which
may cause actual results to differ materially from those set forth in the
statements. The forward-looking statements may include statements regarding
product development, product potential, or financial performance. No
forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Actinium Pharmaceuticals undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise.
Contact:
Steve
O'Loughlin
Vice President, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
soloughlin@actiniumpharma.com
Vice President, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
soloughlin@actiniumpharma.com
Source:
Actinium Pharmaceuticals
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