Actinium (NYSE: $ATNM)
Announces Initiation of Phase 2 Clinical Trial of Actimab-A in Patients Newly
Diagnosed with Acute Myeloid Leukemia Over Age 60
Webinar to be held at 9:00
AM ET to highlight Actimab-A Phase 2 clinical trial and protocol revisions agreed
to by the FDA
Protocol revisions agreed to
by the FDA include the use of peripheral blast burden as an inclusion criteria,
the mandated use of Hydroxyurea in patients with high peripheral blast burden
and the elimination of low dose cytarabine
Trial will enroll 53
patients in a multicenter, open-label study designed to evaluate patient
complete response rates and overall survival
NEW
YORK - September 27, 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 initiated a Phase 2 clinical
trial of Actimab-A in patients newly diagnosed with Acute Myeloid Leukemia
(AML) who are over the age of 60. Actimab-A, Actinium's most advanced alpha
particle immunotherapy (APIT) program consists of the CD33 targeting monoclonal
antibody, HuM195, and the alpha-emitting radioisotope, actinium-225.
"We
are excited to have initiated the Phase 2 trial of Actimab-A for elderly
patients who are newly diagnosed with AML and ineligible for 7+3 treatment.
These older patients face a poor prognosis and have limited viable treatment
options" said Sandesh Seth, Actinium's Executive Chairman. "We are
encouraged by the safety and efficacy signals we have seen thus far and look
forward to the execution of this trial with an eye toward interim and top-line
results which are both expected in 2017."
This
Phase 2 clinical trial is a multicenter, open-label study that will enroll 53
patients. Patients will receive 2.0 µCi/kg/fractionated dose of Actimab-A via
two injections given at day 1 and day 7. The Phase 2 trial is designed to
evaluate complete response rates at up to day 42 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 with topline results expected in the
second half of 2017. The Phase 2 trial will include peripheral blast burden as
an inclusion criteria and in patients with high peripheral blast (PB) burden,
the use of Hydroxyurea will be mandated with the goal of bringing PB burden
below a key threshold number that the Company has identified from two previously
complete Phase 1 clinical trials totaling 38 patients. In addition, the use of
granulocyte colony-stimulating factors (GCSF) will be mandated. Low dose
cytarabine has been eliminated from the protocol and the Phase 2 clinical trial
will evaluate Actimab-A as a monotherapy. The secondary endpoint of the Phase 2
trial will be overall survival.
Dr.
Joseph Jurcic, Principal Investigator of the Actimab-A Phase 2 trial and
Director of Hematologic Malignancies; Professor of Medicine at Columbia
University Medical Center said, "Actimab-A has been studied in two
clinical trials thus far in patients with AML ranging in age from 18-87 who had
a wide array of genetic risk factors that were at various stages of disease
progression. Actimab-A has shown a promising safety and efficacy profile thus
far that we believe differentiates Actimab-A from other CD33 targeting drug
candidate, which is an exciting space in AML. Our PB burden hypothesis
indicates that of all factors related to AML including age, stage of disease and
genetic factors, peripheral blast burden showed to be the most relevant. With
PB burden serving as an inclusion criteria in this Phase 2 trial and the use of
Hydroxyurea being mandated in patients with PB burden above a key threshold we
look forward to conducting this clinical trial in this older patient population
that has a great unmet medical need."
The
Company will host a webinar Tuesday, September 27, 2016 at 9:00 AM ET to
discuss the Phase 2 clinical trial. Details for the webinar are as follows:
Date:
Tuesday, September 27, 2016
Time: 9:00 AM ET
Webinar Link: https://onecast.thinkpragmatic.com/ses/awQiM-9OD7Iysoul6ZD6BQ~~
Speakers: Joseph Jurcic, M.D., Director of Hematologic Malignancies; Professor of Medicine at Columbia University Medical Center
Actimab-A Principal Investigator
Sandesh Seth, Executive Chairman, Actinium Pharmaceuticals
Dragan Cicic, M.D., Chief Medical Officer, Actinium Pharmaceuticals
Time: 9:00 AM ET
Webinar Link: https://onecast.thinkpragmatic.com/ses/awQiM-9OD7Iysoul6ZD6BQ~~
Speakers: Joseph Jurcic, M.D., Director of Hematologic Malignancies; Professor of Medicine at Columbia University Medical Center
Actimab-A Principal Investigator
Sandesh Seth, Executive Chairman, Actinium Pharmaceuticals
Dragan Cicic, M.D., Chief Medical Officer, Actinium Pharmaceuticals
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 in a
53 patient, multicenter, open-label Phase 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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