Actinium Pharmaceuticals
(NYSE: $ATNM) to Host Webinar to Provide Update on Actimab-A Phase 2 Clinical
Trial
Webinar to be
Held on Tuesday, September 27, 2016 at 9:00 AM ET
Webinar to
feature Principle Investigator Joseph Jurcic, M.D., Professor of Clinical
Medicine and Director of the Hematologic Malignancies Section of the
Hematology/Oncology Division at Columbia University Medical Center
NEW
YORK - September 21, 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 will host a webinar on
Tuesday, September 27, 2016 at 9:00 AM ET to provide an update on the Actimab-A
Phase 2 Clinical Trial. Details of the webinar are below:
Date: Tuesday, September 27, 2016
Time: 9:00 AM ET
Webinar Link:
Time: 9:00 AM ET
Webinar Link:
"Since
presenting our Phase 1 data on June 1, 2016, we have made progress on our
Actimab-A program", stated Sandesh Seth, Executive Chairman of Actinium
Pharmaceuticals. "We look forward to providing an update on the Actimab-A
Phase 2 trial that will include the protocol changes that have been agreed to
by the FDA."
Dr.
Joseph Jurcic, M.D., Principle Investigator for the Actimab-A Phase 2 trial
said, "Actimab-A is intended to treat patients over the age of 60 that are
newly diagnosed with acute myeloid leukemia, which is a patient population with
significant unmet medical needs. The results from the Actimab-A Phase 1
clinical trial showed an encouraging safety and efficacy profile that gives us
great excitement for the Phase 2 clinical trial of Actimab-A."
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.
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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