Actinium Pharmaceuticals
(NYSE: $ATNM) Initiates Pursuit of Scientific Advice for Iomab-B from the
European Medicines Agency
Company is
seeking guidance on development plan of Iomab-B for the EU market
Actinium's small
and medium-sized (SME) status and orphan designation results in a 100%
reduction in fees for scientific advice
NEW
YORK - October 25, 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 the European
Medicines Agency (EMA) Scientific Advice process for Iomab-B. The EMA provides
scientific advice to companies regarding the appropriate studies for the
development of a medicine. The goal of scientific advice is to facilitate the
development and availability of high-quality, effective and acceptably safe
medicines, for the benefits of patients.
The
Scientific Advice process allows Actinium to dialogue with regulators from the
EMA to determine the appropriate development program for Iomab-B in Europe. The
EMA created this program to increase the probability of positive outcomes and
to reduce the risk of objections during the evaluation of a
market-authorization application. Iomab-B, Actinium's lead drug candidate, has
been granted orphan designation in the European Union (EU) by the EMA. Iomab-B
is intended to be used, upon marketing authorization, in preparing patients
with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age
of 55 for a bone marrow transplant (BMT), often referred to as a hematopoietic
stem cell transplant (HSCT). Iomab-B is currently in a 150 patient multicenter,
pivotal Phase 3 trial that is being conducted in the United States.
Sandesh
Seth, Executive Chairman of Actinium Pharmaceuticals said, "We are very
excited about the potential of Iomab-B in Europe to address an urgent unmet
medical need. We believe Iomab-B is a potentially revolutionary therapy for
relapsed or refractory AML patients who are over the age of 55 that could
benefit from a bone marrow transplant. This remains a patient population that
is drastically underserved on a global scale. Today's initiation for scientific
advice, together with our SME status and orphan designation for Iomab-B in the
EU, is invaluable as we explore the regulatory pathway for Iomab-B in the EU.
We will continue to drive the development of Iomab-B in the U.S. and beyond as
we endeavor to bring Iomab-B to all patients that could potentially benefit
from this drug candidate."
About Iomab-B
Iomab-B
is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal
antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred
Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen
widely expressed on white blood cells. This antigen makes BC8 potentially
useful in targeting white blood cells in preparation for hematopoietic stem
cell transplantation in a number of blood cancer indications, including acute
myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic
leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD),
Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive
isotopes, BC8 carries radioactivity directly to the site of cancerous growth
and bone marrow while avoiding effects of radiation on most healthy tissues.
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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