Actinium Pharmaceuticals
(NYSE: $ATNM) Granted Orphan Designation from the European Medicines Agency for
Iomab-B
·
Orphan designation is
expected to provide increased communication and guidance from regulators and
10-year market exclusivity should marketing authorization be obtained
·
Orphan designation for
Iomab-B follows SME (small or medium-sized enterprise) status, which was
granted in August 2016
·
Iomab-B now has orphan
designation in the US and EU
NEW
YORK - October 18, 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’s lead asset, Iomab-B, has
been granted orphan designation in the European Union (EU) by the European
Medicines Agency (EMA).
Iomab-B
is intended to be used, upon approval, 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.
"We
are excited to have been granted orphan designation in the EU for Iomab-B,
which comes in addition to the SME status Actinium was granted and orphan
designation for Iomab-B in the U.S.," stated Sandesh Seth, Executive
Chairman of Actinium Pharmaceuticals. "We believe Iomab-B represents a
potentially revolutionary therapy for relapsed or refractory AML patients who
are over the age of 55 who could benefit from a bone marrow transplant, which
is a drastically underserved patient population. With additional regulatory
support for Iomab-B in the EU through orphan designation and SME status we hope
to one day bring Iomab-B to the patients of the EU."
The
EMA grants orphan designation to rare diseases that are defined as life-threatening
or chronically debilitating conditions that affect no more than 5 in 10,000
people in the EU. With an estimated 30 million people living in the EU this
equates to approximately 250,000 people or less for each rare disease.
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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