Company Now Positioned to Prepare and Initiate Pivotal Phase 3
NEW YORK--(BUSINESS WIRE)--
Actinium Pharmaceuticals, Inc. (OTCQB:ATNM.OB) ("Actinium" or "the
Company"), a biopharmaceutical company developing innovative targeted
payload immunotherapeutics for the treatment of advanced cancers, has
successfully transferred the technology for the manufacture of Iomab™-B
(BC8-I-131), a drug being developed for therapeutic treatment of
incurable blood cancers. The Company now intends to complete plans to
scale-up, submit an Investigational New Drug (IND) Application to the
U.S. Food and Drug Administration and initiate a pivotal Phase 3
clinical trial in 2014.
The processes for radiolabeling, testing and evaluating the stability of
Iomab™-B have been successfully completed, and plans for scale-up are
underway. Actinium has also acquired inventory of the monoclonal
antibody BC8 and has planned future large-scale manufacturing of this
“Moving ahead with the manufacturing of Iomab™-B brings us one step
closer to commencing a multicenter trial in an area where a new drug is
badly needed,” said Dr. Kaushik J. Dave, President and CEO of Actinium
Pharmaceuticals. “We hope that our drug candidate might prove to be a
life-saving treatment for patients who currently have very few options.”
Actinium expects Iomab™-B will add to the Company’s existing product
line that includes Actimab™-A (Ac-225-Lintuzumab), currently in Phase
1/2 clinical trials. Actimab™-A is an antibody-directed alpha emitter
being evaluated for acute myeloid leukemia.
Iomab™-B is a radioimmunoconjugate consisting of BC8, a novel murine
monoclonal antibody, and iodine 131 radioisotope. BC8 has been developed
by 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 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
Actimab™-A is a drug candidate construct made using Actinium
Pharmaceuticals' proprietary patented technology for arming monoclonal
antibodies with alpha emitters actinium 225 and bismuth 213. Antibodies
are used as high precision delivery systems that bring powerful alpha
emitters into or immediately next to targeted cancer cells. Actimab™-A
consists of the Lintuzumab monoclonal antibody and 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. The
technology was first developed by Dr. David Scheinberg at Memorial Sloan
Kettering Cancer Center.
Lintuzumab is a monoclonal antibody that targets CD33, found on myeloid
leukemia cells. It is the humanized version of M195, the antibody
initially developed by Dr. David Scheinberg of Memorial Sloan Kettering
About hematopoietic stem cell transplantation
Hematopoietic stem cell transplantation is a $1.3 billion per year
market in the U.S. Over the period 2004–2007 (most recent available
data), it was the hospital procedure with the fastest-growing number of
hospital stays and aggregate cost growth in the U.S., according to the
U.S. Government Agency for Healthcare Research and Quality.
In 2010, about 20,000 transplants were performed in the U.S.
Approximately 12,000 were autologous and approximately 8,000 were
allogeneic. Worldwide, there were about 60,000 transplants overall;
about 34,000 autologous and 26,000 allogeneic. The number of patients
over the age of 50 has been steadily increasing over the last decade and
based on the latest available data grew from 8 percent in 2000 to 21
percent in 2005 and 27 percent in 2007.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company that
develops innovative alpha particle immunotherapeutics based on its
proprietary platform for the therapeutic utilization of alpha particle
emitting actinium-225 and bismuth-213 radiopharmaceuticals in
association with monoclonal antibodies.
For more information:
Visit our website www.actiniumpharmaceuticals.com
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as that term is
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 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.
Actinium Pharmaceuticals, Inc.
Source: Actinium Pharmaceuticals, Inc.