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Actinium Completes Technology Transfer For Manufacturing Of Its Lead Drug Candidate Iomab-B

Published: Dec 19, 2013 7:00 am

Company Now Positioned to Prepare and Initiate Pivotal Phase 3 Clinical Trial

New York, NY (Press Release) 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 anti­body.

“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.

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 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 healthy tissues.

About Actimab™-A

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 Cancer Center.

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.

Source: Actinium Pharma­ceu­ticals.



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