- Webinar topics will cover FDA Advisory Panel on Mylotarg, developments with other CD33 targeted
therapies and update on Actimab-A
- Webinar to be led by Dr. Joseph Jurcic, Director of Hematologic Malignancies at Columbia University
Medical Center and Dr. Mark Berger, Actinium’s Chief Medical Officer who was the lead clinician on Mylotarg’s initial approval in
2000
NEW YORK, July 06, 2017 (GLOBE NEWSWIRE) -- Actinium Pharmaceuticals, Inc. (NYSE
MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking
effective treatment options will hold a webinar focused on its Actimab-A program and recent developments related to CD33
targeted Acute Myeloid Leukemia (AML) therapies. Until this year, Mylotarg, which targets CD33, was the only drug approved
for the treatment of AML in several decades. The drug was withdrawn from the market and the sponsor (Pfizer) recently
resubmitted BLA to the FDA and an FDA Advisory Committee Meeting will be held on July 11, 2017. The CD33 antigen is a
validated target that is the focus of drug development programs from several companies using different antibody based approaches
including; naked antibodies (Boehringer Ingelheim), bispecific (Amgen, Johnson and Johnson/Amphivena), antibody drug conjugates
(Immunogen, Pfizer, and, until recently, Seattle Genetics) and radioimmunotherapy (Actinium and Bayer).
Dr. Mark Berger, Actinium’s Chief Medical Officer said, “Having led the original approval of a CD33 targeting
therapy in AML, I know firsthand that CD33 is an excellent target given its high expression rates in AML and specificity for
hematologic cells. Several recent events in the CD33 AML field bolster our belief that Actimab-A, which outside of Mylotarg
is the most advanced development program targeting CD33, has the potential to be a best in class asset. While several
technological approaches are being studied, we believe that our actinium-225 radioisotope approach may be most beneficial to
patients based on the promising efficacy and safety profile that has been demonstrated in multiple clinical trials to date.
In addition, we look forward to providing an update on the Actimab-A phase 2 trial which is on track for interim results
later this year in light of these developments.”
Webinar Information:
Date: Thursday, July 13, 2017
Time: 8 AM EDT
Webinar Link: https://onecast.thinkpragmatic.com/ses/xDpWQuiPDXTcAa0Ox1VPkA~~
Upcoming Actimab-A Milestones |
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Interim Analysis |
2H:2017 |
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Complete Patient Enrollment |
1H:2018 |
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Top Line Data Results |
1H:2018 |
About Actimab-A
Actimab-A, Actinium's most advanced alpha-particle based product candidate, is currently being studied in a
53-patient, multicenter Phase 2 trial for patients newly diagnosed with acute myeloid leukemia (AML) age 60 and above. AML is
a cancer of the blood and bone marrow that affects red blood cells, white blood cells and platelets. A majority of patients
with AML express CD33, a protein expressed on the cell surface. Actimab-A targets CD33, a protein abundantly expressed on the
surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML
cancer cells. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225
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. Actimab-A is being developed as a first-line therapy as a monotherapy that is administered via
two 15-minute injections that are given 7 days apart. Actimab-A is a second-generation therapy from the Company’s
HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in over 100 patients
in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above
by the U.S. Food and Drug Administration. There currently exists a well-defined and urgent medical need for effective
therapies for patients newly diagnosed with AML who are 60 years and older.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for
patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to
deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead
product candidate, Iomab-B, is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant,
commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with
blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that
result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients
seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently
conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory
acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a
multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being
developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the
toxicities of standard frontline therapies. In addition, Actinium is developing Actimab-M, which is being studied in patients
with relapsed or refractory multiple myeloma in a Phase 1 clinical trial. Actinium is also utilizing its alpha-particle
immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225
that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY.
To learn more about Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.
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: Actinium Pharmaceuticals, Inc. Steve O'Loughlin Principal Financial Officer soloughlin@actiniumpharma.com Investor Relations Marek Ciszewski, J.D. 949.574.3860 ATNM@liolios.com