SOURCE: Actinium Pharmaceuticals
Successful Completion of the Third Cohort of AML Patients Followed by Opening of the Trial for Treatment at Increased Dose Level
Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM)
("Actinium" or "the Company"), a biopharmaceutical company developing
innovative targeted payload immunotherapeutics for the treatment of
advanced cancers, announced today that the Company is moving forward
with enrollment and treatment of additional patients in its clinical
trial for acute myeloid leukemia (AML) in patients over the age of 60.
Actinium will proceed with patient screening and enrollment for the
fourth cohort, who, in keeping with trial protocol, will be injected
with two doses 4 to 7 days apart of the Company's investigational new
drug Actimab-A at a higher activity level of 2.0 μCi/kg per dose.
In
the previously completed third cohort in which patients received two
doses of Actimab-A at 1.5 μCi/kg per dose two out of three Actimab-A
treated patients achieved complete remission with different degrees of
hematological recovery (CRi). These responses were documented in the
settings of high pre-treatment leukemia burdens of up to 80% in the bone
marrow. In the second cohort treated at a lower dose level of Actimab-A
of 1.0 μCi/kg per dose, one patient achieved CRi.
"As we start
this last dose level in the Phase 1 portion of our trial, we are very
encouraged with results so far," commented Kaushik J. Dave, President
and CEO of Actinium Pharmaceuticals. "We hope to establish the maximum
tolerated dose soon which would allow us to proceed with the Phase 2
portion of the trial, as agreed with the FDA."
The trial is a
prospective, open-label study, designed to determine the safety and
efficacy of Actimab-A in newly diagnosed AML patients who cannot
tolerate current high dose chemotherapeutic regimens.
Actinium previously announced positive interim data from the
ongoing Phase 1/2 trial of Actimab-A in older patients with newly
diagnosed Acute Myeloid Leukemia ("AML"). Most notably, median overall
survival ("OS") of the seven secondary AML patients (with prior
myelodysplastic syndrome, or MDS) in the study was 9.1 months, which
compares favorably to historical norms of 2 to 5 months depending on the
treatment modality. Older AML patients are already higher risk, with
secondary AML patients considered to have the more severe and less
treatable form of AML, and as a consequence have shorter expected
survival. The clinical abstract was published and is available online in
Blood, the official Journal of the American Society of Hematology.
About Actimab-A
Actimab-A
is a radiolabeled antibody being developed for newly diagnosed AML in
patients over 60, and is currently in a multicenter Phase 1/2 clinical
trial. Based on Actinium's alpha-particle immunotherapy (APIT) platform,
Actimab-A consists of the CD33 antibody lintuzumab linked to the
actinium-225 payload. Actimab-A has attracted support from leading
experts at the prestigious and high-volume cancer treatment hospitals
due to the potential of its safety and efficacy profile, as well as its
potential potency, specificity and ease of use. Clinical trials are
being conducted at world-class cancer institutions such as Memorial
Sloan Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins
Medicine, Columbia University Medical Center, University of Pennsylvania
Health System, Fred Hutchinson Cancer Research Center, and the Texas
Oncology-Baylor Charles A. Sammons Cancer Center. The Company expects
additional updates to its Phase 1/2 clinical trial in December 2014.
Actimab candidates are in early development for other cancers.
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 radiotherapy 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 plans to conduct a single, pivotal, multicenter Phase 3 clinical
study of Iomab-B in refractory and 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 continuing its
clinical development in a Phase 1/2 trial for newly diagnosed AML
patients over the age of 60 in a single-arm multicenter trial.
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