Full Press Release Details
Pharmaceuticals, Inc.
Actinium Pharmaceuticals
Actimab-A Phase I/II Trial Interim Data Demonstrate Extension of Overall Survival to 9.1 months in Elderly Secondary Acute Myeloid
New York, NY - November
6, 2014 -- Actinium Pharmaceuticals, Inc. ("Actinium" or the "Company") (NYSE MKT: ATNM), a biopharmaceutical
company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced positive
interim data from the ongoing Phase I/II 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 is a prolongation of life compared to historical norms of typically 2 to 5 months.1
Older AML patients are already higher risk, with secondary AML patients considered to have the more severe and less treatable
form of AML, and the shortest expected survival. The clinical abstract will be published and available online in Blood,
the official Journal of the American Society of Hematology.
"Alpha emitting isotopes may
result in more efficient leukemia cell killing without the toxicity of intensive chemotherapy," said Joseph Jurcic, M.D.,
Professor of Medicine and Director of the Hematologic Malignancies Section of the Hematology/Oncology Division at Columbia University
Medical Center, and lead study investigator. "In this study, Actimab-A was safely and effectively combined with low-dose
chemotherapy in older AML patients. Even at this early stage in development, the tolerability of the regimen and promising survival
data in this poor-risk population are highly encouraging and support our center's commitment to this program. Because many
of these patients cannot tolerate intensive chemotherapy, potentially less toxic treatments such as this are desperately needed."
"We believe the data presented
provide further evidence that Actimab-A has substantial clinical activity, including a survival benefit, in the hardest to treat
AML patients," said Dragan Cicic MD, Chief Medical Officer of Actinium. "The potential efficacy in killing other treatment
resistant leukemia cells combined with the limited side effects identified in the study to date could offer a new hope to patients
whose age, comorbidities and nature of disease currently leaves them with very limited treatment options. We continue to work with
a world-class team of clinical investigators to advance this program and technology."
1 Oran B, and Weisdorf DJ. Survival
for older patients with acute myeloid leukemia: a population-based study. Haematologica 2012; 97(12):1916-1924. doi:10.3324/haematol.2012.066100.
1 N Okuyama et al, Prognosis of acute
myeloid leukemia transformed from myelodysplastic syndromes: A multicenter retrospective study, Leukemia Research 37 (2013)
The interim analysis from this company-sponsored
trial is consistent with results from the prior three trials in Actinium's HuM195-Alpha Program. The abstract, Phase I
Trial of Targeted Alpha-Particle Therapy Using Actinium-225 (225Ac)-Lintuzumab (Anti-CD33) in Combination with Low-Dose
Cytarabine (LDAC) for Older Patients with Untreated Acute Myeloid Leukemia (AML), will be published and available online in
Blood, the official Journal of the American Society of Hematology.
In this interim analysis, a total
of 9 patients were evaluated thus far with a median age of 76 (range 73-81). All had intermediate or poor risk cytogenetics, and
7 of 9 patients had secondary AML as a result of prior MDS. These 7 secondary AML patients had a median OS of 9.1 months from study
entry (range 2.3-24 months). Of these, 2 patients lived longer than 12 months and the longest surviving patient lived greater than
24 months. Overall, for all 9 patients median OS was 5.4 months (range 2.2-24 months).
Two dosing levels have been evaluated
to date (0.5 or 1.0 Ci/kg/fraction), and the study is ongoing at higher doses until the maximum tolerated dose ("MTD")
is reached. Despite not having yet reached MTD, the Company has observed significant bone marrow blast reductions, another important
marker of efficacy. Of the 7 evaluable patients in the overall study, 5 patients (71%) had bone marrow blast reductions with a
mean of 61% reduction.
The sites participating in this
multi-center trial are 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 to announce further information related to Actimab-A development subsequent
to its Clinical Advisory Board meeting, during the ASH 2014 time frame (December 6-9, 2014).
Elderly, high risk patients ordinarily
have a life expectancy of 5 or fewer months if treated with standard chemotherapy, though only about a third of them do receive
treatment because of toxicity. The other two-thirds receive best supportive care, with 2 months survival, according to Oran and
Weisdorf (Haematologica 2012; 1916-24). The majority (5 of 7) of the secondary AML patients receiving Actimab-A had been
previously treated with hypomethylating agents, a criterion which would have excluded such patients from some other clinical trials.
Previous treatment with hypomethylating agents, and subsequent failure, further demonstrates the disease severity of patients in
the Actimab-A trial.
The safety profile of Actimab-A
was satisfactory and acceptable for this patient population in this interim analysis. The only drug-related serious adverse events
seen were related to myelosuppression, which is expected in the treatment of leukemia.
The antibody portion of Actimab-A,
HuM195 (also known as lintuzumab) when labeled with alpha particles has been evaluated in three prior studies, including two studies
of Bismab-A, which was an earlier, first generation construct, and an investigator sponsored trial with Actimab-A. Today's
interim results mark the first look at what the Company believes are clinically meaningful data in the ongoing, Company sponsored
Phase I/II trial of Actimab-A.
Secondary AML is a common form of
AML in the U.S., and is defined as AML that develops following exposure to cytotoxic agents or as a subsequent event in another
hematologic disorder, usually MDS. According to the American Cancer Society there is an annual incidence of 12,000 new cases of
MDS in the U.S. Between 30% and 50% of these new cases go on to develop AML, or approximately 3,600-6,000 secondary AML patients
Actimab-A is a radiolabeled antibody
being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase I/II 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 I/II 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 Iomab-B will be used, upon approval, in preparing patients for hematopoietic stem cell transplant,
commonly referred to as bone marrow transplant. The Company is preparing 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 program, 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.
Forward-Looking Statement 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
undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events
Actinium Pharmaceuticals, Inc.
VP Investor Relations and Finance