Actinium Announces Initiation of Phase 2 Clinical Trial of Actimab-A in Patients Newly Diagnosed with Acute Myeloid Leukemia ...
September 27 2016 - 7:00AM
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 has initiated a Phase 2
clinical trial of Actimab-A in patients newly diagnosed with Acute
Myeloid Leukemia (AML) who are over the age of 60. Actimab-A,
Actinium's most advanced alpha particle immunotherapy (APIT)
program consists of the CD33 targeting monoclonal antibody, HuM195,
and the alpha-emitting radioisotope, actinium-225.
“We are excited to have initiated the Phase 2
trial of Actimab-A for elderly patients who are newly diagnosed
with AML and ineligible for 7+3 treatment. These older patients
face a poor prognosis and have limited viable treatment options”
said Sandesh Seth, Actinium’s Executive Chairman. “We are
encouraged by the safety and efficacy signals we have seen thus far
and look forward to the execution of this trial with an eye toward
interim and top-line results which are both expected in 2017.”
This Phase 2 clinical trial is a multicenter,
open-label study that will enroll 53 patients. Patients will
receive 2.0 µCi/kg/fractionated dose of Actimab-A via two
injections given at day 1 and day 7. The Phase 2 trial is designed
to evaluate complete response rates at up to day 42 after Actimab-A
administration, where complete response is defined as complete
remission (CR) or complete remission with incomplete platelet
recovery (CRp). A formal interim analysis is expected to occur in
mid-2017 with topline results expected in the second half of 2017.
The Phase 2 trial will include peripheral blast burden as an
inclusion criteria and in patients with high peripheral blast (PB)
burden, the use of Hydroxyurea will be mandated with the goal of
bringing PB burden below a key threshold number that the Company
has identified from two previously complete Phase 1 clinical trials
totaling 38 patients. In addition, the use of granulocyte
colony-stimulating factors (GCSF) will be mandated. Low dose
cytarabine has been eliminated from the protocol and the Phase 2
clinical trial will evaluate Actimab-A as a monotherapy. The
secondary endpoint of the Phase 2 trial will be overall
survival.
Dr. Joseph Jurcic, Principal Investigator of the
Actimab-A Phase 2 trial and Director of Hematologic Malignancies;
Professor of Medicine at Columbia University Medical Center said,
“Actimab-A has been studied in two clinical trials thus far in
patients with AML ranging in age from 18-87 who had a wide array of
genetic risk factors that were at various stages of disease
progression. Actimab-A has shown a promising safety and efficacy
profile thus far that we believe differentiates Actimab-A from
other CD33 targeting drug candidate, which is an exciting space in
AML. Our PB burden hypothesis indicates that of all factors related
to AML including age, stage of disease and genetic factors,
peripheral blast burden showed to be the most relevant. With PB
burden serving as an inclusion criteria in this Phase 2 trial and
the use of Hydroxyurea being mandated in patients with PB burden
above a key threshold we look forward to conducting this clinical
trial in this older patient population that has a great unmet
medical need.”
The Company will host a webinar Tuesday,
September 27, 2016 at 9:00 AM ET to discuss the Phase 2 clinical
trial. Details for the webinar are as follows:
Date: Tuesday, September 27, 2016Time: 9:00 AM ETWebinar Link:
https://onecast.thinkpragmatic.com/ses/awQiM-9OD7Iysoul6ZD6BQ~~Speakers:
Joseph Jurcic, M.D., Director of Hematologic Malignancies;
Professor of Medicine at Columbia University Medical Center.
Actimab-A Principal InvestigatorSandesh Seth, Executive Chairman,
Actinium PharmaceuticalsDragan Cicic, M.D., Chief Medical Officer,
Actinium Pharmaceuticals
About Actimab-A
Actimab-A, Actinium's most advanced alpha
particle immunotherapy (APIT) program, is in a multicenter,
open-label, Phase 2 clinical trial for patients newly diagnosed
with Acute Myeloid Leukemia (AML) over the age of 60. Actimab-A is
being developed as a first-line therapy and it has attracted
support from some of the leading experts at the most prestigious
cancer treatment hospitals due to the potential of its safety and
efficacy profile. Actimab-A consists of the monoclonal antibody,
HuM195, and the radioisotope, 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. HuM195 is the humanized
version of M195 and is a monoclonal antibody that targets CD33,
which is abundantly found on myeloid leukemia cells. Both the alpha
particle technology and HuM195 were initially developed at Memorial
Sloan Kettering Cancer Center. Actimab-A is a second-generation
therapy from the Company’s HuM195-Alpha program, which has now been
studied in almost 90 patients in four clinical trials.
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
radioimmunotherapy 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 is conducting a single, pivotal,
multicenter Phase 3 clinical study of Iomab-B in refractory or
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 in a 53 patient, multicenter, open-label Phase 2
trial for patients newly diagnosed with AML over the age of 60 in a
single-arm multicenter trial.
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
Vice President, Finance and Corporate Development
soloughlin@actiniumpharma.com