SOURCE: Actinium Pharmaceuticals
Last Actimab-A Cohort in the Phase 1 Portion of the Phase 1/2 Trial Begins
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 that the first patient was successfully
treated with Actimab-A drug candidate in the fourth and last cohort of
the ongoing Phase 1/2 trial of Actimab-A. Actimab-A is being developed
for newly diagnosed AML patients over the age of 60 ineligible for
standard induction chemotherapy.
Patients in this last cohort
are being treated at 2.0 μCi/kg per dose of Actimab-A. To date, three
cohorts of patients have been treated at dose levels of 0.5, 1.0 and 1.5
μCi/kg per fractionated dose, respectively. The treatment consists of
two fractionated doses one week apart following cytoreduction with low
dose cytarabine. Maximum tolerated dose (MTD) has not been reached yet
and there was no peri-induction mortality among these high risk
patients. However, dose dependent responses have been observed.
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). "We are now moving towards completion of
the Phase 1 portion of the trial," said Dr. Kaushik Dave, the President
and CEO of Actinium Pharmaceuticals. "The fact that at these late stages
of the dose escalating trial we have confirmed an exemplary safety
profile while already observing clinical responses and survival benefit
is very encouraging."
In this Phase 1/2 trial design, maximum tolerated dose will automatically become the Phase 2 portion dose.
About Actimab-A
Actimab-A, Actinium's most advanced alpha particle
immunotherapy program 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. Actimab-A is being developed as a first
line therapy and 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
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. Lintuzumab is the humanized version of M195 and
is a monoclonal antibody that targets CD33, found on myeloid leukemia
cells. Both the alpha particle technology and lintuzumab were initially
developed at Memorial Sloan Kettering Cancer Center.
About Iomab-B
Iomab-B™ is being developed to prepare patients for
hematopoietic stem cell transplantation (HSCT) and will enter a single,
pivotal Phase 3 clinical study in relapsed/refractory AML. 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's disease (HD), Non-Hodgkin lymphomas (NHL) and
multiple myeloma (MM).
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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