- Actimab-A has received Orphan Drug Designation in the U.S.
- Orphan Designation in the EU can result in regulatory assistance, reduced fees and 10 years of market exclusivity
Actinium
Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a
biopharmaceutical company developing innovative targeted therapies for
cancers lacking effective treatment options, announced today that the
Company has submitted an application with the European Medicines Agency
(EMA) seeking Orphan Designation for Actimab-A for patients newly
diagnosed with acute myeloid leukemia (AML) age 60 and above who are
ineligible for currently used induction therapies. Actimab-A is
currently in a 53-patient, multicenter open label Phase 2 trial where it
is being studied as a monotherapy in these patients who have low
peripheral blast (PB) burden. In a previously completed Phase 1 trial,
Actimab-A showed a 50% composite response rate at the dose level of 2.0
μCi/kg/fraction, which is the dose level being studied in the current
Phase 2 trial, in patients with low PB burden.
“Orphan
designation brings significant benefits to the drug development
process,” said Sandesh Seth, Executive Chairman of Actinium
Pharmaceuticals. “We are excited to have submitted this application with
the EMA and we are optimistic that Actimab-A will soon have orphan
designation in the EU just as it does in the U.S. If this were to occur,
both of our clinical product candidates, Iomab-B and Actimab-A, would
have orphan designation in the U.S. and EU, which are the largest
addressable markets for our product candidates.”
About EU Orphan Designation
The
EMA, through its Committee for Orphan Medicinal Products (COMP),
examines applications for orphan designation. To qualify for orphan
designation, the prevalence of the condition must be less than 5 in
10,000, it must be life threatening or chronically debilitating and
there must be no satisfactory method of treating the condition. Sponsors
who obtain orphan designation receive numerous incentives including
protocol assistance, a reduction or waving of fees and 10 years of
market exclusivity should the therapy be approved. The process of filing
and receiving the orphan medicines designation can take between eight
to fourteen months in most cases. To learn more please visit EMA’s COMP
website http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30.
About Actimab-A
Actimab-A,
Actinium's most advanced alpha particle immunotherapy (APIT) product
candidate, is currently in a 53-patient, multicenter Phase 2 trial for
patients newly diagnosed with AML age 60 and above. Actimab-A is being
developed as a first-line therapy and is a monotherapy that is
administered via two 15-minute injections that are given 7 days apart.
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 calls.
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 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 almost 90 patients in four clinical trials.
Actimab-A has been granted Orphan Drug Designation for newly diagnosed
AML age 60 and above.
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. 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.
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