Today before the opening
bell, Actinium Pharmaceutics reported that it has engaged Goodwin Biotechnology
in a manufacturing supply agreement. In this agreement, Goodwin Biotechnology
will be the overseer of the current Good Manufacturing Practices production of
a monoclonal antibody that is expected to be used in an upcoming phase 3
clinical trial of Iomab™-B. Iomab™-B is to be used in preparation of patients
for hematopoietic stem cell transplant (HSCT), which is commonly referred to as
a bone marrow transplant (BMT).
“This agreement with Goodwin
Biotechnology represents a major risk mitigation step in conducting our phase 3
trial of Iomab™-B,” said Kaushik J. Dave, President and CEO of Actinium.
“Goodwin Biotechnology has significant experience in working with companies
like ours and the capabilities to provide the scale-up needed for a late-stage
clinical trial. Its competencies in process and product implementation, quality
assurance, and GMP manufacturing make it ideally suited as a manufacturing
partner for Actinium as we look forward to launching this pivotal phase 3 trial
later this year.”
“We are very excited to be
working with Actinium on Iomab™-B, their lead product candidate,” said Karl
Pinto, CEO of Goodwin Biotechnology. “Actinium’s cutting edge proprietary
platform is able to target different types of cancers that are without any
approved treatment options. We look forward to a long-term partnership with
Actinium, not only on Iomab™-B, but hopefully also on other products in their
pipeline such as Actimab-A.”
Based out of New York,
Actinium is a biopharmaceutical company developing innovative targeted payload
immunotherapeutics for the treatment of advanced cancers. Currently, it is
conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B.
In that study, the radioimmunoconjugates and its treatment efficacy are being
examined in refractory and relapsed Acute Myeloid Leukemia (AML) patients, who
are over 55 years of age, with a primary endpoint of durable complete
remission.
For more information on
Actinium, visit: www.actiniumpharmaceuticals.com
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