Actinium Pharmaceutics, Inc. (ATNM) Engages Goodwin Biotechnology To Supply Iomab™-B For Its Phase 3 Clinical Study
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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 (OTCPK: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: actiniumpharmaceuticals.com
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