On March 13, 2018 Actinium Pharmaceuticals reported that the Medical College of Wisconsin received clearance from the U.S. Food and Drug Administration (FDA) for the previously announced Investigational New Drug (IND) application for the Phase 1 trial of Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia (AML) patients (Press release, Actinium Pharmaceuticals, MAR 13, 2018, View Source [SID1234524720]). This investigator initiated trial will be conducted at the Medical College of Wisconsin and led by principal investigator Dr. Sameem Abedin in collaboration with Dr. Ehab Atallah. This trial will enroll up to 18 patients and will assess safety as well as efficacy, which will be based on response rates, percentage of patients receiving a bone marrow transplant and overall survival. Actimab-A is an antibody radio-conjugate (ARC) that combines the anti-CD33 antibody lintuzumab with the radioisotope actinium-225. CLAG-M is a salvage chemotherapy regimen consisting of cladribine, cytarabine, filgrastim and mitoxantrone that has become the standard of care at many institutions across the U.S. in AML patients with relapse.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "The use of our actinium-225 – anti-CD33 ARC in combination with cytotoxic therapies such as CLAG-M has the potential to improve outcomes for a significant number of patients. We believe our ARC approach, which has shown to be potent while having minimal extramedullary toxicities in over 100 patients to date, has the potential to be synergistic with cytotoxic chemotherapy agents. CLAG-M has shown compelling results in patients with relapsed or refractory disease and we believe that the combination with our ARC can improve response rates, transplant rates and overall survival for patients. We are excited to begin enrolling patients on this trial and look forward to working with Dr. Abedin, Dr. Atallah and their colleagues at the Medical College of Wisconsin on this important Phase 1 study."

This Phase 1 combination trial is the fourth clinical trial from Actinium’s CD33 program. The Company’s other CD33 program trials include its Phase 2 trial Actimab-A trial for patients newly diagnosed with AML who are over the age of 60 and unfit for intense chemotherapy and the Phase 1 Actimab-M trial for patients with refractory multiple myeloma. A Phase 2 trial is planned for patients with high-risk myelodysplastic syndrome with a p53 genetic mutation for myeloablation prior to a bone marrow transplant.

Sandesh Seth, Actinium’s Chairman and CEO said, "We see the use of our ARC’s in combination with chemotherapy as an exciting development opportunity that has the potential to bring benefits to a significant number patients. We believe that this will be the first of many combinations given the potency of our ARC approach together with its minimal extramedullary toxicities and its unique mechanism of action. Together these attributes make our ARC a versatile therapy that we believe can bring benefits to patients as a monotherapy, in combination and for myeloablation prior to a bone marrow transplant."

About Actimab-A

Actimab-A is Actinium’s lead drug candidate from its CD33 program and is an antibody radio-conjugate (ARC) that is comprised of the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope. This ARC is currently being studied in the Phase 2 Actimab-A is clinical trial in patients that are newly diagnosed with AML who are over the age of 60 that are ineligible for intense chemotherapy, also known as unfit patients. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration and the European Medicines Agency. The Company is also conducting the Phase 1 Actimab-M trial, an investigator initiated trial for patients with refractory multiple myeloma. Also, Actinium plans to begin the Phase 2 Actimab-MDS trial for patients with high-risk myelodysplastic syndrome (MDS) that have a p53 genetic mutation myeloablation prior to a bone marrow transplant. Actimab-A is a second-generation therapy from the Company’s CD33 Program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in over 100 patients in four clinical trials.