On July 11, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported its presence at the Health Physics Society ("HPS") 64th Annual Meeting that is being held July 7th – 11th in Orlando, Florida (Press release, Actinium Pharmaceuticals, JUL 11, 2019, View Source [SID1234537474]). During HPS, Actinium presented the findings of two studies that support the safety of healthcare professionals who provide care to patients treated with Iomab-B, Actinium’s lead product candidate, which is being studied in the pivotal Phase 3 SIERRA trial. The studies evaluated radiation exposure to healthcare professionals who cared for patients treated with Iomab-B and the exposure from handling blood samples from patients following Iomab-B infusion. Both studies reported minimal radiation exposure to the respective healthcare professionals. One study of 105 healthcare professionals from 5 SIERRA sites that provided care to patients receiving Iomab-B observed a mean cumulative radiation exposure of 0.09 mSv or millisieverts, which is significantly less than the 50 mSv annual occupational dose limit for staff. Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the CD45 targeting antibody, apamistamab, and the radioisotope iodine-131 that is intended to be a re-induction and conditioning agent prior to a BMT or Bone Marrow Transplant. The SIERRA trial is a multicenter, 150 patient study for patients with active, relapsed or refractory AML or Acute Myeloid Leukemia that is the only randomized Phase 3 trial to offer a potentially curative BMT to this patient population for which there is no standard of care.
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!
Details of the HPS presentations on Iomab-B are as follows:
Title: Occupational Radiation Exposures to Clinical Staff Working With 131I – Iomab-B
Summary: Data from 105 healthcare professionals from five SIERRA sites was analyzed. Staff monitored when only providing care to Iomab-B treated patients had a mean cumulative exposure of 0.07 mSv despite high levels of radiation being administered with targeted Iomab-B while staff who provided care for multiple patients, including those receiving other forms or radiation therapy, had a mean cumulative exposure of 0.11 mSv. Radiation exposure levels to all staff were found to be minimal, with mean cumulative exposure of 0.09 mSv, contributing minimal exposure to the 50 mSv annual occupational limit. The study sited training, education, customized physical shielding and more advanced safety procedures as leading to minimal additional radiation exposure.
Title: Iomab-B Study Blood Sample Handling and Occupational Radiation Extremity Exposure
Summary: Radiation exposure levels were minimal and not a safety concern to clinical staff involved in blood specimen collecting and handling.
Dr. Qing Liang, Actinium’s Vice President, Head of Radiation Sciences, said, "The safety of patients and site staff is our number one concern, so I am excited that the data from these studies demonstrated minimal radiation exposure to staff caring for patients in the Iomab-B SIERRA trial. I am confident that our collective efforts, together with the supportive data presented here at the Health Physics Society Meeting, will have a positive impact on the SIERRA trial, Iomab-B and our other ARC therapeutic candidates."
"Staff at clinical sites are often surprised to learn that they can be exposed to higher amounts of radiation when flying on an airplane than compared to providing care to patients treated with Iomab-B. These study data solidly support this fact with the 0.09 mSv mean exposure to staff significantly lower than the 50 mSv annual occupational limit and even lower than the annual radiation 3 mSv, we all receive from natural background. Since joining Actinium, I have focused on building relationships with the radiation safety and nuclear medicine caregivers at existing and prospective sites for our SIERRA trial, educating site staff and working with my clinical colleagues to further optimize the SIERRA trial for patients and site staff. I believe that such efforts bode well not only for the SIERRA trail but also for Iomab-B in a commercial setting, assuming its approval," Concluded Dr. Liang."
The Health Physics Society has nearly 4,000 members including scientists, safety professionals, physicists, engineers and other professionals from academia, industry, the federal government and national laboratories.
Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "The SIERRA trial is a complex study involving multiple stakeholders at sites, including transplant physicians, radiation safety officers, nuclear medicine physicians and the nursing staff who provide care that is critical for these patients. Our team has worked intensely to address the needs of each of these stakeholders and I am proud that our efforts have taken Iomab-B from the single center where it was originally studied at to 19 clinical trials sites in the SIERRA trial thus far. The two studies presented at HPS which demonstrated that staff can safely provide care to patients with minimal radiation exposure are important and augment the promising interim feasibility and safety data that we have presented from the SIERRA trial. We are focused on continuing to generate positive data from the SIERRA trial for Iomab-B as we see a tremendous opportunity to improve outcomes for a significant number of patients with our ARC’s focused on targeted conditioning for BMT and cell therapies."