Clinical-stage biopharmaceutical company Actinium Pharmaceuticals Inc. (ATNM:NYSE-Amex), which is engaged in developing targeted radiotherapies capable of delivering cancer-killing radiation at the cellular level, yesterday announced "positive top-line results from the pivotal Phase 3 trial for its lead product candidate Iomab-B."
The company explained that the Phase 3 SIERRA Iomab-B study enrolled a t total of 153 patient subjects aged 55 or older who were diagnosed with active elderly relapsed or refractory acute myeloid leukemia (r/r AML).
The multi-center, randomized study was designed to evaluate the use and effectiveness of Iomab-B as a conditioning regimen prior to a bone marrow transplant (BMT) in comparison to a control arm of patients treated with salvage therapies. The firm noted that treatment options in the control group included various chemotherapies and targeted agents and noted that since presently no standard of care exists for this patient population, it employed a combination of methods that reflect real-world treatments of r/r AML patients.
ATNM shares opened 6% higher yesterday at US$10.32 (+US$0.59, +6.06%) over Friday's US$9.73 closing price and reached a new 52-week high price yesterday morning of US$13.38.
Actinium Pharmaceuticals advised that during the SIERRA trial, Iomab-B successfully achieved its primary endpoint described as "durable complete remission or dCR of six months post initial remission after a BMT in Iomab-B arm compared to conventional care arm demonstrating statistical significance p<0.0001."
The company's chief medical officer, Avinash Desai, M.D., commented, "We are excited that the randomized, controlled, multi-center, pivotal SIERRA trial has delivered these results for patients that need new treatment options. Our goal is to increase access to BMT and improve patient outcomes with Iomab-B, and these topline results move us in this direction given their statistical significance."
"We will continue to work on our Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for approval of Iomab-B, " Dr. Desai added.
Actinium Pharmaceuticals' chairman and CEO Sandesh Seth remarked, "This is a significant milestone in Actinium's lifecycle and a testimony to the quality of our team . . . Our recently strengthened team is executing to enable our mission to disrupt the field of bone marrow conditioning with Iomab-B, first in r/r AML and then by building upon its robust prior clinical results in several hematological diseases. We look forward to sharing additional clinical data from the SIERRA trial by year-end."
The company stated that "Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45."
The firm noted numerous studies showing that patients who received BMTs demonstrated increased survival rates. The company explained that currently, the vast majority of patients with blood cancers do not receive a BMT as, historically, the approaches utilized are too toxic and do not aid in remission.
The company indicated that it has now studied the effects of Iomab-B in more than 400 patients in multiple clinical trials who have almost all have advanced forward with BMTs and have demonstrated increased survival after treatment.
Actinium Pharmaceuticals indicated that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Iomab-B for treatment of r/r AML in patients 55 or older who do not meet the current BMT therapy requirements. The company listed that the FDA previously issued Orphan Drug Designation for Iomab-B.
Actinium is a clinical-stage biopharma co. headquartered in New York, that is focused on the development of targeted radiotherapies to deliver cancer-killing radiation with cellular-level precision.
The company stated that "Iomab-B has been studied in over four hundred patients in six disease indications including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma, non-Hodgkin's lymphoma (NHL) and multiple myeloma across twelve clinical trials."
Actinium Pharmaceuticals started yesterday with a market cap of around US$245.05 million, approximately 25.19 million shares outstanding, and a short interest of about 1.57. ATNM shares opened 6% higher yesterday at US$10.32 (+US$0.59, +6.06%) over Friday's US$9.73 closing price and reached a new 52-week high price yesterday morning of US$13.38. The stock traded yesterday between US$10.01 and US$13.89 per share and closed for trading at US$13.54 (+US$3.81, +39.16%).
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