Featured Company News - Actinium Declares Activation of 15th Clinical Trial Site in the Phase-3 SIERRA Trial for Iomab-B
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LONDON, UK / ACCESSWIRE / October 27, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Actinium Pharmaceuticals, Inc. (NYSE: ATNM) ("Actinium"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=ATNM. The Company announced on October 25, 2017, that it has successfully activated the fifteenth clinical trial site for the pivotal Phase-3 SIERRA trial. Actinium is a clinical-stage biopharmaceutical Company working towards developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow before a bone marrow transplant, and for the targeting and killing of cancer cells. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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About Iomab-B
Iomab-B is Actinium's lead product candidate, which aims to provide safer myeloablation of the bone marrow before the bone marrow transplant. Thus, it could prove to be a potentially curative treatment option for this patient population as well as for patients with other leukemias, lymphomas, myelomas, and other blood disorders. Once it is approved, Iomab-B would prepare and condition patients for a bone marrow transplant, also known as hematopoietic stem cell transplant. This transplant is considered as the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B basically targets cells that express CD45, which is a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. Since Iomab-B directly carries iodine-131 to the bone marrow in a targeted manner, it can avoid the side effects of radiation on healthy tissues while effectively killing the patient's cancer and marrow cells.
Iomab-B History
In its Phase-2 clinical study comprising 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) aged 50 and older, Iomab-B generated complete remissions in 100% of the patients who experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in around 300 patients in various blood cancer indications, such as acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL), and multiple myeloma (MM). The drug has been granted the Orphan Drug Designation for relapsed or refractory AML in patients aged 55 and above by the US Food and Drug Administration and the European Medicines Agency.
About the SIERRA Trial
SIERRA stands for study of Iomab-B in elderly relapsed or refractory acute myeloid leukemia. SIERRA trial is a 150-patient, multicenter pivotal Phase-3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are aged 55 and above.
The study intends to compare Iomab-B and a bone marrow transplant to the physician's choice of salvage chemotherapy. The primary endpoint is durable complete remission (dCR) of at least 6 months.
Trial Update on Trial by Year-end
Actinium affirmed that it would share an update on the Iomab-B SIERRA trial by the end of 2017.
The SIERRA trial would have three safety analyses by an independent Data Monitoring Committee when it reaches 25%, 50%, and 75% patient enrollment.
In addition to that, Actinium may request two ad-hoc efficacy analyses after 70 and/or 110 patients have engrafted and given enough time to accomplish the primary endpoint of durable complete remission at six months post-treatment.
A Unique Clinical Opportunity for Actinium
Sandesh Seth, Chairman and Chief Executive Officer (CEO) at Actinium, mentioned that before the SIERRA trial, Iomab-B had only been studied in a single center. But now, through the SIERRA trial, Actinium has been able to bring this important therapeutic drug to the leading transplant centers in the US. The trial sites include MD Anderson Cancer Center in Texas, Memorial Sloan Kettering Cancer Center in New York, Mayo Clinic in Minnesota, Mayo Clinic in Florida, Washington University School of Medicine in Missouri, Yale Cancer Center in Connecticut, Baylor Charles A. Sammons Cancer Center in Texas, The University of Kansas Cancer Center in Kansas, Roswell Park Cancer Institute in New York, University Hospitals Cleveland Medical Center in Ohio, The Ohio State University Comprehensive Cancer Center in Ohio, Penn State Hershey Cancer Institute in Pennsylvania, Loyola University Medical Center in Illinois, Banner MD Anderson Cancer Center in Arizona, and Fred Hutchinson Cancer Research Center in Washington. These fifteen centers collectively perform a third of all AML related bone marrow transplants.
The introduction of Iomab-B in these centers works well for the enrollment in the trial and also for the commercial opportunity for Iomab-B, as the top fifty centers account for around 80% of bone marrow transplants.
Moreover, as of now, there is no visible competition for Iomab-B from any drug or drug candidate that can provide safer myeloablation and enable improved outcomes of bone marrow transplant.
Seth also highlighted that Actinium plans to build on the clinical experience, infrastructure, and supply chain capabilities that it has established so far, for the completion of the trial in accordance with prior guidance. A successful outcome in this trial would establish Iomab-B as the standard of care in providing safer myeloablation first in in AML and then in the other hematologic indications in which it has shown positive results.
Last Close Stock Review
On Thursday, October 26, 2017, the stock closed the trading session at $0.65, tumbling 13.96% from its previous closing price of $0.76. A total volume of 1.67 million shares have exchanged hands, which was higher than the 3-month average volume of 968.40 thousand shares. Actinium Pharma's stock price surged 10.27% in the last one month. The stock currently has a market cap of $50.51 million.
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