Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced that it has submitted a request for a CMC (Chemistry, Manufacturing and Control) meeting to the U.S. Food and Drug Administration (FDA) for the company's Iomab-B drug candidate currently undergoing preparations for starting the pivotal Phase 3 trial by the middle of 2015. 

The Company expects to obtain further guidance from the FDA that will allow completion of the processes and methods for large scale manufacturing and testing of clinical and commercial grade drug product.

“We are now in the final stages in our preparations to commence the Phase 3 trial for Iomab-B while simultaneously establishing the necessary infrastructure to enable the Company to quickly commercialize Iomab-B, if approved by FDA,” said Kaushik J. Dave, President and Chief Executive Officer of Actinium Pharmaceuticals, Inc. "We believe input from the FDA will be invaluable as we finalize our proprietary manufacturing processes to support both the clinical trials and future commercialization.”
 
About AML -- Acute myeloid leukemia (AML) is an aggressive cancer of the blood and bone marrow. It is characterized by an uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014. Patients over age 60 comprise the majority of those diagnosed with AML, with a median age at diagnosis of about 67 years. Treatment approaches in this population are limited because a majority of these individuals are judged too frail and unable to tolerate standard induction chemotherapy or as having disease generally unresponsive to currently available drugs. Elderly, high risk patients ordinarily have a life expectancy of 5 or fewer months if treated with standard chemotherapy, which only about a third of them do because of toxicity. The other two-thirds receive best supportive care, with 2 months survival, according to Oran and Weisdorf (Haematologica 2012; 1916-24).

About Iomab-B -- Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study if it is successful. The trial population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including 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). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

Neurocrine Biosciences (NASDAQ: NBIX) announced the steering committee of ENDO 2015 has selected the abstract of their recently completed clinical study of NBI-77860 in classic congenital adrenal hyperplasia for an oral presentation on the initial day of the Endocrine Society's 97th Annual Meeting. ENDO is the world's largest endocrinology meeting drawing over 10,000 experts from around the world.  The ENDO 2015 meeting will be held in San Diego from March 5-8, 2015.

"We are pleased to have been selected to hold an oral presentation at the annual meeting of the Endocrine Society and to share the clinical data of NBI-77860 in classic congenital adrenal hyperplasia with the broader scientific community," said Chris O'Brien, M.D., Chief Medical Officer at Neurocrine. "Congenital adrenal hyperplasia is a disease with a significant unmet medical need and NBI-77860 may potentially make an important difference in patients' lives. The ENDO annual meeting brings together the world's thought leaders in endocrinology to discuss the latest advances in the field and we look forward to discussing our clinical results at this meeting."

The oral presentation of the results from the initial clinical study of NBI-77860 for the treatment of classic congenital adrenal hyperplasia will occur at the 97th Annual Meeting of the Endocrine Society on Thursday, March 5, 2015 from 11:30 am to 1:00 pm (PST). The session is entitled "HPA Axis and Adrenal: Receptors to Clinical Impact."