Actinium to Partner With Aplastic Anemia & MDS International Foundation Patient and Family Forums

SOURCE: Actinium Pharmaceuticals

Scientific Advisory Board Member Dr. Sergio Giralt to Lead Bone Marrow Transplant Educational Sessio

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, is partnering with the Aplastic Anemia & MDS International Foundation, a leading non-profit health organization, to present educational forums to patients and their families on bone marrow transplant, MDS, aplastic anemia and PNH.

The next AA&MDSIF Patient and Family Conference will take place in Cleveland, Ohio at the Cleveland Airport Marriott on Saturday May 2, 8:30am-5:00pm.

Sergio Giralt, MD, Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, and Actinium Scientific Advisory Board Member, will present "Understanding BMT, Before and During" and "Bone Marrow Transplant: Managing Post BMT Health and Support" as part of the bone marrow transplant educational track. Additional conferences will take place throughout 2015 in San Francisco, Boston, Chicago and Tampa with a variety of distinguished speakers.

About Bone Marrow TransplantBone marrow transplants (BMT) are used to treat a variety of hematologic conditions including leukemia and MDS. BMT involves first clearing a patient's body of his or her own immune cells and then transplanting bone marrow, the source of all blood- and immune-forming cells, from a tissue-matched donor. The new cells, which are free of cancer, repopulate the patient's bone marrow and eventually give rise to a functioning set of blood and immune cells, providing a lifelong cure. BMT offers the chance of a "curative" outcome (2+ year survival), and therefore can play a central role in the treatment of acute myeloid leukemia (AML). The impact of BMT on AML continues to increase with AML being the most common and fastest growing indication for allogeneic BMT, comprising 25% to 30% of all BMT recipients. There are currently over 100,000 BMT survivors across all indications and this number is expected to increase to 250,000 by 2020 and 500,000 by 2030, with 25% of them over age 60.

About AAMDS International FoundationThe Aplastic Anemia & MDS International Foundation (AA&MDSIF) is the world's leading nonprofit health organization dedicated to supporting patients and families living with aplastic anemia, myelodysplastic syndromes (MDS), paroxysmal nocturnal hemoglobinuria (PNH), acute myeloid leukemia (AML) and related bone marrow failure diseases. AA&MDSIF provides answers, support and hope to thousands of patients and their families around the world. It is a patient-focused, patient-centered organization, serving patients and families throughout the three phases of bone marrow failure diseases: the life changing phase of diagnosis, the life threatening phase of treatment and the lifelong phase of living with disease.

About Iomab-B™
Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. 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).

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
 

Actinium Doses the First Patient in the Fourth, Final Cohort of Its Actimab-A Trial

SOURCE: Actinium Pharmaceuticals

Last Actimab-A Cohort in the Phase 1 Portion of the Phase 1/2 Trial Begins  

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced that the first patient was successfully treated with Actimab-A drug candidate in the fourth and last cohort of the ongoing Phase 1/2 trial of Actimab-A. Actimab-A is being developed for newly diagnosed AML patients over the age of 60 ineligible for standard induction chemotherapy.

Patients in this last cohort are being treated at 2.0 μCi/kg per dose of Actimab-A. To date, three cohorts of patients have been treated at dose levels of 0.5, 1.0 and 1.5 μCi/kg per fractionated dose, respectively. The treatment consists of two fractionated doses one week apart following cytoreduction with low dose cytarabine. Maximum tolerated dose (MTD) has not been reached yet and there was no peri-induction mortality among these high risk patients. However, dose dependent responses have been observed. 

In the previously completed third cohort in which patients received two doses of Actimab-A at 1.5 μCi/kg per dose, two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). "We are now moving towards completion of the Phase 1 portion of the trial," said Dr. Kaushik Dave, the President and CEO of Actinium Pharmaceuticals. "The fact that at these late stages of the dose escalating trial we have confirmed an exemplary safety profile while already observing clinical responses and survival benefit is very encouraging."

In this Phase 1/2 trial design, maximum tolerated dose will automatically become the Phase 2 portion dose.

About Actimab-A
Actimab-A, Actinium's most advanced alpha particle immunotherapy program is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single arm multicenter trial. Actimab-A is being developed as a first line therapy and has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile.

Actimab-A consists of the Lintuzumab monoclonal antibody and actinium 225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. Lintuzumab is the humanized version of M195 and is a monoclonal antibody that targets CD33, found on myeloid leukemia cells. Both the alpha particle technology and lintuzumab were initially developed at Memorial Sloan Kettering Cancer Center.

About Iomab-B
Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. 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).

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Actinium Pharmaceuticals Opens Enrollment for the Fourth and Final Cohort in the Company's Ongoing Phase I/II Trial in Acute Myeloid Leukemia

SOURCE: Actinium Pharmaceuticals

Successful Completion of the Third Cohort of AML Patients Followed by Opening of the Trial for Treatment at Increased Dose Level

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company is moving forward with enrollment and treatment of additional patients in its clinical trial for acute myeloid leukemia (AML) in patients over the age of 60. Actinium will proceed with patient screening and enrollment for the fourth cohort, who, in keeping with trial protocol, will be injected with two doses 4 to 7 days apart of the Company's investigational new drug Actimab-A at a higher activity level of 2.0 μCi/kg per dose.

In the previously completed third cohort in which patients received two doses of Actimab-A at 1.5 μCi/kg per dose two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 80% in the bone marrow. In the second cohort treated at a lower dose level of Actimab-A of 1.0 μCi/kg per dose, one patient achieved CRi.

"As we start this last dose level in the Phase 1 portion of our trial, we are very encouraged with results so far," commented Kaushik J. Dave, President and CEO of Actinium Pharmaceuticals. "We hope to establish the maximum tolerated dose soon which would allow us to proceed with the Phase 2 portion of the trial, as agreed with the FDA." 

The trial is a prospective, open-label study, designed to determine the safety and efficacy of Actimab-A in newly diagnosed AML patients who cannot tolerate current high dose chemotherapeutic regimens. 

Actinium previously announced positive interim data from the ongoing Phase 1/2 trial of Actimab-A in older patients with newly diagnosed Acute Myeloid Leukemia ("AML"). Most notably, median overall survival ("OS") of the seven secondary AML patients (with prior myelodysplastic syndrome, or MDS) in the study was 9.1 months, which compares favorably to historical norms of 2 to 5 months depending on the treatment modality. Older AML patients are already higher risk, with secondary AML patients considered to have the more severe and less treatable form of AML, and as a consequence have shorter expected survival. The clinical abstract was published and is available online in Blood, the official Journal of the American Society of Hematology.

About Actimab-A
Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. Based on Actinium's alpha-particle immunotherapy (APIT) platform, Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload. Actimab-A has attracted support from leading experts at the prestigious and high-volume cancer treatment hospitals due to the potential of its safety and efficacy profile, as well as its potential potency, specificity and ease of use. Clinical trials are being conducted at world-class cancer institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins Medicine, Columbia University Medical Center, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, and the Texas Oncology-Baylor Charles A. Sammons Cancer Center. The Company expects additional updates to its Phase 1/2 clinical trial in December 2014. Actimab candidates are in early development for other cancers.

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Actinium Announces New Data From Ongoing Phase 1/2 Trial of Actimab-A Demonstrating Safety and Robust Clinical Efficacy in High Risk Elderly Acute Myeloid Leukemia Patients

SOURCE: Actinium Pharmaceuticals
 
Strong Anti-Leukemic Effect Demonstrated in Cohort 3; No Dose Limiting Toxicities Observed

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today the completion of the third cohort of the Company's ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients. Cohort 3, which included 3 additional patients, demonstrated no dose limiting toxicities in patients older than 60 and up to 87 years of age who were not eligible for currently approved therapies. Two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 88% in the bone marrow. In the previous cohort treated at a lower dose level of Actimab-A, one patient achieved CRi.

"The positive results on both safety and anti-leukemic effect demonstrated in the completed third cohort represents a significant achievement for the Actimab-A program, and supports the advancement to a higher dose with the potential to further enhance the already strong results we have seen to date," stated Dragan Cicic, MD, Chief Medical Officer of Actinium. "We believe the responses observed for Actimab-A, with minimal toxicity being reported, are impressive in this disease setting. These findings build upon those presented and published over the past year which demonstrated a clear survival benefit in secondary AML patients. We remain steadfast in our belief that Actimab-A could play an important role in the treatment regimen for newly diagnosed elderly secondary AML patients who currently have limited treatment options, and have historically achieved overall survival of only 2 to 5 months, depending on treatment modality."

The primary goals of the Phase 1 trial portion of the ongoing Phase 1/2 clinical trial are to establish the safety profile, determine the maximum tolerated dose (MTD) and assess the preliminary clinical activity of Actimab-A in newly diagnosed AML patients over 60. In the first cohort, patients were treated with two doses of Actimab-A at 0.5 μCi/kg activity level. In the second cohort, patients received two doses of Actimab-A at 1.0 μCi/kg activity level, and in the third cohort, patients received two doses at 1.5 μCi/kg activity. As the drug candidate continues to be well tolerated in in these high risk elderly AML patients, the trial will advance to a fourth cohort at two doses of Actimab-A at a μCi/kg activity level of 2.0. Upon reaching the MTD in the Phase 1 portion of the trial, the Phase 2 portion would begin at the established MTD level.

Actinium previously announced positive interim data from the ongoing Phase 1/2 trial of Actimab-A in older patients with newly diagnosed AML. Most notably, median overall survival ("OS") of the seven secondary AML patients (with prior myelodysplastic syndrome, or MDS) in the study was 9.1 months, which compares favorably to historical norms of 2 to 5 months, depending on the treatment modality. Older AML patients are already higher risk, with secondary AML patients considered to have the more severe and less treatable form of AML, and as a consequence, have shorter expected survival. The clinical abstract was published and is available online in Blood, the official Journal of the American Society of Hematology.

About Actimab-A
Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. Based on Actinium's alpha-particle immunotherapy (APIT) platform, Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload. Actimab-A has attracted support from leading experts at the prestigious and high-volume cancer treatment hospitals due to the potential of its safety and efficacy profile, as well as its potential potency, specificity and ease of use. Clinical trials are being conducted at world-class cancer institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins Medicine, Columbia University Medical Center, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, and the Texas Oncology-Baylor Charles A. Sammons Cancer Center. The Company expects additional updates to its Phase 1/2 clinical trial in December 2014. Actimab candidates are in early development for other cancers.

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.