actinium pharmaceuticals inc (ATNM) Key Developments
Actinium Pharmaceuticals Opens Enrollment for the Fourth and Final Cohort for Phase I/II Trial in Acute Myeloid Leukemia
Mar 24 15
Actinium Pharmaceuticals, Inc. announced 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. 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. Most notably, median overall survival 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.
Actinium Pharmaceuticals, Inc. Announces Completion of the Third Cohort Ongoing Multi-Center Phase 1/2 Study for Actimab-A
Mar 18 15
Actinium Pharmaceuticals, Inc. announced 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 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 ¼Ci/kg activity level. In the second cohort, patients received two doses of Actimab-A at 1.0 ¼Ci/kg activity level, and in the third cohort, patients received two doses at 1.5 ¼Ci/kg activity. As the drug candidate continues to be well tolerated in these high risk elderly AML patients, the trial will advance to a fourth cohort at two doses of Actimab-A at a ¼Ci/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 Pharmaceuticals, Inc. Announces Amendments to Certificate of Incorporation
Mar 4 15
Effective February 26, 2015, Actinium Pharmaceuticals, Inc. amended its Certificate of Incorporation to remove the board size provision and update the classified board provision. Pursuant to the staggered board provision, the directors shall be divided into three classes, designated Class I, Class II, and Class III. Class I shall consist of up to three directors, Class II shall consist of up to three directors, and Class III shall consist of up to three directors. Each such director shall serve for a term ending on the date of the third annual meeting of shareholders following the annual meeting at which the director was elected. In order to implement a classified Board of directors, Class I shall serve a twelve month term from the date of the 2013 annual stockholders meeting; Class II shall serve a twenty four (24) month term from the date of the 2013 annual stockholders meeting; and Class III shall serve a 36 month term from the 2013 annual stockholders meeting. Directors elected at each annual meeting commencing in 2014 shall be elected for a three year term as specified above.
Actinium Pharmaceuticals, Inc. Presents at BioCentury 22nd Annual Future Leaders in the Biotech Industry Conference, Mar-20-2015 11:00 AM
Feb 26 15
Actinium Pharmaceuticals, Inc. Presents at BioCentury 22nd Annual Future Leaders in the Biotech Industry Conference, Mar-20-2015 11:00 AM. Venue: Millennium Broadway Hotel & Conference Center, New York, New York, United States. Speakers: Kaushik J. Dave, Chief Executive Officer, President, Interim Chief Financial Officer, Principal Accounting Officer and Director.
Actinium Pharmaceuticals, Inc. Presents at 3rd Annual SACHS Cancer Bio Partnering and Investment Forum, Feb-23-2015
Feb 22 15
Actinium Pharmaceuticals, Inc. Presents at 3rd Annual SACHS Cancer Bio Partnering and Investment Forum, Feb-23-2015. Venue: The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St, 40th Floor (D Elevator Bank), New York, NY10007, United States. Presentation Date & Speakers: Feb-23-2015, Dragan Cicic, Chief Operating Officer and Chief Medical Officer.