Actinium Strengthens Executive Team and Enhances Clinical Development Capabilities with the Appointment of Dr. Mark Berger as Chief Medical Officer

Source:  Actinium Pharmaceuticals, Inc.

• Dr. Berger brings 20 years of drug development experience highlighted by the FDA approvals of Mylotarg^® for acute myeloid leukemia, the only drug approved in AML in several decades, and Tykerb^® for breast cancer
• Dr. Dragan Cicic appointed to newly created position of Chief Technical Officer to execute on pipeline expansion and strategic initiatives

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced that Dr. Mark Berger has been appointed Chief Medical Officer effective today. Dr. Berger joins Actinium with significant drug development expertise that includes the planning and execution of clinical trials that led to the FDA approval of Mylotarg for acute myeloid leukemia (AML) while at Wyeth Research (now Pfizer), and Tykerb for breast cancer while at GlaxoSmithKline. He also has experience in patient care and lab-based cancer research. Dr. Berger will report to Sandesh Seth, Actinium’s Executive Chairman.

“Dr. Berger has a stellar track record in hematology/oncology research and drug development that makes him perfectly suited for the position of Chief Medical Officer at Actinium,” said Sandesh Seth. “Dr. Berger led the development of Mylotarg, which like Actimab-A, is a CD33 targeting agent. Mylotarg remains the only drug approved in AML in the last several decades, and Dr. Berger was integral to Mylotarg’s approval as highlighted by his presentation to ODAC. This along with Mark’s many other accomplishments in drug development, medical training and research experience gives us great confidence in his ability to build a robust clinical development organization to execute on the clinical development of Iomab-B, Actimab-A and our future clinical programs.” 

“I am impressed with the potential for Actinium’s radioimmunotherapy technology,” Dr. Berger said. “The data to date on Iomab-B and Actimab-A are very compelling and suggest that radioimmunotherapy has the potential to be safe and effective particularly in difficult clinical indications such as bone marrow transplant conditioning in patients with AML, or in the treatment of older patients with AML. I am excited to join the Actinium team and look forward to executing on a clinical development strategy that will bring these therapies to approval.”

In addition, Dr. Dragan Cicic, Actinium’s previous Chief Medical Officer, has been appointed to the newly created position of Chief Technology Officer. In his new role, Dr. Cicic will be responsible for leveraging Actinium’s alpha particle immunotherapy (APIT) technology platform to further expand Actinium’s clinical pipeline. Dr. Cicic will also be responsible for driving strategic initiatives including research collaborations and partnerships as well as continuing to expand relationships with the medical and scientific communities.

“Actinium’s growth and progress particularly in 2016 has been transformative and Dr. Berger’s joining is a continued step in that direction,” said Dr. Cicic. “I am excited to work with Dr. Berger and am confident that he will have a lasting impact on the execution of our late stage clinical trials. I welcome my new responsibilities and look forward to having the opportunity to focus extensively on our APIT platform to create value by laying the groundwork for new clinical programs and through strategic initiatives.”

Dr. Berger joins Actinium from Kadmon Corporation where he was Senior Vice President, Clinical Research. In this role he was responsible for all clinical aspects of new drug development including designing and managing clinical trials in oncology indications (non-small cell lung cancer and glioblastoma) and non-oncology indications (chronic graft versus host disease and polycystic kidney disease). Dr. Berger joined Kadmon after serving as Chief Medical Officer of Deciphera Pharmaceuticals. Prior to Deciphera, Dr. Berger was Vice President for Clinical Development at Gemin X Pharmaceuticals where he led the clinical strategy, design and management of clinical trials for two novel oncology agents including obatoclax, a pan Bcl-2 inhibitor. Based on the results of a randomized Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon in March of 2011 for a total consideration of $525 million including $225 million in an upfront cash payment.

Before his work with biotechnology companies, Dr. Berger held key positions in two global pharmaceutical companies. Dr. Berger previously served as Group Director, Medicine Development Centre-Oncology for GlaxoSmithKline. In this position Dr. Berger managed the development of Tykerb (lapatinib) in lung and breast cancer where he designed and led two Phase 2 clinical trials before planning and leading a 399 patient pivotal Phase 3 trial that resulted in the FDA approval of Tykerb in breast cancer.  In addition, he managed the Lapatinib Expanded Access Program (LEAP) that enrolled over 4000 patients on a global basis.  Dr. Berger began his career in drug development at Wyeth Research where he led the planning and execution of the pivotal Phase 2 trial for Mylotarg, which was the first antibody targeted chemotherapy agent and targeted CD33, similar to Actimab-A. He presented the Mylotarg clinical data at the FDA’s Oncology Drug Advisory Committee meeting, after which Mylotarg received accelerated FDA approval for patients with relapsed AML.

Dr. Berger has a B.A. in biology from Wesleyan University and received his M.D. from the University of Virginia School of Medicine. He did his Hematology-Oncology fellowship at the University of Pennsylvania where he was an Assistant Professor of Medicine, and also was a Research Fellow at the Ludwig Institute for Cancer Research and the Imperial Cancer Research Fund, both in London. Dr. Berger is board certified in internal medicine, hematology and medical oncology.

About Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Actinium Pharmaceuticals Appoints Jeannine Larrieux, Ph.D. as Director of Analytical Development to Support BLA and IND Enabling Analytical Studies for Current and Future Clinical Programs

Source:  Actinium Pharmaceuticals, Inc.

- Dr. Larrieux brings significant experience managing analytical development quality control of immunotherapies to treat cancer and small molecule therapies at pharmaceutical and biotechnology organizations

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that Jeannine Larrieux, Ph.D. has been appointed Director of Analytical Development. Dr. Larrieux will be responsible for analytical assay development, conducting biologics license application (BLA) and investigational new drug (IND) enabling studies, authoring CMC analytical sections for BLA and IND filings and supporting both internal and external quality assurance (QA) and quality control (QC) efforts.

“Dr. Larrieux is an accomplished analytical professional who is bringing over 20 years of highly relevant industry experience in matters related to regulatory submissions, project management and QA/QC to Actinium,” said Sandesh Seth, Actinium’s Executive Chairman. “Dr. Larrieux is yet another invaluable addition to the Actinium team that will contribute enormously to the development of our clinical programs Iomab-B and Actimab-A as well as future clinical programs we hope to unveil in the near future.”

Dr. Larrieux joins Actinium following analytical consulting assignments in the U.S. and Europe. Prior to this, she was Head of AS&T at Novartis where she focused on cell therapy products aimed to treat acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). Prior to Novartis, Dr. Larrieux was Laboratory Manager at Dendreon Corporation where she supported Phase 3 and Phase 4 clinical studies. In addition, Dr. Larrieux has worked at Pfizer, Purdue Pharma and Wyeth in analytical roles.

Dr. Larrieux earned her Ph.D. in Material Chemistry from Polytechnic Institute of NYU, an M.S. degree in Chemistry from Polytechnic University and a BS.c. degree in Chemistry from State University of HAITI (PAP). In addition, she is a member of the Regulatory Affairs Professionals Society (RAPS) and a member of the American Society for Quality (ASQ).

About Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Actinium Pharmaceuticals Announces Submission of EU Orphan Designation Application for Actimab-A

Source:  Actinium Pharmaceuticals, Inc.

-  Actimab-A has received Orphan Drug Designation in the U.S.

-  Orphan Designation in the EU can result in regulatory assistance, reduced fees and 10 years of market exclusivity

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that the Company has submitted an application with the European Medicines Agency (EMA) seeking Orphan Designation for Actimab-A for patients newly diagnosed with acute myeloid leukemia (AML) age 60 and above who are ineligible for currently used induction therapies. Actimab-A is currently in a 53-patient, multicenter open label Phase 2 trial where it is being studied as a monotherapy in these patients who have low peripheral blast (PB) burden. In a previously completed Phase 1 trial, Actimab-A showed a 50% composite response rate at the dose level of 2.0 μCi/kg/fraction, which is the dose level being studied in the current Phase 2 trial, in patients with low PB burden.

“Orphan designation brings significant benefits to the drug development process,” said Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. “We are excited to have submitted this application with the EMA and we are optimistic that Actimab-A will soon have orphan designation in the EU just as it does in the U.S. If this were to occur, both of our clinical product candidates, Iomab-B and Actimab-A, would have orphan designation in the U.S. and EU, which are the largest addressable markets for our product candidates.”

About EU Orphan Designation

The EMA, through its Committee for Orphan Medicinal Products (COMP), examines applications for orphan designation. To qualify for orphan designation, the prevalence of the condition must be less than 5 in 10,000, it must be life threatening or chronically debilitating and there must be no satisfactory method of treating the condition. Sponsors who obtain orphan designation receive numerous incentives including protocol assistance, a reduction or waving of fees and 10 years of market exclusivity should the therapy be approved. The process of filing and receiving the orphan medicines designation can take between eight to fourteen months in most cases. To learn more please visit EMA’s COMP website http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30.

About Actimab-A

Actimab-A, Actinium's most advanced alpha particle immunotherapy (APIT) product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer calls. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 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. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML age 60 and above.

About Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Actinium Highlights Results from Phase 1 Clinical Trial of Actimab-A at 58th American Society of Hematology Annual Meeting

Source:  Actinium Pharmaceuticals, Inc.

• Analysis of 2 Actimab-A Phase 1 clinical trials show that 42% of patients with low peripheral blast (PB) burden responded to Actimab-A while no patients with high PB burden responded to Actimab-A
  
• Key threshold level for low PB Burden per PB Burden Hypothesis identified as 200 blasts/µL
   
• Actimab-A has progressed to Phase 2 trial as a monotherapy via two simple fifteen minute injections administered a week apart in patients below PB burden threshold

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that results from its Phase 1 trial of Actimab-A were presented at the 58^th American Society of Hematology Annual Meeting (ASH) that is currently ongoing in San Diego, CA. Data from the previously conducted Phase 1 study pertaining to safety, efficacy and PB burden were highlighted during the poster session. Actimab-A is currently being studied in a 53-patient Phase 2 clinical trial as a monotherapy for patients newly diagnosed with Acute Myeloid Leukemia (AML) age 60 and above who are ineligible for currently used induction therapies. The Phase 2 trial is studying Actimab-A as a monotherapy administered via two fifteen minute intravenous injections of 2.0 μCi/kg/fraction of Actimab-A given a week apart. PB burden below 200 blasts/µL will serve as an inclusion criteria and patients above this threshold will be administered hydroxyurea to reduce their peripheral blasts counts prior to Actimab-A administration. Results from the Phase 1 trial showed that patients with PB burden below 200 blasts/µL who received a dose of 2.0 μCi/kg/fraction of Actimab-A saw a 50% response rate.

Actinium’s PB burden hypothesis states that patients below the key threshold level of 200 blasts/µL have an increased response rate to Actimab-A while patients above the key threshold are unlikely to respond. An analysis of 2 clinical trials with Actimab-A totaling 38 patients, of which 36 were evaluable, showed that 42% (8 of 19) of patients with blasts counts below 200/µL responded to Actimab-A while no patients with blast counts above 200/µL responded to Actimab-A. The Phase 1 trial was a dose escalation study using a 3+3 design. Dose escalation proceeded if dose-limiting toxicities (DLT) were seen in less than 33% of patients. Maximum tolerable dose (MTD) was not reached in the Phase 1 trial.

Dr. Joseph Jurcic, Director of Hematologic Malignancies and Professor of Medicine at Columbia University Medical Center and Principal Investigator of the study said, “Older patients with AML, particularly those that have progressed from MDS, are difficult to treat and have very few treatment options since many have already received lower-intensity therapy with hypomethylating agents. The results from this Phase 1 trial were encouraging in regards to both the safety and efficacy of Actimab-A. We are particularly excited to have identified that patients with peripheral blasts below 200/µL have higher response rates to Actimab-A and that we can reduce blast counts in patients above that level using hydroxyurea. Actimab-A has shown promise in older AML patients, including those previously treated for MDS--a population excluded from trials with most novel agents, including ongoing studies with other CD33-directed therapies. We look forward to continuing to study Actimab-A in the ongoing Phase 2 trial and potentially meeting this critical need.”

Of the 18 patients in the Phase 1 trial, 28% (5 of 18) had objective responses (2 CR, 1CRp and 2 CRi). Amongst patients with objective responses, median response duration was 9.1 months (range, 4.1-16.9 months). At the 3 highest dose levels in the Phase 1 trial (1.0 μCi/kg/fraction - 2.0 μCi/kg/fraction) objective responses were seen in 33% of patients (5 of 15). Mean bone marrow blast reduction amongst evaluable patients was 66% with 57% of patients having bone marrow blast reduction of 50% or greater and 79% of patients (11 of 14) had bone marrow blast reductions after Cycle 1 of therapy. The Phase 1 trial enrolled patients newly diagnosed with AML who are age 60 and above who were administered Actimab-A in combination with low-dose Cytarabine. Median patient age was 77 with 67% of patients having prior myelodysplastic syndrome (MDS) of which, 83% received prior therapy consisting of either hypomethylating agents (HMAs) or a hematopoietic stem cell transplant (HSCT).

A formal interim analysis will occur after 31 patients receive Actimab-A, which the Company expects to occur in mid-2017. The Company anticipates the Phase 2 trial to be complete by the end of 2017.

“Actimab-A, given its benign toxicity profile combined with potent efficacy as evidenced by the results presented today along with its ease of administration via 2 injections, represents an exciting therapy for elderly patients with AML,” said Sandesh Seth, Executive Chairman of Actinium. “Due to our peripheral blast burden hypothesis and optimized Phase 2 protocol we have great excitement for the current Phase 2 clinical trial and future development pathways for Actimab-A.”

About Actimab-A

Actimab-A, Actinium's most advanced alpha particle immunotherapy (APIT) product candidate, is currently in a 53-patient, multicenter Phase 2 trial for patients newly diagnosed with AML age 60 and above. Actimab-A is being developed as a first-line therapy and is a monotherapy that is administered via two 15-minute injections that are given 7 days apart. Actimab-A targets CD33, a protein abundantly expressed on the surface of AML cells via the monoclonal antibody, HuM195, which carries the potent cytotoxic radioisotope actinium-225 to the AML cancer calls. Actinium-225 gives off high-energy alpha particles as it decays, which kill cancer cells and as actinium-225 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. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in almost 90 patients in four clinical trials. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML age 60 and above.

About Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Actinium Further Strengthens Clinical Development Team with Senior Hire to Support Later-Stage Clinical Trials

Source:  Actinium Pharmaceuticals, Inc.


Director of Clinical Operations brings nearly two decades of clinical development and pharmaceutical industry experience to Actinium

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 appointment of Gregory Bergonio, M.S.H.S., to the position of Director of Clinical Operations. Mr. Bergonio’s initial responsibility will be focusing on the advancement of the Actimab-A Phase 2 clinical trial as well as earlier stage clinical programs that the company plans to undertake.

“We are very excited to welcome Greg to the clinical development team at Actinium,” said Sandesh Seth, Actinium’s Executive Chairman. “Greg’s joining comes at an ideal time given our increased development efforts as a result of the Actimab-A Phase 2 trial and Iomab-B pivotal Phase 3 SIERRA trial. Greg’s direct experience in AML and significant knowledge of clinical trial management will have an immediate impact on our capabilities that we expect will add efficiency and scale to our current and planned clinical development efforts.”

Most recently, Mr. Bergonio worked at Novartis as an expert clinical manager in their oncology global development unit with a focus on acute myeloid leukemia (AML). At Novartis, Greg managed a wide array of clinical development activities focused on driving effective operations at clinical trials sites on an international basis. In addition, he coordinated interdisciplinary efforts focused on inspection preparation activities associated with the new drug application (NDA) submissions at the site and sponsor level. Prior to Novartis, Greg worked at a number of large multi-national pharmaceutical companies and CROs including Bausch & Lomb, OSI, Forest Laboratories, Inc. and Kern McNeill International where he gained experience in the therapeutic areas of oncology, cardiology, CNS and ophthalmology. Greg has a Master of Science Degree in Health Sciences with a focus on Clinical Research Administration from George Washington University and a Bachelor of Science Degree in Nursing from Fairleigh Dickinson University.

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires high-dose chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors.

 

 

Actinium Issues Letter to Shareholders Highlighting 2016 Accomplishments and Anticipated Milestones for 2017

Source:  Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, announced today that it has issued a letter to shareholders highlighting the Company’s accomplishments in 2016 and anticipated milestones for 2017.

Key Accomplishments To-Date in 2016

Iomab-B Pivotal Phase 3 Trial Initiated, Significant and Growing Support from Major Transplant Hospitals, Orphan Drug Protection Awarded and Process for EU Access Started

• The Phase 3 pivotal trial dubbed the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial for Iomab-B was initiated in 1H:2016, as forecasted, representing a major step forward for this program given the manufacturing issues that were a key focus in 2015.
• Significant enthusiasm for Iomab-B and the SIERRA trial was seen at our Investigator Meeting in July with continued participation interest post-meeting from most of the leading bone marrow transplant (BMT) centers.
• Orphan Drug Designation awarded for Iomab-B in the US and the EU with potential regulatory, financial and marketing incentives.
• Initiated pursuit of Scientific Advice for Iomab-B from the European Medicines Agency (EMA) to explore regulatory pathway in the EU and awarded preferential Small and Medium-Sized Enterprise (SME) status providing enhanced support from regulators.
• Expected prominent position in major peer reviewed scientific publication and outreach program at the American Society of Hematology (ASH) annual meeting will continue to drive interest for Iomab-B and the SIERRA trial.

Promising Phase 1 Trial Results for Actimab-A Sets Stage for Ongoing Phase 2 Clinical Trial to Yield Potentially Best in CD33 Class Results

• Results from an analysis of the two Actimab-A Phase I trials in our HuM195-Alpha program showed that Actimab-A was well tolerated amongst patients who have few treatment options due to the toxicity of chemotherapy and also had promising efficacy.
• A key discovery made while analyzing these trials was that patients with high levels of immature white blood cells or Peripheral Blasts (PBs) had lower treatment response rates than those with lower PB’s.  This finding gave rise to the PB Burden Hypothesis which postulates that PB levels are predictive of, and inversely correlated with patient responses to Actimab-A. 
• The ongoing Phase 2 trial stipulates low PB burden below a key threshold as an inclusion criteria with use of hydroxyurea mandated to lower PB burden where necessary in order to maximize the addressable patient population.
• Importantly, the Phase 2 PB burden threshold corresponds to a response rate of fifty percent at equivalent dose levels in the Phase I trials.  If these results are replicated in the ongoing Phase 2 they will imply that Actimab-A with its benign safety profile and relatively simple regimen and route of administration is a best in class treatment compared to other CD33 programs.

Regulatory and intellectual property related activity, strategic hiring sets stage for international expansion and growth

• Activity related to strengthening the intellectual property remains robust with key patents being filed and notices of allowance being received this year for Iomab-B, Actimab-A and the platform. 
• Orphan drug designation for Iomab-B in the U.S. and EU was achieved this year as mentioned earlier.  Pursuit of orphan designation in the EU for Actimab-A is expected imminently.
• An independent analysis indicates the EU market for Iomab-B is larger than the U.S. market with a favorable reimbursement outlook and the company has begun exploring regulatory approval strategies.
• Key managerial hires were made in the supply chain, quality control and clinical development areas to support the expanded clinical development and pipeline expansion activity expected going forward.

Positive Outlook for 2017 and Beyond

• Efficiently execute on the pivotal Phase 3 SIERRA trial to reach the first independent Data Monitoring Committee (DMC) report at 25% of enrollment by 1H:2017, 50% and 75% in 2H:2017 and maintain the pace of enrollment to enable topline results the following year.
• Report interim data from Phase 2 trial for Actimab-A by mid-2017 and explore the regulatory pathway for a pivotal trial based on this data.
• Complete enrollment of the Phase 2 trial by end of 2017 and report top line data results.
• Actively explore strategic partnership, licensing and collaborations as appropriate.
• Continue to expand our clinical development, regulatory and supply chain teams to support our continued growth and begin to explore early commercial efforts.
• Initiate additional clinical programs with the first trial expected to begin in 2017 and the second trial expected to begin in 2018.

The full letter to shareholders can be viewed and downloaded through the following link:
http://ir.actiniumpharma.com/shareholder-letters. 

Sandesh Seth, Executive Chairman of Actinium said, “2016 has been a key transitional year for the Company as Iomab-B began the pivotal Phase 3 SIERRA trial and Actimab-A began a Phase 2 trial underpinned by promising Phase 1 results. In addition, we focused on building a foundation for the future with key hires, expansion of our intellectual property portfolio, execution of key regulatory pathways and by bolstering our balance sheet.  We look ahead to 2017 with great excitement as we expect to have data for both of our clinical trials which we believe will validate their potential and serve to unlock value.”

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires high-dose chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors.