Actinium Pharmaceuticals Inc (ATNM)

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Actinium Pharmaceuticals to Sponsor 4th Annual Summit on Hematologic Malignancies


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March 16, 2017
Actinium Advisor, Dr. John Pagel, to be a featured speaker in the Emerging Drugs Showcase session titled, “Radioimmunotherapy in AML: Iomab-B and Actimab-A”

NEW YORK, March 16, 2017 (GLOBE NEWSWIRE) -- 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 is a sponsor of Oncology Meeting Innovations’ 4th Annual Summit on Hematologic Malignancies, which is being held March 30th – April 2nd, 2017 at the Fairmont Chateau Whistler in British Columbia, Canada. Dr. John Pagel, Chief of Hematologic Malignancies at the Swedish Cancer Institute will speak in the Emerging Drugs Showcase session titled, “Radioimmunotherapy in AML: Iomab-B and Actimab-A” on Saturday April 1, 2017.


The 4th Annual Summit on Hematologic Malignancies brings together translational researchers, clinical researchers and key community oncologists to address the challenges of the rapidly evolving area of oncology. The Summit is intended to foster discussion and debate on the evolution of treatment and features a focused approach towards individual patient populations through case-based discussions.

Actinium’s Executive Chairman, Sandesh Seth said, “Meetings such as this Summit on Hematologic Malignancies are vital as they afford us the opportunity to meet with physicians who are not only investigators in our trials but also physicians who can refer patients to our trials. Actinium is honored to have the opportunity to sponsor this event and we are thrilled that Dr. Pagel will be speaking on behalf of Iomab-B and Actimab-A to this fantastic audience.”

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. In addition, Actinium is developing Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial. 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.

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This news release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact:

Actinium Pharmaceuticals, Inc.
Steve O'Loughlin
Vice President, Finance and Corporate Development
[e-mail]

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Source: Actinium Pharmaceuticals
Released March 16, 2017

http://www.actiniumpharma.com/news-media/press-releases/detail/223/actinium-pharmaceuticals-to-sponsor-4th-annual-summit-on


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Shelf - https://www.sec.gov/Archives/edgar/data/1388320/000121390017002475/fs32017_actiniumpharma.htm



Our most advanced products are Iomab™-B, an antibody-drug construct containing iodine 131 (I-131), used in myeloconditioning for hematopoietic stem cells transplantation (HSCT) in various indications and Actimab™-A, an antibody-drug construct containing actinium 225 (Ac-225), currently in human clinical trials for acute myeloid leukemia (AML). We are currently conducting a pivotal Phase 3 trial of Iomab™-B for bone marrow conditioning for HSCT in patients with relapsed or refractory AML age of 55 and older, which upon successful completion of our clinical trials we intend to submit for marketing approval. We are currently also considering filing an application with the U.S. Food and Drug Administration (FDA) for breakthrough therapy designation for Actimab™-A and/or Iomab™-B. We are developing our cancer drugs using our expertise in radioimmunotherapy. In addition, our Ac-225 based drug development relies on the patented Alpha Particle Immunotherapy Technology (APIT) platform technology co-developed with Memorial Sloan Kettering Cancer Center (MSKCC). The APIT technology couples monoclonal antibodies (mAb) with extremely potent but comparatively safe alpha particle emitting radioactive isotopes, in particular actinium 225. The final drug construct is designed to specifically target and kill cancer cells while minimizing side effects. We intend to develop a number of products for different types of cancer and derive revenue from partnering relationships with large pharmaceutical companies and/or direct sales of its products in specialty markets in the United States.



In December 2015, we announced that the FDA cleared our IND filing for Iomab-B. In June 2016, we announced the pivotal Phase 3 clinical trial for Iomab-B was initiated and assuming that the trial meets its end points, it will form the basis for a Biologics Licensing Application (BLA). We established an agreement with the FDA that the path to a BLA submission would include a single, pivotal Phase 3 clinical study if it is successful. The population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed 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. We believe 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 physicians 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.



In September 2016, we initiated the Phase 2 clinical trial for Actimab-A. This Phase 2 clinical trial is a multicenter, open-label study that will enroll 53 patients. Patients will receive 2.0 µCi/kg/fractionated dose of Actimab-A via two injections given at day 1 and day 7. The Phase 2 trial is designed to evaluate complete response rates at up to day 42 after Actimab-A administration, where complete response is defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRp). A formal interim analysis is expected to occur in mid-2017 with topline results expected in the second half of 2017. The Phase 2 clinical trial includes peripheral blast burden as an inclusion criteria and in patients with high peripheral blast (PB) burden, the use of Hydroxyurea will be mandated with the goal of bringing PB burden below a key threshold number that we have identified from two previously complete Phase 1 clinical trials totaling 38 patients. In addition, the use of granulocyte colony-stimulating factors (GCSF) will be mandated. Low dose cytarabine has been eliminated from the protocol and the Phase 2 clinical trial will evaluate Actimab-A as a monotherapy. The secondary endpoint of the Phase 2 clinical trial will be overall survival.



In February 2017, we initiated a Phase 1 investigator initiated clinical trial to study Actimab-M in multiple myeloma (MM). Multiple myeloma is a cancer of plasma cells that is currently incurable. The Phase 1 trial will enroll up to 12 patients with relapsed or refractory multiple myeloma who have positive CD33 expression. This Phase 1 study is designed as a dose escalation study intended to assess safety, establish maximum tolerable dose (MTD) and assess efficacy. Patients will be administered Actimab-M on day 1 at an initial dose of 0.5 µCi/kg and then assessed at day 42 for safety and efficacy. The dose can be increased to 1.0 µCi/kg or reduced to 0.25 µCi/kg based on safety assessment that will evaluate dose limiting toxicities (DLTs). Patients may receive up to 8 cycles of therapy but in no event will cumulative administration exceed 4.0 µCi/kg of Actimab-M.

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Form 4 250K @ $1.39 (options) by the CEO and Interim CFO

https://www.sec.gov/Archives/edgar/data/1388320/000121390017002501/xslF345X03/f4031417dave_actinium.xml

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Seth Form 4 750K @ 1.39 (options)
https://www.sec.gov/Archives/edgar/data/1388320/000121390017002469/xslF345X03/f4031417sandesh_actinium.xml
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Form 4
Nicholson, C. David
75k (options) @ 1.39
https://www.sec.gov/Archives/edgar/data/1388320/000121390017002465/xslF345X03/f4031417nicholson_actinium.xml

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Form 4
TRAVERSA SERGIO
75k (options) @ 1.39
https://www.sec.gov/Archives/edgar/data/1388320/000121390017002467/xslF345X03/f4031417traversa_actinium.xml
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Form 4
Steinhart Richard I
75k (options) @ 1.39
https://www.sec.gov/Archives/edgar/data/1293789/000121390017002453/xslF345X03/f4031417steinhart_actinium.xml
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Form 4
CICIC DRAGAN
75k (options) @ 1.39
https://www.sec.gov/Archives/edgar/data/1388320/000121390017002450/xslF345X03/f4031417cicic_actinium.xml
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10-K
https://www.sec.gov/Archives/edgar/data/1388320/000121390017002461/f10k2016_actiniumpharma.htm

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Should I really keep going here?

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Form 3
Berger Mark Stanley
325K conv @ 1.04
https://www.sec.gov/Archives/edgar/data/1388320/000121390017002448/xslF345X02/f3031617berger_actinium.xml

On March 14, 2017, the Company named Mark Berger a named executive officer. Mr. Berger is the Company’s Chief Medical Officer

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Wow, and I haven't even scanned the 10-K yet.
So, just winging it, with the filing of the shelf for 200M. Wow, seems like a lot doesn't it? Let's see if when Actinium actually does do their next offering how much Memorial Sloan Kettering Cancer Center (MSKCC) eats up or if we get someone that actually holds onto the bacon.
Possibly we'll see a run on data before the trigger an offering, a big run too. One can hope. See how this trades from now till the 1st and if we get any action from the summit.

Good luck and let's see this puppy stay over the $ at least.