Actinium Pharmaceuticals Inc (ATNM)

[Bigdoggy4u]

Good Morning Members,



This morning we are excited to bring you something that is making huge strides in completing all of the phases for FDA approval of one of its marquee drug candidates...

This one has multiple drugs in the FDA approval process from phase 1 candidates all the way to phase 3 candidates. If just one of these candidates gets approved, it could mean that this tiny biotech company could explode overnight.

So, without wasting anymore time, put Actinium Pharmaceuticals, Inc. (ATNM) on your radar immediately.

Priced right at $1.18, Actinium Pharmaceuticals, is a biotechnology company that engages in developing targeted payload immunotherapeutics for the treatment of advanced cancers.

There are several key reasons why we love ATNM at these levels:

ATNM just released news of receipt of positive scientific advice for lomab-B
Initiation of Phase 3 of lomab-B
Actimab-A set to move into Phase 2 trial shortly
Large addressable patient populations and/or populations where there is currently NO approved treatment underscore the blockbuster drug potential of the pipeline
Awareness of Acute Myeloid Leukemia (AML) cancer is beginning to gain mainstream attention
Actinium Pharmaceuticals is well-funded, has a strong balance sheet, and risk of near term dilution is minimal
Institutional ownership is on the rise
Memorial Sloan Kettering Cancer Center controls over 5 million shares or 10.% of total shares outstanding

In good company



In addition to increasing institutional buying, investors should know that Actinium's largest shareholder is a subsidiary of Memorial Sloan Kettering Cancer Center, widely considered to be the nation's #1 ranked cancer research facility. Memorial Sloan Kettering Cancer Center Actinium's largest shareholder controls over 5 million shares of 10.6% of total shares outstanding.



Recent developments



March 21, 2017: Actinium Announces Receipt of Positive Scientific Advice from the European Medicines Agency for Iomab-B
March 11, 2016: Actinium Initiates Pursuit of EU Orphan Designation for Iomab-B
March 30, 2016: Actinium Receives Orphan Drug Designation From FDA for Iomab-B in Treating Refractory and Relapsed Acute Myeloid Leukemia in Elderly Patients
June 1, 2016 Actinium Provides Positive Actimab-A Phase 1 Results and Announces Timing for Phase 2 Clinical Trial
June 2, 2016: Acute Myeloid Leukemia (AML) is beginning to gain mainstream attention after CancerCare made June 2016 the first ever (AML) Awareness Month
June 29, 2016: Actinium Pharmaceuticals Initiates Pivotal Phase 3 SIERRA Trial (Iomab-B)


Recent Updates:



Actinium Pharmaceuticals Issues Mid-Year Letter to Shareholders Highlights





- Iomab-B Phase 3 SIERRA trial enrollment is accelerating as the number of clinical trial sites increase, competitive position as only induction and conditioning regimen remains unchallenged



- Actimab-A Phase 2 trial remains on target to yield interim data in the second half of 2017



- Executive, clinical development and product development teams laser focused on trial enrollment ensuring maximum opportunities for significant and enduring shareholder value and patient outcomes



There's a ton of updates attached to the letter, more than we could fit on an email so make sure to check it out here: https://finance.yahoo.com/news/actinium-pharmaceuticals-issues-mid-letter-123000295.html







Actinium Announces Receipt of Positive Scientific Advice from the European Medicines Agency for Iomab-B





- EMA guidance provides clear regulatory pathway for EU approval for Iomab-B



- Trial design, primary endpoint and planned statistical analysis from the Iomab-B U.S. pivotal Phase 3 SIERRA trial are acceptable as the basis for a Marketing Authorization Application



- EMA intent from Scientific Advice Program feedback is to increase the probability of positive outcomes and reduce risk of objections during evaluation of a Marketing Authorization Application



NEW YORK, March 21, 2017 (GLOBE NEWSWIRE) -- 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 has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B. In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application. In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. The EMA requested supporting data and information that is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial. The SIERRA trial is a 150 patient, randomized controlled study of Iomab-B that is currently enrolling patients in the U.S. Upon approval, Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT) with an initial indication in patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above.



Sandesh Seth, Executive Chairman of Actinium Said, “We thank the EMA for their assistance throughout the Scientific Advice process and for this helpful feedback. We are excited that the EMA finds the design, endpoints and statistical analysis of the Iomab-B SIERRA trial acceptable. Their opinion is an extremely favorable outcome as this will potentially reduce the time and cost to gain marketing authorization in the EU, which is a larger addressable market than the U.S. in terms of number of patients and transplant procedures. With orphan designation for Iomab-B in the EU and now with this positive Scientific Advice, a clear regulatory pathway, we are well positioned to maximize the value of Iomab-B by working strategically to make this potentially curative therapy available to patients in the EU in addition to our efforts in the U.S.”





This bit of news has us very excited for ATNM's future as it looks like they have been given a clear pathway to crack the code that is FDA approval.





About ATNM

Actinium Pharmaceuticals, Inc. (ATNM: NYSE MKT) is a publicly traded biopharmaceutical company developing innovative targeted payload immunotherapies for the treatment of advanced cancers.



The Company's radioimmunotherapy product candidates are based on the combination of the cancer targeting precision of monoclonal antibodies (mAb) that seek out specific types of cells combined with the cytotoxic killing power of radioisotopes that unleash their energy once they have reached their target.



Iomab-B, licensed from Fred Hutchinson Cancer Research Center and Actinium's lead product, is in a single, pivotal Phase 3 clinical trial. Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant in relapsed or refractory Acute Myeloid Leukemia (AML) patients over the age of 55. Iomab-B is a myeloablative therapy, meaning it destroys a patient's bone marrow so that a patient can receive bone marrow from a donor via a transplant.



Actimab-A, is Actinium's lead alpha-particle therapy that was licensed from Memorial Sloan Kettering Cancer Center. Actimab-A is intended to treat newly diagnosed AML patients over the age of 60 and is in a Phase 1/2 clinical trial at leading cancer centers in the United States. Actimab-A recently completed the Phase 1 portion of the clinical trial and will begin the Phase 2 portion of the trial with an optimized protocol this year.



Actinium Pharmaceuticals has a committed focus to its clinical programs but maintains research and development efforts based on its Alpha Particle Immunotherapy Platform (APIT).


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.

Ok lets dive a little deeper into its candidates to show you exactly what these guys are all about, beginning with its most promising candidate, Iomab-B...

Iomab-B for Hematopoietic Stem Cells Transplantation:



Iomab-B (BC8-I-131 construct) has already been successfully used as a myeloconditioning/myeloablative agent in over 250 patients with incurable blood cancers. In both Phase I and Phase II trials Iomab-B has led to effective cures in patients with no options left. The only potentially curative treatment option for those patients is bone marrow transplantation (BMT), also known as a hematopoietic stem cell transplant (HSCT), but vast majority of patients over the age of 50 are either ineligible for myeloablative conditioning due to concomitant conditions or have a high burden and/or very resistant disease that makes reduced dose conditioning futile.



BC8-I-131 has demonstrated ability to successfully prepare such patients for bone marrow transplants when no other treatment was indicated. ATNM intends to develop Iomab-B through a regulatory approval via a pivotal registration trial in AML refractory/relapsing patients. That would allow for a relatively quick path to the market and provide a potentially curative treatment to patients who currently have little or no chance of achieving even a temporary remission, let alone a cure.



The targeting part of the Iomab-B construct is a monoclonal antibody that targets CD45, an antigen widely expressed on hematopoietic cells but not other tissues. Due to this broad expression, Iomab-B has demonstrated utility in other groups of patients and other indications as well, including Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Hodgkin’s Disease and Non-Hodgkin Lymphoma. These are follow-on indications which could be pursued simultaneously or delayed, for cash conservation, and financed from commercial revenues.



The company is already preparing a program for replacing iodine 131 with Actinium 225 to create a second generation drug that would enable a significant expansion of use, described below as Actimab-B, Iomab-B was invented by researchers at the Fred Hutchinson Cancer Research Center (FHCRC), ATNM’s key collaborator on this program from whom ATNM obtained rights for all the commercial uses. FHCRC played a pivotal role in developing the entire field of bone marrow transplantation and the lead Hutchinson researcher, Dr. E. Donnall Thomas received the 1990 Nobel Prize in physiology/medicine for work in this area.





Phase I Trial with single dose of Actimab-A

In collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) we are conducting a first-in-man Phase I dose escalation trial to determine the safety, pharmacology, and biological activity of Actimab-A in Acute Myeloid Leukemia (AML). Eighteen patients (median age, 64 yrs; range, 45–80 yrs) with relapsed/refractory AML were treated to date. Patients received a single infusion of Actimab-A at doses of 0.5, 1, 2, 3, or 4 µCi/kg (µCi –microCurie; total dose, 23–390 µCi). No acute toxicities were seen.

Dose limiting toxicity (DLT) was suppression of the entire bone marrow lasting over 35 days and consequent death due to sepsis. It occurred in one patient treated with 3 µCi/kg and in both patients receiving 4 µCi/kg. Toxicities outside of the target organ (bone marrow) were limited to transient grade 2/3 liver function abnormalities. With follow-up from 1–24 months (median, 2 months), no evidence of damage to kidneys due to radiation was seen. Peripheral blood blasts (leukemia cells) were eliminated in 10 of 16 evaluable patients who received a full treatment dose. Bone marrow blast reductions of over 33% were seen in 10 of 15 evaluable patients at 4 weeks, including 3 patients with 5 percent or fewer blasts. Actimab-A is tolerable at doses less than 4 µCi/kg and has antileukemic activity.

Acute Myeloid Leukemia is characterized by very high numbers of immature cancerous white blood cells of certain kind that are similar to normal young blood cells and all immature white blood cells are called blasts. It is not normal for a person to have any blasts circulating in peripheral blood (peripheral blasts) and to have more than 5 percent of blasts in the bone marrow.

Phase I/II AML Trial with two consecutive fractionated doses of Actimab-A

After receiving clearance from the FDA the Company started Phase I/II multi-center AML trial with fractionated doses of Actimab-A. ATNM has concluded contracts with and provided training to 6 participating trial centers (Baylor University Medical Center, MSKCC, Johns Hopkins Medicine, University of Pennsylvania Health System, and Fred Hutchinson Cancer Center). The Phase I (dose escalating) portion of the trial is ongoing. For the proposed Phase I/II study, patients are eligible if they have previously untreated newly diagnosed acute myeloid leukemia according to World Health Organization criteria, are age 60 years or older, and are unfit for or decline intensive chemotherapy, or are 70 years or older with newly diagnosed AML. This target population has had better outcomes than relapsed and refractory patients who have been most of the patients in ATNM’s previous trials.

Maximum enrollment in the Phase I portion of the trial is 21 patients in dose escalating cohorts of 3 patients each with the goal of determining the maximum tolerated dose (MTD) for Actimab-A. There is a six week interval between dose levels. Once MTD has been determined, it will be used as the dose level for the Phase II portion of the trial which will enroll up to 53 patients. There are 4 planned dose levels in the Phase I portion of the trial.


ATNM TECHNOLOGY PLATFORM

ATNM’s Alpha Particle Immunotherapy (APIT) platform is a highly potent and selective form of targeted radiotherapy. It is based on attaching powerful alpha emitting radioisotopes Actinium 225 or Bismuth 213 to monoclonal antibodies (mAbs) which are large molecules capable of binding specifically to cancer cells. By virtue of carrying alpha emitters, mAbs bring them directly to cancer cells where alpha emitters can selectively kill the targeted cell. Figure below presents a schematic of a drug based on the Company’s APIT technology.

The power of alpha emitters is best understood when compared to beta emitters, an alternative form of radioisotope used in cancer drugs. The killing power of a radioactive particle is directly proportional to its energy and inversely proportional to its range. Alpha particle carries the most energy but travels the shortest path, while beta particle has less energy but goes farther in the body.

Being 100 times more powerful than beta particles, alpha therapy is effective in cancers that are not sensitive to beta irradiation. Prime examples are the past and current clinical trials in AML. APIT has demonstrated extremely high cancer cell kill levels even though AML is not considered particularly radiosensitive and radiotherapy is not used in treating the disease. Based on these inherent isotope traits, the Company and Dr. David Scheinberg, Chairman of the Molecular Pharmacology and Chemistry Program at Memorial Sloan Kettering Cancer Center (MSKCC), ATNM’s key scientific collaborator, developed alpha particles as an ideal payload for targeted cancer radiotherapy. While their potency is 100-fold higher than beta’s and cytotoxins’ significantly increases the killing power of alpha particle drugs against targeted tumor cells, their extremely short range limits any damage inflicted on healthy tissues.

In addition to its potency and range of emission, there are other key considerations for evaluating the suitability of particular radioisotopes for medical use. Among them are half-life of the isotope, which is an indication of the period over which it remains radioactive, and its pharmacokinetics, i.e. its distribution in the body and its eventual elimination from it. For these reasons, Actinium 225 (Ac-225) and the isotope derived from it, Bismuth 213 (Bi-213), were selected as lynchpins of the Company’s technology. Both isotopes have relatively short half-lives and favorable and controllable pharmacokinetics. However, for efficacy, logistics and cost reasons ATNM has decided to focus its efforts on Actinium 225 which has a 10 day half life versus Bismuth-213’s half life of 46 minutes.


Start your own research on ATNM immediately as this one is poised to have a major breakout today. And, as always, stay tuned for more news and updates!







Sincerely,


The Stock Expert





Notice and Disclaimer-Please Read Carefully

TheStockExpert.com is engaged in the business of marketing and advertising companies for monetary compensation. All content in our releases is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Neither the information presented nor any statement or expression of opinion, or any other matter herein, directly or indirectly constitutes a solicitation of the purchase or sale of any securities. TheStockExpert.com sponsored advertisements do not purport to provide an analysis of any company's financial position, operations or prospects and this is not to be construed as a recommendation by TheStockExpert.com or an offer or solicitation to buy or sell any security. Neither the owner of TheStockExpert.com nor any of its members, officers, directors, contractors or employees is licensed broker-dealers, account representatives, market makers, investment bankers, investment advisors, analyst or underwriters. Investing in securities, including the securities of those companies profiled or discussed on this website is for individuals tolerant of high risks. Viewers should always consult with a licensed securities professional before purchasing or selling any securities of companies profiled or discussed in our releases. It is possible that a viewer's entire investment may be lost or impaired due to the speculative nature of the companies profiled. Remember, never invest in any security of a company profiled or discussed in a release or on our website unless you can afford to lose your entire investment. Also, investing in micro-cap securities is highly speculative and carries an extremely high degree of risk. To review our complete disclaimer and additional information, please visit TheStockExpert.com. TheStockExpert.com makes no recommendation that the securities of the companies profiled or discussed in our releases or on our website should be purchased, sold or held by investors. Third parties and/or affiliates of TheStockExpert.com may at any time have a position in the securities mentioned herein and may increase or decrease such positions without notice which will negatively affect the market. TheStockExpert.com has not currently been compensated for any investor awareness campaign regarding ATNM. TheStockExpert.com was previously compensated $35,000 for an investor awareness campaign regarding ATNM, which has expired. Any compensation received constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company?.???????

Notice of Stock Price Movements and Volatility. Viewers of this newsletter should understand that trading activity and stock prices in many if not all cases tend to increase during the advertisement campaigns of the profiled companies and in many if not all cases tend to decrease thereafter. This tends to create above average volatility and price movements in the profiled company during the advertisement campaign that viewers should take into consideration at all times. Campaigns vary in length, and many are for short periods of time, typically less than a week. Some of the content in this release contains forward-looking information within the meaning of Section 27 A of the Securities Act of 1 993 and Section 21 E of the Securities Exchange Act of 1 934 including statements regarding expected continual growth of the profiled company and the value of its securities. In accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1 995 it is hereby noted that statements contained herein that look forward in time which include everything other than historical information, involve risk and uncertainties that may affect a company's actual results of operation. A company's actual performance could greatly differ from those described in any forward looking statements or announcements mentioned in this release. Factors that should be considered that could cause actual results to differ include: the size and growth of the market for the company's products; the company's ability to fund its capital requirements in the near term and in the long term; pricing pressures; unforeseen and/or unexpected circumstances in happenings; etc. and the risk factors and other factors set forth in the company's filings with the Securities and Exchange Commission. However, a company's past performance does not guarantee future results. Generally, the information regarding a company profiled is provided from public sources which we believe to be reliable but is not guaranteed by us as being accurate. Further specific financial information, filings and disclosures as well as general investor information about the profiled company, advice to investors and other investor resources are available at the Securities and Exchange Commission ("SEC") website www.sec.gov and the Financial Industry Regulatory Authority ("FINRA") website at www.finra.org. Any investment should be made only after consulting with a qualified investment advisor and reviewing the publicly available financial statement and other information about the company profiled and verifying that the investment is appropriate and suitable. TheStockExpert.com makes no representations, warranties or guarantees as to the accuracy or completeness of the information provided or discussed. Viewers should not rely solely on the information obtained in this release or on our website. Viewers should use the information provided by us regarding the profiled companies as a starting point for additional independent research on the companies profiled or discussed in order to allow the viewer to form his or her own opinion regarding investing in the securities of such companies. Factual statements, or the similar, made by the profiled companies are made as of the date stated and are subject to change without notice and TheStockExpert.com Network has no obligation to update any of the information provided. TheStockExpert.com its owners, officers, directors, contractors and employees are not responsible for errors and omissions. From time to time certain content in our releases or website is written and published by our employees or third parties. In addition to information about our profiled companies, from time to time, our releases and website will contain the symbols of companies and/or news feeds about companies that are not being profiled by us but are merely illustrative of certain activity in the micro cap stock market that we are highlighting. Viewers are advised that all analysis reports and news feeds are issued solely for informational purposes. Any opinions expressed are subject to change without notice. It is also possible that one or more of the companies discussed or profiled in our release or on our website may not have approved certain or any statements within the website. TheStockExpert.com encourages viewers to supplement the information obtained from this release and our website with independent research and other professional advice. The content in this release is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. This release may provide hyperlinks to third party websites or access to third party content. TheStockExpert.com, its owners, officers, directors, contractors and employees are not responsible for errors and omissions nor does TheStockExpert.com control, endorse, or guarantee any content found in such sites. By accessing, viewing, or using the website or communications originating from this release, you agree that TheStockExpert.com, its owners, officers, directors, contractors and employees, are not responsible for any content, associated links, resources, or services associated with a third party website. You further agree that TheStockExpert.com, its owners, officers, directors, contractors and employees shall not be liable for any loss or damage of any sort associated with your use of third party content. Links and access to these sites are provided for your convenience only. TheStockExpert.com uses third parties to disseminate information to subscribers. Although we take precautions to prevent others from obtaining our subscriber list, there is a risk that our subscriber list, through no wrong doing on our part, could end up in the hands of an unauthorized party and that subscribers will receive communications from unauthorized third parties. You agree to hold TheStockExpert.com, its operators, owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur arising out of the use of our website or the information in our press releases, profiles and opinions. You agree that use of our website is at your sole risk. TheStockExpert.com disclaims all warranties of any kind, express or implied. We encourage viewers to invest carefully and read the investor issuer information available at the web sites of the SEC. The SEC has launched an investor-focused website to help you invest wisely and avoid fraud at www.investor.gov and filings made by public companies can be viewed atwww.sec.gov and/or then FINRA at: www.finra.org . In addition, FINRA has published information at its website on how to invest carefully at www.finra.org/investors/index.htm.

Questions regarding any information contained in this report may be sent to [e-mail]. To review TheStockExpert.com’s website and its disclaimer, please visit www.TheStockExpert.com.

1817 Rushland Grove Lane
Johns Island SC 29455
USA

Unsubscribe | Change Subscriber Options