Small and Mid-Cap Growth Stocks Research and Notifications
News out in after hours !!! Actinium Pharmaceuticals (NYSE-MKT: ATNM)- Actinium Submits Iomab-B IND Application to the U.S. FDA
Good morning broad Street members,
Our new biotech play (NYSE: ATNM) issued FDA news after market close! (see press release below)
Actinium Submits Iomab-B IND Application to the U.S. FDA
Company Gearing Up for Pivotal, Phase 3 Clinical Trial
NEW YORK, NY–(Marketwired – November 17, 2015) – Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium” or “the Company”), is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Iomab-B, a radioimmunotherapeutic that conditions Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant (HSCT), commonly referred to as a Bone Marrow Transplant (BMT). Pending the FDA’s acceptance of the IND filing, Actinium will initiate a single, pivotal Phase 3 clinical study in refractory and relapsed AML patients over the age 55.
“We are excited to have submitted the Iomab-B IND application to the FDA,” said Kaushik J. Dave, Ph.D., MBA, CEO of Actinium. “We focused heavily on Iomab-B in 2015 and overcame our previous manufacturing hurdles, which gave us great confidence when we met with the FDA for our pre-IND meeting. Our filing, well ahead of our year end guidance, is a great milestone for Actinium.”
Sandesh Seth, Actinium’s Executive Chairman commented, “This much anticipated regulatory filing is an important one that marks the first step in Actinium’s transition to a later development stage biopharmaceutical company. As we prepare for the pivotal Phase 3 clinical trial for Iomab-B in 2016, we have added key members to our executive, regulatory and clinical operations teams and will continue to add selectively. This strengthening of the company will enable us to meet our goals of efficient execution of not only the Iomab-B program but also of the Actimab-A Phase 2 trial planned for early 2016, as well as other pre-clinical and clinical programs expected for next year.”
About the Iomab-B Pivotal, Clinical Trial
Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could 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 Acute Myeloid Leukemia (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. 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 physician 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.
About Iomab-B
Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the 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). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.
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.
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 INFORMATION
Contact:
Steve O’Loughlin
Senior Director, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
soloughlin@actiniumpharma.com
An excerpt from the cover letter of a 14A filing on November, 13th 2015, should get you started on your due diligence and give everyone a good idea of why we like ATNM right now.
Dear Actinium Shareholders,
“Above all else, we wish to thank all our shareholders, new and old, for their faith in our ability to execute on our strategy and generate shareholder value. As outlined in our letter to you in July, we acknowledge that we have faced challenges this year, specifically with manufacturing process and scale-up issues pertaining to Iomab TM -B. We are pleased to have overcome these obstacles and now with these challenges behind us and our organization stronger than ever before, we are eager to embark on a new era for Actinium. We have made significant strides with Iomab-B and are on track to file the IND by year end. With respect to Actimab-A, we are excited to be near the conclusion of the Phase 1 portion of the clinical trial, which will be highlighted at the 57 th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida on December 4 – 8, 2015. We are eager to begin the Phase 2 portion of the trial as we are very well-positioned competitively. We look forward to the future with confidence in our strategy as we progress into 2016. We will strive to deliver sustainable results that will drive growth and generate shareholder value as we continue to drive the business forward in 2016 and beyond. Key Achievements in 2015″
• On track to submit the Iomab-B IND filing in the fourth quarter of 2015
• Completed the majority of the Phase 1 clinical trial for Actimab-A, the final three confirmatory patients are now enrolling which will enable the Phase 2 trial to start in 2016
• Actimab-A’s positive results imply leadership position in the renewed race for CD-33 targeting drugs in AML
• Started work on an exciting new indication for one of our drug candidates with proof of concept studies expected in 2016
• Successfully labeled an antibody with Actinium-225 creating an exciting new pipeline candidate with broad hematology applications
• Strengthened our development team with key senior level hires in place ahead of the upcoming Phase 3 clinical trial for Iomab-B and Phase 2 trial for Actimab-A next year
***Much Anticipated IND Filing to Enable Initiation of Iomab-B’s Single, Pivotal, Phase 3 Clinical Trial in 2016
In 2015, we successfully addressed our manufacturing challenges, bolstered our development team in key areas and established a clear regulatory pathway for Iomab-B. In addition, we further strengthened our intellectual property portfolio with a provisional patent application for infusion administration of Iomab-B. These achievements give us great confidence as we look past our planned fourth quarter IND filing toward to the upcoming pivotal, Phase 3 clinical trial. We have hired and will continue to hire key professionals to our clinical, project management, manufacturing, quality control and regulatory teams to ensure that we execute the Iomab-B trial in the most efficient and timely manner. With these new members firmly on board, we are confident in our ability to execute and look forward to providing you, our shareholders, with regular updates on our progress as we seek to obtain regulatory approval for Iomab-B and deliver this important, potentially breakthrough therapy to patients.
Actinium Pharmaceuticals Inc (NYSE: ATNM) Check the company website for investor presentation and more in-depth information about their drug pipeline. http://www.actiniumpharma.com
*Actinium Pharmaceuticals (ATNM) is a biopharmaceutical company specializing in the development of cancer drugs. They are the leading biotechnology company developing alpha particle linked antibodies to treat cancer.
We will be back with much more soon. I think the timing is perfect here.
The Team
DISCLAIMER
Broadstreetalerts is a wholly owned subsidiary of Small Cap Specialists LLC, herein referred to as SCS LLC.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: SCS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold SCS LLC, 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. The information contained herein 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. SCS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and SCS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead SCS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. SCS LLC is compliant with the Can Spam Act of 2003. SCS LLC does not offer such advice or analysis, and SCS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries and extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur. Understand there is no guarantee past performance will be indicative of future results.
In preparing this publication, SCS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, SCS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. SCS LLC is not responsible for any claims made by the companies advertised herein, nor is SCS LLC responsible for any other promotional firm, its program or its structure. SCS LLC has been compensated thirty thousand dollars cash via bank wire by Star Media LLC for a two day investor relations/advertising campaign of ATNM. Our coverage of ATNM may continue beyond this contract at our discretion.
Please Note: We do NOT accept free trading or restricted securities as payment for our services.
SCS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA. SCS LLC is not a Broker/Dealer and does not engage in high frequency trading.