New Immunotherapy Had Positive Results In Cancer Patients After Other Treatments Failed – Forbes

Natural Killer cells have been engineered to attack blood cancers with excellent provisional results ... [+] from a small clinical trial.

A new cell-based immunotherapy for some types of blood cancer has posted promising initial results in a small clinical trial on patients who had exhausted all other treatment options.

The new study, led by researchers from MD Anderson Cancer Center was published yesterday in the New England Journal of Medicine and used a type of immune cell, called a Natural Killer (NK) cell. The NK cells were engineered to target a protein called CD19 found on B-lymphoblasts and which can become cancerous and cause several types of blood cancer. The study tested the treatment on 11 patients with either chronic lymphocytic leukemia (CLL) or non-Hodgkins lymphoma (NHL), finding a 73% response rate. Of the 8 people who responded, 7 maintained a complete response over a year after the initial treatment.

All our patients had failed conventional therapies and therefore there was no alternative treatment available for them, said said Katy Rezvani, M.D., Ph.D.,lead author of the paper and professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson. We are encouraged by the results of the clinical trial, which will launch further clinical studies to investigate allogeneic cord blood-derived CAR NK cells as a potential treatment option for patients in need, she added.

Most cell based therapies use a different type of modified immune cell; CAR T-cells. These therapies have shown initial promise in some types of blood cancer, but there have been several setbacks with side-effects in patients and the scaleability and cost of the technology. Importantly, the NK cells used on the patients in the new study were made from donated umbilical cord blood, whereas most CAR T-cell therapies currently rely on a long and expensive process of extracting T-cells from the patient themselves, genetically modifying them and expanding the cells before the therapy is ready for use.

This means the new NK cell therapy can theoretically be produced in bulk and doesn't rely on extracting T-cells from the patient, which can be incredibly difficult, especially if the patient has received a lot of previous therapies which can affect T-cell numbers.

Strictly speaking, the manufacturing and engineering steps for CAR T and CAR NK cells are very similar. The main difference is that unlike commercial CAR T-cells, where one product is used to treat one patient (an autologous product),CAR NK cells are not patient specific, allowing for multiple doses to be manufactured from one donor that can then be used to treat multiple patients, said Rezvani.

CAR T-cell therapies, although posting some wonderful results, particularly in children with hard-to-treat, relapsed leukemias, do come with a lot of side effects, particularly neurotoxicity and cytokine release syndrome, which is life-threatening if not quickly treated. These toxicities were not seen in this initial, small trial, giving the researchers hope that perhaps this therapy may have fewer serious side-effects than other similar approaches.

As well as CAR T-cells, there is also another therapy already available which targets CD19, a drug called blinatumomab (Blincyto). What potential advantages does the new NK cell therapy have over this approach?

These are living cells that persist after infusion and will potentially continue to protect the patient from their cancer over time unlike blinatumomab that needs to be given as a continuous infusion and in multiple cycles, said Revzani. In addition, with the caveat of the small number of patients that we have treated so far and the relatively short follow up time, our approach appears to be less toxic, she added.

MD Anderson have licenced the development of this therapy and other similar B-cell targeting therapies to company Takeda Pharmaceuticals.

Our vision is to improve upon existing treatments by developing armored CAR NKs that could be administered off-the-shelf in an outpatient settingenabling more patients to be treated effectively, quickly and with minimal toxicities, said Rezvani, adding that the team also plans to expand the trial to encompass other CD19-expressing malignancies such as B-cell leukemias.

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New Immunotherapy Had Positive Results In Cancer Patients After Other Treatments Failed - Forbes

Viewpoints: Where’s The Praise About Good News On Declining Opioid Deaths?; Shutting Down Air, Trade Over Coronavirus Will Be More Harmful In Long Run…

Opinion writers weigh in on these health care issues and others.

The Wall Street Journal:Opioid Inflection Point?A report by the Centers for Disease Control and Prevention last week that drug overdose deaths have declined for the first time in nearly three decades drew little attention until President Trump flogged it in his State of the Union address. Heres hoping the opioid scourge that has taken hundreds of thousands of lives is finally abating. Drug overdose deaths fell 4.1% in 2018 thanks to fewer fatalities from prescription opioids, according to the CDC. Overdoses from natural and semisynthetic opioids such as oxycodone and hydrocodone fell by 13.4%, and 3.2% from heroin, though these declines were partially offset by a 10% increase from synthetic opioids like fentanyl. (2/5)

The Washington Post:In Combating Coronavirus, Slamming The Door To China Will Hurt More Than HelpViruses are tiny parasites. They have a singular mission: to invade a host cell and use its machinery to replicate themselves complete with their own genetic material and then go on to infect other host cells. The new coronavirus, which has a comparatively large genome, is racing through part of China and beginning to spread around the world, transmitted from person to person. The family of coronavirus is so named because of a crownlike appearance of spikes some say it looks like the sun during an eclipse, with a halo. But there is nothing sunny about its emergence as a respiratory disease that can harm and kill human beings. (2/5)

Stat:The Novel Coronavirus Exposes A Flaw In The Nagoya ProtocolThe speed with which the sequence of 2019-nCoV has been shared is a potent reminder of how we should avoid tying up the research community in red tape when we are in a race to find a new vaccine or treatment for a new virus or other pathogen.Coronavirus Coverage: Read the rest of STATs up-to-the-minute reporting on the coronavirus outbreak. But that is precisely what a legally binding international agreement, the Nagoya Protocol on Access and Benefit Sharing, has inadvertently ended up doing. This supplementary international agreement to the Convention on Biological Diversity could make it extraordinarily difficult to conduct disease surveillance or forge research collaborations around the world. (Thomas B. Cueni, 2/5)

The Washington Post:The Coronavirus Reawakens Old Racist Tropes Against Chinese PeopleAt a middle school a few blocks from my house, a rumor circulated among the children that all Asian kids have the coronavirus and should be quarantined. Misinformation has also reached higher education: In college campuses across the United States, some non-Asian students have acknowledged avoiding Asian classmates for no other reason than, well, the coronavirus came from Asia. The disease apparently emerged in December from a live-food market in Wuhan, China. There have been over 20,000 confirmed cases in China, and the World Health Organization reported 146 confirmed cases in 23 other countries. There are serious concerns of a global pandemic, but the coronavirus has also reawakened centuries-old prejudices against Chinese people. (John Pomfret, 2/5)

The New York Times:How Abortion Warps Our PoliticsWhere will abortion opponents stand in 2020? President Trump recently made his bid for their votes, becoming the first president to speak in person at the annual March for Life in Washington, an event held since 1974. Two days later, a Democratic presidential hopeful, Pete Buttigieg, told a woman who called herself a proud pro-life Democrat that he would not support more moderate abortion language in the Democratic National Committee platform basically suggesting that, on this issue, she will not find affirmation or support from her party. (Gracy Olmstead, 2/5)

Stat:Stem Cell Clinics, Especially Rogue Ones, Need To Be Better RegulatedRogue stem cell clinics continue to victimize hopeful patients seeking cures for cancer, Parkinsons disease, autism, chronic pain, and more. Most of these treatments are unproven and unsupported by evidence, wasting precious time and health care dollars for desperate patients and often doing more harm than good to patients health and survival.Yet public demand for stem cell treatments is outpacing our ability to regulate them. Government agencies like the Food and Drug Administration and the Federal Trade Commission should be stepping up to the plate to do this, but it isnt likely that the money will be found soon to do that. (David A. Pearce, 2/6)

Stat:Taxpayer-Funded Research Should Be Open ScienceIn the three years since Donald Trump was inaugurated as president, I have rarely supported anything he proposed. And for nearly 50 years as an academic researcher, I have almost always sided with the professional research establishment. Yet on one issue I now find myself siding with the president and opposing the scientific establishment. In December, E&E News reported that the president was considering an executive action requiring that all federally funded research become available to the public immediately upon publication. After all, taxpayers paid for much of this research, which could enhance their health or quality of life, and it should become open science. (Robert M. Kaplan, 2/6)

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Viewpoints: Where's The Praise About Good News On Declining Opioid Deaths?; Shutting Down Air, Trade Over Coronavirus Will Be More Harmful In Long Run...

Abnormal Bone Formation After Trauma Explained and Reversed in Mice – Michigan Medicine

Hip replacements, severe burns, spinal cord injuries, blast injuries, traumatic brain injuriesthese seemingly disparate traumas can each lead to a painful complication during the healing process called heterotopic ossification. Heterotopic ossification is abnormal bone formation within muscle and soft tissues, an unfortunately common phenomenon that typically occurs weeks after an injury or surgery. Patients with heterotopic ossification experience decreased range of motion, swelling and pain.

Currently, theres no way to prevent it and once its formed, theres no way to reverse it, says Benjamin Levi, M.D., Director of the Burn/Wound/Regeneration Medicine Laboratory and Center for Basic and Translational Research in Michigan Medicines Department of Surgery. And while experts suspected that heterotopic ossification was somehow linked to inflammation, new U-M research explains how this happens on a cellular scaleand suggests a way it can be stopped.

To help explain how the healing process goes awry in heterotopic ossification, the research team, led by Levi, Michael Sorkin, M.D. and Amanda Huber, Ph.D., of the Department of Surgerys section of plastic surgery, took a closer look at the inflammation process in mice. Using tissue from injury sites in mouse models of heterotopic ossification, they used single cell RNA sequencing to characterize the types of cells present. They confirmed that macrophages were among the first responders and might be behind aberrant healing.

Macrophages are white blood cells whose normal job is to find and destroy pathogens. Upon closer examination, the Michigan team found that macrophages are more complex than previously thoughtand dont always do what they are supposed to do.

Macrophages are a heterogenous population, some that are helpful with healing and some that are not, explains Levi. People think of macrophages as binary (M1 vs. M2). Yet weve shown that there are many different macrophage phenotypes or states that are present during abnormal wound healing.

Specifically, during heterotopic ossification formation, the increased presence of macrophages that express TGF-beta leads to an errant signal being sent to bone forming stem cells.

For now, the only way to treat heterotopic ossification is to wait for it to stop growing and cut it out which never completely restores joint function. This new research suggests that there may be a way to treat it at the cellular level. Working with the lab led by Stephen Kunkel, Ph.D. of the Department of Pathology, the team demonstrated that an activating peptide to CD47, p7N3 could alter TGF-beta expressing macrophages, reducing their ability to send signals to bone-forming stem cells that lead to heterotopic ossification.

During abnormal wound healing, we think there is some signal that continues to be present at an injury site even after the injury should have resolved, says Levi. Beyond heterotopic ossification, Levi says the studys findings can likely be translated to other types of abnormal wound healing like muscle fibrosis.

The team hopes to eventually develop translational therapies that target this pathway and further characterize not just the inflammatory cells but the stem cells responsible for the abnormal bone formation.

The paper is published in the journal Nature Communications. Other U-M authors include: Charles Hwang, William Carson IV, Rajarsee Menon, John Li, Kaetlin Vasquez, Chase Pagani, Nicole Patel, Shuli Li, Noelle D. Visser, Yashar Niknafs, Shawn Loder, Melissa Scola, Dylan Nycz, Katherine Gallagher, Laurie K. McCauley, Shailesh Agarwal, and Yuji Mishina.

Paper Cited: Regulation of heterotopic ossification by monocytes in a mouse model of aberrant wound healing, Nature Communications, DOI: 10.1038/s41467-019-14172-4

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Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results for 2019 – Yahoo Finance

Bristol-Myers Squibb Company (NYSE:BMY) today reports results for the fourth quarter and full year of 2019, which highlight continued strong sales and robust operating performance, along with the ongoing advancement of the companys pipeline.

"By all measures, 2019 was a transformative year for Bristol-Myers Squibb as we progressed our strategy through the acquisition of Celgene, delivered strong operational and financial performance, and continued to drive important science for patients," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. "With an expanded portfolio of high-performing brands, eight potential commercial launch opportunities, a deep and broad early pipeline, and the financial flexibility to continue to invest in innovation, the company enters 2020 uniquely positioned to transform patients lives through science and create long-term sustainable growth."

Fourth Quarter

$ amounts in millions, except per share amounts

2019*

2018

Change

Total Revenues

$7,945

$5,973

33%

GAAP Diluted EPS

(0.55)

0.71

N/A

Non-GAAP Diluted EPS

1.22

0.94

30%

Full Year

$ amounts in millions, except per share amounts

2019*

2018

Change

Total Revenues

$26,145

$22,561

16%

GAAP Diluted EPS

2.01

3.01

(33)%

Non-GAAP Diluted EPS

4.69

3.98

18%

*Includes Celgene results from November 20, 2019 through December 31, 2019.

FOURTH QUARTER FINANCIAL RESULTS

All comparisons are made versus the same period in 2018 unless otherwise stated.

ACQUISITION OF CELGENE CORPORATION

Otezla is a trademark of Amgen Inc.

FOURTH QUARTER PRODUCT AND PIPELINE UPDATE

Product Revenue Highlights

Global product revenue increases in the fourth quarter of 2019, as compared to the fourth quarter of 2018, drove revenue increases.

* Represents product revenues for Celgene products only from November 20, 2019, which was the date of the closing of the acquisition, through December 31, 2019. See "Worldwide Product Revenue," which is available on bms.com/investors, for information on the revenue for these products and other products of the company and Celgene presented on a quarterly basis for 2018 and 2019.

Oncology

Opdivo

Regulatory

Clinical

Cardiovascular

Eliquis

Clinical

Immunology

Orencia

Regulatory

Clinical

Hematology

Conferences

In December, at the 2019 American Society of Hematology (ASH) Annual Meeting, the company announced important new data and analysis from its hematology portfolio:

The following data were also presented at the ASH Annual Meeting by the company and its partners:

Revlimid

Regulatory

Reblozyl

Regulatory

Clinical

ide-cel

Clinical

liso-cel

Regulatory

BUSINESS DEVELOPMENT UPDATE

CAPITAL ALLOCATION

Bristol-Myers Squibb maintains a balanced approach to capital allocation focused on future business development and sourcing external innovation as a priority, de-leveraging in the near term to maintain strong investment grade credit ratings and less than 1.5x debt/EBITDA by 2023, planning for annual dividend increases, subject to board approval, and disciplined share repurchases.

In that context, the company today announced its board of directors approved an increase of $5 billion to the share repurchase authorization for the companys common stock. This is incremental to the current share repurchase program announced in October 2016 under which the company has approximately $1 billion remaining and increases the companys total outstanding share repurchase authorization under the companys share repurchase program to approximately $6 billion.

The specific timing and number of shares repurchased will be determined by the companys management at its discretion and will vary based on market conditions, securities law limitations and other factors. The share repurchase program does not obligate the company to repurchase any specific number of shares, does not have a specific expiration date and may be suspended or discontinued at any time. The repurchases may be effected through a combination of one or more open market repurchases, privately negotiated transactions, transactions structured through investment banking institutions and other derivative transactions.

FINANCIAL GUIDANCE

Bristol-Myers Squibb is providing 2020 GAAP EPS guidance range of $0.75 to $0.95 and non-GAAP EPS guidance range of $6.00 to $6.20. In addition, the company is providing for 2021, a non-GAAP EPS guidance range of $7.15 to $7.45. Both GAAP and non-GAAP guidance for 2020 and non-GAAP guidance for 2021 includes the impact of the Celgene acquisition and the Otezla divestiture and assume current exchange rates. Key 2020 GAAP and non-GAAP line-item guidance assumptions are:

GAAP

non-GAAP

Revenue

$40.5B - $42.5B

$40.5B - $42.5B

Gross margin as a percentage of revenue

Approximately 74%

Approximately 80%

Marketing, selling, and administrative expenses

$6.8B - $7.0B

$6.8B - $7.0B

Research and development expenses

$10.1B - $10.3B

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Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results for 2019 - Yahoo Finance

Kleo Pharmaceuticals Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic – BioSpace

NEW HAVEN, Conn., Feb. 6, 2020 /PRNewswire/ -- Kleo Pharmaceuticals, an immuno-oncology company developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, announced today that it has received Investigational New Drug (IND) authorization to proceed from the U.S. Food and Drug Administration (FDA) to initiate a safety and tolerability clinical study combining KP1237, a CD38-targeting antibody recruiting molecule (ARM), with patients' own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients.

The single-arm study will be conducted in 25-30 patients with exploratory endpoints that assess the MRD (minimal residual disease) conversion rate at 90-100 days after transplantation. Recent clinical trials have identified MRD negativity post-transplant as a potential surrogate of long-term remission in MM. The trial is expected to begin enrollment in the first half of 2020, and topline data are expected in the second half of 2021.

"We are excited to have clearance to initiate a clinical trial in the US that addresses a significant unmet medical need in newly diagnosed, post-transplant multiple myeloma patients," said Kleo CEO Doug Manion, MD. "Approximately 30,000 individuals are diagnosed with multiple myeloma in the United States each year, with at least 1/3 of those patients undergoing autologous stem cell transplants."

In this trial, KP1237 is being investigated as a "cell homing" molecule to target the patient's activated NK cells to the CD38-expressing tumor. Current anti-CD38 therapeutic antibodies kill NK cells and are not approved for use in this clinical settingi.

Nonclinical efficacy datapresented at the 2019 American Society of Hematology (ASH) Annual Meeting demonstrated that CD38-ARMs are able to kill multiple myeloma cells by antibody-dependent cellular cytotoxicity without depleting CD38-expressing immune cells. Nonclinical data also demonstrated that the CD38-ARM molecule did not induce complement-dependent cytotoxicity (CDC) suggesting it is not likely to cause CDC in humans. Kleo's 2019 ASH posters can be viewed hereand here.

About Kleo Pharmaceuticals, Inc. Kleo Pharmaceuticals is a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics based on the groundbreaking research of its scientific founder Dr. David Spiegel at Yale University. Similar to complex biologic drugs, Kleo's compounds recruit the immune system to destroy cancer cells, with the advantage of being smaller and more versatile, leading to potentially improved safety and efficacy over biologics. They are also much faster and less costly to design and produce, particularly against novel targets. Kleo is advancing several drug candidates based on its proprietary technology platforms, all of which are modular in design and enable rapid generation of novel immunotherapies that can be optimized against certain cancers, or enhance the properties of existing immunotherapies. These include Antibody Recruiting Molecules (ARMs), Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs). Biohaven Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc. (Nikkei:PPTDF) are investors in Kleo Pharmaceuticals. For more information visit http://kleopharmaceuticals.com.

Forward-Looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will," "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATIONTiberend Strategic Advisors, Inc.Maureen McEnroe, CFA (Investors)212-375-2664mmcenroe@tiberend.com

Ingrid Mezo (Media)646-604-5150imezo@tiberend.com

i DARZALEX (daratumumab) injection [package insert on the internet]. Horsham, PA: Janssen Biotech, Inc., http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf (2019, accessed 05 February 2020).

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Actinium Pharmaceuticals, Inc. to Present at the 22nd Annual BIO CEO & Investor Conference – BioSpace

NEW YORK, Feb. 5, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc.(NYSE AMERICAN: ATNM)("Actinium") today announced that Sandesh Seth, Actinium's Chairman & CEO, will be presenting at the 22nd Annual BIO CEO & Investor Conference. Hosted by the Biotechnology Innovation Organization (BIO), the 22nd Annual BIO CEO & Investor Conference will take place February 10th and 11th at the New York Marriott Marquis in New York City.

Presentation Details

Date:Tuesday, February 11Time:10:15 am ETPresenter:Sandesh Seth, Chairman and CEOLocation:New York Marriott Marquis, Ziegfeld Room

Members of Actinium's Executive team will be available for one-on-one meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so by contacting Steve O'Loughlin, Principal Financial Officer via email at soloughlin@actiniumpharma.com.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, apamistamab-I-131 (Iomab-B) is being studied in the ongoing pivotal Phase 3Study ofIomab-B inElderlyRelapsed orRefractoryAcute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over fifty percent enrolled and promising single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. Apatmistamamb-I-131 will also be studied as a targeted conditioning agent in a Phase 1/2 anti-HIV stem cell gene therapy with UC Davis and is expected to be studied with a CAR-T therapy in 2020. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc.

More information is available at http://www.actiniumpharma.com, http://www.sierratrial.com and our Twitter feed @ActiniumPharma, http://www.twitter.com/actiniumpharma.

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 535-7743

Media:Alisa Steinberg, Director, IR & Corp Commsasteinberg@actiniumpharma.com(646) 237-4087

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