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Novel cancer treatment wins endorsement of FDA advisers – Washington Post

Posted: July 13, 2017 at 7:44 am

Food and Drug Administration advisers on Wednesday enthusiastically endorsed a first-of-its-kind cancer treatment that uses patients’ revved-up immune cells to fight the disease, concluding that the therapy’s benefits for desperately ill children far outweigh its potentially dangerous side effects.

The unanimous recommendation from theOncologic Drugs Advisory Committeemeans the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier.

Timothy Cripe, a panel member who is an oncologist with Nationwide Children’s Hospitalin Columbus, Ohio, called the treatment the “most exciting thing I’ve seen in my lifetime.”

Novartis, the drugmaker behind the CAR T-cell therapy, is seeking approval to use it for children and young adults whose leukemia doesn’t respond to traditional treatments a group that numbers 600 or so patientsa year in this country. But the approach also is being tested for a range of diseases from non-Hodgkin lymphoma and multiple myeloma to solid tumors.

If cleared by the FDA, it would be the first gene therapy approved in the United States. But unlike traditional gene therapy, the new treatment doesn’t replace disease-causing genes with healthy ones. Instead, it uses technology to reprogram immune cells called T cells to target and attack malignancies.

When a patient is treated under the Novartis process, T cells are extracted from a patient’s blood, frozen and sent to the company’s plant in Morris Plains, N.J. There, the cells are genetically modified to attack the cancer, expanded in number, refrozen and shipped back to the patient for infusion.

Once inside the body, the cells multiply exponentially and go hunting for the CD19 protein, which appears on a kind of white blood cell that can give rise to diseases, such as leukemia and lymphoma.The turnaround time for manufacturing the therapy, called vein-to-vein time, will be an estimated 22 days, Novartis officials told the committee Wednesday.

From the start of Wednesday’smeeting, committee members made clear that they were not concerned about the treatment’s efficacy, which has been well established 83 percent of patients went into remission in the pivotal Novartis trial. Rather, the panel homed in onhow to best to handle possible shot-term toxicities, as well as long-term safety risks and manufacturing quality.

Most patients in the Novartis study experienced something called cytokine release syndrome, which causes fever and flulike symptoms that can range from mild to extremely severe, said Stephan Grupp, an oncologist at the Children’s Hospital of Philadelphia who led the Novartis trial. Some patients in that study also had neurological problems, including seizures and delirium. But there were no cases of fatal brain swelling, as occurred in another company’s trial, Grupp said.

To try to ensure safety, Novartis is limiting the therapy’s availability to 30 to 35 medical centers where personnel have had extensive training with the treatment. The company also plans to post Novartis employees at hospitals using the therapy and to follow patients for up to 15 years.

During the committee meeting, hundreds of people packed the hearing room at FDA headquarters in Silver Spring, Md., including prominent scientists, such as Carl June of the University of Pennsylvania, who developed the treatment. Though the FDA isn’t required to follow the guidance of its advisory committees, it usually does.

David Maloney, medical director for cellular immunotherapy at Fred Hutchinson Cancer Research Center in Seattle, said he was elated that the field is moving forward. It represents a paradigm shift in treating cancers, said Maloney, who is extensively involved in CAR T-cell research but not in the Novartis product.

One of the big issues in CAR-T cell therapy the cost, which analysts say could be in the hundreds of thousands of dollars wasn’t discussed because that is beyond the FDA’s purview. Novartis hasn’t released pricing information.

During the public comment portion of the hearing, Amy Kappen, whose 5-year-old daughter underwent CAR T-cell therapy in Philadelphia, called for approval. The treatment beat back her daughter’s cancer and brought back the sparkle in her eyes. And while she died three months later, our children deserve this chance, Kappen said.

For other parents, there were happier outcomes. Don McMahon, whose son Connor was treated at Duke Children’s Hospital in North Carolina, said the therapy was far less debilitating than what he endured on standard chemotherapy during two relapses. The boy, an avid hockey player, is doing well now.

Thomas Whitehead, whose daughter was the first pediatric patient to receive the treatment, choked up while telling panel members about Emily’s experience. She got CAR T-cell therapy when she was 6 and close to death from leukemia. The treatment almost killed her, but she recovered and today is cancer free.

“If you want to see what a cure looks like for relapsed ALL [acute lymphoblastic leukemia], shes standing right beside me,” said Whitehead, his voice cracking.

Read more:

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Limited coverage, subsidies for some in Senate GOP’s proposed health-care overhaul

This cancer doctor is running for Congress. Here’s why

‘This is not the end’: Using immunotherapy and a genetic glitch to give cancer patients hope

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A Simple App Helped Cancer Patients Get Better Treatment, Live Longer – Healthline

Posted: at 7:44 am

Research shows a web-based communication tool enabled metastatic cancer patients to live five months longer. It could be applied to numerous chronic conditions.

Cell phones can help you hail cars, order dinner, or send electronic payments to friends with the tap of a button.

Tablets and laptops compute faster, store more, and are easier to afford than ever before.

You can take calls from your wrist, too.

Thats why it was only a matter of time before doctors and researchers discovered ways to make the pervasive handheld technology an integral instrument in collaborative medical treatment.

And they have, in the form of a web-based tool that allows cancer patients to report in real time their symptoms and side effects and get better treatment as a result.

[Self-reporting software] can fundamentally alter communication between patients and their oncology nurses and physicians by improving knowledge of symptoms and side effects, said Ethan M. Basch, MD, professor of medicine at the Lineberger Comprehensive Cancer Center of the University of North Carolina. This can enable earlier actions that avoid downstream complications.

Earlier this year, Basch and colleagues released a first-of-its-kind study that looked at the impact of self-reporting software in helping patients get more medical attention during cancer treatment, and in turn, extending their lives.

Baschs study, which included 766 patients at Memorial Sloan Kettering Cancer Center in New York, tested a simple web-based tool. Patients who were undergoing treatment for cancer used a computer program to report any symptoms, side effects, or concerns. (The program was designed specifically for this study and is not available commercially.)

The app also allowed doctors and nurses to monitor a patients recovery and follow up with additional treatment options. If a patients side effects were severe or worsening, nurses received an e-mail alert so they could call the patient to follow-up, or make sure a doctor reached out to the patient later.

During a patients appointment, findings from the tool were printed out and provided for the doctor and patient to discuss. And a detailed analysis helped the entire care team closely track symptoms, side effects, and complications, Basch said.

This finding is promising because it shows that although we already are quite conscientious about symptom management in clinical practice, that by using simple electronic tools we can even do better, Basch said.

The increased engagement self-reporting software provides may help people with cancer live longer.

In Baschs study, patients with metastatic cancers who were undergoing chemotherapy and used the tool routinely during the study lived an average of five months longer than patients who did not use the tool.

The possible mechanism for prolonging life in this study is first that peoples physical function and mobility were significantly improved, and we know from prior research that keeping people more active improves longevity, Basch said. The second reason is likely the increased duration of life-prolonging chemotherapy. In this study we found that people using the self-reporting tool remained on chemotherapy for two months longer likely because their side effects were better managed.

Patients who are undergoing cancer treatment, including chemotherapy, often experience severe side effects. These include, but are not limited to, nausea, uncontrolled pain that leads to hospitalization, and vomiting or diarrhea. Often, doctors and nurses arent aware of these symptoms, and patients are left to endure them at home.

Last year, Basch released anotherstudythat found patients who used the tool experienced a better quality of life during their cancer treatments. They had fewer visits to emergency rooms and fewer hospitalizations.

Doctors are unaware of half their patients’ symptoms, Basch said. We cant provide adequate treatment when we dont know their full experiences.

Today, many doctors and oncologists rely on patients to self-report their symptoms and side effects of treatments. If something is bothersome or getting worse, patients are encouraged to call their doctors to report the issues. In the time between visits, however, patients may forget an event or downplay its significance.

In the current system, between visits, the onus is upon the patient to pick up the phone and call the office or send an electronic message to the office when they have problems, and we know that the majority of patients are hesitant to do that much of the time, Basch said. By introducing a simple electronic tool, we remove that barrier through systematic, proactive collections and communications of patients symptom data. This improves relationships between patients and clinicians because it eases communication and enables focus on those problems that really matter during encounters.

While exciting and encouraging, there are many steps to implementing a widely used self-reporting tool. Currently, Baschs findings are being confirmed in a larger clinical trial. This trial uses a more user-friendly interface thats available on both a web browser and a mobile device.

When the research is in and if it confirms what Basch originally found the work of convincing doctors, hospitals, and insurance companies to support this type of intervention begins.

Now that weve demonstrated benefits associated with patient electronic symptom reporting, were turning our attention toward implementation, specifically working out how to integrate this approach into clinical care workflow and into electronic health records symptoms, Basch said.

Baschs initial field of interest is cancer treatment. As an oncologist, hes seeking ways to help the patients he interacts with every day. However, he knows the possibilities for this type of web-based reporting go beyond cancer treatment.

This kind of tool has tremendous promise across chronic illnesses that have symptoms, such as heart failure, diabetes, arthritis, and many others, he said.

For now, Basch and his colleagues will continue to explore the use of this type of software for patients of all kinds, and hope for confirmation of their original findings. When that day comes, Basch will be ready to help doctors and medical professionals of all stripes find helpful, smart ways to implement self-reporting software for their patients.

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Billionaire Patrick Soon-Shiong opens ‘next generation’ cancer treatment institute in El Segundo – The Daily Breeze

Posted: at 7:44 am

Pledging to provide cancer patients with groundbreaking advancements in care, billionaire physician Patrick Soon-Shiong opened a state-of-the-art treatment and diagnostics center in El Segundo on Tuesday.

The Chan Soon-Shiong Institute for Medicine at Mariposa or CSS Institute, for short will use pioneering next-generation immuno-oncology treatments for all types of cancers, officials said at a grand opening ceremony.

I think the idea that chemotherapy is toxic and metastasis is fatal is what this institute is going to try to disprove, Soon-Shiong said, sitting beside his wife, Michele Chan, El Segundo Mayor Suzanne Fuentes and a team of top clinicians. We truly believe we must change for all patients with cancer this concept that high-dose chemotherapy is the standard of care.

The facility at 2040 E. Mariposa Ave. is down the street from the future training center of the Los Angeles Lakers, a team in which Soon-Shiong holds a minority ownership interest.

Fuentes thanked Soon-Shiong and his biotech parent company, NantWorks, for choosing to open the institute in El Segundo, which is experiencing a biotech boom with companies such as Kite Pharma moving in.

Technology developed in this city nearly 50 years ago landed a man on the moon, and more than half of the satellites and vehicles in space were manufactured in El Segundo, Fuentes said. While our aerospace industry continues to thrive, we are poised for a new generation of scientific advancement to once again change the world.

Soon-Shiong, a South African-born surgeon who became the worlds wealthiest doctor after he invented the cancer drug Abraxane, told a crowd of city officials, medical professionals and reporters that the institute will blend cutting-edge research with personal care.

Specifically, patients will undergo hyper-individualized treatment designed to supercharge the bodys immune system using natural killer cells, virus vaccines and molecular diagnostics.

This will be first institute in the country that will take on this ability to actually activate your immune system, transfer natural killer cells and then identify whats driving the tumor and give you a virus injection like a flu shot, Soon-Shiong said.

The institute will grow an unlimited supply of the killer cells, which are few naturally in the bloodstream.

Soon-Shiong thanked Chan for her work designing the facilitys contemporary aesthetic, which has a calming color palette to provide patients with a sense of not only dignity, but comfort.

The CSS Institute opening comes one week after Culver City-based NantWorks acquired a controlling stake in the Verity Health hospital chain, which operates St. Vincent Medical Center in downtown Los Angeles and St. Francis Medical Center in Lynwood.


Officials said the goal is to expand the level of care at the CSS Institute to underserved patients in those hospitals.

Lennie Sender, a co-director of the institute and medical director of Hyundai Cancer Institute at Childrens Hospital of Orange County, said the new facility will be a footprint and prototype for the broader system.

Our goal is to put close to 100 percent of our patients on trial, Sender said. In the country as a whole, only 3 percent of cancer patients go in trial and, in prestigious universities, 40 to 50 percent do. No one has ever achieved 100 percent.

One of the first trials patients will be enrolled in is for a pancreatic cancer vaccine, and trials for other tumor types will follow.

To our knowledge, these trials will be the first in the nation to combine low-dose chemo-radiotherapy with natural killer cell and fusion proteins to activate the patients immune system, the institutes surgical co-director, John Lee, said in a statement.

Sender did not say how many patients can be treated at the facility, but he said the idea is to start small.

Patients will be accepted based on their biology, he said, not their wallet.

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15 percent of men regret prostate cancer treatment choices years later, study finds – STAT

Posted: at 7:44 am


fter years of introspection, about 15 percent of men with localized prostate cancer regretted the decisions they made regarding treatment, a survey of almost 1,000 patients showed.

About twice as many men expressed regret after radical prostatectomy or radiation therapy as compared with active surveillance. The single biggest contributor to regret was treatment-associated sexual dysfunction, as reported in the Journal of Clinical Oncology.

Regret was a relatively infrequently reported outcome among long-term survivors of localized prostate cancer, Dr. Richard M. Hoffman of the University of Iowa in Iowa City and co-authors concluded. However, our results suggest that better informing men about treatment options, in particular, conservative treatment, might help mitigate long-term regret. These findings are timely for men with low-risk cancers who are being encouraged to consider active surveillance.


These findings are particularly relevant now when men with low-risk cancers are facing challenging decisions between selecting an active treatment or active surveillance that presents a potential trade-off between cancer control and adverse effects, they added.

The findings leave little doubt about the importance of informed decision making and the need for physician-patient discussions prior to deciding a course of action for early-stage prostate cancer, said Dr. Otis Brawley, chief medical officer for the American Cancer Society in Atlanta.

I think that this whole paper is a huge cry that we need to make sure that people are informed and are taking part in their treatment decisions, Brawley told MedPage Today.

The lower rate of regret among men on active surveillance might also reflect on the informed decision-making process, although the study did not specifically examine that issue, he added.

In the United States, its almost impossible to put someone on observation, after you have told them they have cancer, and not inform them, the way I think someone should be informed, said Brawley. Its very easy to tell someone you have cancer and were going to do a radical prostatectomy next Monday and not inform them. It may very well be that the people who got observation were more fully or better informed and better understood what they were facing, compared with the people who got aggressive therapy.

The study had its genesis in the recognition that many early-stage prostate cancers have an indolent clinical course and are unlikely to evolve into life-threatening disease. The recognition sparked controversy and discussion about tradeoffs between treatment options and treatment-associated adverse effects. Increasingly, recent clinical guidelines have emphasized the need for informed discussions between patients and clinicians before deciding how to manage early prostate cancer.

A study reported earlier this year reinforced the need for informed decision making based on physician-patient discussions about treatment options. The study showed high rates of regret among men who relied primarily on internet-based information about prostate cancer treatment to decide how their own disease should be treated.

Hoffman and co-authors surveyed 934 patients with early-stage prostate cancer enrolled in one of six U.S. cancer registries from 1994 to 1995 and who had at least 15 years of follow-up. The survey instrument elicited information about general health status and clinical and demographic factors, as well as treatment decisions, informed decision making, regret, and outlook on life.

Almost 60 percent of the patients had low-risk disease characteristics (PSA

Overall, 14.6 percent of the survey participants expressed regret about their treatment decisions. The total regret percentage included 8.2 percent of men who opted for conservative management (including active surveillance), 15.0 percent of men who had surgery, and 16.6 percent of those who underwent definitive radiotherapy.

The authors performed a multivariable analysis to identify factors associated with treatment regret. They found that moderate or substantial sexual dysfunction was the most commonly cited factor associated with decision regret, mentioned by 39 percent of men with regret. The only other significant factors were moderate or substantial bowel function bother, and concerns about rising PSA levels.

Older age at cancer diagnosis and informed treatment decision making had inverse associations with regret, the authors reported.

This story was originally published by MedPage Today. Hoffman disclosed no relevant relationships with industry. One or more co-authors disclosed relationships with Blue Cros & Blue Shield, Astellas, Dendreon, Medivation, and royalty/patent interests.

15 percent of men regret prostate cancer treatment choices years later, study finds – STAT

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Mayo Clinic Minute: Fast-track breast cancer treatment – Winchester News Gazette

Posted: at 7:44 am

INZ021-028>031-035>049-051>057-062>065-072-131015-/O.CON.KIND.FF.A.0007.000000T0000Z-170714T1200Z//00000.0.ER.000000T0000Z.000000T0000Z.000000T0000Z.OO/Carroll-Warren-Tippecanoe-Clinton-Howard-Fountain-Montgomery-Boone-Tipton-Hamilton-Madison-Delaware-Randolph-Vermillion-Parke-Putnam-Hendricks-Marion-Hancock-Henry-Vigo-Clay-Owen-Morgan-Johnson-Shelby-Rush-Monroe-Brown-Bartholomew-Decatur-Jennings-Including the cities of Lafayette, Frankfort, Kokomo, Crawfordsville, Anderson, Muncie, Indianapolis, Terre Haute, Shelbyville, Bloomington, and Columbus1007 PM EDT Wed Jul 12 2017…FLASH FLOOD WATCH REMAINS IN EFFECT THROUGH FRIDAY MORNING…The Flash Flood Watch continues for* Portions of central Indiana, east central Indiana, north central Indiana, south central Indiana, southeast Indiana, and west central Indiana, including the following areas, in central Indiana, Bartholomew, Boone, Clinton, Decatur, Hamilton, Hancock, Hendricks, Howard, Johnson, Madison, Marion, Morgan, Rush, Shelby, and Tipton. In east central Indiana, Delaware, Henry, and Randolph. In north central Indiana, Carroll. In south central Indiana, Brown and Monroe. In southeast Indiana, Jennings. In west central Indiana, Clay, Fountain, Montgomery, Owen, Parke, Putnam, Tippecanoe, Vermillion, Vigo, and Warren. * Through Friday morning* Heavy rains at times will fall onto a saturated ground.* Flooding may be localized, but very severe where it occurs.A Flash Flood Watch means that conditions may develop that leadto flash flooding. Flash flooding is a VERY DANGEROUS SITUATION.You should monitor later forecasts and be prepared to take actionshould Flash Flood Warnings be issued.&&$$

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Immuno-Oncology Market, By Type [mAb (Naked, Conjugate), Cancer Vaccines, Immune Checkpoint Inhibitors (PD-1 … – PR Newswire (press release)

Posted: at 7:44 am

The report “Immuno-Oncology Market, By Type [mAb (Naked, Conjugate), Cancer Vaccines, Immune Checkpoint Inhibitors (PD-1, PD-L1, CTLA-4]), By Application (Lung, Melanoma, Leukemia, Lymphoma) – Global Forecast to 2022” provides a detailed analysis of the current and future market scenario of the global Immuno-oncology market with a brief overview of the industry. The report also provides insight about the major drivers and challenges, along with the latest trends and developments impacting the industry growth. In addition, the report also highlights various opportunities available for growth of the global Immuno-oncology market.

According to this edition of the report, the Immuno-oncology market is anticipated to hit billions of dollars within the next 5-10 years. The report also provides the sales of major marketed Immuno-oncology drugs.

On the basis of type of product, the global Immuno-oncology market has been segmented into major product classes including monoclonal antibodies, therapeutic vaccines, and immune checkpoint inhibitors amongst others. According to the report, monoclonal antibodies segment was estimated to account for the largest share in 2016 due to rising prevalence of cancer & rising usage in a number of therapies (antibody-directed enzyme prodrug therapy and radio immunotherapy). Based on geography, the report divides the market into North America, Europe, and Asia-Pacific. In 2016, North America was estimated to account for the largest share.

Primarily, the Immuno-oncology market is dominated by Lung Cancer & Melanoma applications with several companies and academic institutions focusing on novel treatment approaches, thus making the major contribution to the global immuno-oncology market. The report provides the market analysis of major indications along with the forecast till 2022.

Moreover, a major focus has been on the ongoing clinical trials for the development of innovative products. In this context, we have provided information about the Immuno-oncology programs at various stages of clinical development. The study also provides a comprehensive overview of various aspects of the clinical trials in the Immuno-oncology market, such as phases, and product type. In addition, the report highlights the strategic collaborations amongst the players for enhancing their market share.

The latter part of the report discusses some of the prominent players in the Immuno-oncology market. Some of the key players dominant in the market are Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche, and Merck among others. A brief business overview of each player has been provided, along with their product and pipeline portfolios and recent developments.

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Immuno-Oncology Market, By Type [mAb (Naked, Conjugate), Cancer Vaccines, Immune Checkpoint Inhibitors (PD-1 … – PR Newswire (press release)

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Genomic Testing in Oncology: From Single Genes to Whole Genomes – (blog)

Posted: at 7:44 am

Personalized medicine would be nothing without genomic testing tools.Heres an overview of how the field has rapidly evolved in the past years.

BRCA (BReast CAncer) is one of the most famous gene variants for breast cancer testing. But aside from being a game-changer from a scientific perspective, it also changed the laws of genomic testing.

The legal case Association for Molecular Pathology v. Myriad Genetics challenged the validity of gene patents in the United States, specifically patents owned by Myriad Genetics that covered human DNA sequences, including BRCA.Since then, the U.S. Patent Office no longer accepts patents on isolated DNA sequences. Myriads patents have also been challenged in Europe by a coalition led by the Institut Curie.

In 2013, BRCA was again at the center of attention whenAngelina Jolieannounced that she had undergone a double mastectomy because of family history of breast cancer and the presence of the BRCA 1 mutation. Following this decision, thousands of women worldwide requested similar surgery to their practitioner.

In Europe, such approach is less common but may be proposed to patients with aspecific profile. As BRCA is a somatic mutation, if a patient tests positive the chances are high that a member of its family does too. In France, if a patient tests positive for this mutation, he has the legal obligation to inform their family that they should test themselves.

More surprisingly,The Washington Postreported this March that employers in the US could impose hefty penalties on employees who decline to participate in genetic testing as part of workplace wellness programs if a proposed bill is passed.

Though it is quite easy to interpret a single mutation such as BRCA, there are far more variables to account for in theoncology field. A study of more than 1,000 colorectal cancer patients at the Dana-Farber Cancer Institute has revealed that about 10% in total show mutations in genes thought to increase the susceptibility to cancers.

Thanks to new improvements, we are now able to consider dozens of genes at the same time. But this comes with a challenge. Results of genetic testing are increasingly complex and difficult for those without genetics expertise to interpret correctly, Dr. Allison Kurian from Stanford University toldReuters Health.

Companies are trying to overcome these difficulties by developing automated analysis, such as the famous IBM Watson for Genomics that analyzes genetic variants based on the whole scientific literature available, though so far such an approach has not reached a sufficient clinical level of evidence to be used in routine practice.Sophia Genetics is also building on the promise of data-driven medicine that began with DNA sequencing by helping clinicians adopt the most advanced genomic data analysis to better diagnose and treat patients.

Multigene diagnostics are now reaching the stage of industrial scale-up, making these tests more reliable, sensitive, sensible and highly reproducible. Thanks to multi-gene testing, physicians can now predict the risk of recurrence or adapt treatments for a higher response rate and lower toxicity. For example, thegold standard treatment for patients with HER2+ breast cancer is Roches blockbuster Herceptin (trastuzumab), the third of thebest-seller drugs of 2016.

Another example is Genomic Health, in the US, whoseOncotypeDXanalyzes the activity of a group of genes that can affect how a cancer is likely to behave and respond to treatment. Having been on the market since 2004, it has amassed a hefty evidence base with over 700,000 users.

In Europe, this and other tests likeNanostrings ProsignaorMyriads Endopredictare performed either by private or public institutions and cost around 2,000, withdifferent quotations in each country based on their individual health insurance systems.

Startups, such as the BelgianOncoDNA,which combines an innovative test and data analysis, could offer solutions to reduce the price. The team at US-basedColor Genomicswants, in the words of the CEO, Elad Gil, to democratize access to genetic testing. The company plans to charge 230 ($249) for an analysis of BRCA1 and BRCA2, plus 17 other cancer risk genes. That is one tenth the price of many tests now on the market. The recent expansion of high-throughput technology platforms including low-cost sequencing of circulating and tumor-derived DNA and RNA and rapid quantification of microRNA offers further opportunities to build extended pattern across multiplatform data.

The recent expansion of high-throughput technology platforms, including low-cost sequencing of tumor-derived DNA and RNA in the blood and rapid quantification of microRNA offers further opportunities to build extended pattern across multiplatform data.

On the other hand, while more genetic changes can be identified with whole exome and whole genome sequencing than with select gene sequencing, the significance of much of this information is still unknown. Because not all genetic changes affect health, it is difficult to know whether identified variants are involved in the condition of interest. I dont doubt genetic testing in oncology has a promising future trying to solve these challenges.

Images via BlueRingMedia, ktsdesign / Shutterstock;Myriad Genetics

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Growth Opportunities in the Western European Oncology Diagnostics Market, Forecast to 2021 – PR Newswire (press release)

Posted: at 7:44 am

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The oncology diagnostics market is experiencing consolidation between the major pharma and diagnostic participants who are collaborating to devise and implement disruptive technologies for cancer diagnosis. The research focuses on highlighting some of the major trends occurring in the market alongside these strategic partnerships.

Furthermore, emphasis is on the key challenges in the European market in terms of regulations pertaining to companion diagnostics for cancer detection and monitoring. The deliverable outlines some of the major drivers and restraints, impact analysis of major growth opportunities, as well as market engineering measurements.

With early detection being a key imperative in oncology diagnosis, the study highlights some of the major technology trends in the market with the application of Artificial Intelligence and Big Data as well as Liquid Biopsy and Next Generation Sequencing, which are expected to reduce the turnaround time for cancer detection, thus speeding up the treatment uptake. Emphasis is given to the emerging biomarkers across the types of cancer, which are expected to aid in faster and easier diagnosis of the disease.

Furthermore, analysis is provided for the key participants that are working towards devising new solutions which help to detect these biomarkers, thereby supporting accurate detection and monitoring. In addition to the key participants across the market, new market entrants by different cancer types have been profiled.

Some of the key questions answered by the study include: How is the market attractiveness for oncology diagnostics building up over the years? What is the future market potential? How is the adoption of technology affecting the European oncology diagnostic market? Which are the disruptions affecting the value chain equilibrium? How are the new technology trends impacting service providers? How is the changing economic scenario affecting the regional market? Which are the most opportune markets in Europe? What is the application of companion diagnostics on the overall market? How is it expected to impact the market over the next few years? Download the full report:

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IMMUNE Pharmaceuticals’ Oncology Subsidiary, CYTOVIA, Announces the Filing of a World-Wide Patent Protecting … – Business Wire (press release)

Posted: at 7:44 am

NEW YORK–(BUSINESS WIRE)–Cytovia, Inc. (Cytovia) the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ:IMNP) (“Immune” or the Company), a clinical stage biopharmaceutical company, announced the filing of a patent protecting the use of Ceplene (histamine dihydrochloride) in hematologic cancers. The new patent is based on favorable clinical results in patients with acute myeloid leukemia (AML) who had persistent cancer cells in their bone marrow. The patent aims to protect the use of Ceplene in forms of cancer where malignant cells may harbor a mutated oncogene,NPM1mut(mutated nucleophosmin gene). These forms of cancer include AML, non-Hodgkin lymphoma, acute promyelocytic leukemia and myelodysplastic syndrome.

A mutated NPM1 gene (NPM1mut) is found in cancer cells in approximately 25-30% of patients with AML. The presence ofNPM1mutcancer cells in bone marrow after the completion of chemotherapy (i.e. persistence of leukemic cells or minimal residual disease) is associated with high relapse risk and poor overall survival. In a recent clinical study in the New England Journal of Medicine only19%of adult AML patients in complete remission with persistence ofNPM1mutcancer cells remained relapse-free, and only40 %survived for more than 2 years (Iveyet al., 2016).

In Cytovias proprietary Re:Mission phase IV trial in AML, adult patients in complete remission received Ceplene and low-dose IL-2 to prevent relapse. At onset of treatment with Ceplene/IL-2, nine patients (51-76 years old) had persistentNPM1mutcancer cells in bone marrow. Five of these 9 patients (58%) remained relapse-free, and 6/9 patients (78%) survived for more than 2 years.

The persistence ofNPM1mutleukemic cells after the completion of chemotherapy heralds poor prognosis in AML, and no targeted therapy is available for these patients, said Dr. Anna Martner at the Sahlgrenska Cancer Center, University of Gothenburg. Our results merit an extended clinical trial aiming to clarify to what extent treatment with Ceplene/IL-2 may eradicate persistent leukemia.

We are encouraged by these new results, said Dr. Daniel Teper, of Cytovia. The Company is in discussion with leading hematologists to pursue larger studies aiming to confirm the clinical benefit of Ceplene/IL-2 in multiple hematological cancers with overexpression of NPM1mut .

The Re:Mission phase IV trial studied 84 AML adult patients who received Ceplene and low-dose IL-2 to prevent relapses. For details of the trial design, please visit

Most Patients with AML initially achieve complete remission from leukemia after receiving chemotherapy. However, the majority of adult patients will experience relapse of AML with poor prospects of long-term survival. Ceplene, used in conjunction with low-dose IL-2, has been developed to prevent relapses in the post-chemotherapy phase of AML. A previous phase III trial in 320 patients confirmed the efficacy of Ceplene/IL-2 in preventing relapse of AML.

Ceplene, in combination with low-dose Proleukin (interleukin-2 (IL-2)), has been approved in over 30 countries in Europe and in Israel for the treatment of AML for maintenance of remission and prevention of relapse of leukemia. For the vast majority of AML patients there is currently no other approved therapy to prevent relapse post first remission.

About Ceplene

Ceplene (histamine dihydrochloride) is an immunostimulant that is administered in conjunction with low-dose interleukin-2 (IL-2), for maintenance of first remission in patients with AML. Ceplene has been shown in an international phase III clinical study to prevent relapse of leukemia in AML patients in first remission while maintaining good quality of life during treatment. Ceplene acts by countering dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong pharmacological rationale forthe combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 supported the safety and efficacy of Ceplene demonstrated in the international phase III study. Following Cytoviasrecent acquisition of Ceplene from Mylan, the Companynow holds worldwide rights for Ceplene.

About AML

AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, and typically become free of detectable leukemia, achieving “complete remission”. However, within 1-2 years the majority of adult patients will experience a relapse of leukemia, of which the prognosis for survival is 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. AML represents an orphan indication with particularly high unmet need.

About Immune Pharmaceuticals Inc.

Immune Pharmaceuticals Inc. (NASDAQ:IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune’s lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn’s disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH). Also, Immune’s pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet and AmiKet Nano for the treatment of neuropathic pain.

Immune’s oncology subsidiary, Cytovia, plans to develop Ceplene for maintenance remission in AML in combination with IL-2. Additional oncology pipeline products include Azixaand crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs, which are novel technology platforms.

For more information, please visit Immune’s website, the content of which is not a part of this press release.

Forward-Looking Statements

This news release, and any oral statements made with respect to the information contained in this news release, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal” or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. Forward-looking statements include, among others, statements regarding the Company’s ability to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.

There can be no assurance that the Company will ever successfully complete its anticipated corporate restructuring, or that the Company will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. Factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that ongoing or future clinical trials will not be successful; the risk that our compounds under development will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct future trials or commercialize our product candidates on attractive terms, on a timely basis or at all; the risk that our product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. There is no certainty that Cytovia or its commercial partners will achieve a certain market share of the addressable market in AML. There is also uncertainty that the reimbursement price will be maintained in Europe or that it will accepted in Latin America. In addition, among other risks, there can be no guarantee that concomitant investment by Pint will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of the licensing and investment agreements will be realized.

These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and our other filings with the U.S. Securities and Exchange Commission.

You are urged to carefully review and consider the disclosures found in our filings, which are available atwww.sec.govor You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein (including those relating to the corporate reorganization and exploration of strategic alternatives), whether as a result of new information, future events or otherwise, except as required by law.

IMMUNE Pharmaceuticals’ Oncology Subsidiary, CYTOVIA, Announces the Filing of a World-Wide Patent Protecting … – Business Wire (press release)

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Beaumont unveiling high-tech cancer fighter – Detroit Free Press

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The gantry that will be used at the new Proton Therapy Center at Beaumont Hospital’s Cancer Institute in Royal Oak arrived from Belgium and is unloaded in May 2016. The gantry is about 100 tons and will be housed inside a facility with concrete walls as thick as 9 feet. Proton therapy is effective in treating some forms of cancer, solid and localized tumors(Photo: Romain Blanquart, Detroit Free Press)Buy Photo

Beaumont Health will unveil today a high-tech cancer-fighting therapy that is considered ideal for destroying cancer cells close to vital organs.

The $40-millionProton Therapy Center in Royal Oak will beone of only 25 such operational centers in the country and the only one in Michigan. The treatment, which targets cancer cells more precisely,is called proton beam therapy.

Although the therapy is touted as a way toboost thequality of life for patients because it can reduce side effects, proton beam therapy is also controversial because of the cost and has been called”the Death Star of American medical technology.”

Beaumont officials say the “high-tech alternative to X-ray radiation” for cancer patientscan lead to fewer side effects and offers hope against formerly incurable cancers.

This technology will allow us to define future treatment strategies for cancer, Dr. Craig Stevens, chairman ofRadiation Oncology forBeaumont Health, has said.We will have the capability to retreat cancer that would have otherwise been considered unsalvageable and incurable.

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In Beaumont’s2015 announcement of construction on its25,200-square-foot Proton Therapy building, Stevens said “proton therapy is ideal for tumors close to vital organs.”

Proton beam therapy “uses high-speed protons to fight cancer by aiming a high-energy ionizing beam at the tumor, destroying its cells,” according to Beaumont.

Stevens acknowledged that the treatment is not effective against all cancers, but he said in theannouncement that “it can be very effective in treating solid and localized tumors, including some pediatric cancers, soft tissue sarcomas, brain tumors and head/neck cancers.”

But detractors including Amitabh Chandra, a professor of social policy and director of health policy researchat Harvard University’s Kennedy School of Government, who made the Death Star referencein a 2012 Bloomberg story have criticized the cost and complexity of the devices.

“Proton-beam therapy is like the Death Star of American medical technology nothing so big and complicated has ever been confronted by the system. It’s a metaphor for all the problems we have in American medicine,” Chandra said.

Bret Jackson, president of the Economic Alliance for Michigan, which is a business and labor coalition, disputed the need for such a center in the state.

Were concerned that it will be used on patients that wont receive any additional benefit, and perhaps unnecessarily,”Jackson said. “We dont think proton beam facilities in Michigan are necessary.The scientific studies on the efficacy of proton beamtherapy are mixed.”

And cost in the current health care environment is a real concern, Jackson said, suggesting that patients could be left with a substantial bill in the end.

The 2012 Bloomberg story said costs for proton beam therapy treatments could be about $50,000. An updated figure was not immediately available.

The Arlington, Va.-based American Society for Radiation Oncology released guidelines in 2014 detailing which cancers the group feels should be covered by private insurers and Medicare when the treatment is used. The group noted that the technology is attractive because it reduces the radiation dose to healthy tissues, potentially increasing patients’ quality of life.

“To date, scientific evidence exists confirming that PBT is particularly useful in a number of pediatric cancers, particularly those in the brain, as well as for certain adult cancers such as ocular melanoma(a type of eye cancer),” the group said in a news release at the time.

The release, however, also echoed the criticism.

“(Proton beam therapy)has attracted significant attention due to its relative cost, which can be dramatically more than traditional external beam radiation therapy due to the significant expense of building and maintaining proton therapy centers,” the release said.

Contact Eric D. Lawrence: Follow him on Twitter: @_ericdlawrence. Staff writer JC Reindl contributed to this report.

About proton beam therapy

Proton therapy uses high-speed protons to fight cancer by aiming a high-energy ionizing beam at the tumor, destroying its cells.

A cyclotron, or particle accelerator, creates protons from hydrogen molecules spun at extremely high speeds. They travel up to two-thirds the speed of light.

The proton beam is sent to a treatment room through a transport system consisting of magnets, called the beam line, finally arriving in the gantry. The gantry is a device that rotates around the patient delivering a beam of protons. The beam is directed to the patient through a nozzle that targets the tumor.

Source: Beaumont Health

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Beaumont unveiling high-tech cancer fighter – Detroit Free Press

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