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Sorry never met him. Why?
PPHM presenting there???
Sanofi exercises option on second therapeutic program with Selecta Biosciences SASY.PA - RTRS
13-May-2015 13:13
May 13 (Reuters) - Sanofi SA SASY.PA:
Exercises option on second therapeutic program with selecta biosciences to
develop an antigen-specific immunotherapy based on synthetic vaccine particle technology
Selecta biosciences says eligible to receive research support and several milestones totaling up to $300 million
Selecta biosciences says selecta is also entitled to up to double digit
tiered royalties
Bristol-Myers Squibb to Present Data at 2015 American Society of Clinical Oncology (ASCO) Annual Meeting that Demonstrate the Promise of its Broad Immuno-Oncology Portfolio Across Solid Tumors and Blood Cancers Including Mul BMY.N - BSW
13-May-2015 14:02
http://www.businesswire.com/news/home/20150513005539/en
Pivotal Phase III studies (CheckMate -057 & -017) in both advanced non-squamous and squamous non-small cell lung cancer in which treatment with Opdivo demonstrated superior survival versus chemotherapy with docetaxel in previously-treated patients, to be disclosed
First pivotal Phase III trial of investigational Opdivo+Yervoy regimen compared to Opdivo or Yervoy monotherapy in advanced melanoma, to be presented (CheckMate -067)
First Phase III data for an investigational Immuno-Oncology agent in multiple myeloma, ELOQUENT-2 results for elotuzumab, to be presented
Breadth and depth of Immuno-Oncology portfolio showcases Opdivo and Yervoy clinical trial results in additional tumor types, including small-cell lung cancer, renal cell carcinoma, hepatocellular carcinoma and glioblastoma
PRINCETON, N.J.--(Business Wire)-- Bristol-Myers Squibb Company (NYSE:BMY) today announced new clinical research from three of its Immuno-Oncology agents will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 29-June 2. Building on the scientific advances the company has pioneered in Immuno-Oncology, Bristol-Myers Squibb will present data for Opdivo and Yervoy across multiple solid tumor types, as well as elotuzumab in relapsed or refractory multiple myeloma.
Data to be presented at ASCO illustrate Bristol-Myers Squibb`s commitment to developing treatment options with the potential to offer patients with cancer the possibility of long-term survival through its transformative Immuno-Oncology research.
Key oral data presentations include:
CheckMate -057, -017: First disclosure from Phase III trials will be presented for CheckMate -057 (Late Breaking Abstract #109) and CheckMate -017 (Abstract #8009), evaluating Opdivo in previously-treated non-squamous and squamous non-small cell lung cancer (NSCLC) against docetaxel therapy, respectively. Data from CheckMate -057 will be featured in an ASCO press conference on Friday, May 29, 1:00 - 2:00 PM CDT and presented during a Clinical Science Symposium on Saturday, May 30 from 8:51 - 9:03 AM CDT. Data from CheckMate -017 will be presented during an oral abstract session on Sunday, May 31 from 4:30 - 4:42 PM CDT.
CheckMate -067: New Phase III research evaluating the Opdivo+Yervoy regimen in first-line treatment of advanced melanoma (Late Breaking Abstract #1) will be featured in an ASCO press conference on Sunday, May 31, 8:00 - 9:00 AM CDT. These data also will be presented during the plenary session on Sunday, May 31 from 1:35 - 1:50 PM CDT.
ELOQUENT-2: The first presentation of a Phase III, open-label study (Abstract #8508) evaluating elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma will be featured in an ASCO presscast on Wednesday, May 13 at 12:00 PM EDT. An oral presentation of these data will take place on Tuesday, June 2 from 9:45 - 9:57 AM CDT.
CA209-040: The first presentation of findings from a Phase I/II Opdivo trial in advanced hepatocellular carcinoma (Late Breaking Abstract #101) will be featured in an ASCO press conference on Friday, May 29, 1:00 - 2:00 PM CDT. An oral presentation of these data will take place at a Clinical Science Symposium on Saturday, May 30 from 8:27 - 8:39 AM CDT.
"At Bristol-Myers Squibb, patients are the inspiration behind our pioneering research in the field of Immuno-Oncology, which has led to the approval of novel agents for the treatment of some of the hardest to treat cancers," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. "We are proud that our revolutionary research led to the introduction of Yervoy and Opdivo, and are excited about sharing new data at ASCO in both solid tumors and hematologic cancers."
Protein C inhibitor (PCI) binds to phosphatidylserine exposing cells with implications in the phagocytosis of apoptotic cells and activated platelets.
http://www.ncbi.nlm.nih.gov/pubmed/25000564
Item 5.02 Departure Of Directors Or Certain Officers; Election Of Directors; Appointment Of Certain Officers; Compensatory Arrangements of Certain Officers.
On May 11, 2015, the Compensation Committee of the Board of Directors (“Committee”) of Peregrine Pharmaceuticals, Inc. (the “Company”), approved a broad based annual grant of stock options (“Grants”) for fiscal year 2016 to substantially all of the Company’s employees, the Company’s three non-employee directors and one consultant to purchase an aggregate of 3,299,903 shares of common stock. The Grants will be from the Company’s 2011 Stock Incentive Plan and will be evidenced by and subject to the terms of a Stock Option Agreement. Included as recipients of the Grants are the following named executive officers:
Named
Executive Officer Title Number of Shares
Underlying Stock Option Grants
Steven W. King President and Chief Executive Officer 300,000
Paul J. Lytle Chief Financial Officer 150,000
Joseph S. Shan V.P., Clinical & Regulatory Affairs 100,000
Mark R. Ziebell V.P., General Counsel 100,000
Shelley P.M. Fussey V.P., Intellectual Property 75,000
In determining the number of shares of common stock covered by the Grants to the named executive officers, the Committee reviewed a report prepared by an independent compensation consulting firm which established proposed grant guidelines at a long-term incentive value (“LTI Value”) for equity based awards at the fiftieth percentile of the Company’s peer group to ensure that the Company’s stock option granting practices for named executive officers and other employees were aligned with competitive norms. The LTI Value of the Grants to named executive officers were below the fiftieth percentile of LTI Value of the Company’s peer group as set forth in the report prepared by the independent compensation consulting firm.
The Committee has determined that the exercise price of the Grants will be equal to the closing price of the Company’s common stock on May 11, 2015, the date of grant, and shall vest quarterly in equal installments over a two year period.
Asymmetric Lipid Membranes: Towards More Realistic
Model Systems
http://www.mdpi.com/2077-0375/5/2/180
Abstract: Despite the ubiquity of transbilayer asymmetry in natural cell membranes, the
vast majority of existing research has utilized chemically well-defined symmetric liposomes,
where the inner and outer bilayer leaflets have the same composition. Here, we review
various aspects of asymmetry in nature and in model systems in anticipation for the next
phase of model membrane studies.
Keywords: asymmetry; vesicles; model membranes; phospholipids
Cell Death and Differentiation (2015)
http://www.nature.com/cdd/journal/v22/n3/full/cdd2014219a.html
T-cell death
http://onlinelibrary.wiley.com/doi/10.1111/vox.12200/abstract
Background and Objectives
Extracorporeal photochemotherapy (ECP) is an established therapy in various diseases, such as cutaneous T-cell lymphoma and graft-versus-host disease. This study was performed to investigate the practicability of a flow cytometric T-cell evaluation after ECP as a tool to validate the quality of ECP procedures and to enable the comparability of treatments with different ECP devices.
Materials and Methods
Peripheral blood mononuclear cells (PBMNCs) of healthy volunteer blood donors were treated by offline ECP. To quantify the effect of ECP on T cells in vitro, phosphatidylserine exposure and 7-aminoactinomycin D (7-AAD) reactivity as well as the proliferative activity of phytohaemagglutinin-induced, viable CD3+ lymphocytes were analysed by flow cytometry.
Results
AThe expected T-cell death after ECP was confirmed by 7-AAD measurements. Phosphatidylserine exposure gradually increased between 20 and 70 h after ECP. Treatment-related inhibition of T-cell proliferation was 92·6 ± 1·4%.
Conclusion
The combination of viability, phosphatidylserine exposure and T-cell division analyses by flow cytometry in a single-platform system provides a valuable tool to validate ECP procedures.
Processing and Topology of the Yeast Mitochondrial Phosphatidylserine Decarboxylase 1
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481278/
You are welcome - AND I'm sure they all know PS and the potential of bavi
Please stop me....
From 2011
http://www.journals.elsevier.com/chemistry-and-physics-of-lipids/most-cited-articles/
Killing of melanoma cells and their metastases by human lactoferricin derivatives requires interaction with the cancer marker phosphatidylserine.
I just found quite a lot by searching with that name:
dagmar zweytick
http://europepmc.org/articles/pmc4155172
I don't know if this has something to do with PS
http://m.pnas.org/content/111/14/E1409.full#F2
Next one....
http://www.cell.com/biophysj/abstract/S0006-3495%2813%2901793-1
R-DIM-P-LF11-322, derived from the cationic human host defense peptide lactoferricin, exhibits selective antitumor activity against several human cancer cell types. We have shown that cancer cells expose the negatively charged phosphatidylserine (PS) on the outer leaflet of the plasma membrane (1), which in healthy cells only comprises neutral lipids as phosphatidylcholine (PC) or cholesterol. Therefore the membrane interaction of R-DIM-P-LF11-322 with membrane mimics composed of mixtures of PS, PC and cholesterol was studied. Lipid analysis of normal melanocytes and melanoma revealed a slight increase of PC and cholesterol in the cancer lipid extracts.
From 2011
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175029/
Abstract
This study was performed in the aim to identify potential targets for the development of novel therapy to treat cancer with poor outcome or treatment efficacy. We show that the negatively charged phospholipid phosphatidylserine (PS) is exposed in the outer leaflet of their plasma membrane not only in tumor cell lines, but also in metastases and primary cultures thereof, which contrasts with a lack of PS exposure by differentiated non-tumorigenic counterparts. Studied tumor cell lines were derived from non-tumorigenic and malignant melanomas, prostate- and renal cancer, glioblastoma and a rhabdomyosarcoma. Importantly, also metastases of melanoma expose PS and there is a correlation between malignancy of melanoma cell lines from different stages of tumor progression and PS exposure. The PS exposure we found was neither of apoptotic nor of experimental artificial origin. Finally potentially malignant and non-malignant cells could be differentiated by sorting of a primary cell culture derived from a glioblastoma based on PS exposure, which has so far not been possible within one culture due to lack of a specific marker. Our data provide clear evidence that PS could serve as uniform marker of tumor cells and metastases as well as a target for novel therapeutic approaches based on e.g. PS-specific host defense derived peptides.
Austria - university Graz
http://steiermark.orf.at/news/stories/2699129
Google translation
Grazer researchers: cancer defense of human milk The protein molecule lactoferricin in breast milk is important for the immune defense of newborn babies. Biowissenschafter at the University of Graz seen in the peptide a beacon of hope for future precise treatment of skin cancer and difficult to treat tumors of the brain. Dagmar Zweytick from the Institute for Molecular Bioscience at the University of Graz a phospholipid on the surface of cancer cells and their metastasis has been identified in a previous research project, which can serve as a universal cancer marker. Positive charge The Grazer researcher and her colleagues realized that the natural immune defense peptide lactoferricin extremely attracted feels and interacts with the membrane surface of the cancer cells because of its positive charge of the negatively charged lipid phosphatidylserine (PS). Healthy cells will be left lying on the other hand, lactoferricin left - a feature that can be harnessed for the targeted treatment of cancer, in which only the diseased cells to be attacked.
Targeted strengthening
The Graz researchers then examined under an EU co-operation project, as one might strengthen the molecular mechanism of lactoferricin by targeted modification. In its natural form, the defense peptide is in fact too weak to bring massive tumor cells to die. Patent pending In a recent, funded by the Austrian Science Fund FWF project, the Graz team therefore attempted to optimize the anti-tumor peptide. "We modify the peptide by single amino acids are replaced, which should ultimately lead to an even increased selective effectiveness. Meanwhile, we have developed and patented two cationic peptides on antitumor Lactoferricin basis. Cell death within eight hours In its recent publication in the research journal "BioMetal" were the first to demonstrate in cell cultures for they have developed derivatives of the milk peptide a high specific activity of a melanoma cell line and metastases Zweytick and Project Officer Sabrina Riedl. "They show opposite lactoferricin from the mother's milk is more than ten times the toxicity of skin cancer cells, healthy cells but it hurt just as lactoferricin" summed Zweytick. At the same time it was also recognized that the structure of the modified peptides is crucial and peptides with a hairpin structure brought the best results so far. According Zweytick these are taken into the cell, migrate to the mitochondria and release the natural cell death. "The cells died within eight hours," said the researcher. Furthermore we have also found high activities of the derivatives compared to glioblastomas (an aggressive brain tumor).
You can find it....
https://molekularbiologie.uni-graz.at/de/neuigkeiten/detail/article/derstandard-artikel-ueber-dr-dagmar-zweytick/
Ich und meine Mitarbeiterin Sabrina Riedl konnten nachweisen, dass Krebszellen das negativ geladene Phospholipid Phosphatidylserin (PS) im Gegensatz zu gesunden Zellen an der Außenseite ihrer Membran tragen", erklärt die Projektleiterin Dagmar Zweytick. Bei verschiedenen Prozessen, etwa bei der Bildung einer Krebszelle, klappt nämlich das negativ geladene Lipid nach außen und gibt auf diese Weise einen zuverlässigen Biomarker ab. Dieser in der Fachwelt bis zur Veröffentlichung der Grazer Erkenntnisse oft angezweifelte Umstand ist von enormer Tragweite, da er den oft schwierigen Weg für eine zielgenaue Krebsbehandlung aufzeigt.
"Tatsächlich fanden wir dieses negativ geladene Lipid nicht nur auf der Zellmembran von Zelllinien verschiedener Krebsarten, sondern auch bei Metastasenzellen und primären Krebszellen", betont Zweytick. Zudem deutet die Studie an unterschiedlichen Hauttumoren darauf hin, dass der exponierte PS-Gehalt mit der Bösartigkeit des Gewebes zunimmt.
I think Immuno-onkology is popping up everywhere in Europe - there are Comprehensive Cancer Centers all over the continent.
For all my German speaking friends:
http://www.faz.net/aktuell/wirtschaft/unternehmen/immunonkologie-krebsbehandlung-mit-immuntherapien-13501804.html
Stock drying up at this level
Nothing - NO volume
Yes. We are at 159
Plexxikon and Merck to Collaborate on Combination Study Evaluating Investigational Immuno-oncology Regimen - BSW
07-May-2015 14:30
Study will Evaluate Merck`s Anti-PD-1 Therapy, KEYTRUDA® (pembrolizumab), in Combination with Plexxikon`s PLX3397 BERKELEY, Calif. & KENILWORTH, N.J.--(Business Wire)-- Plexxikon Inc., a member of Daiichi Sankyo Group, and Merck (NYSE:MRK), known as MSD outside the US and Canada, through a subsidiary, today announced a collaborative clinical trial that will evaluate the combination of PLX3397, Plexxikon`s investigational CSF-1R inhibitor, and KEYTRUDA® (pembrolizumab), Merck`s anti-PD-1 therapy, which provides the potential for a double blockade of cancer-induced immune suppression. The Phase 1/2 trial will enroll patients with advanced melanoma and multiple other solid tumors with the goal of determining the safety and tolerability of the combination therapy. The trial is expected to begin enrollment by mid-year.
"We are excited to evaluate PLX3397 in combination with KEYTRUDA, as each agent is designed to attack cancer cells in different ways. Cancer cells use multiple tactics to evade host immune responses, and the combination of these two agents is being investigated to re-activate anti-tumor immunity using distinct and complementary mechanisms," stated Gideon Bollag, Ph.D, chief executive officer of Plexxikon, a member of the Daiichi Sankyo Group. "Importantly, both PLX3397 and KEYTRUDA have potential application in multiple types of cancer."
"We are at an important juncture in the advancement of immuno-oncology, and this is why Merck is focused on this area of breakthrough science," stated Dr. Eric Rubin, therapeutic area head, oncology early-stage development, Merck Research Laboratories. "Given the promising data observed with KEYTRUDA and PLX3397, we are eager to see how combining these medicines may be complementary in increasing the immune response."
About PLX3397
PLX3397 is a novel oral small molecule that potently and selectively inhibits CSF-1R, KIT, and mutant FLT3 kinases. CSF1R and KIT regulate key components of both the tumor and its microenvironment (macrophages, osteoclasts, mast cells). In addition to melanoma and other solid tumors to be studied in this collaborative trial, PLX3397 is being evaluated in several other clinical indications, including tenosynovial giant cell tumor (TGCT), historically called pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), breast cancer and glioblastoma. For more information on PLX3397 clinical trials, please visit www.clinicaltrials.gov.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 85 clinical trials - across more than 30 tumor types and over 14,000 patients - both as a monotherapy and in combination with other therapies.
Selected Important Safety Information for KEYTRUDA®
Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced melanoma receiving KEYTRUDA (the approved indication in the United States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor for signs and symptoms of hypophysitis. Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.
Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Other clinically important immune-mediated adverse reactions can occur. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, adrenal insufficiency, myasthenic syndrome, optic neuritis, and rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.
For the treatment of advanced melanoma, KEYTRUDA was discontinued for adverse reactions in 6% of 89 patients who received the recommended dose of 2 mg/kg and 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving KEYTRUDA. The most frequent serious adverse drug reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in =20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.
About Plexxikon
Plexxikon, a member of the Daiichi Sankyo Group since April 2011, is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company`s drug Zelboraf® (vemurafenib/PLX4032) was approved by the FDA in 2011, and is being co-promoted in the U.S. by Daiichi Sankyo, Inc. and Genentech. Plexxikon is developing a portfolio of preclinical and clinical stage compounds to address significant unmet medical needs in oncology and other therapeutic areas. Plexxikon`s Scaffold-Based Drug DiscoveryTM platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant advantage over other drug discovery approaches. For more information, visit: www.plexxikon.com.
Merck`s Focus on Cancer
Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For Merck Oncology, helping people fight cancer is our passion, supporting accessibility to our cancer medicines is our commitment, and pursuing research in immuno-oncology is our focus to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
Hmmm... if you bought 1981 at $800....
IMS Health Finds Global Cancer Drug Spending Crossed $100 Billion Threshold in 2014 IMS.N - BSW
05-May-2015 13:43
Five-Year Growth Averages 6.5 Percent;
Higher Prevalence of Cancers, Earlier Treatments, Innovative Therapies,
Improved Survival Rates Transform Clinical Landscape PARSIPPANY, N.J.--(Business Wire)-- Earlier diagnosis, longer treatment duration and increased effectiveness of drug therapies are contributing to rising levels of spending on medicines for cancer care. According to a new report released today by the IMS Institute for Healthcare Informatics, total global spending on oncology medicines - including therapeutic treatments and supportive care - reached the $100 billion threshold in 2014, even as the share of total medicine spending of oncologics increased only modestly.
Growth in global spending on cancer drugs - measured using ex-manufacturer prices and not reflecting off-invoice discounts, rebates or patient access programs - increased at a compound annual growth rate (CAGR) of 6.5 percent on a constant-dollar basis during the past five years. Oncology spending remains concentrated among the U.S. and five largest European countries, which together account for 66 percent of the total market, while the rising prevalence of cancer and greater patient access to treatments in pharmerging nations continues to grow and now accounts for 13 percent of the market.
The study - Developments in Cancer Treatments, Market Dynamics, Patient Access and Value: Global Oncology Trend Report - is a comprehensive review and updated perspective on the current and future clinical landscape, marketplace dynamics for oncology-related pharmaceuticals, and patient access to medicines and their value.
Targeted therapies have dramatically increased their share of the total global oncology spend, rising 14.6 percent CAGR during the past five years with steady increases across all regions. At the same time, payers and national health systems have intensified their scrutiny of the value of these medicines relative to their incremental benefits over existing treatments, with cost effectiveness assessments frequently resulting in limited patient access to these drugs. Access and reimbursement issues are likely to become more complicated in coming years as individual and combination oncology medicines address multiple cancer types and patient populations with varying dosage and clinical value.
"The increased prevalence of most cancers, earlier treatment initiation, new medicines and improved outcomes are all contributing to the greater demand for oncology therapeutics around the world," said Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics. "Innovative therapeutic classes, combination therapies and the use of biomarkers will change the landscape over the next several years, holding out the promise of substantial improvements in survival with lower toxicity for cancer patients."
The report`s key findings include the following:
Global oncology market continues to experience steady growth. The global market for oncology drugs, including those used in supportive care, increased 10.3 percent in 2014 and reached $100 billion, up from $75 billion five years earlier. The compound annual growth rate in spending over the past five years has been 6.5 percent globally on a constant exchange rate basis. Growth in the U.S. has risen more slowly at 5.3 percent CAGR, reaching $42.4 billion in 2014. Oncology drug spending has risen slightly as a percentage of total drug spending over the past five years in all regions, most notably in the EU5 countries where oncology now represents 14.7 percent of total drug spending, up from 13.3 percent in 2010. Within the U.S., the increase has been more modest, rising to 11.3 percent from 10.7 percent over the same period. Targeted therapies now account for nearly 50 percent of total spending and have been growing at 14.6 percent CAGR since 2009.
Clinical outcomes are improving for major cancers. In most instances, five-year survival rates have risen through continuous and small improvements in detection and treatment - including refinements with existing treatments and gains from new treatment options. Within the U.S., two-thirds of Americans diagnosed with cancer now live at least five years, compared to just over half in 1990. The strong pipeline of medicines in clinical development include new "immuno-oncologics" that hold out the promise of improved survival with lower toxicity for some patients, as well as combination therapies that can address multiple pathways in a tumor, potentially leading to substantial increases in survival. Additionally, therapeutic effectiveness in multiple genetic subpopulations is being improved through the use of real-world evidence from deep biomarker data linked to treatment information. Molecular diagnostics are rapidly transforming drug development and patient selection, but only one-third of new oncology drugs have an identified biomarker at time of launch.
Patient access to cancer drugs varies across all markets. The availability of new oncology medicines varies widely across the major developed countries, with patients in Japan, Spain and South Korea having access in 2014 to fewer than half of the new cancer drugs launched globally in the prior five years. In pharmerging markets, availability of newer targeted therapies remains low but is increasing. Even among wealthy countries, new drugs may not be reimbursed and, as a result, will only reach a very small number of patients. Average therapy treatment costs per month have increased 39 percent in the U.S. over the past ten years in inflation-adjusted terms. Over the same period, patient response rates have improved by 42 percent and treatment duration has increased 45 percent, reflecting improved survival rates. Within the U.S., patient out-of-pocket costs have risen sharply for intravenous cancer drugs, increasing 71 percent from 2012 to 2013, reflecting changes in plan designs and increased outpatient facility costs.
Patients are engaging social media and online networks throughout their cancer journey. Public discussion boards, followed by Twitter, are the most dominant channels used by patients during their cancer journey as they proactively engage on a wide range of topics including conversations regarding treatment options and financial concerns. In a six-month assessment of social media discussions related to prostate cancer, the most frequent topic of discussion was treatment options, followed by financial concerns.
The full version of the report, including a detailed description of the methodology, is available at www.theimsinstitute.org. It can also be downloaded as an app via iTunes at https://itunes.apple.com/app/ims-institute/id625347542. The study was produced independently as a public service, without industry or government funding.
About the IMS Institute for Healthcare Informatics
The IMS Institute for Healthcare Informatics provides key policy setters and decision makers in the global health sector with unique and transformational insights into healthcare dynamics derived from granular analysis of information. It is a research-driven entity with a worldwide reach that collaborates with external healthcare experts from across academia and the public and private sectors to objectively apply IMS Health`s proprietary global information and analytical assets. More information about the IMS Institute can be found at: http://www.theimsinstitute.org.
About IMS Health
IMS Health (NYSE:IMS) is a leading global information and technology services company providing clients in the healthcare industry with comprehensive solutions to measure and improve their performance. End-to-end proprietary applications and configurable solutions connect 10+ petabytes of complex healthcare data through the IMS One cloud platform, providing comprehensive insights into diseases, treatments, costs and outcomes. The company`s 15,000 employees blend global consistency and local market knowledge across 100 countries to help clients run their operations more efficiently. Customers include pharmaceutical, consumer health and medical device manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community.
As a global leader in protecting individual patient privacy, IMS Health uses anonymous healthcare data to deliver critical, real-world disease and treatment insights. These insights help biotech and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders to identify unmet treatment needs and understand the effectiveness and value of pharmaceutical products in improving overall health outcomes. Additional information is available at www.imshealth.com.
IMS Health
Tor Constantino, +1-484-567-6732 tconstantino@us.imshealth.com
Copyright Business Wire 2015
This link for Munich does work:
http://www.muenchner-studienzentrum.me.tum.de/index.php?option=com_content&view=article&id=15&Itemid=29
Click on: Öffentlicher MSZ-Studienmonitor at the end of the page
Then you come to another page - search for sunrise (first white box left side)
Germany - Munich
https://webapps.imse.med.tum.de/ctms2/jsp/trialregister/searchform.jsf?icd=
It's here: http://www.mri.tum.de/
Germany - Kassel
http://www.klinikum-kassel.de/index.php?parent=4130
last link on this page - #60
Germany - Immenhausen (north of Kassel)
I thought I posted that before:
http://www.lungenfachklinik-immenhausen.de/index.php?seitenid=208&parent=68&lang=
There is one PPHM-investigational site in Grosshansdorf (north of Hamburg).
I just found this clinic there:
http://www.lungenclinic.de/?L=0
An Investigational Immunotherapy for Lung Cancer
PR Newswire
ROCKVILLE, Md., April 30, 2015
ROCKVILLE, Md., April 30, 2015 /PRNewswire-USNewswire/ -- Lung cancer impacts the lives of millions of people worldwide. In nearly 40 percent of people diagnosed with lung cancer, it has metastasized, or spread to other areas of the body, making it difficult to treat. Immunotherapy is a type of therapy that uses the body's own immune system to help fight cancer. Immunotherapy may help the body's immune system target cancer cells.
One clinical trial currently studying this investigational approach to treating lung cancer is Keynote 24. The medication being investigated is called pembrolizumab and it targets PD-1, a protein found on some cells of the immune system. Some tumors express certain proteins that are often not recognized by the immune system, so it does not know to attack those tumors. The goal of Keynote 24 is to see if pembrolizumab will help the immune system recognize and attack these tumors in people with stage 4, non-small cell lung cancer (NSCLC)—the most common type of lung cancer (about 9 out of 10 cases).
What is learned in this study may help researchers develop new options for patients with advanced lung cancer.
The Keynote 24 study is being sponsored by Merck and conducted at research centers around the world. About 300 people will participate. To learn more about the study and its possible risks and benefits, visit Keynote24Trial.com.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/an-investigational-immunotherapy-for-lung-cancer-300074355.html
SOURCE Keynote 24 study
ASTRAZENECA PLC - UNIT MEDIMMUNE HAS ENTERED INTO A COLLABORATION TO CONDUCT CLINICAL TRIALS IN IMMUNO-ONCOLOGY WITH IMMUNOCORE LIMITED RTRS
Strong Merck cancer drug sales upstage rival Bristol-Myers BMY.N
29-Apr-2015 00:49
By Ransdell Pierson and Bill Berkrot
April 28 (Reuters) - Investors betting that Bristol-Myers Squibb BMY.N will emerge as the leading player in a hot new class of cancer drugs hit the pause button on Tuesday as a rival therapy from Merck & Co MRK.N showed much higher sales.
Bristol shares fell as much as 2.7 percent and closed off 1 percent after reporting sales of Opdivo, a therapy that helps the immune system fight cancer, totaled $40 million in the first quarter of the year. That was below Wall Street forecasts of $50 million.
Merck said its Keytruda treatment had quarterly sales of $83 million, topping Wall Street estimates of about $70 million, helped by early compassionate use patients converting to paying customers following approval. (Full Story) (Full Story)
"When investors saw Opdivo's number was below Keytruda's, that caused concern," said John Boris, an analyst with Suntrust Robinson Humphrey. Merck shares closed up 5 percent, though the gains were mostly attributed to positive new safety data on its top-selling Januvia diabetes treatment.
Boris and other industry analysts said the early sales data represent only the first skirmish in a long battle for market share between Bristol-Myers and Merck. Some expect both drugs will eventually generate billions of dollars in annual sales, particularly if proven effective against other forms of cancer.
In addition, excitement over Bristol-Myers' cancer treatments have pushed shares to trade at 28.5 times expected 2016 per share earnings, Boris said. That compares with a multiple of 15.1 for Merck and 17.6 for the pharmaceutical sector.
"Based on price per fundamentals, we like the value of Merck versus Bristol at the moment," said Les Funtleyder, healthcare portfolio manager for ESquared Asset Management, which currently holds Merck but not Bristol shares.
Ori Hershkovitz, a managing partner at Nexthera Capital in New York, said Bristol-Myers is trading more like a high-flying biotech.
"The minute biotech gets pummeled, Bristol bears the brunt," he said, noting biotech stocks have retreated sharply in recent weeks on fears they were overly inflated.
EARLY ADVANTAGE
Opdivo was approved in December to treat advanced melanoma. In March, it received clearance to treat a common form of lung cancer, giving Bristol an early-mover advantage in a much larger market.
Keytruda has been approved for advanced melanoma since September and awaits regulatory approval in lung cancer.
Both drugs work by blocking a protein called PD-1, helping the immune system recognize and destroy cancer cells. Roche Holding AG ROG.VX, AstraZeneca Plc AZN.L and Pfizer Inc PFE.N are also developing similar treatments.
Boris forecast Opdivo annual sales reaching $7 billion by 2020 and said Tuesday's weakness in Bristol shares represents a buying opportunity. Opdivo has been shown to prolong survival in melanoma and lung cancer, according to clinical trial data.
Keytruda has not yet demonstrated a survival benefit but is expected to do so in coming trials. Boris predicted it will capture annual sales of $3.7 billion by 2020.
Bristol Chief Scientific Officer Francis Cuss told analysts on Tuesday that strong data on Opdivo along with the U.S. approvals in lung cancer and melanoma and expected European approval "really puts us in a very strong competitive position."
The company recently reported strong results from a combination of Opdivo and its older immunotherapy Yervoy in advanced melanoma. It plans to apply for approval of the combination therapy by mid-year.
Merck head of global human health, Adam Schechter, told analysts that the market will be big enough to handle several competitors, "so I don't think it should be looked at as one company versus the other."
Pfizer is racing to catch up with Merck and Bristol-Myers, by beginning late-stage trials this year of its PD-1 inhibitor and conducting trials of four other immuno-oncology drugs.
PD-1 treatments "will be the workhorses for the foreseeable future, but they will need to be added to standard therapies or to (other) immuno-oncology treatments," Pfizer Chief Executive Ian Read said in an interview. "That's where the market will be, and we will be well positioned with those combination agents."
Wall Street is counting on Bristol-Myers Squibb Co to report a higher first-quarter profit, with sales of its recently approved Opdivo treatment for advanced melanoma helping to offset the negative impact of the stronger dollar. Investors will look for details on ongoing and planned trials of Opdivo and the company's other immuno-oncology drugs against a variety of cancers.