DOCSLIB.ORG

Immunotherapy Opportunity Emerges for Alzheimer Disease

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Immunotherapy Opportunity Emerges for Alzheimer Disease RESEARCH HIGHLIGHTS Nature Reviews Drug Discovery | Published online 26 Feb 2016; doi:10.1038/nrd.2016.38 NEURODEGENERATIVE DISEASE Immunotherapy opportunity emerges for Alzheimer disease Although an overactive immune trafficking to the brain, which 1-month interval between sessions, system was thought to be involved promoted clearance of Aβ and reached performance levels com- in the development of Alzheimer improved cognitive function in parable to control mice. Conversely, disease (AD), recent studies have a mouse model of AD. As PD1 when mice that had received a single indicated that boosting the immune checkpoint blockade has been shown session of PD1 blockade were response in the brain might ameliorate to stimulate an IFNγ-dependent examined 2 months later there was disease. Now, writing in Nature immune response in cancer only a marginal improvement in Medicine, Schwartz and colleagues immuno therapy, Schwartz and memory, suggesting that repeated report that immune-checkpoint colleagues set out to explore the treatment sessions are needed to blockade directed against the therapeutic potential of PD1 maintain the beneficial effects. programmed cell death protein 1 blockade in AD. Examination of the brains of (PD1) pathway promotes cerebral To do this, they treated the 5XFAD mice after treatment with amyloid-β (Aβ) clearance and 5 familial AD mutations (5XFAD) the PD1-specific antibody revealed a improves cognitive function in mouse model of AD at 10 months reduction in the cerebral Aβ-plaque mouse models of AD. old (an age at which cerebral pathology load in the hippocampus and in the In a previous study, the authors is advanced) with 2 intraperitoneal cerebral cortex (the main anatomical demonstrated that inhibition of injections of a PD1-specific antibody regions with robust Aβ-plaque forkhead box P3-positive regulatory at 3-day intervals. When analysed pathology), and this was more T cells increased interferon-γ 7 days after the first treatment, pronounced after two sessions of PD1 (IFNγ)-dependent leukocyte the mice exhibited a systemic IFNγ blockade. In addition, astrogliosis immune response. Analysis of was reduced in the hippocampus of the myeloid cell population in the 5XFAD mice treated with either one brains of mice following treatment or two sessions of PD1 blockade. demonstrated IFNγ-dependent Similar beneficial effects of PD1 recruitment of monocyte-derived blockade were observed in a second macrophages (characterized by high mouse AD model (APP/PS1 mice), expression of lymphocyte antigen in which the treatment reduced 6c and expression of the chemokine hippocampal Aβ-plaque load. receptor CCR2, which is associated Taken together, these findings with myeloid cell-mediated identify immune checkpoint blockade neuroprotection in AD) to the brain. as a novel therapeutic strategy for Importantly, these immune AD. Importantly, PD1-specific effects were accompanied by reduced antibodies have been shown to be cognitive deficits (as determined relatively safe and well tolerated by improvements in spatial learning in cancer immunotherapy. and memory in the radial-arm Sarah Crunkhorn water-maze task) 1 month after treatment. Moreover, when tested ORIGINAL ARTICLE Baruch, K. et al. PD-1 2 months after treatment initiation, immune checkpoint blockade reduces pathology 5XFAD mice that received 2 sessions and improves memory in mouse models of Alzheimer’s disease. Nat. Med. 22, 135–137 (2016) Brain light/Alamy Stock Photo Brain of the anti-PD1 therapy, with a NATURE REVIEWS | DRUG DISCOVERY www.nature.com/nrd ©2016 Mac millan Publishers Li mited. All ri ghts reserved. RESEARCH HIGHLIGHTS Nature Reviews Neurology | Published online 29 Jan 2016; doi:10.1038/nrneurol.2016.8 ALZHEIMER DISEASE Cancer immunotherapy drug reduces symptoms of Alzheimer disease in mice Immune checkpoint blockade, a insufficient macrophage recruitment similar to that seen in patients strategy used to treat certain cancers, to the CNS. “Anti-inflammatory and with AD. PD1 blockade evoked an The treatment might represent a novel therapeutic immunosuppressive strategies have IFN‑γ‑dependent systemic immune not only strategy against Alzheimer disease failed in the clinical trials,” explains response, which promoted clearance arrested (AD), according to a recent mouse Schwartz. “To drive an immune- of existing amyloid-β deposits, study published in Nature Medicine. dependent cascade needed for brain reduced neuroinflammation and disease The cancer immunotherapy drug, repair, systemic immunity should be gliosis, and improved memory progression, administered to AD model mice, boosted, rather than suppressed.” performance. but partially evoked an immune response that The researchers assessed the effect In 12‑month-old 5xFAD mice reduced amyloid plaque burden and of an antibody against programmed that received two PD1 blockade reversed it reversed cognitive impairment. cell death protein 1 (PD1; a molecule treatments, spaced 1 month apart, AD is accompanied by chronic that restrains immune activation) on spatial navigation performance was neuroinflammation. Michal pathological and cognitive correlates comparable to that of wild-type mice. Schwartz and colleagues from the of AD in 5xFAD and APP/PS1 mice. “The repeated treatment not only Weizmann Institute of Science, These mice are widely used AD arrested disease progression, but Rehovot, Israel, had previously put models that carry several mutations partially reversed it,” Schwartz says. forward the hypothesis that neuro­ associated with familial AD and PD1 blockers have been inflammation in AD is linked to develop cerebral amyloid pathology approved by the FDA for the treatment of metastatic melanoma Untreated Two anti-PD1 treatments and non-small-cell lung cancer, and are currently being investigated for the treatment of glioblastoma. “We believe this approach can be trans­ lated to clinical studies in Alzheimer disease in a relatively short time,” Schwartz contends. Hemi Malkki ORIGINAL ARTICLE Baruch, K. PD‑1 immune checkpoint blockade reduces pathology and improves memory in mouse models of Alzheimer’s disease. Nat. Med. http://dx.doi.org/10.1038/ PD1 blockade reduces Aβ deposition (red) and GFAP expression (marker of gliosis; green) in the nm.4022 hippocampus of 5xFAD mice. Scale bar 50 μm. Adapted with permission from Macmillan Publishers Ltd. Nature Reviews | Neurology NATURE REVIEWS | NEUROLOGY www.nature.com/nrneurol © 2016 Macmillan Publishers Limited. All rights reserved BIOWORLDTM TODAY THE DAILY BIOPHARMACEUTICAL NEWS SOURCE JANUARY 22 , 2016 BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS VOLUME 27, NO. 14 ‘FORWARD’ MARCH? Abingworth closes Alkermes jolted by dual phase III misses $105M fund for clinical co-development work in ALKS 5461 depression program By Cormac Sheridan, Staff Writer By Michael Fitzhugh, Staff Writer DUBLIN – Abingworth has raised $105 Missed efficacy endpoints in two phase III trials ofAlkermes plc’s lead candidate, million for its first dedicated clinical co- the once-daily depression medicine ALKS 5461, dragged company shares development fund, which will extend (NASDAQ:ALKS) down by 44.2 percent, or $26.71, to close at $33.71 on Thursday, as its focus on putting up cash to help big analysts deeply discounted the drug’s chances of success, cutting millions of dollars pharma progress its pipeline without of projected revenue from the company’s future earnings. damaging its all-important P&L line. Alkermes, which is pushing ahead with the program, said that in response it will The London-based venture capital increase trial enrollment and update its statistical analysis plan for a third late-stage firm has already been doing that for See Alkermes, page 3 See Abingworth, page 4 IN THE CLINIC FINANCINGS THE BIOWORLD BIOME KEEN ON FUSION PROTEINS Vasopharm gets $22M KEYTRUDA: KEY TO NEURODEGENERATION? Staging area: Philogen bid for phase III traumatic PD-1 blockers improve targets earlier melanoma, brain injury trial cognition in Alzheimer’s phase III injecting lesions By Cormac Sheridan, Staff Writer mice, study shows By Randy Osborne, Staff Writer DUBLIN – Vasopharm GmbH raised By Anette Breindl, Senior Science Editor Philogen SpA’s “idea is to stop €20 million (US$21.7 million) in a new Treating mouse models of Alzheimer’s [melanoma] when you have metastases, funding round to take its lead molecule, disease with an antibody that blocks PD- but only at the skin,” co-founder Dario VAS203, into a European phase III 1, the same molecule targeted by Merck Neri told BioWorld Today, as his firm registration trial in traumatic brain injury & Co Inc.’s Keytruda (pembrolizumab), helped them clear amyloid plaque and See Philogen, page 5 See Vasopharm, page 6 improved their cognitive performance, scientists from the Israeli Weizmann IN THIS ISSUE REGULATORY Institute of Science reported in the Jan. 18, 2016, issue of Nature Medicine. Oversight committee The approach is counterintuitive. Financings, p. 2 may offer Shkreli Inflammation is a feature of Alzheimer’s Other news to note, p. 2, 4-6 immunity for testimony as well as many other neurodegenerative Regulatory front, p. 7, 9 disorders, and insofar as immunity has By Mari Serebrov, Regulatory Editor been a target in Alzheimer’s disease, the Appointments & advancements, p. 7-10 goal has been to reduce it, not increase it. A congressional committee is trying In the clinic, p. 9-11 to force indicted pharma exec Martin Inflammation-reducing approaches, Shkreli to appear at a hearing next week though, like many other things,
Load more

Recommended publications
  • Say on Pay Results (As of September 5)
    THIS REPORT CAN BE ACCESSED AT HTTP://WWW.SEMLERBROSSY.COM/SAYONPAY NOTE: THIS WILL BE OUR FINAL SAY ON PAY UPDATE FOR 2012. WE WILL ISSUE A FULL REPORT PROVIDING RESULTS FOR THE ENTIRE 2012 PROXY SEASON IN JANUARY 2013. PLEASE CONTINUE TO VISIT OUR SAY ON PAY BLOG FOR UPDATES. SAY ON PAY RESULTS 2012 RUSSELL 3000 SEPTEMBER 5 2012 SAY ON PAY RESULTS: RUSSELL 3000 SHAREHOLDER VOTING SUMMARY OF FINDINGS 2012 Vote Results (n=2,025) 2 The majority of companies continue to pass Say on Pay in 2012 with substantial shareholder support: — 1,466 companies (72%) passed with over 90% support — 381 companies (19%) passed with between 70% and 90% support — 125 companies (6%) passed with between 50% and 70% support — 53 companies (2.6%) in the Russell 3000 have failed Vote of the Week McKesson received a vote of 62%, a decline of 8% from 2011, amidst criticism from shareholders and 3 their advisors over high relative CEO pay and retirement benefits Vote Results by Industry Health Care companies have received proportionally less support than other industries, while 4 Consumer Staple and Financial companies have received the most support Vote Results and Market Value 5 There does not appear to be a strong correlation between a company’s market value and Say on Pay vote result How Vote Results Changed in 2012 6 Companies below 70% in 2011 have generally received increased vote support in 2012: — 26 of 30 companies that failed in 2011 have passed in 2012 — Companies between 50‐70% in 2011 have improved by an average of 13% in 2012 Vote results for companies
    [Show full text]
  • Fidelity® Total Market Index Fund
    Quarterly Holdings Report for Fidelity® Total Market Index Fund May 31, 2021 STI-QTLY-0721 1.816022.116 Schedule of Investments May 31, 2021 (Unaudited) Showing Percentage of Net Assets Common Stocks – 99.3% Shares Value Shares Value COMMUNICATION SERVICES – 10.1% World Wrestling Entertainment, Inc. Class A (b) 76,178 $ 4,253,780 Diversified Telecommunication Services – 1.1% Zynga, Inc. (a) 1,573,367 17,055,298 Alaska Communication Systems Group, Inc. 95,774 $ 317,970 1,211,987,366 Anterix, Inc. (a) (b) 16,962 838,941 Interactive Media & Services – 5.6% AT&T, Inc. 11,060,871 325,521,434 Alphabet, Inc.: ATN International, Inc. 17,036 805,292 Class A (a) 466,301 1,099,001,512 Bandwidth, Inc. (a) (b) 34,033 4,025,764 Class C (a) 446,972 1,077,899,796 Cincinnati Bell, Inc. (a) 84,225 1,297,065 ANGI Homeservices, Inc. Class A (a) 120,975 1,715,426 Cogent Communications Group, Inc. (b) 66,520 5,028,912 Autoweb, Inc. (a) (b) 6,653 19,028 Consolidated Communications Holdings, Inc. (a) 110,609 1,035,300 Bumble, Inc. 77,109 3,679,641 Globalstar, Inc. (a) (b) 1,067,098 1,707,357 CarGurus, Inc. Class A (a) 136,717 3,858,154 IDT Corp. Class B (a) (b) 31,682 914,343 Cars.com, Inc. (a) 110,752 1,618,087 Iridium Communications, Inc. (a) 186,035 7,108,397 DHI Group, Inc. (a) (b) 99,689 319,005 Liberty Global PLC: Eventbrite, Inc. (a) 114,588 2,326,136 Class A (a) 196,087 5,355,136 EverQuote, Inc.
    [Show full text]
  • Guidelines with Regard to the Composition, Calculation and Management of the Index
    INDEX METHODOLOGY Solactive Pharma Breakthrough Value Index Version 2.1 dated September 03, 2020 Contents Important Information 1. Index specifications 1.1 Short Name and ISIN 1.2 Initial Value 1.3 Distribution 1.4 Prices and Calculation Frequency 1.5 Weighting 1.6 Index Committee 1.7 Publication 1.8 Historical Data 1.9 Licensing 2. Composition of the Index 2.1 Selection of the Index Components 2.2 Ordinary Adjustment 2.3 Extraordinary Adjustment 3. Calculation of the Index 3.1 Index Formula 3.2 Accuracy 3.3 Adjustments 3.4 Dividends and other Distributions 3.5 Corporate Actions 3.6 Correction Policy 3.7 Market Disruption 3.8 Consequences of an Extraordinary Event 4. Definitions 5. Appendix 5.1 Contact Details 5.2 Calculation of the Index – Change in Calculation Method 2 Important Information This document (“Index Methodology Document”) contains the underlying principles and regulations regarding the structure and the operating of the Solactive Pharma Breakthrough Value Index. Solactive AG shall make every effort to implement regulations. Solactive AG does not offer any explicit or tacit guarantee or assurance, neither pertaining to the results from the use of the Index nor the Index value at any certain point in time nor in any other respect. The Index is merely calculated and published by Solactive AG and it strives to the best of its ability to ensure the correctness of the calculation. There is no obligation for Solactive AG – irrespective of possible obligations to issuers – to advise third parties, including investors and/or financial intermediaries, of any errors in the Index.
    [Show full text]
  • The Weekly Shot Biotech Issue a Weekly Summary of Healthcare Industry Valuation and Near-Term Catalysts June 17, 2010
    Small Cap The Weekly Shot Biotech Issue June 17, 2010 A weekly summary of healthcare industry valuation and near-term catalysts The Weekly Shot: Overview and Comment - Small Cap Biotechnology Next week's sector highlights include LGND’s Thursday analyst event at the Eventi - Pharmaceuticals and Large Cap Biotech Hotel in NYC. The company on 6/15 announced updated 2010 revenue guidance of approx $25M, op ex of approx $30M, and expects to finish the year with $30M - Generics and Specialty Pharmaceuticals in cash (vs approx $43M as of 1Q10). Management will likely focus on partner GSK’s progress with add’l trials of Promacta (for ITP), which could potentially expand the drug’s label to Hep C, AML, and MDS (LGND receives <10% royalty from GSK). Investors should focus on pipeline plans following LGND’s opportunistic 2008/09 M&A activity. Key pipeline programs include LGD-4033 (ph.I, SARM candidate from PCOP) and RG7348, partnered with Roche (ph.I, Hep C candidate from MBRX). We do not expect major data announcements at the event. FDA’s Pediatric Drugs Advisory Committee will meet Monday to discuss pediatric safety reviews of multiple approved drugs, including Kogenate, Casodex, Apidra, NovoLog, Arimidex, Desmopressin, Prevacid, Nexium, Aciphex, Priolex, OraVerse, Zemuron, and Suprane . While important from a public safety perspective, we do not anticipate regulatory activity to be announced. Brian Lian, Ph.D. Small caps biotechs rebounded mid-week as elevated volatility continued across 212.500.6646 [email protected] the broader market. Investors are struggling to balance economic data supporting a modest recovery against concerns on EU debt loads, financial reform legislation, and aggressive govt rhetoric on BP’s oil spill.
    [Show full text]
  • Fourth-Quarter Biotech Job Picture
    CAREERS AND RECRUITMENT Fourth-quarter biotech job picture Michael Francisco he number of biotech sector jobs advertised in the fourth quarter of Finally, the Jackson Laboratory (Bar Harbor, ME, USA) announced a T2011 was down slightly compared with the third quarter, whereas tentative plan to create a center for personalized medicine and genomics pharma sector hiring numbers were similar (Nat. Biotechnol. 29, 1053, in Connecticut. The Jackson Laboratory for Genomic Medicine, to be 2011) as seen in three representative job databases tracked by Nature located near the University of Connecticut Health Center in Farmington, Biotechnology (Tables 1 and 2). would have a budget of about $1.1 billion, with The Jackson Laboratory China continues to attract new investment, as Quintiles Transnational providing $809 million through federal research grants and philanthropy. (Research Triangle Park, NC, USA) launched Kun Tuo, a Beijing-based The center would employ 300 people within the first 10 years and 600 contract research organization providing clinical trial management, employees within 20 years. regulatory submission preparation, biostatistics and data management Fourth-quarter downsizings within the life science industry are shown services to Chinese biotech and pharma companies. Quintiles plans to in Table 3. add 300 employees in China this year. The US Northeast was another hotbed of job growth, with 11 New York–based medical centers coming together with Illumina (San Diego) Table 2 Advertised job openings at the ten largest pharma companies and Roche (Basel) to create the New York Genome Center, a nonprofit Number of advertised openingsb a genomics collaboration that will include the creation of a research facil- Company Number of employees Monster Biospace Naturejobs Johnson & Johnson 119,200 487 12 0 ity in Manhattan in the spring.
    [Show full text]
  • The Securities and Exchange Commission Has Not Necessarily Reviewed the Information in This Filing and Has Not Determined If It Is Accurate and Complete
    The Securities and Exchange Commission has not necessarily reviewed the information in this filing and has not determined if it is accurate and complete. The reader should not assume that the information is accurate and complete. OMB APPROVAL UNITED STATES SECURITIES AND EXCHANGE COMMISSION OMB Number: 3235-0006 Washington, D.C. 20549 Oct 31, FORM 13F Expires: 2018 FORM 13F COVER PAGE Estimated average burden hours per 23.8 response: Report for the Calendar Year or Quarter Ended: 09-30-2020 Check here if Amendment Amendment Number: This Amendment (Check only one.): is a restatement. adds new holdings entries. Institutional Investment Manager Filing this Report: Name: The PNC Financial Services Group, Inc. Address: The Tower at PNC Plaza 300 Fifth Avenue Pittsburgh, PA 15222-2401 Form 13F File Number: 028-01235 The institutional investment manager filing this report and the person by whom it is signed hereby represent that the person signing the report is authorized to submit it, that all information contained herein is true, correct and complete, and that it is understood that all required items, statements, schedules, lists, and tables, are considered integral parts of this form. Person Signing this Report on Behalf of Reporting Manager: Name: Gregory H. Kozich Title: Senior Vice President & Controller Phone: (888) 762-2265 Signature, Place, and Date of Signing: /s/ Gregory H. Kozich Pittsburgh, PA 11-06-2020 [Signature] [City, State] [Date] Report Type (Check only one.): X 13F HOLDINGS REPORT. (Check here if all holdings of this reporting manager are reported in this report.) 13F NOTICE. (Check here if no holdings reported are in this report, and all holdings are reported by other reporting manager(s).) 13F COMBINATION REPORT.
    [Show full text]
  • The Securities and Exchange Commission Has Not Necessarily Reviewed the Information in This Filing and Has Not Determined If It Is Accurate and Complete
    The Securities and Exchange Commission has not necessarily reviewed the information in this filing and has not determined if it is accurate and complete. The reader should not assume that the information is accurate and complete. OMB APPROVAL UNITED STATES SECURITIES AND EXCHANGE COMMISSION OMB Number: 3235-0006 Washington, D.C. 20549 Oct 31, FORM 13F Expires: 2018 FORM 13F COVER PAGE Estimated average burden hours per 23.8 response: Report for the Calendar Year or Quarter Ended: 12-31-2017 Check here if Amendment Amendment Number: This Amendment (Check only one.): is a restatement. adds new holdings entries. Institutional Investment Manager Filing this Report: Name: US BANCORP \DE\ Address: U.S. BANCORP 800 NICOLLET MALL MINNEAPOLIS, MN 55402-7020 Form 13F File 028-00551 Number: The institutional investment manager filing this report and the person by whom it is signed hereby represent that the person signing the report is authorized to submit it, that all information contained herein is true, correct and complete, and that it is understood that all required items, statements, schedules, lists, and tables, are considered integral parts of this form. Person Signing this Report on Behalf of Reporting Manager: Name: Julie von Arx Title: Assistant Vice President Phone: 651-605-8656 Signature, Place, and Date of Signing: Julie von Arx Minneapolis, MN 02-01-2018 [Signature] [City, State] [Date] Report Type (Check only one.): X 13F HOLDINGS REPORT. (Check here if all holdings of this reporting manager are reported in this report.) 13F NOTICE. (Check here if no holdings reported are in this report, and all holdings are reported by other reporting manager(s).) 13F COMBINATION REPORT.
    [Show full text]
  • 8Th Annual BIO Investor Forum
    Monday Conrad Duke of Windsor Park South Basildon East Foyer Jade/Astor February 11, 2013 4th Floor 3rd Floor 7:00 – 7:55am Networking Breakfast: Grand Ballroom 8:00 – 8:45am Fireside Chat with Robert Hugin, Chairman and CEO, Celgene Corporation (Astor) Oxygen Proteon Therapeutics 9:00 – 9:25am Innovus Pharma Galena BioPharma GTx Biotherapeutics Tobira Therapeutics Show Me the Money: Reimbursement in an ACA World Transition Regado Biosciences 9:30 – 9:55am Verastem Advaxis ChemoCentryx (Jade) Therapeutics ALS TDI (PAG) CoLucid Pharmaceuticals ImmunoCellular 10:00 – 10:25am Advanced Cell Technology TBD Rigel Pharmaceuticals Actinium Pharmaceuticals Therapeutics Onconova Therapeutics Furiex 10:30 – 10:55am ReNeuron GENFIT NPS Pharmaceuticals Oncology: uniQure Pharmaceuticals Panning for Gold—Prospecting Fate Therapeutics Lexicon the Pancreatic Pipeline 11:00 – 11:25am Palatin Technologies CEL-SCI Corporation Repros Therapeutics Zafgen Pharmaceuticals (Jade) NovaBay Provectus LL Society (PAG) Tonix 11:30 – 11:55am Agenus Pharmaceuticals Pharmaceuticals Five Prime Therapeutics Pharmaceuticals 12:00 – 12:55pm Opening Plenary Session: Word on the Street – Buy-Side View for 2013 (Jade) – Box Lunch Catabasis Pharmaceuticals Fireside Chat with John Lechleiter, 1:00 – 1:25pm Anteo Diagnostics Atossa Genetics Targacept Synergy Pharmaceuticals Promedior Chairman, President & CEO, Eli Lilly KineMed (Astor; 1:00-1:45pm) 1:30 – 1:55pm ProMetic Life Sciences CytRx Corporation Biotie Therapies Cytokinetics TVAX Biomedical Good Start Genetics 2:00 – 2:25pm
    [Show full text]
  • Cleveland Biolabs
    Controlling Cell Death To Protect Human Life iJ Cleveland BioLabs 2011 Annual Report company with focus for is being developed ue U.S Food Drug Administrations nal Efficac U-LC agent and an oncologic supportive care the FDAs traditional drug approval pathway We anticipate that CBLB5O2 upon nsure as radiation countermeasure will be sold to the U.S government for the national stockpile and other defense-related purposes friendly foreign governments and the nuclear energy industry and upon licensure as an anti-cancer agent will be sold to the public through traditional channels Since our inception we have pursued the research development and commercialization of products that have the potential to evidence direct anti-cancer activity prevent and treat acute radiation syndrome and counteract the toxic effects of radio and chemotherapies for oncology candidates in that patients Presently we have nine product our pipeline are being developed and Inc directly by us and our majority-owned subsidiaries Incuron LLC Panacela Labs Mission Statement CBLIs mission is to develop and commercialize innovative drugs to treat cancer and protect scientific healthy tissues from radiation chemotherapy or ischemic conditions using revolutionary concepts developed at CBLI and in collaboration with distinguished academic partners Talented scientists experienced drug development executives and innovative entrepreneurs comprise balanced CBLI team united by common goals to make difference in the lives of untreatable patients and to cure people suffering from previously
    [Show full text]
  • Sponsors.Pdf
    Customer Name OSP0001 ABB Automation Inc. OSP0002 ABT Associates Inc. OSP0003 Acromed Corporation OSP0004 ADRC Technologies Inc. OSP0005 Aerogen Inc. OSP0006 Aeropharm Inc. OSP0007 Air Products Inc. OSP0008 Algaeventure Systems OSP0009 AmTrust Bank OSP0010 Analex Corporation OSP0011 Applied Pavement Technology Inc. OSP0012 Arcus Technology OSP0013 Babcock & Wilcox OSP0014 Booz Allen Hamilton OSP0015 BP America OSP0016 Bramhall Engineering & Surveying Co Inc. OSP0017 Caddscan Engineering OSP0018 CalAsia Pharmaceuticals OSP0019 Cedar Fair LLP OSP0020 Centerior Energy OSP0021 Central Parc LLC OSP0022 Cleveland Advanced Manufacturing Program OSP0023 Cleveland BioLabs Inc. OSP0024 Cleveland Medical Devices Inc. OSP0025 Constella Group OSP0026 Controlsoft Inc. OSP0027 Crain's Cleveland Business OSP0028 Creative Department LLC OSP0029 Curragh Chemistries Inc. OSP0030 Cytodyne Technologies OSP0031 DataQ Instruments Inc. OSP0032 Deformation Control Technology Inc. OSP0033 Deloitte Consulting OSP0034 Dominion East Ohio Gas OSP0035 Donald McTigue Esq Attorney-at-Law OSP0036 Dr. Mitchell Wax OSP0037 Dr. Sarah Staneff OSP0038 Dr. Theodore Castele OSP0039 Evergreen Cooperatives of Cleveland Ohio OSP0040 Federal Mogul Corporation OSP0041 Ferro Corporation OSP0042 Flow Parametrics LLC OSP0043 Ford Motor Company OSP0044 Forest City Enterprises OSP0045 Gebauer Company OSP0046 Gemstar Group OSP0047 General Electric OSP0048 General Electric Consumer&Industrial OSP0049 General Electric Lighting OSP0050 General Motors Corporation OSP0051 General Motors North American Operations OSP0052 General Motors-CWR Division OSP0053 Group Services Inc. OSP0054 Hemisphere Corporation OSP0055 Hydraulic Press Brick Company OSP0056 ICF Incorporated OSP0057 Industrial Advisors Bureau Inc. OSP0058 Industry Week Magazine OSP0059 Innovative Developments OSP0060 I-Open Ventures LLC OSP0061 JEK Analytics OSP0062 Jones Day Reavis and Pogue OSP0063 JumpStart Inc OSP0064 Keip Government Solutions Consulting OSP0065 Keithley Instruments Inc.
    [Show full text]
  • Rare Diseases, When Taken Together, Are Are Together, When Taken Diseases, Rare to According at All
    2013 MEDICINES IN DEVELOPMENT REPORT Rare Diseases A Report on Orphan Drugs in the Pipeline PRESENTED BY AMERICA’s biopharmACEUTICAL RESEARCH COMPANIES More Than 450 Medicines in Development for Rare Diseases Rare diseases, when taken together, are A major area of this research targets Orphan Drugs in Development* not that rare at all. In fact, according to rare cancers, accounting for more than Application the National Institutes of Health (NIH), one-third of all rare disease medicines in Submitted 30 million Americans have one of the development. Other top research areas Phase III nearly 7,000 diseases that are officially include genetic disorders, neurologi- Phase II deemed “rare” because alone they each cal conditions, infectious diseases and Phase I affect fewer than 200,000 people in autoimmune disorders. the United States. Sometimes, only Despite some recent victories, research a few hundred patients are known to 105 into treatments for rare diseases is a have a particular rare disease. daunting quest. This ongoing innovation Simply receiving a diagnosis of a rare and the hundreds of new medicines in disease often becomes a frustrating development now offer hope that physi- 85 quest, since many doctors may have nev- cians will have new treatment options er before heard of or seen the disease. for patients confronting a rare disease. This is, however, a time of great progress and hope. Biopharmaceutical 65 Contents research is entering an exciting new era Innovative Orphan Drugs with a growing understanding of the in the Pipeline ......................................... 2 human genome. Scientific advances have given researchers new tools to Orphan Drug Approvals ...........................4 explore rare diseases, which are often Challenges in Clinical Trials ......................6 more complex than common diseases.
    [Show full text]
  • 2018 Medicines in Development for Cancer
    2018 Medicines in Development for Cancer Bladder Cancer Product Name Sponsor Indication Development Phase ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II (nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II (tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com receptor linked to IL-2) NantKwest Culver City, CA ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II (IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com NantKwest non-muscle invasive bladder cancer Culver City, CA (BCG unresponsive) (Fast Track) B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II (anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com Bavencio® EMD Serono 1L urothelial cancer Phase III avelumab Rockland, MA www.emdserono.com (anti-PD-L1 inhibitor) Pfizer www.pfizer.com New York, NY BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II (gene therapy) Cambridge, MA (Fast Track) www.biocancell.com Medicines in Development: Cancer ǀ 2018 1 Bladder Cancer Product Name Sponsor Indication Development Phase Capzola® Spectrum Pharmaceuticals non-muscle invasive bladder cancer application submitted apaziquone Henderson, NV (Fast Track) www.sppirx.com Cavatak® Viralytics bladder cancer (+pembrolizumab) Phase I coxsackievirus Sydney, Australia www.viralytics.com CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II (oncolytic immunotherapy)
    [Show full text]