Shruti Bhat PhD, MBA, Operations Excellence Expert
  • Home
  • About Shruti
  • Books
  • Insights
  • Operational Excellence
  • Research
    • Innovation Management
    • Leading Research and Development
    • Developer's Diary
  • Case Studies
  • Tools
    • Whitepapers
    • Articles >
      • Business Transformation
      • Process Improvement
      • Business Continuity
      • Change Management
      • Digital Transformation
      • Quality Improvement
    • Checklists and Templates
    • Free eBook
    • Videos
  • Blog
  • Engage Shruti
    • Consulting >
      • Operational Excellence Consulting
      • Business Transformation Consulting
      • Innovation Management Consulting
    • Workshops
  • Contact

Drug clinical research updates

1/3/2010

0 Comments

 
Geron says its cancer vaccine met safety, tolerability goals in study.
Geron Corp.correspondent reports that its developing cancer treatment GRNVAC1 met safety and tolerability goals in a midstage study." The study of the "developing vaccine, aimed at prompting the immune system to fight tumor cells," involved "patients with acute myelogenous leukemia." Further, 14 of the study's 20 patients in remission from AML remain in complete clinical remission and the median duration of clinical remission is 12 months.

Voreloxin may improve survival for patients with AML.
Sunesis Pharmaceuticals Inc.'s "drug candidate voreloxin improved survival for patients with treatment-resistant leukemia in clinical testing," according to the company. Sunesis reported "results from two mid-stage trials of voreloxin as a treatment for acute myeloid leukemia," and said it will advance the drug into more testing. The company also "said patients who were dosed with the drugs once a week for three weeks had median survival of 8.7 months, and half of those who took the drugs for two weeks survived for more than 5.8 months."

Arixtra may reduce SVT complications.
According to researchers at the American Hematology Society's annual meeting, "Pulmonary embolism, deep vein thrombosis, and other potentially fatal complications of superficial vein thrombosis (SVT) were less frequent in patients treated with fondaparinux (Arixtra) in a pioneering trial. The placebo-controlled study of more than 3,000 patients in 17 European countries found that "fondaparinux slashed rates of pulmonary embolism and deep vein thrombosis by about 80% over a 45-day treatment period." One of the researchers also "said the data finally established that a low molecular weight heparin is effective in reducing SVT complications, although such drugs have long been used empirically to treat the condition."

One-fifth of dialysis patients undergoing PCI may be given contraindicated antithrombotics. More than one-fifth of patients on dialysis who undergo angioplasty are given blood thinners they should not be given, according to a study published in the Journal of the American Medical Association.  

The investigators looked at data on "22,778 dialysis patients who underwent PCI." Altogether, "5,084 patients (22.3%) received a contraindicated antithrombotic." The investigators found that "patients who received the antiplatelet agent eptifibatide or the anticoagulant enoxaparin, which are renally cleared and therefore not recommended for dialysis patients, had higher unadjusted rates of inhospital bleeding...than patients who received recommended antithrombotics."

Depressed patients on paroxetine may experience personality changes.
According to a study published in the J. Archives of General Psychiatry, selective serotonin reuptake inhibitor (SSRI) "antidepressants effect profound and rapid personality changes in those who respond to them. Compared to a group of depressed patients doing talk therapy and another taking a placebo drug," study participants "who took the SSRI paroxetine (marketed as Paxil) and reported some depression relief had more dramatic personality changes, becoming less negative and emotional, less easily discouraged or embarrassed, and more self-confident and assertive."

In the study of "240 adults with a major depressive disorder" divided into groups receiving paroxetine, cognitive therapy, and a placebo,participants taking paroxetine became less neurotic and more extraverted than those receiving cognitive therapy or placebo. Extraversion, which is associated with positive emotions, is believed to help protect from depression, while neuroticism, the tendency to experience negative emotions and emotional instability, is thought to contribute to depression, psychologist and lead author Tony Tang, PhD, of Northwestern University, explained, adding that "becoming more extraverted and less neurotic may" also "help prevent a relapse of depression."  

Claude Robert Cloninger, MD, "a professor of psychiatry, genetics, and psychology at Washington University in St. Louis," who was not involved in the study, who told "WebMD that the conclusions of the new study 'confirm earlier work showing that particular personality traits are indicators of vulnerability to depression.' He added, 'What this work does well is show' that depression is 'not just a matter of mood,' and that SSRIs 'are not specific just for depression’.

Cetrorelix does not meet main goal in late-stage study.
AEterna Zentaris Inc. said Monday its enlarged prostate drug cetrorelix did not meet its main goal in a late-stage clinical study.The company "said there were no clear differences in effectiveness between the drug and placebo," and it also "said it will shift its focus to several cancer drugs," such as perifosine. The company announced similar results from its North American studies, which is prompting doubts regarding regulatory approval.  
Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
0 Comments

Your comment will be posted after it is approved.


Leave a Reply.

    Shruti Bhat, global leader in business turnaround, operational excellence and continuous improvement
    To contact Dr. Shruti Bhat text or WhatsApp at 1.403.969.6219

    New Book Released!

    Revolutionizing Industries with Lean Six Sigma

    Shruti's YouTube Channel ...

    Picture

    Blog Categories

    All
    3D Printing
    Agile
    Artificial Intelligence
    Automation
    Biotechnology
    Books
    Business Continuity
    Business Turnaround
    Case Studies
    Change Management
    Checklists
    Chemical Industry
    Continuous Improvement
    Design Thinking
    Digitalization
    Drug Delivery
    External News Links
    Hall Of Fame
    Healthcare
    Hoshin Kanri
    HR Development
    Innovation
    Insights
    ISO
    Just In Time
    Kaizen
    Leadership
    LEAN
    Lean Six Sigma
    Life Sciences
    Machine Learning
    Manufacturing
    Medical Devices
    Mistake Proofing
    Motivational Cards
    MSMEs
    Nanotechnology
    Operational Excellence
    Packaging
    Patents
    Personal Products
    Process Improvement
    Product Development
    Productivity Increase
    QbD
    Quality Management
    R&D Leadership
    Robotics
    Service Industry
    Six Sigma
    Strategy
    Supply Chain Logistics
    Telecom Industry
    Templates
    TQM
    Videos
    Voice Of Customer
    Whitepaper
    Workshops

    Shruti's books...

    Picture
    top ten strategic decision-making tools for operational excellence
    shruti bhat, business process management, continuous improvement
    kaizen for pharmaceutcials, medical devices and biotech industry book by Dr Shruti Bhat
    Book on Continuous improvement tools by Dr Shruti Bhat
    kaizen for leaders, continuous process improvement tool to increase profit and organizational excellence by shruti bhat
    kaizen, shruti bhat, continuous improvement, quality, operations management
    how to lead a successful business transformation
    leading organizations through crisis
    emotional intelligence
    how to overcome challenges of creating effective teams
    modular kaizen Vs Blitz kaizen
    How to increase employee engagement as a new boss

Connect with Dr. Shruti Bhat at- ​Twitter, YouTube, LinkedIn​

© Copyright 1992- 2025 Dr. Shruti Bhat ALL RIGHTS RESERVED.
See Terms and Conditions for details on this site usage.
Subscribe to Operational Excellence Academy YouTube Channel
​Subscribe to Operational Excellence Academy YouTube Channel
SHRUTI BHAT, CONTACT
Click to connect.
Created by Macro2Micro Media