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Posts from the ‘Biomarkers’ category

AB Science files for Pancreatic Cancer approval

By on October 18, 2012

AB Science confirms the filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the treatment of Pancreatic Cancer.

ab science logo AB Science files for Pancreatic Cancer approval Paris based biopharmaceutical company AB Science announced in an October 16 news release that the company has applied to the European Medicines Agency (EMA) for approval of masitinib in pancreatic cancer.

Masitinib is a tyrosine kinase inhibitor of PDGF, PDGFR, FGFR, FAK, c-KIT. A phase 3 clinical trial (NCT00789633) in pancreatic cancer is underway that compares masitinib with gemcitabine to placebo with gemcitabine.  The trial started in November 2008 with an estimated enrollment of 320 patients at 68 study locations. As far as I am aware no data has yet been presented for this trial.

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Using CSF Biomarkers for Differential Diagnosis of Neurological Diseases

By on August 30, 2012

Drug development for neurodegenerative brain diseases such as Parkinson’s or dementia, of which Alzheimer’s is the most common form, needs to focus on patients early in the disease, not those where brain damage has already occurred.

Diagnosing and treating patients more effectively earlier will, even if you aren’t able to instigate a cure, offer the ability to modify the disease progression and slow or delay when brain damage occurs.  In the case of Alzheimer’s, once the amyloid plaques (tangles of misshapen proteins) have accumulated in nervous tissue, it has so far been impossible to untangle or remove them.

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Improving Clinical Trials through the use of Biomarkers

By on August 29, 2012

What is a Biomarker?

According to the Biomarkers Definitions Working Group, a biomarker is:

“a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.”

An example of a common biomarker is blood pressure. High blood pressure is a surrogate for cardiovascular disease and risk of stroke.

Why are Biomarkers important?

Biomarkers can be used for diagnosis and for monitoring the safety and effectiveness of treatments. They are increasingly becoming important in the selection of patients for clinical trials, and as potential surrogates for clinical endpoints that may take a long time to occur e.g. measuring how long someone will live in a cancer trial (overall survival).

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AACR 2012: Future is combinations of novel cancer agents

By on April 23, 2012

A standing room only audience at the recent annual meeting of the American Association for Cancer Research (AACR) heard from several distinguished speakers on what the future of cancer drug therapy is likely to look like: combinations of novel cancer agents.

This AACR session was one of the highlights of the meeting and would have merited from being part of the plenary program.

AACR 2012 Engelman Strategies to Overcome Resistance 300x215 AACR 2012: Future is combinations of novel cancer agentsJeffrey Engelman from MGH persuasively presented on why we need combination therapies to overcome resistance. He noted that:

  • Most cancers are not sensitive to currently available single-agent therapies
  • Even when sensitive to single-agent therapies, cancers develop resistance, often necessitating combinations
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AACR 2012: the automation of preclinical drug discovery will be a driver of innovation

By on April 18, 2012

There was so much good science on display at the recent 2012 annual meeting of the American Association for Cancer Research (AACR) in Chicago that any blog posts are but a personal snapshot or postcard.

AACR 2012 Bill Sellers Picture 300x168 AACR 2012: the automation of preclinical drug discovery will be a driver of innovationOne enduring image I have from the plenary presentation on “The Genetic Basis for Cancer Therapy“ by Bill Sellers, VP/Global Head Oncology at Novartis Institutes for BioMedical Research was the video he showed of the robots that are used for automated cell profiling.

Imagine the advertisements that show robots being used to build cars, but now the robots are undertaking automated laboratory work in pursuit of new cancer compounds. Wow!

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Challenges with Head and Neck Cancer Drug Development

By on January 25, 2012

Head and neck cancer is not something we hear much about when it comes to new therapies, yet it is the sixth most common non-skin cancer in the world.

Head and neck squamous cell carcinoma (HNSCC) has an incidence of 600,000 cases a year, with 50,000 of those occurring in the United States.

Outcomes remain disappointing for patients, with disease free survival (DFS) rates of only 30-40% for patients with locally advanced HNSCC.  Five-year survival rates of around 50% have improved little for many years.

Zalutumumab failed to show OS benefit

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Targeting IDH1 in Glioma Patients

By on January 17, 2012

One of the challenges of the next decade in cancer research will be targeting cancer metabolism; imaging is likely to play a key role in drug development.

Targeting IDH1 in Glioma PatientsThe cover of the January 11 online issue of Science Translational Medicine (STM) shows a brain tumor (glioma) in red, detected using non-invasive nuclear magnetic resonance imaging that highlights cancer metabolism.

In a paper published in STM, Andronesi and colleagues from Harvard & other Cambridge, MA institutions (including Agios Pharmaceuticals – more on them later), showed that excess production of the metabolite 2-hydroxyglutarate (2HG) could be used as a biomarker for a subset of glioma.

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New Imaging Agents may improve Glioblastoma Surgery

By on November 1, 2011

Cancer Research UK issued a press release today about a phase 2 trial (GALA-5) in glioblastoma that caught my attention.

The trial, led by Colin Watts from the University of Cambridge, will treat patients with 5-Amino-Levulinic Acid (5-ALA), a metabolic marker of malignant glioma cells.  5-ALA is preferentially taken up by brain tumor cells and then converted into a strongly fluorescing porphyrin.

This conversion by the body of 5-ALA to a fluorescent chemical, shows the location of the glioblastoma when imaged under ultraviolet light.

cr 078690 300x225 New Imaging Agents may improve Glioblastoma Surgery

The practical application of this is that it allows better identification of the tumor margins and avoids the removal of unnecessary brain tissue.

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Vitamin E may improve gemcitabine effectiveness in pancreatic cancer

By on October 14, 2011

It’s been a bad week for vitamins, especially with the publication of data from the SELECT trial that showed healthy men taking 400 IU/day of Vitamin E had a 17% increased risk of prostate cancer.

However, there is some evidence in support of tocotrienols (unsaturated form of Vitamin E) having a potential role to play in anti-cancer therapy.  One paper that caught my attention was the work by Kazim Husain and colleagues from the Moffitt Cancer Center and Research Institute in Tampa.

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Prostate Cancer Screening – the debate continues

By on October 10, 2011

The recent announcement from the United States Preventative Services Task Force (USPSTF) on prostate cancer screening has stimulated a lot of debate.  ”Dr Len’s Cancer Blog” from the American Cancer Society has a thoughtful piece about the “to screen or not to screen” dilemma. It is reminiscent of the breast cancer mammography debate.

Scott Hensley’s post on “Shots”, the NPR health blog also provides a good overview of the debate and issues. I confess I was surprised by the vehemence of the response from some practising urologists on twitter such as Dr Benjamin J. Davies (@daviesbj), Assistant Professor of Urology at the University of Pittsburgh School of Medicine:

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