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Commentary on Science, Innovation & New Products

Posts by Pieter Droppert

ESMO 2012 Gefitinib in Esophageal Cancer – can we identify the responders?

ESMO 2012 Gefitinib Press Briefing 300x225 ESMO 2012 Gefitinib in Esophageal Cancer   can we identify the responders?At the European Society for Medical Oncology (ESMO) 2012 Congress in Vienna, David Ferry, Professor of Medical Oncology at New Cross Hospital in Wolverhampton, reported the results of the Cancer Oesophagus Gefinitib (COG) study, a UK 450 patient, multicenter, phase III clinical trial that looked at whether gefitinib (Iressa) could improve overall survival in esophageal cancer patients who had progressed after chemotherapy.

This is a disease for which there are no treatments that prolong life in the 2nd or 3rd line setting! Sadly, the trial results were negative; there was no difference in overall survival between the placebo and gefitinib study arms.

The results are shown in the graphic that Professor Ferry presented:

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ESMO 2012 ODM-201 shows promise as a future competitor to enzalutamide

ESMO 2012 ODM 201 Poster 300x210 ESMO 2012 ODM 201 shows promise as a future competitor to enzalutamideAt the European Society for Medical Oncology (ESMO) meeting in Vienna today, the first published clinical data for a new second generation anti-androgen (ODM-201) was presented. Company representatives inform me that the poster will be available on the Orion Pharma website in a few days. (Update Oct 9: it is now available, but all the text on the PDF of the poster available for download appears to have been intentionally blurred to make it unreadable!)

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ESMO 2012: TH-302 Pancreatic Cancer Survival Data Fails to Impress

Mitesh Borad ESMO 2012 300x225 ESMO 2012: TH 302 Pancreatic Cancer Survival Data Fails to ImpressAt the 2012 Congress of the European Society for Medical Oncology (ESMO 2012) in Vienna,  Mitesh J. Borad MD, Assistant Professor of Medicine at the Mayo Clinic in Scottsdale, AZ presented the results of the TH-CR-404 phase 2 clinical trial that compared the efficacy and safety of TH-302 (Threshold Pharmaceuticals) plus gemicitabine versus gemcitabine alone in patients with untreated advanced pancreatic cancer.

TH-302 is an experimental cancer drug in development that kills cells i.e. is cytotoxic under conditions of low oxygen (hypoxia) found in the microenvironment of cancer tumors. Sally Church, PhD on Pharma Strategy Blog has written about the mechanism of action for TH-302 and the results presented earlier this year at the 2012 annual meeting of the American Association for Cancer Research (AACR).

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ESMO 2012: ODM-201 a new generation antiandrogen for advanced prostate cancer

One of the late-breaking abstracts (not yet published) that I am looking forward to at the forthcoming annual Congress of the European Society for Medical Oncology (ESMO 2012) in Vienna is on ODM-201 (Orion Pharma):

LBA25-PR:  ARADES trial: A first-in-man, open-label, phase I/II safety, pharmacokinetic, and proof-of-concept study of ODM-201 in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC)

ODM-201 is a new antiandrogen from Finnish company, Orion Pharma, and is being developed in partnership with Endo Pharmaceuticals (NASDAQ: ENDP).

Orion Logo 300x136 ESMO 2012: ODM 201 a new generation antiandrogen for advanced prostate cancerIn a corporate presentation, Orion Pharma describe ODM-201 as:

  • Potentially best-in-class antiandrogen
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Innovation in Action: helping people to see again

Can you imagine what it must be like to go blind? Degenerative diseases of the eye such as age-related macular degeneration (AMD) and retinitis pigmentosa (RP) can result in loss of vision and blindness.

Retinitis pigmentosa is an inherited genetic condition for which there is no cure. It results in the progressive loss of function of the retinal photoreceptors that convert light into electrical nerve impulses that travel down the optic nerve to the brain for processing into the images we see. As you reduce the ability to process light, so you start to lose your sight and can end up totally blind.

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ESMO 2012 Vienna Congress Plenary Preview #ESMO12

The 2012 Congress of the European Society for Medical Oncology in Vienna, Austria from 28 September to 2 October is a meeting I am looking forward to attending.

 ESMO 2012 Vienna Congress Plenary Preview #ESMO12

Last year at the 2011 European Multidisciplinary Cancer Congress (ECCO/ESMO/ESTRO) in Stockholm we saw a lot of new data, including the phase III trial results for the ALSYMPCA trial with radium-223 (Alpharadin) in advanced prostate cancer and the Bolero-2 trial with everolimus (Afinitor) in ER/PR+ HER2- breast cancer.

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Using CSF Biomarkers for Differential Diagnosis of Neurological Diseases

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

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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Creating an artificial jellyfish to model the human heart

Nature Biotechnology August 2012 Cover Creating an artificial jellyfish to model the human heartRegular blog readers will know I think tissue engineering is an exciting area where you can see innovation in action – advances in basic science can translate into ways to artificially create replacement organs and body parts.

Research published online 22 July 2012 in Nature Biotechnology by Janna Nawroth and colleagues at the California Institute of Technology (Caltech) and Harvard University, shows how biomedical engineers are learning from the structure and function of other animals.

In a Nature Biotechnology article titled “a tissue-engineered jellyfish with biomimetic propulsion” researchers describe how they were able to combine rat cardiac muscle cells and a synthetic elastomer membrane into a medusoid like structure that mimicked the propulsion of a jellyfish.
jelly artificial color 150x150 Creating an artificial jellyfish to model the human heart

Credit: Caltech and Harvard University

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The Potential of Gene Therapy to Restore Hearing Loss

listening ear 150x150 The Potential of Gene Therapy to Restore Hearing Loss Imagine that you are born deaf and live in a world of silence – what price would you pay for a new treatment that might restore your hearing?

That is the market opportunity that may be available for biotechnology and pharmaceutical companies as the basic science around congenital hearing loss starts to yield insights that could translate into new products.

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