IBTA E News
Posted on: 08/13/2010
E News August 2010
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Dear Friend of the International Brain Tumour Community
Trabedersen: Antisense Pharma has announced that the US Food and Drug Administration (FDA) has issued an Investigational New Drug (IND) authorisation for clinical studies with trabedersen for patients with high-grade glioma. This authorisation entitles the company to include US clinics both in the phase III study SAPPHIRE and in further studies. The SAPPHIRE study is confined to recurrent or refractory anaplastic astrocytoma (WHO grade III). The Company has said: “A further clinical trial with trabedersen to treat glioblastoma patients is in preparation.” (Source: Company announcement). This development should encourage more brain tumour treatment centres to participate in the trial and therefore provide a wider choice of trials to their patients.
Toca 511: Tocagen is developing its CAGT Prodrug Activator product candidate, Toca 511 with 5-FC for the potential treatment of brain tumours. The first human study is being conducted in subjects who have recurrent glioblastoma multiforme. Three neurosurgery centres in the United States are participating in this first study: UCLA, UCSF, and Cleveland Clinic. (Source: Company announcement). The NBTS has given a grant to assist with this research.
Recentin: Astra Zeneca has reviewed topline results from the Phase III REGAL study, evaluating Recentin in recurrent glioblastoma. These results showed evidence of clinical activity for cediranib, but did not meet the primary endpoint of progression-free survival for either cediranib alone or in combination with lomustine chemotherapy, and there was no benefit in overall survival versus lomustine alone. (Source: Company announcement).
Avastin: In connection with the FDA’s Oncologic Drugs Advisory Committee’s (ODAC) vote of 12-1 against the use of bevacizumab (Avastin) in combination with chemotherapy for the first-line treatment of metastatic breast cancer, Dr. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products referred to the role of QOL measurements: “Sponsors really need to pay very close attention to [measuring quality of life], build it carefully into their protocols, and approach it with the same degree of caution and resources…as one would with a primary endpoint.” QOL measurements are assuming a greater relevance in assessments of new therapies.
Communication with patients: The myMDAnderson personal health information portal has now been available for over a year and allows referring physicians to access their patient’s laboratory results, diagnostic imaging and pathology reports. Patients can also view this information after the results have been discussed with them by a treating specialist, thus allowing them to refer back to the results – over 28,000 patients have done so in the first twelve months. This web facility also enables patients to ask questions of their care team. It appears to be a good patient-friendly initiative, perhaps others will follow.
Slow progress: “Over the last 30 to 40 years, with all the cancer research efforts out there, we have only been able to extend the survival rate in these patients [GBM patients] by about one month per decade of research. People who have this kind of cancer survive for an average of 14.5 months after diagnosis, although some with this form of cancer can live longer than that average. I don’t think anyone would label this satisfactory progress.” Source - Waldemar Debinski, M.D., Ph.D., director of the Brain Tumor Center of Excellence at Wake Forest University.
Ependymomas: An international team incorporating researchers from the USA, Canada and the UK, and led by St Jude Children’s Research Hospital, studied 204 ependymoma brain tumours and identified more than 200 genes as potentially important for triggering the tumour or helping it spread. They also found that the pattern of DNA gain or loss differed depending on the tumour’s location in the brain or spine.
Brain metastases: The US National Cancer Institute is planning to sponsor a series of clinical trials aimed at improving the outcomes of patients suffering from brain metastases. Researchers interested in participating should contact Dr Nancy Lin of Harvard University ( Nancy_Lin@dfci.harvard.edu), Dr Morris Groves of MD Anderson Cancer Center (email@example.com) or Dr David Peereboom of Cleveland Clinic (firstname.lastname@example.org).
Supporting organisations: The number of organisations supporting this year’s International Brain Tumour Awareness Week (31 October – 6 November) and the Walk Around the World for Brain Tumours, which are project-managed by the IBTA, has now reached 130. There is no financial commitment involved. Enquiries: email@example.com Don’t forget to also advise us of your walks, events, and future patient and scientific conferences, so that we may report or list them on the IBTA website.
China: The IBTA will have a display at the World Cancer Congress, being organised by the International Union Against Cancer (UICC) in Shenzhen during 18-21 August. We have always been keen to promote the development of patient and family brain tumour support groups in China and will seek to make contacts for that purpose while at the Congress.
Taiwan: Researchers in Taiwan have been able to suppress glioma tumour progression in a rat model by combining ultrasound to transiently permeabilize the blood-brain barrier and then to manipulate magnetic chemotherapeutic nanoparticles by an external magnetic field monitored by MRIs.
European funding: The European Commission has issued invitations for health funding applications under the Seventh Framework Programme (FP7). They are available here. There are specific opportunities for rare cancers, brain tumours, and paediatric cancers. We have alerted contacts in Europe to these calls. One of the problems is the paperwork required to apply for and to manage a project under this scheme. Patient involvement in clinical trials is supported: "The early involvement of patients and their advocacy groups in the planning, implementation, and monitoring of a clinical trial is considered important so that patients' needs are appropriately considered. This may also increase the rate of enrollment of trial participants and can have a positive effect on the performance of the clinical trial."
GliomaPredict: Dr Howard Fine and colleagues at the neuro-oncology branch of the US National Cancer Institute have designed a program to assign glioma patients to a specific molecular subtype. They write: “We developed GliomaPredict as a computational tool that allows the fast and reliable classification of glioma patients into one of six previously published stratified subtypes based on sets of extensively validated classifiers derived from hundreds of glioma transcriptomic profiles.”
VEGF-targeted therapies: Lee M Ellis and David A Reardon have written a cautionary note about the more extensive, infiltrative and distant disease that might follow anti-VEGF treatment and encourage the collection of data about patterns of disease progression and rates of metastatic and distant recurrence following anti-angiogenic treatments. “As in physics, in biology, for every action, there is a reaction. We must be sure that the biological reaction does not negatively affect patient survival”.
Italy: Giovanni Camporeale of BrainLife reports that Il Fondo di Gio organised a scientific conference on 15 May with the title “IT IS NOT TRUE THAT “HOPE DIES LAST”: HOPE NEVER DIES. A meeting with Doctors and Researchers", at Sala Imperatore, Savoia Excelsior Palace, Trieste, Italy. The President of Il Fondo di Gio is Francesca Scropetta, who was a caregiver to her young son, Giovanni, who sadly passed away from a brain tumour.
Thank you for your continuing support.
Denis Strangman (Chair and Co-Director)
International Brain Tumour Alliance IBTA
Kathy Oliver (Co-Director)
PO Box 244, Tadworth, Surrey
KT20 5WQ, United Kingdom
Tel:+ (44) + (0) + 1737 813872
Fax: + (44) + (0) +1737 812712
Mob: + (44) + (0) + 777 571 2569
The International Brain Tumour Alliance is a not-for-profit, limited liability company registered in England and Wales, registered number 6031485. Registered office: Roxburghe House, 273-287 Regent Street, London W1B 2AD, United Kingdom. All correspondence should be sent to the Co-Director’s address above, not to the registered office.
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