Oxford, UK - 13 December 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that it has initiated a Phase I/II trial of ProSavin, its novel gene-based treatment for Parkinson's disease. This follows regulatory clearance from the French Health Products Safety Agency (AFSSAPS) of the Company's Clinical Trial Application. Patient recruitment for the Phase I/II trial will start immediately. The trial is being conducted at the Henri Mondor Hospital in Creteil, which is a European centre of excellence for neurosurgery and a member of the Assistance Publique Hopitaux de Paris (APHP) in France.

The primary objectives of the trial are to assess the safety and efficacy of ProSavin. The analyses of patients will include the application of advanced non-invasive neuro-imaging techniques, in collaboration with the Commissariat a l'Energie Atomique (CEA) and Service Hospitalier Frederic Joliot (SHFJ)/ Molecular Imaging Research Centre (MIRCen) in Orsay, France.

ProSavin uses gene therapy to restore dopamine production in the brain. Parkinson's disease is caused by the degeneration of dopamine producing nerve cells, leading to movement impairments. The product uses the Company's LentiVector(R) system to deliver the genes for three enzymes (tyrosine hydroxylase, GTP-cyclohydrolase 1 and aromatic amino acid decarboxylase) that are required for the synthesis of dopamine. ProSavin is administered locally to the region of the brain called the striatum, converting the target cells into a replacement dopamine factory within the brain, thus replacing the patient's own lost source of the neurotransmitter.

Long-term efficacy data in the industry-standard preclinical model of Parkinson's disease have shown that ProSavin induces almost complete recovery of movement function and other behavioural measurements. In this model, the therapeutic effect of ProSavin following a single administration has been maintained for over 24 months with no diminishment.

Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: "The strength of the preclinical safety and efficacy data with ProSavin has established strong scientific support for the clinical development of this pioneering product candidate for Parkinson's disease. If ProSavin's safety and efficacy profile is replicated in humans, then the product could represent a fundamentally new approach for the treatment of Parkinson's disease and could significantly expand the worldwide market for existing therapies, which is estimated to be approximately US$3 billion."

The Phase I/II trial of ProSavin

ProSavin will be the first gene-based treatment for Parkinson's disease to be evaluated in a European clinical trial. Patients in the trial will have been diagnosed with Parkinson's disease and will be failing on current treatment with L-DOPA but they will not have progressed to drug-induced dyskinesias. It is a two-stage study. The first stage is an open-label dose escalation to evaluate two dose levels of ProSavin in cohorts of three patients each. Oxford BioMedica plans to report preliminary results once the first cohort of patients is assessable, which is expected in mid-2008. In the second stage of the trial, a further 12 patients will be recruited to confirm efficacy of the optimal dose.

Current surgical approaches to the treatment of Parkinson's disease require the destruction of brain tissue or the permanent placement of electrodes in the case of deep brain stimulation. These treatments have certain limitations and side-effects. The surgical procedure for administration of ProSavin entails stereotactic bilateral injection into the striatum under general anaesthesia using MRI-imaging and mapping. The procedure is designed to be non-destructive to tissue and does not leave any device in the brain.

The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an efficacy assessment at six months after treatment. The secondary objective of the trial is to asses the extent to which patients' current therapy (L-DOPA) can be reduced following administration of ProSavin.

The principal investigator for the trial is Stephane Palfi, MD, PhD, a neuroscientist at MIRCen/SHFJ-CEA and neurosurgeon at the Henri Mondor Hospital. Dr. Palfi commented on the start of the trial: "Current standard therapy for Parkinson's disease is only partially effective in the mid to late stage of disease and can induce debilitating side-effects after long-term use. ProSavin has the potential to address this unmet medical need, offering long-lasting benefit from a single administration. I am very pleased to be involved in the first clinical trial of this potentially exciting new treatment paradigm for Parkinson's disease."

Professor Alan Kingsman of Oxford BioMedica added: "We are delighted to have received a favourable review from the French authorities that allows us to commence patient recruitment in the Phase I/II trial. This clinical trial of ProSavin is the culmination of over ten years of research in Oxford BioMedica and, before that, in Oxford University. It is the first trial using our proprietary LentiVector technology and, as such, this represents a major event for Oxford BioMedica and the future of the pipeline of products that use the same technology."

Press Release

Amsterdam, 12th December, 2007: GlaxoSmithKline today announced the approval of Requip Modutab (ropinirole prolonged release tablets) in eight European countries. In addition, a mutual recognition procedure was recently completed in 17 additional countries in the European Union. This should result in approval and launches in these countries from the first quarter of 2008 onwards. Ropinirole prolonged release tablets is the first and only oral non-ergot once daily dopamine agonist for the treatment of Parkinson's Disease (PD).

Real Life Real PD Media Backgrounder

A recent survey reported today by the European Parkinson’s Disease Association (EPDA), highlighted important aspects of PD as well as the unpredictability of the disease and need for improved symptom control. The Real Life, Real PD survey which was presented today revealed that more than two thirds of patients with PD do not feel in complete control of their symptoms over a 24-hour period5. The survey also concluded that PD affects patients’ emotional wellbeing and their ability to have a restful sleep ultimately having a significant impact on quality of life.

Press Release

Amsterdam, The Netherlands – 12 December 2007 – Findings from a new observational survey show that around one in five patients with troublesome symptoms related to Parkinson's disease may benefit from deep-brain stimulation (DBS) and should be considered for the treatment.1 The survey was conducted in four European countries (Belgium, Germany, Italy, Spain) and Canada with the support of a new screening program, STIMULUS, that has the potential to help neurologists identify patients who could benefit from DBS. The results were presented today at the 17th World Congress on Parkinson’s disease and Related Disorders (WCPD) in Amsterdam.

Press Release

December 2007 (Columbus, Ohio) - Since the spring release of his new book and instructional DVD, Delay the Disease – Exercise and Parkinson’s Disease, David Zid delights in the positive response from participants whose lives are enhanced thanks to following his daily fitness program. Participants worldwide are thrilled that their Parkinson’s symptoms have been minimized.

Press Release

During a lunch debate organised by Alzheimer Europe on 6 November 2007 and hosted by Françoise Grossetête, MEP (France), representatives of different European institutions gave their clearest signal to date that the fight against Alzheimer’s disease and other forms of dementia would feature prominently in the plans of the European institutions in 2008.

The Members of the European Parliament present at the launch all stressed the usefulness of the comparative information on the social support systems in Europe contained in the second Dementia in Europe Yearbook of Alzheimer Europe.

On 5 October 2007, the EFPIA Board endorsed the EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations.

EFPIA has developed the code for its members, in order to enhance transparency and to ensure ethical relationships between the pharmaceutical industry and patient organisations, whilst recognising the independence of patient organisations.

The code sets out standards related to transparency, use of written agreements, non-promotion of prescription medicines, diversified funding of patient organisations, use of patient group logos, editorial control and hospitality.

The code will be implemented across Europe by 1 July 2008, and will be enforced by EFPIA's national industry associations. Each member association will have national procedures and structures to process complaints and impose sanctions in case of breaches of its national code.

The code requires that by the end of March 2009 at the latest, pharmaceutical companies will make the names of patient organisations supported by pharmaceutical companies and the nature of that support publicly available once a year.

The code is available on the EFPIA website at: www.efpia.eu/content/default.asp?PageID=151

On 4 October 2007, a massive and festive outdoor gathering took place in Brussels, at Rond Point Schuman, from 13h to 15h. More than 2000 people attended this festive, multicultural and colourful event to stand for the rights of disabled people.    There were delegations of disabled people from 30 European countries, political speeches and a variety of musical performances. Next to the podium, a van containing the boxes of more than 1 200 000 signatures were ready to be handed over to the EU leaders. Thousands of balloons were released carrying the campaign slogan: WE ACT TODAY FOR A BETTER TOMORROW. Various Belgian authorities, artists, NGOs, Members of the European Parliament attended the event in support of the European Disability Forum's campaign. Hans-Gert Pöttering, President of the European Parliament adressed the participants, as well as Margot Wälstrom, Vice-President of the European Commission, to whom were handed over the signatures.

• For further information on the 1million4disability campaign: www.1million4disability.eu
• Picture of the event:

A new Pan-European survey investigating the unmet need for better day and night symptom control in Parkinson’s disease (PD) patients is today being launched at the European Parkinson’s Disease Association (EPDA) Annual General Meeting, Stresa, Italy.

The Real Life Real PD survey has been developed in conjunction with a steering group of EPDA representatives and GlaxoSmithKline, and will gain patient insights into the realities of living with PD, by understanding the impact that poor symptom control has on quality of life, both ‘day’ and ‘night’. In particular the survey will examine the impact of poor sleep, mood, difficulties with daily activities and relationships with family and friends on quality of life.

Research will be conducted across Europe during November and the interim results will be announced at the XVIIth World Congress on Parkinson’s Disease and Related Disorders in December 2007.

 

For further information, please contact

Emily Bunting
emily_bunting@uk.cohnwolfe.com
+44 (0)20 7331 5310

Sarah Thomas
Sarah_thomas@uk.cohnwolfe.com
+44 (0)20 7331 5447

This survey is being conducted in association with

Press Release

At the end of a week-long exhibition in the European Parliament hosted by Astrid Lulling, MEP (Luxembourg), Alzheimer Europe was able to gather the support of 42 Members of the European Parliament from 19 different European countries for its campaign to make dementia a European public health priority.

Press Release

Preliminary results of the pan- European PRODEST study in 1016 patients with PD were presented at the 11th Congress of the European Federation of Neurological Societies (EFNS) in Brussels this week, revealing unique features of PD-related depression and its treatment. The study confirmed that depressive symptoms associated with PD are not only highly prevalent, but nearly half of patients receiving antidepressant treatment continued to experience depressive symptoms.

These were the issues of  a two day seminar held on August 07 in picturesque surroundings of Lithuania.

Among the participants of the seminar were facilitators, treasurers and other active members of 11 existing support groups as well as initiators of the newly formed groups. Rasma, the facilitator of one of the oldest groups made a report followed by discussions and sharing experience.

The two days was not only the time for learning but also for relaxation and getting to know each other better.  The slogan of the camp was TOGETHER WE WORK  TOGETHER WE WIN.

We want to thank the EPDA board for strengthening the unity and the need for togetherness. Thanks to their effort and support we feel that we are a member of a friendly family.

RASMA ZLATKUVIENE

Press Release

The European Medicines Agency (EMEA) has passed the milestone of the 40th positive opinion recommending the granting of a marketing authorisation for an orphan medicinal product by the European Commission since the Regulation on orphan medicinal products entered into force in 2000. Orphan medicinal products covering more than 30 conditions and potentially benefiting some 1. 6 million patients have been made available for use in the European Union since 2001.

• Press Release EN
• Press Release FR

“It took us more than three years to obtain this important piece of legislation and I would like to congratulate all those that have actively contributed to make it happen. The European Union has taken an important step forward to advance disability rights in Europe, but we need to continue to work together in order to overcome the current gaps of the Regulation”, said today Yannis Vardakastanis, President of the European Disability Forum. 

The overall aim of the Regulation is to guarantee equal treatment for all passengers, including ‘any person with reduced mobility or sensory impairment, intellectual disability or any other cause of disability, age, and whose situation needs appropriate attention and the adaptation to his or her particular needs of the service made available to all passengers’.

The Holiday Inn in Castel Volturno, just outside Naples, Italy, was the setting for Solvay’s 2^nd International Forum on Advanced Parkinson’s Disease. More than 180 people from all over Europe and also Canada attended to talk about the current state of knowledge and debate the best strategy for treating Parkinson’s disease sufferers.

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The event was supported and opened by the European Parkinson’s Disease Association (EPDA). Interim President Stephen Pickard spoke about the EPDA progress since being formed 15 years ago,  and their support  for the Working Group on Parkinson’s Disease, organised by the World Health Organisation in 1997 and for the Global Declaration on Parkinson’s Disease.

In the first session, Leslie Findley (UK), who stepped in at the last minute for Ray Chaudhuri (UK), and Werner Poewe (Austria) locked horns on the best time to start treatment for Parkinson’s, and for what symptoms: motor or non-motor. Next, Erik Wolters (the Netherlands) and Alexander Storch (Germany) examined deep brain stimulation, which has excellent results but only in a limited subset of patients. Newer developments – particularly Duodopa – promise equally effective results with less patient exclusion issues.

After lunch, Eduardo Tolosa (Spain) and Donald Grosset (UK) generated debate on the pros and cons of two mainstays of Parkinson’s treatment: levodopa and dopamine agonists. More screening for complications, particularly behavioural side effects, is recommended.

Completing the day were Maral Mouradian (USA) and Angelo Antonini (Italy), presenting in turn the most current thinking about pharmacokinetics of levodopa and novel modes of administration. Continuous levodopa infusion into the duodenum reduces the dopamine peaks in the brain and helps reduce dyskinesias, improving quality of life.

A coach journey to Naples, including a rather tricky slalom up through the congested winding streets to the restaurant to see the dusk fall on the beautiful panoramic bay, rounded off a very enjoyable and educational day.

The forum, organized by Dr. Cláudio Sandner, received excellent feed-back from all the participants and brought up plenty of stimulating discussions. Many speakers commented on the quality and good balance of the sessions – something not always characteristic of industry organised events! Subsequent feedback from delegates suggest that this event contributed much to the understanding of Duodopa and its role in advanced Parkinson’s disease.  This in turn has moved many of them along the adoption process for the product.

Press Release

The National Council for Palliative Care will be celebrating at the Royal Society of Medicine on 3rd July both its achievements and future challenges. The keynote debate will focus on future of palliative care and quality of life of an increasingly ageing population.

Press Release

The CHMP has started a referral procedure for ergot-derived dopamine agonists (bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide), a class of medicines that is primarily used in the treatment of Parkinson’s disease. The referral procedure was initiated by the United Kingdom under Article 31 of the Community code on human medicinal products (Directive 2001/83/EC as amended) to re-assess the balance of benefits and risks of all these products in view of the risk of fibrotic disorders and cardiac valvulopathy reported with some of these medicines.

Referrals under Article 31 are initiated in cases involving the interests of the Community or concerns relating to the protection of public health.

Further information on the work of the EMEA, can be found on the EMEA website (www.emea.europa.eu).

Press Release

Updated and extended to take account of the Mental Capacity Act (2005), Artificial Nutrition & Hydration: Guidance in End of Life Care for Adults gives practical, evidence-based guidance on an important and sensitive aspect of care.

This publication will help health and social care workers in all settings understand what needs to happen when decisions about ANH are being made. It identifies the legal and ethical issues that might arise and suggests a stepped approach to decision-making. It contains detailed case studies which explain how ANH decision-making can work in practice. It also includes a series of tables with information about alternative ways of providing ANH, different clinical scenarios and suggested ways of opening up conversations on these issues.

Press Release

The National Council for Palliative Care (NCPC) and the NHS End of Life Care Programme are pleased to announce the publication of “Building on Firm Foundations: Improving end of life care in care homes, examples of innovative practice”. This document is designed to help care homes learn from each others practice to improve end of life care.

Press Release

This data will be presented by Dr Jonathan Brotchie, an internationally recognised expert on Parkinson’s disease at ‘The 11th International Congress of Parkinson’s Disease and Movement Disorders’ 5 June in Istanbul, Turkey and published in The Movement Disorders Society’s journal.

Press Release

Columbus, Ohio – May 2007- Patients are discovering first-hand that daily exercise has a positive effect on the course of Parkinson’s Disease, minimizing symptoms and delaying the effects of the disease. 

More than 30 celebrities have designed and autographed plates to be auctioned on EBAY from April 20 to May 5 as a fundraiser for the Parkinson Society Maritime Region in Canada. Proceeds from the auction will benefit research, education and support services.

The tulip is the Society’s symbol of hope and April is Parkinson’s Awareness Month. More than 1.2 million people in Canada and the US live with Parkinson ’s for which there is no known cause or cure.

Press Release

Advice and care from medical teams is invaluable but reassurance and empathy from a fellow person with Parkinson's is often essential for people facing the choices and challenges of a debilitating disease such as Parkinson's.

As part of its ongoing mission to ease the lives of as many people with Parkinson's as possible, the EPDA today launches an international initiative by enabling people with Parkinson's treated with DBS to share their experiences with other people in as many countries as possible.

Press Release

Advice and care from medical teams is invaluable but reassurance and empathy from a fellow person with Parkinson's is often essential for people facing the choices and challenges of a debilitating disease such as Parkinson's.

As part of its ongoing mission to ease the lives of as many people with Parkinson's as possible, the EPDA today launches an international initiative by enabling people with Parkinson's treated with DBS to share their experiences with other people in as many countries as possible.

EURODIS Press Release

EURORDIS is urging the rapporteur and the three parties involved to immediately restart their informal trialogue towards a first-reading adoption of the Regulation and to always keep in mind the interest of European patients.

Press Release

This makes Exelon, currently indicated for Alzheimer's dementia, the first medication available to treat dementia in Parkinson's patients in the European Union and the only cholinesterase inhibitor to be authorized for more than one type of dementia. Exelon has already received marketing authorization for dementia associated with PD in Switzerland and several Latin American countries, including Brazil.

The EU approval is based on the results of the EXPRESS study, a large-scale, randomized, well-controlled study involving 541 patients from 12 study centers in Europe and Canada and follows the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) earlier this year.

"Exelon provides an important advance in the therapy of dementia associated with Parkinson's disease", said Professor Werner Poewe, Head of Neurology, University Hospital, Innsbruck, Austria. "In the EXPRESS study, patients taking Exelon showed significant benefits regarding memory, concentration and behavioral problems. Patients and their caregivers reported in particular an increased interest and ability to conduct social conversations. This does not only translate into a better quality of life for PD patients suffering from dementia but also a substantial improvement in the quality of life for their families," Werner Poewe concluded.

At any one time, up to 40 percent of people with Parkinson's disease suffer from dementia . Patients with dementia associated with Parkinson's disease typically have problems with memory, concentration, activities of daily living, as well as depression, anxiety, apathy and hallucinations . However, probably due to the absence of treatment, current diagnosis rates are low.

"When my husband developed dementia associated with Parkinson's disease, I became a nervous wreck. He would ask me the same question again and again and again," said Mrs I., spouse of PD patient suffering from dementia. "Since he has started taking this new medicine he pays more attention, we have conversations and he can go to the shop by himself. It is wonderful. I know it won't go away completely, but these tablets have really changed our lives. Everything is different now."

WHO News Release

An estimated 6.8 million people die every year as a result of neurological disorders. According to a study published in the European Journal of Neurology, June 2005, in Europe, the economic cost of neurological diseases was estimated at about 139 billion Euros in 2004.

Access to appropriate care is difficult for many people with neurological disorders, their families and caregivers. WHO advocates for the integration of  neurological care into primary health care. For many people seeking medical care, primary health care is the only access to health care they have. In these settings, doctors can use low-technology interventions. Community-based rehabilitation is also an option. 

The report recommends a series of simple but effective actions. It argues for greater commitment from decision makers, increased social and professional awareness, strategies that address stigma and discrimination, national capacity building and international collaboration.

The new report was developed by WHO in partnership with key NGOs in the field of neurological disorders and organizations caring for people affected by these conditions. It benefited from contributions of experts and reviewers from all regions of the world.