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Réponse à: Re: Hé les ami(e)s des myasthénqiues .... envoi de micheliane le 07 Aout 2004 17:10:22:

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Aspreva Initiates Phase III Trial with CellCept for Myasthenia Gravis
June 7, 2004

Aspreva Pharmaceuticals, in partnership with F. Hoffmann-La Roche, today announced the initiation of a global phase III study of CellCept (mycophenolate mofetil) for myasthenia gravis (MG).

This randomized, placebo controlled clinical trial builds on the results of earlier promising studies, to fully investigate the efficacy and safety of CellCept for patients with this debilitating neurological autoimmune disease. No new medications for this condition have been approved since 1955.

The CellCept MG trial, which has received health authority approval in the US, Canada and the UK, will ultimately recruit 136 patients at 22 sites in five countries. Local ethics committee approvals are pending. Results of the study are expected in 2006.

This study is an important part of Aspreva’s development programme designed to achieve regulatory approval for existing marketed drugs for less common, often neglected conditions. Last year Aspreva announced that through a unique partnership agreement it had acquired the global* rights from Roche to develop the transplant medication CellCept for all autoimmune conditions.

Physicians managing patients with less common diseases often have little or no hard clinical evidence on which to base their treatment decisions, and often have to rely on anecdotal information. Aspreva’s clinical trials programs, which will enhance the evidence base, and aims to achieve regulatory approval, will increase the availability of important medications for these patients.

Professor of Neurology and MG clinician and researcher at Duke University Dr Donald Sanders commented: ‘Patients with MG often have to sacrifice disease control in order to reduce the side effects of their treatment. The Aspreva study is of particular interest as it should allow us to see if CellCept will enable reduced reliance on steroids while maintaining effective disease control. This trial will provide the hard clinical evidence we need to make the best treatment decisions for our patients. Based on published reports, largely uncontrolled, it is highly probable that a well-designed study of MMF, such as this, will demonstrate efficacy.’

The Myasthenia Gravis Foundation of America has welcomed the study. Chairperson, Esther Land said: ‘This is the first phase III study of a new medication for myasthenia gravis for 49 years. It is so exciting for us that a company like Roche, through their partnership with Aspreva, is paying attention to the needs of MG patients. Increased disease control with reduced drug toxicity is an important goal for the MG Foundation. We await the outcome with interest.’

CellCept is also currently being investigated for the treatment of a number of other neurological autoimmune conditions including multiple sclerosis.

* excluding Japan

About Myasthenia Gravis
Myasthenia gravis is a rare, debilitating neurological autoimmune disease. Patients with MG produce auto-antibodies which prevent the nerves from sending messages to the muscles. The resulting muscle fatigue makes it hard for patients to perform even simple every-day tasks such as carrying the shopping or even brushing their hair. Eye muscles can be affected resulting in double vision. In extreme cases breathing and swallowing can become difficult with life-threatening consequences. Complete remission is infrequent and long-term immunosuppression is usually required.
The overall prevalence of the disease is 13 to 15 per 100,000, with a predominance seen in women age 20-40 and men age 50-70. The prevalence of MG over the last 50 years has steadily increased.
Current therapies for MG include:
• short-acting agents, such as cholinesterase inhibitors, intravenous IgG and plasma exchange. These treatments do not offer sustained symptom control or long-term remission.
• thymectomy, surgical removal of the thymus, which can sometimes offer complete remission in a subset of young patients.
• long-term immunosuppression, which is the main-stay of current treatment. Corticosteroids are used almost universally, along with other agents to spare steroids, such as azathioprine and cyclosporine. The damage to the acetylcholine receptors by the auto-reactive antibodies is completely reversible if the autoimmune process can be controlled, but many patients can not achieve optimal disease control at a safe steroid dose.

There are no approved treatments for MG with the exception of cholinesterase inhibitors. There is an urgent need for new treatments that offer faster onset of action, better disease control, and superior steroid tapering with a more favorable safety profile.

About CellCept
CellCept was first approved in 1995 for renal transplant, and the indications for CellCept now also include heart, liver and pediatric kidney transplants. In the USA CellCept is the leading branded transplant medicine for the prevention of rejection, and it has been used to treat approximately 593,000 transplant patients worldwide. In over a decade of clinical experience CellCept has demonstrated that it provides potent immunosuppression, preventing organ rejection without the long-term toxic effects associated with other therapies. For example, CellCept has been shown to significantly reduce the incidence of rejection - by about 50% - within the first 6 months of kidney transplantation, without any observed additional kidney or liver toxicities. CellCept prevents immune reactions through a unique mode of action which is highly relevant for many autoimmune disease patients.

About Aspreva Pharmaceuticals
Aspreva Pharmaceuticals is focused on addressing the needs of patients with less common diseases by developing new indications for approved medicines. Aspreva’s asset partnering program allows its partners to maintain core brand focus while extending the benefits of their medicines to a broader patient population. Aspreva has also initiated a clinical trial of CellCept for the treatment of the rare?? skin disorder pemphigus vulgaris, and is in the final planning stages of a phase three clinical trial of CellCept for the treatment of the autoimmune disorder lupus nephritis.

About Roche
Hoffmann-La Roche (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world’s leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well being and quality of life. Among the company’s areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C. For more information on the Roche pharmaceuticals business in the United States, visit the company’s website at: http://www.rocheusa.com.


For more information:

Sandra MacPherson
Aspreva Pharmaceuticals
250-744-2488

• Re: Hé les ami(e)s des myasthénqiues .... Micheliane 08/08/2004 17:25:05 (1)
  • Re: Hé les ami(e)s des myasthénqiues .... M. Ahmed Idrissi 08/08/2004 22:28:09 (0)