HATFIELD, England, July 26, 2012 /PRNewswire/ -- Eisai today announces the publication of results from a pivotal Phase III study[1] of Fycompa(R) (perampanel), the first in a new class of adjunctive treatment in people with partial-onset seizures, with or without secondary generalised seizures, aged 12 years and older. According to research published in the August 2012 issue of Neurology(R), the medical journal of the American Academy of Neurology, the Study 304 data, published online today show that once-daily, adjunctive perampanel at doses of 8 or 12mg improved seizure control in people with uncontrolled partial-onset seizures, and that both doses had an acceptable safety and tolerability profile. Study 304 is one of three pivotal Phase III studies in the EXPLORE (EXamining Perampanel Observations from Research Experience) clinical trial programme. The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some people. The incidence of uncontrolled epilepsy remains high despite many new anti-epileptic drugs (AEDs) and it is estimated that the proportion of people diagnosed with epilepsy who, are or will become, refractory to treatment range from 20% to as high as 40%.[2] Perampanel selectively (non-competitively) blocks postsynaptic AMPA receptor-mediated excitatory neurotransmission.[3,4] Epileptic seizures are primarily … Continue reading →

PALM BEACH, Fla. The Genetics Policy Institute announced that it has joined with the Oakland University William Beaumont Institute for Stem Cell and Regenerative Medicine as an organizing partner of the Second Midwest Conference on Stem Cell Biology and Therapy Oct. 5-7 at Oakland University in Rochester. GPIis proud to partner with ISCRMin this important scientific conference, which will showcase the latest discoveries from top laboratories around the region and beyond, said Bernard Siegel, GPIexecutive director and founder of the annual World Stem Cell Summit. We take pride that ISCRMwas officially launched at our 2010 World Stem Cell Summit in Detroit. GPIs support for this conference underscores our continuing commitment to advance stem cell research in the Midwest. Researchers from hospitals, medical organizations, academic institutions and the business community throughout the country will discuss not only the latest advances in this rapidly expanding field of medical science, but the ethical and moral issues that surround it. There are unlimited opportunities in the rapidly progressing areas of stem cell biology and regenerative medicine, said Dr. RasulChaudhry, director of the ISCRM. This conference is a great way to showcase not only Oakland University, Beaumont Health System, and ISCRM but the strength of … Continue reading →

Peter Aldhous, San Francisco bureau chief It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use. It was on this basis that in 2008 the FDA began moves to shut downRegenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx. Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling. Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. "This is really round one," he says. "Our position remains that a patient's cells … Continue reading →