Hot Topics

Stem Cell Status
The most recent attempt at developing a mass-produced drug from human stem cells started with two steps back. Osiris Therapeutics’ Prochymal failed in two late-stage clinical trials as it was no more effective than the placebo in treating graft-versus-host disease (GvHD). Prochymal is made with mesenchymal stem cells obtained from young adults’ bone marrow. The drug is designed to subdue the aggressive response that occurs in GvHD, a potentially fatal complication of bone marrow transplantation as the immune cells in donated marrow attack the recipient’s organs.
In a step forward in stem cell research, scientists made good use of the fat extracted during liposuction. Unwanted fat cells from flabby arms and drooping bellies were transformed into induced pluripotent stem cells, or iPS cells. Normally, skin cells are used to make iPS cells, but the team at Stanford University's School of Medicine in California found that fat cells were easier to work with, according to the Proceedings of the National Academy of Sciences. To create iPS cells, genes are used to return extracted cells to a more immature state, in which they can then be redirected to form any type of cell.
—Andrew Matthius

One Less
Merck’s Gardasil, the vaccine for young women to prevent cervical cancer, may soon become an equal opportunity drug as an FDA advisory panel recommended it be approved for use in young men. Gardasil targets four strains of human papillomavirus, or HPV, two of which are responsible for 90% of genital warts cases in both men and women. The other two strains cause 70% of cervical cancer, according to CNN. The vaccine was not originally approved for or tested on men. Merck recently conducted three new trials with more than 5,000 males ages 9 to 26 in various countries including the U.S. The vaccine was 89% effective in preventing genital warts, but significantly less effective in participants already exposed to HPV, according to WebMD. Side effects included headaches, low-grade fevers, and pain at the injection site.
“Essentially, we have a fantastic opportunity to extend the benefit of the vaccine to men,” said Anna Giuliano, the trials' principal investigator, to CNN. "This is a sexually transmitted infection. If we can reduce infection in men, we have the potential to have a much broader public health impact by reducing the overall burden of disease in the community at large." The vaccine would cost $390 total and be administered to males ages 9 to 26 in three doses over a period of six months. Gardasil has yet to be approved for use in males, but the FDA usually follows the recommendations of its advisory committees. This advisory panel also recommended that GlaxoSmithKline’s Cervarix, a new HPV vaccine, be approved for use in young women 10 to 25 years of age. No word yet on young men. —A.M.

EU Approval
St. Jude Medical is hoping its new Brio neurostimulator, the world’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device, can provide big relief to some of the estimated 6.3 million Parkinson’s disease patients worldwide. The company announced that its new DBS device received CE Mark approval, meeting all health and safety requirements for sale in the European Union. A 67-year-old man who has suffered from Parkinson’s disease for more than 26 years became the first person implanted with the Brio. “Deep brain stimulation therapy is often the preferred treatment for many Parkinson’s disease patients,” said Dr. Volker Sturm, chairman of neurosurgery at the University Hospital of Cologne in Germany where the surgery was performed. “For these patients, device size and longevity are important considerations. The small size of the Brio neurostimulator is a real improvement and a good choice for this patient.”
The Brio, usually implanted near the collarbone, is about the size of a man’s wristwatch with a 10mm profile and approximate weight of 29 grams. It also has the greatest recommended implant depth of any rechargeable DBS device. These aspects combine to make it less noticeable and more comfortable for patients. The Brio’s battery has a 10-year longevity approval and can be recharged through a portable, wireless charging system. The battery’s long life helps maximize the time between device replacement procedures.
The Brio DBS system works by delivering mild electrical pulses to stimulate areas in the brain associated with motor control to influence the irregular nerve signals responsible for the symptoms of Parkinson’s. St. Jude Medical is developing DBS applications for other neurological and psychiatric disorders including depression and essential tremor. —A.M.