Cincinnati Children's Hospital Medical Research Scores Big Win: New Drug Quickly Approved, Shrinks Kids' Brain Tumors



Children's Hospital



CINCINNATI (TDB) -- Swiss pharmaceutical giant Novartis announced today in Europe the FDA granted accelerated approval for a new drug that shrinks brain tumors otherwise requiring surgery.  The drug was tested on 28 patients at Cincinnati Children's Hospital Medical Center and nearly a third had a reduction in the size of their tumors.  Doctors say the drug should fill an unmet medical need.  All of the patients were being treated for subpendymal giant cell astrocytoma, known to physicians as SEGA, an inherited disease related to a genetic disorder called tuberous sclerosis.  Tuberous sclerosis can cause severe mental retardation and seizures.  Novartis credited the breakthrough to Cincinnati Children's Hospital in an announcement from Basel today. Early approval came because the results in Cincinnati were so dramatic. Still, Novartis said more studies are taking place:

 
"The accelerated approval of Afinator [generic name everolimus} is based on an open-label, single-arm 28-patient study conducted by Cincinnati Children's Hospital Medical Center. The effectiveness of Afinator is based on an analysis of change in SEGA volume. A Phase III study is under way that compares Afinator to placebo to explore the clinical benefits of Affinator for patients with treatment associated with TS. 

"Prior to this FDA approval, the only treatment option for growing SEGAs, which primarily affect children and adolescents, was brain surgery. Tuberous sclerosis is a genetic disorder affecting approximately 25,000 to 40,000 people in the U.S. that may cause tumors to form in vital organs. SEGAs, benign brain tumors, occur in up to 20% of patients with TS."

Cincinnati Children's opened its clinic for tuberous sclerosis in the early 1990s and it now has a team of researchers battling the genetic disorder. Dr. David Neal Franz is the clinic director and you can learn more about him by clicking here.  Franz did not start out to become a physician.  He went to Earlham College in Richmond, Ind., and majored in history and literature.  That small liberal arts school set Dr. Franz on the path, though, that should help make life a little bit easier for many people on this planet.

Ohio's Concord Grape Crop: Researchers Spot Anti-Breast Cancer Compound In The Color Purple

COLUMBUS (TDB) -- A new medical study suggests that Concord grapes, the most common variety of grapes grown in Ohio, contain natural compounds that may help protect against breast cancer. The research has just been published by the Journal of Medicinal Foods and says 100 percent grape juice was able to block a known carcinogen, benzo (a) pyrene, from connecting to the DNA of healthy human breast cells. The experiments were done in test tubes.

Scientists suspect that anthocyanins, the anti-oxidants that give grape juice its deep purple color, warrant further research. It could be good news for Ohio, which is positioning itself as a player in the bio-tech industry. Grapes grow well in the state, and the research may prove a way to harness Ohio's existing agricultural production base to its emerging medico-scientific economic development plans.

Keith Singletary, a University of Illinois scientist, headed the research team, which included Monica Giusti from Ohio State University's department of food science and technology. The team has been investigating the medicinal properties of grapes, which are believed to increase enzymes that metabolize and detoxify carcinogens. Another way of saying what the scientists are doing: They are digging into the relationship between diet and cancer.

Concord grapes are large and blue. They are the most common and hardiest variety of grapes on the 3,000 acres of vineyards now scattered across Ohio, mostly near Lake Erie and the Ohio River. Concords are harvested during September and early October, and Ohio has the nation's 8th largest grape crop, most of which goes to wine and juices. Concords are specifically used for non-fermented grape drinks. In wines, it can wind up as Vin Rose or Haut Sauterne.

Welch Foods Inc., the nation largest grape juice manufacturer, was touting the research as showing that grapes need more study as a possible breast-cancer preventive.

"This research is the latest to suggest that Concord grape juice may be of value in maintaining breast health by suppressing oxidative stress and inhibiting DNA damage to cells that can lead to the initiation of cancer, or in helping to slow the progression of breast cancer by slowing the multiplication of cancer cells. Dies in high natural antioxidants have been association with a reduced risk of some types of cancers. . . .

Other researchers have been investigating the medicinal properties of grape seeds, which also appear to offer healthy lifestyle benefits that are as yet not fully understood.