January 2007

Jan 02, 2007
By PharmTech Editors

DRUG DELIVERY

Drug-Loaded Nanoparticles Image, Track, and Destroy Cancer Tumors

Ann Arbor, MI (Nov. 15)—Scientists at University of Michigan's Comprehensive Cancer Center ( http://www.cancer.med.umich.edu/) have devised a nanoparticle system that delivers a photodynamic drug directly to brain-cancer tumors. The particles carry "Photofrin" (Axcan Pharma PDT, Inc., Birmingham, AL, http://www.photofrin.com/), a cancer treatment that cuts off blood flow to the tumor, but minimizes damage to healthy tissue caused by free Photofrin in the system. Iron oxide, a contrast agent, enhances magnetic-resonance imaging of the particles, and a laser light activates the drug to collapse the vessels supplying blood to the tumor.

Funded by a nearly $12-million contract from the National Cancer Institute, the research study showed that the system avoids the challenges encountered by other brain-cancer delivery methods, including overcoming the blood–brain barrier, while attacking the tumor with higher doses.

So far, the delivery system has been tested in cell cultures and animal models. If the nanoparticle system proves effective in humans, scientists hope to re-examine previously developed drug candidates that were discontinued because of adverse side effects in patients.

Results of the study have been published in Clinical Cancer Research (Nov. 15, 2006).

–Maribel Rios

REGULATIONS

Von Eschenbach Confirmed as FDA Commissioner

Washington, DC (Dec. 7)—One of the last acts of outgoing Senate Majority Leader Bill Frist (R-TN) was to push through confirmation of Andrew von Eschenbach as the official head of the US Food and Drug Administration (Rockville, MD, http://www.fda.gov/). Frist had to invoke a seldom-used legislative procedure to overcome a number of "holds" on confirmation by fellow senators with serious grievances against the agency. But in the end, the Senate strongly endorsed FDA's new leader Dec. 7 with an 80–11 vote in favor of confirmation.

Von Eschenbach became acting head of FDA in September 2005 following the abrupt resignation of Lester Crawford from the job, and he was nominated to be commissioner in March 2006. Confirmation of the former director of the National Cancer Institute initially was delayed by Democrats angry about FDA's refusal to approve an over-the-counter version of the emergency contraceptive pill, "Plan B." More recently, other senators mounted protests over the sale of the abortifacient "RU-486" and FDA opposition to importation of drugs from overseas. Sen. Charles Grassley (R-IA) was furious over FDA's failure to provide all the information he demanded about possible fraud in clinical studies for the antibiotic, "Ketek."

The new commissioner will have to deal with these and a myriad of contentious issues as the official head of this high-profile agency, which has been attacked in recent years for lax oversight of drug safety, too-slow approval of new generic drugs, conflicts of interest among advisory committee members, and overly favorable treatment of Big Pharma. Von Eschenbach has weathered the drawn-out confirmation process by limiting his public comments to the need to spur innovation to reflect great progress in molecular biology, but he now will have to directly address these and other tough regulatory and legal issues. Inadequate agency funding and the need to renew the prescription drug user fee program are at the top of the list.