The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: National Cancer Institute

Personalized Medicine Conference Highlights a Busy Month

Last week, Harvard Medical School held a conference entitled “Personalized Medicine: The Time is Now.”  Is the time now?  Looking around, it seems like personalized medicine has had a pretty good month:

PBMs Drive Demand

CVS Caremark, the country’s largest pharmacy services provider, partnered with Generation Health to expand pharmacogenomic testing for cancer, cardiovascular diseases, and HIV.  According the GenomeWeb story, CVS Caremark joins Medco‘s 60 million people, meaning the top two PBMs in the U.S. are investing heavily in personalized medicine.

Though note that PBMs’ interest in personalized medicine isn’t wholly neutral, as this post at IVB by Michael McCaughan points out.

Corporate Deals

Three pairs of corporations found the economics sufficiently attractive to strike new partnership deals:

NCI Investment To Advance Research

Finally, helping ensure that there is sufficient research output to advance the field, the National Cancer Institute put out a program announcement entitled “Development, Application, and Evaluation of Prediction Models for Cancer Risk and Prognosis,” which NCI says will be “essential for tailoring therapy to appropriate groups of patients.”

Counterpoint

Still, as the Washington Post notes in its article on the new “Ignite Institute” in Fairfax County: “[y]ou’d be right, of course, to be a bit skeptical,” citing decades of promise and so far few commercial successes in the region.

Bottom Line

Given this month’s developments, our Magic 8-Ball says “Outlook good.”  Stay tuned to see what develops, particularly as personalized medicine and comparative effectiveness grow in prominence at the same time.

Bookmark and Share

Abbott’s ABT-888 Guinea Pig: First Phase 0 Clinical Trial Completed

A press release from the National Cancer Institute yesterday (picked up today by BIO SmartBrief and FierceBiotech) touts a successful first:

The first phase 0 clinical trial of a drug in cancer treatment, involving 13 patients with advanced cancers, showed that the drug, ABT-888, affected its target and was well tolerated. Most importantly, this trial showed that it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly.

The point of a “phase 0″ (phase zero) trial is to focus “primarily on tolerance and the ability of the drug to hit a target.”  The advantage of phase 0 trials is that they:

involve nontoxic drug doses that are administered for short periods of time to small numbers of patients, [so] the preclinical toxicology data required … are less than those required to support a phase I trial; thus, these first-in-human trials can be initiated earlier in the drug development process than traditional phase I studies.

Phase 0 trials come with their own statistical evaluation scheme and endpoints, and although more long-term data is needed on the impact of this approach on timetables and success rates, “phase 0 trials will be a key part of a new approach” in the NCI Experimental Therapeutics (NExT) program.

Here’s NCI’s FAQ from the 2007 introduction of the program, with more info on NExT and phase 0 trials.

Bookmark and Share

Follow

Get every new post delivered to your Inbox.

Join 129 other followers