Breast Cancer Study Aims To Speed New Drugs

3 Comments

breastcancerA new research collaboration involving the National Institutes of Health, the FDA and three drugmakers will be launched today in hopes of getting cancer drugs to the market faster, and test five experimental breast cancer medsReuters writes.

The $26 million, five-year study will be called Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, and use DNA to match the best drug to each patient, and more quickly toss approaches that don’t work or are too toxic. The companies - Amgen, Abbott Labs and Pfizer - agreed to share info on using genes to predict how well patients respond as part of The Biomarkers Consortium, which includes the FDA, the NIH and PhRMA, the industry trade group.

“I think it is the theme for the future of research,” Anna Barker, deputy director of the National Cancer Institute, tells Reuters. “It is the best combination I have seen of state-of-the art biomarkers and state-of-the-art drugs that enable us to put drugs into patients and start evaluating them on a faster basis. It’ll speed up the whole process.”

Patients at 20 cancer centers will be tested after biopsies, but before any surgery, they will be treated with one of 12 different drugs. The group has FDA approval to drop and add drugs throughout the trial without having to stop to write a new protocol. Safeway is paying for a large part of experiment, and Johnson & Johnson, Genentech and Lilly will also provide funding.

UCSF Chancellor and former Genentech exec Sue Desmond-Hellmann says the approach could save the healthcare system money. “It has the opportunity to make clinical trials more efficient so we will spend less to develop new remedies,” she tells Reuters. “I predict that companies will be watching this.”

Jump to comments

Share

Comments

  1. I believe this new approach is positive and significant, rather than operating first. Very early but, looks promising.

  2. The DNA theory of cancer (a limited number of genes causes cancer, so cancers are more or less the same) hasn’t yet produced the types of breakthroughs we all want. Most everyone in cancer research seems to have centered their attention on DNA being the culprit.

    It would be expected that after more than thirty years of pursuing this one angle, and the numerous links that have been made, this should have lead to more progress than is presently observed. There is always a cytogenetic and a biochemical individuality in every cancer.

    Growing evidence suggests that gene-based prediction is not stable and little is known about the prediction power of a gene expression profile as compared to well-known clinical and pathologic predictors. Cancer prognosis from a handful of genetic mutations that drive a cell into uncontrolled growth, has failed many aspects of cancer.

Leave a Comment


6 + three =

Subscribe

RSS Feed

Comments feed for this post only.

Clear

Clear

All rights reserved, UBM Canon. Copyright, UBM Canon.

Thanks for trying out the new Pharmalot printing tools. If you're got any suggestions for how we can help you print better, please let us know by clicking on the contact link at http://www.pharmalot.com/