iSPY 2 Breast Cancer Clinical Trial

Feb 1, 2012 Issue of Clinical Cancer Research Reports from the 2010 Clinical and Translational Cancer Research Think Tank Meeting Sites FNIH’s I-SPY 2 Program

kyee — Thu, 02 Feb 2012 21:39:26 +0000

It has long been evident that cancer is a heterogeneous disease, but only relatively recently have we come to realize the extent of this heterogeneity. No single therapy is effective for every patient with tumors having the same histology. A clinical strategy based on a single-therapy approach results in overtreatment for the majority of patients. Biomarkers can be considered as knives that dissect the disease ever more finely. The future of clinical research will be based on learning whether certain therapies are more appropriate than others for biomarker-defined subsets of patients. Therapies will eventually be tailored to narrow biomarker subsets. The ability to determine which therapies are appropriate for which patients requires information from biological science as well as empirical evidence from clinical trials. Neither is easy to achieve. Here we describe some nascent approaches for designing clinical trials that are biomarker-based and adaptive. Our focus is on adaptive trials that address many questions at once. In a way, these clinical experiments are themselves part of a much larger experiment: learning how (or whether it is possible) to design experiments that match patients in small subsets of disease with therapies that are especially effective and possibly even curative for them. Clin Cancer Res; 18(3); 638–44. ©2012 AACR.

For the full report, go to the February 2, 2012 issue of Clinical Cancer Research, http://clincancerres.aacrjournals.org/content/18/3/638.full

JAMA publishes Commentary about accelerating approval of new cancer treatments

alanhu — Wed, 21 Dec 2011 11:21:33 +0000

The December 21, 2011 issue of the Journal of the American Medical Association includes a Commentary entitled “Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs” authored by Dr. Laura Esserman, MD (and Principal Investigator of the I-SPY 2 Trial) and Janet Woodcock, Director of the Center for Drug Evaluation and Research of the FDA.

The Commentary starts by stating the problem with getting new drugs to market today – “The development of new drugs is becoming increasingly expensive—and oncology drugs, in particular, have a high clinical failure rate. The current return on capital investment in drug development by US public companies was recently reported as less than 0.3%. The low probability of success, coupled with rapidly accelerating expenses, means that drug development is increasingly the purview of only 2 organization types: a few large companies and myriad small, venture capital–funded start-up firms. At an estimated cost of $1.0 billion to $1.8 billion for developing a successful new drug, funding for such risky ventures, particularly for oncology drugs, may diminish.”

The methodology behind the I-SPY 2 Trial is cited in this Commentary as one important example of how to dramatically speed up the process.

To read the full Commentary, click here: JAMA article (Dec 2011).full

I-SPY 2 Trial segment on NBC Nightly News

alanhu — Wed, 21 Dec 2011 11:09:11 +0000

The I-SPY2 Trial was featured in an NBC Nightly News segment on Monday, December 19th. The introduction by Brian Williams states “Right now, as you may know, it typically takes a decade or more to prove that a new drug works, and then to get it approved for women who desperately need it and get it to market. Our chief medical correspondent, Robert Bazell, tells us about an attempt to accelerate that process.”

Watch the video on NBC’s website:

http://video.msnbc.msn.com/nightly-news/45730121/#45730121

Safeway Raises $14.5 Million for Breast Cancer

alanhu — Mon, 05 Dec 2011 18:57:55 +0000

Nov. 8, 2011 - Safeway Inc. today announced its stores raised $14.5 million in October for breast cancer research. The company thanked its customers and employees for their commitment to finding a cure for the most common form of cancer for women.

UCSF’s Carol Franc Buck Breast Care Center is one of the recipients of the Safeway Breast Cancer Awareness campaign funds. “We are so grateful to Safeway for its leadership and vision, and to the company’s customers for every dollar they donate,” said Laura Esserman, M.D., Professor of Surgery and Radiology, and Director of the Carol Franc Buck Breast Care Center at the University of California, San Francisco. “Safeway is providing the critical resources to build systems to revolutionize breast cancer care.”

Read the full article here:

http://www.marketwatch.com/story/safeway-raises-145-million-for-breast-cancer-2011-11-08

ISPY 2 TRIAL Featured on PBS’s NEED TO KNOW Series

admin — Wed, 25 May 2011 21:00:37 +0000

Watch Potential Breakthroughs in Breast Cancer Research on PBS.

ISPY 2 is one of three breakthrough breast cancer clinical trials highlighted in this video.

Former FDA Commissioner Mark McClellan Talks About I-SPY 2

admin — Sat, 30 Apr 2011 02:46:14 +0000

Bio Century TV Webcast examines the need for regulatory reform to speed up drug development.

BioCentury This Week opens an important dialog on “Regulatory Innovation” in its Sunday, Nov. 28 broadcast, devoting the entire program to a conversation with Dr. Mark McClellan, Director of the Engelberg Center for Health Care Reform at the Brookings Institution, and the only person to head both FDA and Medicare. Dr. McClellan discusses obstacles in the current clinical trials process, and the resulting obstacles for drugs reaching patients in a timely and cost-effective manner.

Dr. McClellan specifically highlights the I-SPY2 Clinical Trial as a leading example of the type of regulatory reform necessary to move the industry forward.

The program can be viewed Here

Quintiles Provides $2.6M Grant for I-SPY 2 TRIAL

admin — Thu, 14 Apr 2011 21:54:41 +0000

Quintiles announced today that it will contribute a total of $2.6 million over four years to support I-SPY 2, a unique adaptive clinical trial designed to develop breast cancer therapies twice as quickly and at one-fifth the cost of current methods.

The design of the I-SPY 2 trial represents a major advance in breast cancer research with promising implications for other cancers and other diseases. Quintiles will make its grant in support of I-SPY 2 through QuantumLeap Healthcare Collaborative, a 501(c)(3) non-profit foundation and a co-project manager of the trial.

Click Here to read The full Press Release