Researchers launched a unique collaboration on Wednesday aimed at getting cancer drugs to the market more quickly in which three companies will cooperate with the U.S. government and non-profit groups to test five experimental breast cancer drugs.
The five-year, $26 million study called Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, will aim to use DNA to match the best drug to each patient and to more quickly toss out approaches that do not work or are too toxic.
"They'll get the latest and greatest in terms of targeted drugs," Dr. Anna Barker, deputy director of the National Cancer Institute, said in an interview.
"I think it's the future. Government couldn't have done it on their own and these companies couldn't have done it on their own."
Unusually, the companies agreed to share information on using genes to predict how well a patient will respond as part of the Biomarkers Consortium, which includes the U.S. Food and Drug Administration and the National Institutes of Health.
"I-SPY 2 will provide a path to personalized medicine," said Dr. Laura Esserman, a breast cancer surgeon at the University of California San Francisco who will help lead the clinical trials. "We intend that every drug will graduate with a companion marker."
The trial will match patients to one of five experimental drugs:
-- ABT-888 or veliparib, being developed by Abbott Laboratories. The pill is a PARP inhibitor, which blocks a cell repair enzyme used by cancer cells.
-- AMG 655 or conatumumab, a targeted drug being developed by Amgen. It boosts a protein called APO/TRAIL that causes cancer cells to self-destruct.
-- Amgen's AMG 386, an angiogenesis inhibitor that stops tumors from growing blood vessels to nourish themselves.
-- CP-751,871 or figitumumab, being developed by Pfizer Inc to target the insulin growth factor receptor or IGFR.
-- Pfizer's HKI-272 or neratinib, another targeted therapy called a Pan ErbB inhibitor that targets several related receptors used by cancer cells.
The group is negotiating with other companies to add their experimental drugs to the mix.
"It'll speed up the whole process," Barker said.
The drug company lobby group PhRMA estimates it can take as long as 15 years and cost more than $1.3 billion dollars to take a new drug from laboratory to pharmacy.
Patients at 20 cancer centers will be tested right after they get tiny samples of tissue taken in biopsies. Before they ever get surgery, they will be treated with one of the drugs to see if this helps prevent tumor spread.
Up to 12 different cancer drugs will be tested. Unusually, the group has FDA approval to drop and add drugs throughout the course of the trial without having to stop it to write a whole new protocol.
When dealing with ADHD, learning disorders and autism, how many of us focus on the connection between our gut flora, what we eat, and our mental state?
In an interview Hollywood actor Jean Claude Van Damme has stated that he favoured Arabic food and that the diet followed by the Prophet Muhammad was one that was best for the human body
El Nino has devastated Mozambique's Gorongosa park with political tensions threatening the park
Cupping therapy is an ancient form of alternative medicine in which a therapist puts special cups on skin for a few minutes to create suction, the therapy itself dates back to the time of the Prophet Muhammad.
The Earth has hit a record high with an overall globel temperature the highest ever on record
The National Institute of Health may fund research into mixed embryos to better understand human diseases and develop therapies to treat them.
Travel across multiple time zones disrupts circadian rhythms resulting in jet lag
After five years the radiation levels in the Pacific Ocean are close to normal levels after a nuclear meltdown in the city
A trilateral pledge will see a jump from the current collective clean power levels of about 37% to 50% by 2025
Around 6.5 million deaths globally are attributed each year to poor air quality inside and outside, making it the world's fourth-largest threat to human health, behind high blood pressure, dietary risks and smoking
New World Drug Report research identifies heroin as deadliest drug
Zika has caused alarm throughout the Americas since cases of the birth defect microcephaly were reported in Brazil, the country hardest hit by the outbreak
Philadelphia has become the first big city in the US to place a tax on soda to tackle the obesity crisis
Average global temperatures startlingly higher than normal between March-May
Government study provides strongest evidence of cell phone health effects