TB Alliance, BG Medicine explore biomarkers

Project aims to streamline, shorten drug development for tuberculosis therapies

NEW YORK—The Global Alliance for TB Drug Development (TBAlliance) and BG Medicine Inc. have entered into a collaboration to identifybiomarkers for drug efficacy in the treatment of tuberculosis (TB).
"The clock is ticking, we need to find a faster cure for TBand new biomarkers could expedite our search," says Dr. Maria C. Freire,president and CEO of the TB Alliance. "Clinical trials for TB drugs areespecially time-consuming, so a new biomarker that helps us test novelmedicines faster and more efficiently will be a tremendous asset in developinga better, affordable TB cure."
Today, clinical trials for TB drugs are based on standardtreatment regimens requiring six to nine months of therapy, with efficacyevaluation taking another one to two years to measure relapse rates in thosepatients who have not been successfully cured. In total, clinical trialsrequired to register a TB drug can take a minimum of six years, much longerthan trials for other infectious diseases. The results are high drugdevelopment costs and long delays in introducing new medicines.
"This project demonstrates the broad applicability of thesystems approach to improving drug development to make novel and improvedtherapies available sooner," says Dr. Pieter Muntendam, president and CEO of BGMedicine. "Biomarkers offer a more predictable and less costly avenue inproduct development. Nowhere is this more badly needed than in developing drugsfor TB."
The TB Alliance and BG Medicine will apply systemsapproaches to identify biomarkers for two purposes: first, to provide an earlyindication of a drug's ability to shorten treatment time during Phase IItesting; and, second, to act as a surrogate marker of treatment efficacy thatwould shorten Phase III trials and eliminate the need to follow patients for upto two years post-therapy to determine relapse rates.
The TB Alliance and BG Medicine are conducting thissix-month study in collaboration with Colorado State University (CSU). CSU,with its expertise in TB animal model drug testing, is providing the samplesthat will be analyzed by BG Medicine through its proteomic and metabolomicanalytical platforms. Funding for both BG Medicine and CSU is provided by theTB Alliance. The study is made possible through a grant from the Department ofDevelopment Cooperation of the Netherlands Ministry of Foreign Affairs, theleading Dutch government agency for foreign assistance.
TBaffects one-third of the world's population, resulting in nine million newcases of active disease and two million deaths each year. Current projectionsof TB incidence and mortality reflect the need for shorter, more effective TBtherapy. An estimated 1 billion people will be newly infected between 2000 and2020, 200 million will fall ill and 35 million will die.


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