UPDATED: GlaxoSmithKline slams brakes on trial of MS drug linked to data scandal
The London-based drugmaker slammed the brakes on a Phase I study of a compound known as GSK 2618960, pending a review of questionable data from a non-drug study of a suspected mechanism in multiple sclerosis. The study involved blood samples of MS patients and the role of a protein known as IL-7 in the disease. Evidence of falsified data in the study has cost two GSK researchers their jobs and prompted the drugmaker to take steps to retract the findings of the study published in 2010 in Nature Medicine.
"We have decided to pause an early Phase 1 trial in MS patients so we can reassess the data and determine whether there is a basis to continue in this indication," GSK spokeswoman Melinda Stubbee said in a statement.
The data scandal hit GSK soon after the drugmaker took unprecedented steps recently to provide researchers with access to de-identified, patient-level data from years of clinical trials. The scandal marked a setback for the company's scientific reputation, which executives have tried to restore with swift action in firing the top researcher in charge of the Shanghai R&D site where the alleged data fabrications took place. One other researcher resigned and three scientists have been placed on administrative leave.
The data were tainted enough to prompt GSK to take an additional step, stopping the Phase I study, which records show began in March and sought data on the safety of the compound in both healthy volunteers and MS patients. When GSK halted the study this week, investigators were in the middle of giving the therapy to healthy volunteers as part of the first of three stages of the trial, Stubbee told FierceBiotech. The trial is designed to treat healthy volunteers until the third stage, in which MS patients were expected to take the experimental drug. The study was also supposed to seek data on IL-7 activity after treatment.
Glaxo has not revealed a timeline for its decision on whether to continue development of the compound for MS, Stubbee said. The disease has attracted intense interest from biopharma companies seeking better ways to control the disease, which involves immune system attacks that cause nerve damage. Glaxo's Phase I trial was studying infusions of the drug candidate.
The data in question from the China lab did not test the drug candidate, Stubbee said. Yet those non-drug study results were part of a research program that supported development of the drug candidate. As the Financial Times reported, subsequent preclinical studies have provided evidence that the therapy could benefit patients.
UPDATED: The update corrects the fifth paragraph because of a misstatement from GlaxoSmithKline about how far the Phase I study had progressed before the company halted it. The study was in the first of three stages, not finished with the first two stages, as Fierce was told initially.