Allon Updates Progress of Pivotal Phase 2/3 Clinical Trial
Product News May 20, 2011
Allon Therapeutics Inc. has issued an update on the progress of the pivotal Phase 2/3 clinical trial that is evaluating the Company's lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal degenerative brain disease.
Gordon McCauley, Allon's President and CEO, said the trial has enrolled approximately 50% of the 300 patients specified in the protocol. Enrollment began in the fourth quarter of 2010.
The trial is being conducted under a Special Protocol Assessment (SPA) granted by the United States Food and Drug Administration (FDA), which ensures that the agreed clinical trial design meets the FDA's expectations for a pivotal study.
"Our progress is right on track with our estimate to complete enrollment by the end of 2011 and to report data about a year later," said McCauley.
McCauley continued, "The pace of enrollment is a testament to the patients, caregivers, investigators, and advocacy groups who have been tremendous partners, and who certainly hope this trial will generate data necessary for marketing approval of davunetide as a treatment for PSP."
McCauley also said the trial's Data Safety and Monitoring Board (DSMB) recently approved the continuation of the trial. A DSMB is an independent group of clinical experts with the primary responsibility of monitoring the safety and well-being of subjects and to assure scientific integrity of the study.
A DSMB is independent of the company and the clinical investigators, who are blinded from the safety and efficacy data until all treatment has been completed.