The benefits of fast track status include scheduled meetings seeking FDA input into development plans, the option of submitting a new drug application in sections rather than submitting all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.
CytRx recently initiated a phase II clinical trial with orally-administered arimoclomol for Lou Gehrig’s disease, and patient identification for this trial is underway at several clinical trial sites. Arimoclomol was granted orphan drug status designation by the FDA for the treatment of the condition in May 2005.
“We are delighted that the FDA has permitted us to begin this important clinical trial, and the fast track designation constitutes yet another significant milestone in our effort to help those suffering from this deadly neurodegenerative disease for which there is no effective treatment,” said Steven Kriegsman, president and CEO of CytRx.
Arimoclomol is believed to function by a mechanism that stimulates a normal cellular protein repair pathway through the activation of “molecular chaperones.” Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones with its drug candidates could demonstrate therapeutic efficacy over Lou Gehrig’s disease as well as a broad range of additional diseases.