CYTR shares fell 24% to $1.39 in Tuesday morning trade after the Los Angeles-based biopharmaceutical company reported results from its Phase IIa clinical trial for its lead drug candidate arimoclomol in patients with amyotrophic lateral sclerosis, or Lou Gehrig's disease. CytRx said arimoclomol was shown to be safe and well tolerated at all three doses tested, and the company plans to proceed with activities associated with initiating a Phase IIb clinical trial in the first half of 2007, subject to Food and Drug Administration approval. The company also said that "due to the limited size and duration of the trial" arimoclomol did not show a statistically significant change in disease progression as measured by certain markers.
Arimoclomol is a small molecule that’s designed to stimulate a natural cellular repair pathway by activating compounds called “molecular chaperones.” It has been shown to extend life in ALS-affected mice and was well tolerated in healthy human volunteers in a recently completed phase 1 study. Proteins that are not folded correctly help lead to the symptoms of ALS.
Another disease that is caused by misfolded proteins is Prion disease. If you have ever heard of mad cow, same thing but the human version is called Creutzfeldt-Jakob [in the brain].
The numbers have to show a significant effect on the disease or the trial is considered a failure.
The FDA has also granted arimoclomol “fast-track” status, a program begun in 1997 to hasten review of potential treatments for serious or life-threatening diseases.
CytRX shares closed trading today at $1.35
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment