About one year after Boston Life Sciences Inc. said it had filed for a special protocol assessment (SPA) regarding Altropane, its radioimaging agent for diagnosing Parkinson's disease - and just more than a month after disclosing an agreement had been reached - the Phase III trial has begun.
"It can take even longer," said Marc Lanser, president and chief scientific officer of the Boston-based firm, referring to the SPA. "There are a number of cycles you have to go through."
Boston Life Sciences' stock (NASDAQ:BLSI) closed Thursday at 92 cents, up 3 cents.
The SPA is "a binding agreement by the FDA that if the study is carried out according to protocol, they can't come back and second-guess it," Lanser said. Under the SPA program, the FDA evaluates whether the protocol for a clinical trial is adequate to meet scientific and regulatory requirements for marketing approval. As long as study results are positive, the way is clearer to approval. (See BioWorld Today, June 18, 2003.)
Designed to enroll about 500 subjects, the trial will test Altropane's ability to let clinicians tell Parkinsonian tremors from non-Parkinsonian, and is expected to finish in one year. Altropane could be the first product approved in a new class of molecular targeting diagnostic agents. When the Phase III study is completed, the new drug application - BLSI's first - will follow.
Lander said the guarantee provided by the SPA approach is catching on.
"It's a little bit esoteric, but more and more people are beginning to use it," he said.