FDA proposed fast-track for critical patients could benefit Pluristem
Oct 18, 2012 (Globes - McClatchy-Tribune Information Services via COMTEX) -- Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has been boosted by a report that US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has told scientific advisers that it considering a faster track for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. Pluristem is developing placenta-based cell (PLacental eXpanded or PLX) therapies for inflammatory and ischemic diseases.
Under the new pathway, the FDA would allow developers of such drugs to conduct smaller, faster clinical trial, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical need. Hamburg said that the FDA needed to take into account the needs of people with deadly or debilitating diseases, who may be willing to take on the risks of unproven drugs.
"A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group deputy director of medical programs Allan Coukell. "It would be good for developers, for companies and it would be good for public health."
Pluristem's share price rose 3.8 percent in morning trading on the TASE, following the report, to NIS 15.93, after rising 2.8 percent on Nasdaq yesterday to $4.07, giving a market cap of $193 million. |
