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ImmunoCellular Drug Granted Orphan Drug Status

Posted on: 06/11/2010

ImmunoCellular Drug Granted Orphan Drug Status

ImmunoCellular Therapeutics Ltd. on Friday said that its lead experimental cancer vaccine had been granted orphan drug status by the U.S. Food and Drug Administration, which provides some advantages in commercializing the treatment.

The Los Angeles biotech said it will now be eligible for grant funding for clinical trials, tax credits, an accelerated FDA approval process and exclusive marketing privileges for up to seven years after the drug is approved.

The U.S. orphan drug designation provides incentives to companies with products that aim to treat a rare disease or condition, one that affects fewer than 200,000 Americans.

ImmunoCellular focuses on immune-based therapies for the treatment of brain and other cancers. The company recently completed early stage trial of its cancer vaccine, called ICT-107, which targets processes leading to the most common and most aggressive type of primary brain tumor. Despite this, the condition occurs in only two or three cases cases per 100,000 people in North America and Europe, hence the drug’s eligibility for orphan drug status.

"The designation should facilitate a shorter time period to approval and reflects the FDA’s views on the importance of developing a treatment which will improve survival outcomes for those afflicted with this terrible disease,” said Chief Executive Manish Singh in a statement.

Shares were up 6 cents, or 4.4 percent, to $1.30 in midday trading on the Over-the-Counter Bulletin Board.


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