AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced Monday that its drug Ampligen (rintatolimod) was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer on December 17.
The designation gives AIM seven years of exclusivity rights after Ampligen reaches market. The program is meant to incentivize the development of therapies to treat unmet medical needs. It applies to drugs for the treatment, prevention or diagnosis of a rare disease or condition, one that affects fewer than 200,000 people in the US, or that meets cost recovery provisions.
In September, AIM announced that Ampligen delivered statistically significant positive pancreatic cancer survival results from a multi-year early access program conducted at Erasmus University Medical Center in the Netherlands. The median overall survival was approximately two-fold higher in the Ampligen arm compared to a historical control cohort.
READ: AIM says first patient dosed with Ampligen in study evaluating it as drug combo to treat patients with cancer and COVID-19
“This study data demonstrates that Ampligen has the potential to extend the survival rates of people suffering with pancreatic cancer significantly when compared to the traditional standard of care for this deadly disease,” CEO Thomas Equels said in a statement.
Pancreatic cancer is the fourth leading cause of cancer deaths in the US and is the only cancer among those most commonly diagnosed with a five-year survival rate at just 6%, according to the Pancreatic Cancer Action Network.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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