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AIM ImmunoTech Gets Orphan Drug Tag For Ampligen In Pancreatic Cancer

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  • AIM ImmunoTech Inc's (NYSE: AIM) subsidiary, NV Hemispherx Biopharma Europe, has received formal notification from the European Commission for Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer.
  • Among other benefits, products with Orphan designation can enjoy up to ten years of protection from market competition from similar medicines with similar active components and indications.
  • Earlier, the Committee had recommended that Ampligen receive the designation for pancreatic cancer.
  • Two weeks ago, the Netherlands regulatory authority approved rintatolimod (Ampligen) treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program.
  • In September last year, a statistically significant positive pancreatic cancer survival benefit was observed in the Ampligen arm compared to a historical control cohort seen in a multi-year EAP conducted at Erasmus University Medical Center in the Netherlands. 
  • Price Action: AIM stock gained 11.7% at $2.53 on the last check Wednesday.
 

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Posted-In: European Commission Orphan Drug DesignationBiotech News Penny Stocks Health Care FDA General

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