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ProNAi Therapeutics Inc gets orphan status for cancer drug

ProNAi Therapeutics said it had reached a regulatory milestone - as its cancer drug PNT2258 was designated as an orphan by the US FDA.

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The candidate is designed to target cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer..

ProNAi Therapeutics Inc (NASDAQ: DNAI) said it had reached a regulatory milestone - as its cancer drug PNT2258 was designated as an orphan by the US FDA.

It was awarded the status for the treatment of diffuse large B-cell lymphoma (DLBCL).

The candidate is designed to target cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer.

Dr Nick Glover, president and chief executive of ProNAi, said: Achieving this regulatory milestone for PNT2258 is an important advancement in our registration-oriented development plan for this cancer drug in DLBCL, a disease for which there are limited treatment options, particularly in patients who relapse or do not respond to front-line therapies."

Orphan status is typically granted for novel drugs or biologics that are intended to treat rare medical diseases or conditions that affect less than 200,000 people in the USA.

It means the drug can qualify for certain incentives including seven years of market exclusivity after a drug's approval, tax credits for clinical research costs, and certain application fee waivers.

ProNAi has also previously received European Commission Orphan Drug Designation for PNT2258 for the treatment of patients with DLBCL.
 

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