Patrys antibody gets orphan drug status in myeloma
Patrys (ASX:PAB) has been granted orphan drug designation in the EU for anticancer antibody PAT-SM6 in multiple myeloma.
The European Medicines Agency (EMA) has assigned orphan drug status to PAT-SM6, the company announced today.
Most notably, the designation will grant PAT-SM6 10 years of market exclusivity for the bone marrow cancer type.
Patrys will also be eligible to receive financial incentives and fee reductions from regulatory agencies and access to grant funding schemes. The EMA will meanwhile provide Patrys with scientific and protocol advice to help optimise drug development.
Patrys CEO Dr Marie Roskrow called the granting of orphan drug designation “an important milestone in PAT-SM6 development. [This will] support our efforts to move PAT-SM6 as quickly as possible through the clinical and regulatory development process.”
No single standard therapy exists for multiple myeloma patients that have relapsed or become resistant to conventional treatment. These patients have an expected survival time of just 6-9 months.
But during a recent phase I/IIa clinical trial of PAT-SM6 in end-stage, multiresistant multiple myeloma, two of six patients had demonstrated stable disease post treatment. Two others responded positively to chemotherapy they had previously been resistant to.
Patrys is also developing PAT-SM6 as a melanoma treatment, and the antibody was recently written up in scientific journal Melanoma Research.
Patrys (ASX:PAB) shares were trading 5.41% higher at $0.039 as of around 11.30 am on Thursday.
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