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Investing.com -- Cellectar Biosciences (NASDAQ:CLRB) stock surged 27% after the company received Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for its iopofosine I 131 treatment in relapsed or refractory pediatric high-grade glioma.
The designation underscores the potential of Cellectar’s cancer-targeting radioconjugate monotherapy to address a devastating cancer affecting children and young adults. The FDA had previously granted Orphan Drug Designation for the treatment.
If approved, Cellectar may be eligible to receive a Priority Review Voucher, which can expedite future review processes or be sold to other companies. The designation is intended to encourage development of therapies for serious diseases primarily affecting individuals under 18 years of age.
Interim data from the company’s ongoing CLOVER-2 Phase 1b trial showed promising results. Patients receiving a minimum 55 mCi total administered dose experienced an average of 5.4 months of progression-free survival (PFS) and 8.6 months of overall survival (OS), compared to the typical 2.25 months PFS and 5.6 months OS reported in literature for this condition.
Patients who received additional dosing cycles showed even better outcomes, with an average PFS of 8.1 months and OS of 11.5 months. Two case studies highlighted in a recent presentation demonstrated significant tumor reduction and extended survival in heavily pre-treated patients.
"We believe iopofosine I 131 represents a compelling opportunity for strategic collaboration to accelerate development and bring a potentially first-in-class therapy to patients who urgently need new options," stated James Caruso, president and CEO of Cellectar.
The treatment was reported to be well tolerated with a safety profile consistent with the company’s previous data, showing primarily manageable hematologic adverse events with minimal off-target effects.
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