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FDA grants orphan drug designation to SolaranRx's SRX-1177 for malignant melanoma treatment
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SolaranRx announced it has received orphan drug designation from the FDA for SRX-1177, its product for treating stage IIB to IV malignant melanoma.
SRX-1177 targets melanoma tumors with a novel radiolabeled peptide that selectively attaches to melanocortin-1 receptors over-exposed on about 80% of melanoma samples, according to a press release from SolarnRX.
A standard imaging scan is used with patients injected with SRX-1177 to determine whether they are suitable for treatment, the release stated. Targeted radiation is then delivered through therapeutic doses of SRX-1177 to kill cancer cells but have minimal impact on patients’ healthy cells.
According to the company, the combination of therapy and diagnostics helps create a unique theranostic product for metastatic melanoma.
The FDA grants orphan drug status for novel drugs or biologics to treat rare medical diseases or conditions that affect fewer than 200,000 people in the United States, according to the release. Incentives included with the designation include 7 years of market exclusivity after the drug’s approval, tax credits for clinical research costs and application fee reductions.
“Our efforts are concentrated on advancing development of SRX-1177 through preclinical studies and scaling manufacturing capabilities, ultimately leading to clinical trials,” Les Stewart, CEO and co-founder of SolaranRx, said in the release.
Reference: www.solaranrx.com.