ALBUQUERQUE, N.M.--(BUSINESS WIRE)--SolaranRx announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s lead product, SRX-1177, for the treatment of stage IIB to IV malignant melanoma, a deadly form of skin cancer. SolaranRx’s technology precisely targets deadly melanoma tumors with a novel radiolabeled peptide that selectively attaches to melanocortin-1 (MC1) receptors over-expressed on about 80 percent of melanoma samples.
Patients are injected with SRX-1177 to determine suitability for treatment through a standard imaging scan. Therapeutic doses of SRX-1177 are then injected to deliver targeted radiation to kill cancer cells, with minimal impact on healthy cells. This merger of therapy and diagnostics creates a unique theranostic product for metastatic melanoma.
Melanoma is the most aggressive and deadly form of skin cancer. Once melanoma spreads beyond the primary lesion, treatment becomes increasingly difficult and survival rates decrease dramatically. Current treatments don't work for a majority of patients and have serious, sometimes fatal side effects.
SolaranRx CEO and Co-Founder Les Stewart said achieving the Orphan Drug Designation gives the company access to several benefits and incentives that will aid in the development and commercialization of SRX-1177 as a new treatment option for metastatic melanoma. “Our efforts are concentrated on advancing development of SRX-1177 through pre-clinical studies and scaling manufacturing capabilities, ultimately leading to clinical trials. We are pleased the FDA recognized the significant need for new treatment options for metastatic melanoma, which according to the American Cancer Society, will claim the lives of 9,940 Americans in 2015.”
The FDA Orphan Drug Designation grants an orphan designation to new treatments for conditions affecting less than 200,000 Americans. The benefits of the orphan drug designation (ODD) include tax credits for clinical research costs, seven-year period of marketing exclusivity, and waiver or partial payment of application fees. The designation does not change the normal regulatory requirements for approval.
About SolaranRx, Inc.
SolaranRx, Inc. is developing a new class of therapies and companion imaging agents for the treatment of metastatic melanoma. This merger between therapeutics and diagnostics—often referred to as theranostics—constitutes a new level of personalized medicine for treating metastatic melanoma. SolaranRx seeks to improve treatment and patients’ quality of life, giving new options to clinicians and hope to patients. Visit www.SolaranRx.com.
