Immix Biopharma Receives Institutional Review Board Approval to Enroll Pediatric Patients in Upcoming IMX-110 Clinical Trial, Key Requirement for U.S. Food and Drug Administration Approval of Rare Pediatric Disease Priority Review Voucher
- Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”)
- While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report on drug development by the Government Accountability Office
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LOS ANGELES, Nov. 11, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today announced that it has received Institutional Review Board (“IRB”) approval to enroll pediatric patients in its upcoming IMX-110 clinical trial. Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”). PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA. While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report on drug development by the Government Accountability Office.
“We are pursuing FDA approval of IMX-110 in pediatric rhabdomyosarcoma, a life-threatening cancer in children and the subject of our rare pediatric disease designation from FDA, as well as approval of IMX-110 to treat soft tissue sarcoma in adults,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “Our key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients.”
Rhabdomyosarcoma (“RMS”) is a high-grade, malignant cancer in children, the most common soft tissue sarcoma in pediatric and adolescent populations. The prevalence of RMS in the United States is approximately 20,000 children of all ages. The five-year survival rate ranges from 20% to 30% for children in the high-risk group where cancer spreads widely in the body.
IMX-110 is the first clinical-stage product of ImmixBio’s SMARxT Tissue-Specific™ Platform, which produces Tissue-Specific Therapeutics that accumulate at intended therapeutic sites at 3 to 5 times the rate of conventional medicines.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio™) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases. Our proprietary SMARxT Tissue-Specific™ Platform produces drug candidates that circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all 3 components of the tumor micro-environment (TME). We believe ImmixBio’s TME Normalization™ technology severs the lifelines between the tumor and its metabolic and structural support. Learn more at www.immixbio.com
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Immix Biopharma, Inc.
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