Hoth Therapeutics, Inc. a patient-focused clinical-stage biopharmaceutical company, announced it intends to pursue development of its HT-KIT mRNA Frame Shifting Therapeutic for multiple orphan diseases, which are rare diseases that affect less than 200,000 people in the US. HT-KIT targets a shared cell signaling pathway that may have therapeutic potential for multiple rare cancers, including: Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) Acute myeloid leukemia (AML) Gastrointestinal stromal tumors Drugs intended to treat orphan diseases are eligible to apply for Orphan Drug Designation (ODD), which provides multiple benefits to the sponsor during development and after approval. Hoth intends to pursue these benefits as part of the drug development for HT-KIT for treatment of rare cancers. Benefits of Orphan Drug DesignationUnder the Orphan Drug Act, drug companies can apply for ODD, and if granted, the drug will have a status which gives companies exclusive marketing and development rights along with other benefits to recover the costs of researching and developing the drug. A tax credit of 50% of the qualified clinical drug testing costs awarded upon drug approval is also possible. Regulatory streamlining and provide special assistance to companies that develop drugs for rare patient populations. In addition to exclusive rights and cost benefits, the FDA will provide protocol assistance, potential decreased wait-time for drug approval, discounts on registration fees, and eligibility for market exclusivity after approval. Key benefits of ODD: 7 years exclusivity post-approval Tax credits of 50% off the clinical drug testing cost awarded upon approval Waiver of new drug application (NDA)/ biologics license application (BLA) application fee Hoth recently announced that its novel anti-cancer therapeutic exhibited highly positive results in humanized mast cell neoplasm models, representative in vitro and in vivo models for aggressive, mast cell-derived cancers such as mast cell leukemia and mast cell sarcoma.
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