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Citius Pharmaceuticals Receives FDA Response and Guidance to Pre-IND Consultation Submission for Mino-Wrap
-- Mino-Wrap's novel approach to reducing post-mastectomy infections associated with the use of a tissue expander is on track in its preclinical stage -- Some
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"-- Mino-Wrap's novel approach to reducing post-mastectomy infections associated with the use of a tissue expander is on track in its preclinical stage\n -- Some next steps for Mino-Wrap development include designing and executing a large animal study and the clinical plan\n\n\nCRANFORD, N.J., Dec. 9, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced its receipt of a written response and guidance from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) consultation request for its Mino-Wrap briefing package. Through its global license agreement with the The University of Texas MD Anderson Cancer Center, Citius is developing Mino-Wrap, a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander. The briefing package contained information regarding pre-clinical data and a clinical development plan, along with questions for the FDA regarding safety and efficacy data that would be required to advance Mino-Wrap into clinical trials. \nThe FDA granted a Written Response Only meeting regarding guidance and direction on the Mino-Wrap development plan. The agency indicated that bio absorption simulation studies may provide information to support the development of Mino-Wrap and made suggestions on what should be provided relative to non-clinical support. The FDA provided guidance on the design of the drug elution studies and agreed that a large animal pharmacology study would be appropriate. They also agreed that a 28-day toxicology study appears appropriate and that microbiology support through existing data is acceptable.\n \"The FDA provided us with valuable guidance and confirmed a number of our initial plans on the development of Mino-Wrap,\" said Myron Holubiak, President and CEO of Citius Pharmaceuticals. \"We are very pleased to have guidance support from the agency because this is such an under-recognized problem, and current preventative measures have not yielded very acceptable results. We think we have an important innovation for the prevention of post-operative infections associated with breast reconstructive surgery after mastectomies.\"\nAb...