Humanetics Corporation Announces FDA Acceptance of Investigational New Drug (IND) Application for BIO 300 Injectable Suspension
Humanetics Corporation Announces FDA Acceptance of Investigational New Drug (IND) Application for BIO 300 Injectable Suspension
The Company will initiate its planned clinical study of BIO 300 Injectable Suspension, subject to Institutional Review Board approval and other applicable requirements
Humanetics Corporation, an advanced clinical-stage specialty pharmaceutical company pioneering novel medical countermeasures for military use and applicable civilian clinical indications, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the clinical investigation under its Investigational New Drug (IND) application for BIO 300 Injectable Suspension (IS) may proceed; accordingly, the IND has been opened.
BIO 300 Injectable Suspension is the parenteral formulation of the Company’s oral product, BIO 300 Oral Suspension (also known as BYOGRAYZ™), being developed in parallel as a prophylactic medical countermeasure for warfighters. Humanetics will proceed with the necessary development steps toward initiation of its planned clinical safety investigation, “A Phase 1 Single Ascending Dose Trial of BIO 300 Injectable Suspension in Healthy Volunteers.”
“We are pleased with this latest development in our efforts to bring BIO 300 IS into the clinic,” said Michael D. Kaytor, Ph.D., Chief Scientific Officer of Humanetics. “The injectable form represents yet another potential dual-use presentation of the drug product, both as a medical countermeasure and for multiple clinical applications.”
BIO 300 is an investigational product; it has not yet been approved by FDA for any indication.
About Humanetics Corporation
Humanetics Corporation is an advanced clinical-stage specialty pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on radiation modulators for oncology and inflammatory pulmonary indications, and as medical countermeasures. For more information, visit www.humaneticscorp.com.
Ronald J. Zenk
Humanetics Corporation
952-400-0400
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