Bio-Path Holdings Announces FDA Clearance for Phase I Clinical Trial of Liposomal Grb-2

Strategic Insights -

Bio-Path Holdings, a publicly traded biotechnology company, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase I clinical trial of their lead cancer drug candidate, liposomal Grb-2. This development represents a significant milestone for the company, marking the transition from pre-clinical to clinical-stage status. The FDA's Division of Oncology Products reviewed the Company's data covering pre-clinical studies, safety, chemistry, manufacturing, and controls, and the protocol for the Phase I clinical trial.

Key Takeaways:

  • Bio-Path Holdings, Inc. has received FDA clearance for the IND (Investigational New Drug) of liposomal Grb-2, allowing the company to proceed with a Phase I clinical trial.
  • The Phase I clinical trial will be conducted in patients with chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS).
  • Bio-Path's drug candidate, liposomal Grb-2, is an antisense drug substance targeted to treat several types of cancer and utilizes a neutral lipid-based liposome delivery technology.
  • The FDA's clearance of the IND is a major milestone for Bio-Path, marking the transition from pre-clinical to clinical-stage status.
  • Commencement of the trial will occur after patients are enrolled and administrative details are finalized, with no significant delays expected.
  • Bio-Path Holdings is developing leading-edge, patented, liposomal drug delivery systems with three clinical cancer drug candidates ready for the clinic.
  • The Company's drug delivery technology distributes nucleic acid drugs systemically throughout the human body via simple intravenous infusion.

Statistics:

  • Bio-Path has made the transition from a pre-clinical to a clinical-stage company.
  • The Phase I clinical trial will be conducted in patients with CML, AML, ALL, and MDS.
  • The Company's drug delivery technology can be applied to both double-stranded (siRNA) and single-stranded (antisense) nucleic acid compounds.
  • Bio-Path's drug delivery technology has the potential to revolutionize the treatment of cancer and other diseases where drugable targets of disease are well characterized.

Sources:

  • Bio-Path Holdings, Inc.
  • U.S. Food and Drug Administration (FDA)
  • NewsRx.com
  • Blood Weekly editors