New Book
We are excited to announce the publication of a monograph explaining the pathogenesis of neurotrauma and stroke in the rat model of the SCI. It also discusses neuroprotective and neuroregenerative treatments tested in the rat models.
Kwiecien JM. “Treatment Of Inflammation Initiated By The Spinal Cord Injury, The Brain Injury, Stroke, In Inhibition Of Cerebral And Spinal Cord Edema And Of Inflammation In Neurodegenerative, Immune Mediated And Infectious Diseases Of The Central Nervous System”. USPTO Patent US20220395474A1, December 15, 2022.
(June 29, 2023).
Following the response from the FDA to the pre-IND meeting request the regulatory development of VPCnt-101, a small molecule, synthetic xanthohumol at the pre-clinical stage has been defined in Milestone 1.
Milestone 1 encompasses:
the GMP manufacture of the lead compound VPCnt-101,
the nonclinical efficacy studies in the rat model of the SCI,
obtaining the Orphan Drug Designation from FDA for VPCnt-101 to treat the acute SCI
GLP pre-clinical toxicity study,
submission of the IND to FDA for Clinical Trials phase 2 involving SCI patients and conducted at 2 sites: in Phoenix, AZ, USA and in Lublin, Poland.
The achieving of the Milestone 1 is projected to take 3 years.
The funding for the Milestone 1 is initiated…