Illuminare Biotechnologies, a US-based privately held biotechnology company, announced on Monday that it has dosed its first subject in the phase one trial of Illuminare-1.
The product is being developed to improve the visualisation and delineation of critical nerve structures intra-operatively in real time with the intention of avoiding serious, and potentially permanent, unintended nerve injury.
The first-in-human clinical trial is being carried out at Memorial Sloan Kettering Cancer Center (MSK), jointly with collaborators from Illuminare Biotechnologies, in subjects undergoing robot-assisted radical prostatectomy.
The Phase 1 trial of Illuminare-1 is a dose-escalation study in up to 50 patients undergoing robot-assisted radical prostatectomy. The primary objective of the Phase 1 trial is safety, and secondary objectives include determination of the human pharmacokinetics of Illuminare-1 and selection of optimal dose based on fluorescence to advance in the clinic. The US FDA has granted Fast Track Designation to Illuminare-1.
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data