Pharmaceutical company Moleculin Biotech Inc (Nasdaq:MBRX) said on Tuesday that it will now commence a Phase 1 clinical trial of Investigational New Drug (IND) of its drug candidate WP1066 for treating children with recurrent or refractory malignant brain tumours.
The US FDA has approved the request made by Dr Tobey MacDonald, professor of the Department of Pediatrics at Emory University School of Medicine, director of Pediatric Neuro-Oncology at Aflac Cancer and Blood Disorders Center, who is the trial's principle investigator.
Following the US FDA approval, the trial will be conducted at the Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta.
According to the company, WP1066 is an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while stimulating a natural immune response, targeting brain tumours, pancreatic cancer and haematologic malignancies.
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
QST selects RayStation for advanced carbon ion therapy
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Innate Pharma reports preclinical efficacy of IPH45
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
enGene Holdings names new senior vice president, Urologic Oncology and Clinical Development
CLS secures second order from NIH Clinical Center for Thermal Therapy System accessories