Date: 2017-12-26
Type of information: Granting of a Fast Track status
Product name: VAL-083 - 1,2:5,6-dianhydrogalactitol
Compound: 1,2:5,6-dianhydrogalactitol
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- alkylating agent. VAL-083 (dianhydrogalactitol) is a bi-functional alkylating agent causing N7-guanine alkylation and inter-strand DNA crosslinks. VAL-083's cytotoxic activity is independent of MGMT-expression in various cancer cells and cancer stem cells, suggesting a mechanism that is distinct from that of other alkylating agents. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.
Company: DelMar Pharmaceuticals (USA - CA)
Disease: recurrent glioblastoma
Latest news:
- • On December 26, 2017, DelMar Pharmaceuticals announced that the FDA has granted Fast Track designation for its lead product candidate, VAL-083, in recurrent glioblastoma (rGBM). This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM. These trials include:
- A Phase 2 study in bevacizumab-naïve MGMT-unmethylated GBM patients conducted in collaboration with The University of Texas MD Anderson Cancer Center; and
- A Phase 3 study of patients whose disease has progressed following prior treatment with temozolomide and bevacizumab (the STAR-3 trial).
- Outside of rGBM, DelMar has initiated a Phase 2 clinical trial of VAL-083 in newly-diagnosed MGMT-unmethylated GBM. DelMar also recently received notice of allowance from the FDA of an IND for a Phase 1/2 trial of VAL-083 in patients with recurrent platinum-resistant ovarian cancer.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
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Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
