DelMar Pharmaceuticals, a biotechnology company developing proven cancer therapies in new orphan drug indications, has announced that the United States Patent and Trademark Office (USPTO) issued a notice of allowance for a patent application to improve and develop methods for synthesizing VAL-083, DelMar’s lead drug candidate. This patent is entitled “Method of Synthesis of Substituted Hexitols Such as Dianhydrogalactitol,” and provides a patent term that lasts until 2030.
“This allowance represents our second U.S. patent. We believe that this key patent will provide another important anchor for DelMar’s intellectual property portfolio,” Jeffrey Bacha, DelMar’s president and CEO, said in a company press release. “This patent along with the previously granted patents and patent applications for VAL-083 are part of our continuing strategy to establish a broad portfolio of new patent claims to protect our intellectual property. Our patent applications, claim compositions and methods related to the use of VAL-083 and related compounds as well as methods of synthesis and quality controls for the manufacturing process of VAL-083.”
VAL-083, represents a “first in class” small-molecule chemotherapy, and is characterized as a structurally unique bi-functional alkylating agent mediating interstrand DNA crosslinks.
This compound has already demonstrated activity against non-small cell lung cancer (NSCLC) in preclinical and clinical trials, both as a single agent and in combination with other treatment regimens.
Furthermore, it has the capacity to cross the blood-brain barrier, suggesting VAL-083 may be a therapeutic option for drug-resistant NSCLC and NSCLC patients with brain metastasis.
The median overall survival time for patients with stage IV non-small cell lung cancer (NSCLC) is 4 months, and the 1 and 5-year survival is less than 16% and 2%, respectively. Tyrosine Kinase Inhibitors (TKIs), such as erlotonib and gefitinib or platinum-based regimens such as cisplatin, are used to treat NSCLC following surgery, however, TKI resistance has started to emerge, along with a growing unmet medical need for new therapies to treat NSCLC.
VAL-083 is currently in a Phase I/II clinical trial for the treatment of refractory glioblastoma multiforme (GBM) and has already been approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China.
Company researchers tested the efficacy of VAL-083 for the treatment of NSCLC in a study entitled “In vivo efficacy of VAL-083 in the treatment of non-small cell lung cancer” and presented at the American Association of Cancer Research Annual Meeting.
The team assessed the activity of VAL-083 in mice models of drug-resistant NSCLC in comparison to other drugs, including cisplatin.
The results demonstrated that VAL-083 was more effective in delaying tumor growth and preventing body weight loss in the treatment of TKI-susceptible tumors, when compared to standard cisplatin therapy.
Data obtained from this study suggests that VAL-083 could become a viable treatment option for NSCLC patients that do no respond to TKI therapy, further pushing the clinical development of this drug allowing it to become an accessible therapy for NSCLC worldwide in the future.