DelMar Pharmaceuticals, a company focussed on developing and commercialising proven cancer therapies in new orphan drug indications, has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application number 13/817,096 entitled, "Compositions and methods to improve the therapeutic benefit of suboptimally administered chemical compounds including substituted hexitols such as dianhydrogalactitol and diacetyldianhydrogalactitol."
The allowed patent claims cover DelMar's novel methods and compositions for the utility of chemical agents, compounds, and dosage forms related to administering VAL-083 (dianhydrogalactitol) for the treatment of hyperproliferative diseases, including cancer, to improve efficacy and reduce side effects of previously suboptimal chemotherapeutic agents.
"This is the very first patent application filed when we recognized the broad potential of VAL-083, a drug candidate that has demonstrated promising results in multiple cancer indications in previous clinical trials sponsored by the US National Cancer Institute," commented Jeffrey Bacha, DelMar's president and chief executive officer, "Importantly, this US patent allowance is for a master set of claims covering uses and compositions for VAL-083 and is an integral part of DelMar's robust and comprehensive patent estate expansion strategy."
The USPTO issues a Notice of Allowance after it makes a determination that a claimed invention is novel and nonobvious in light of all known technology in existence, and that a patent should be granted from such an application. Based on the timing of this Notice of Allowance, DelMar Pharmaceuticals expects the forthcoming VAL-083 patent to be issued by mid-2015 and provide intellectual property protection for methods and compositions of use for VAL-083 through 2030.
Mr. Bacha added, "We are confident that we will continue to build upon our intellectual property portfolio designed to protect and enhance the value of VAL-083 as we prepare to advance towards US registration trials in refractory glioblastoma multiforme and prepare to expand our clinical research into non-small cell lung cancer this year."
This is the second notice of allowance the Company received this year from the USPTO for patents covering VAL-083. Upon issuance, DelMar will hold four US patents and one international patent for VAL-083, having filed a total of more than ten new patent applications, which are being prosecuted in the United States and in international jurisdictions.
VAL-083 is a first-in-class, small-molecule chemotherapeutic with a unique mechanism of action. In more than 40 phase 1 and 2 clinical trials sponsored by the US National Cancer Institute, VAL-083 has shown safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the United States for the treatment of gliomas. DelMar is currently studying VAL-083 in a phase 1/2 clinical trial for patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of brain cancer. As a potential treatment for GBM, VAL-083's mechanism of action is unaffected by the expression of MGMT, a DNA repair enzyme that causes resistance to other chemotherapies approved for the treatment of GBM, including front-line treatment with Temodar (temozolomide).