Primagen Holding BV has announced that the U.S. Patent and Trademark Office has granted a patent for its Mitox™ mitochondrial DNA quantification technology as biomarkers for efficacy and adverse events of treatment.
Mitox™ has potential applications as part of the treatment for active antiretroviral (HAART) HIV-1 treatment and other antiviral treatments using nucleoside analogues.
"This patent is an important milestone in our efforts to bring the Mitox™ diagnostic test to market, ultimately giving physicians a new tool for improved patient management," says Jos Rijntjes, Chief Commercial Officer of Primagen.
"Screening for mitochondrial toxicity is a critical component of patient treatment because it gives physicians the ability to assess drug efficacy and toxicity."
"In fact, the FDA has advocated early mitochondrial DNA testing in the development of new antivirals in a recent draft guideline for the pharmaceutical industry."
The patented Mitox™ technology covers the measurement of mitochondrial DNA (and RNA) as a biomarker in the assessment of efficacy and unwanted adverse events of treatment.
The Mitox™ diagnostic test is currently used for early assessment of drug toxicity in the development of nucleoside analogues, compounds known for their potential mitochondrial toxicity.
Nucleoside analogues are used and developed for the treatment of several life threatening viral infections, including HIV-1 and HCV.
Primagen is expanding the use of the Mitox™ technology into the oncology field and presented its first clinical data in April 2006 during the AACR meeting in Washington, DC.
Patents covering the same Mitox™ technology are also currently pending in several other countries. The patent granted by the US PTO, no. 6,967,016, is entitled 'Method of determining therapeutic activity and/or possible side-effects of a medicament.'