The European Patent Office has granted a patent for Rosetta Genomics Ltd., a leading developer and provider of microRNA-based molecular diagnostics, claiming the use of miR-34a for the preparation of pharmaceuticals for treating p53-negative cancers.
The issued claims cover a core element of Rosetta Genomics' microRNA technology in the development of cancer therapeutics associated with p53-negative cancers. The patent is jointly owned with Yeda, the technology transfer company of the Weizmann Institute of Science in Rehovot, Israel.
The p53 protein is a sequence-specific transcription factor that functions as a major tumour suppressor in mammals. Inactivation of the tumour-suppressor function of p53 is one of the most frequent genetic alterations in human cancer, and close to half of all human tumours carry p53 gene mutations within their cells. The invention covered by this new patent discloses the finding that miR-34a, which is a direct transcriptional target of p53, possesses anti-proliferative and pro-apoptotic activities, thereby contributing to the tumour suppressor effects of activated p53.
Overexpression of miR-34a exerts anti-proliferative effects and promotes cell death, whereas inactivation of miR-34a attenuates p53-mediated cell death. Thus, miR-34a is a direct transcriptional target of p53, which may mediate some of the biological effects of this tumour suppressor. Perturbation of miR-34a expression may thus contribute to tumourigenesis.
Commenting on the clinical utility for such a potential microRNA-based therapeutic, Moshe Oren, Department of Molecular Cell Biology, Weizmann Institute of Science and a lead researcher of this work, said, “p53 is a major player in many cancers, and our new findings regarding the role of miR-34a in exerting its effects, has major therapeutic implications. One can envision a therapeutic based on mimicking mir-34a, in p53-negative cancers, thus overcoming part of the negative effects of missing this important tumor suppressor.”
Commenting on the European patent allowance, Kenneth A Berlin, president and chief executive officer of Rosetta Genomics, said, “We are delighted to add this European patent to our growing worldwide intellectual property portfolio. This patent is important as it protects key elements of our microRNA technology to develop treatments for a variety of cancers. These claims provide significant protection for our proprietary technology, create formidable barriers to entry for any would-be competitors and offer multiple opportunities for potential drug development partnerships.”
“Rosetta Genomics has pioneered the development of microRNA technology. We believe we have the earliest and broadest patents and patent applications related to composition of matter on microRNAs. This provides us with the widest access to the Sanger database, which is a key differentiating factor of our technology. This new patent is important for protecting our global leadership position in microRNA technology and resulting diagnostic and therapeutic products,” added Berlin.
miRview are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview mets and miRview mets^2 accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment.
microRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. The unique advantage of microRNAs as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks. It has been suggested that their small size (19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced.
Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics.