Carlsbad, CA and Tucson, AZ (PRWEB) December 05, 2013
RiboMed Biotechnologies, Inc. and NuvOx Pharma today jointly announced that they have entered into a collaborative agreement that will utilize RiboMed’s epigenetic biomarker test, GliomaSTRAT™, to characterize tumors from brain cancer patients and correlate response to NuvOx’s new drug, NVX-108 in the treatment of Glioblastoma multiforme (GBM). NVX-108 is an intravenously delivered drug that, in animal models, increases the concentration of oxygen in tumors and consequently increases tumor sensitivity to radiation treatment. In animals implanted with human tumors which are resistant to radiation because they are low in oxygen, NVX-108 increased tumor oxygen levels by 400% and prolonged survival of the animals with tumors that were treated with radiation.
"The Phase 1B will begin early in Q1 2014 to evaluate the safety and efficacy of NVX-108 in combination with the current standard of care. We anticipate that incorporating RiboMed's GliomaSTRAT into our Phase 1B clinical protocol will improve our ability to further stratify the resulting clinical data to ascertain optimal dosing and corresponding benefit of NVX-108 to patients with this disease, for which there are no good therapies," noted NuvOx’s Chief Business Officer David Wilson.
The standard of care for patients with Glioblastoma brain cancer is surgery, followed by a 6-week course of radiation therapy and treatment with temozolomide. The patient’s response to treatment depends upon their tumor’s sensitivity to both the radiation and to the drug. RiboMed’s GliomaSTRAT is a DNA methylation based test that stratifies brain tumors into 4 groups, by both grade (low grade vs high grade) and response to certain chemotherapeutic drugs, including temozolomide (Temodar®).
"Our goal at RiboMed is to develop Companion Diagnostic tests that will help to prevent the treatment of patients with drugs to which they will not respond," said Dr. Michelle Hanna, CEO and Scientific Director at RiboMed. "Given the differential response of high grade and low grade tumors to radiation, this stratification step could identify the patients that are most likely to benefit from treatment with NVX-108."
RiboMed’s technology for epigenetic testing provides up to 100-fold greater sensitivity than competing methods. Tests utilize RiboMed’s bisulfite-free, methylated DNA enrichment process, MethylMagnet®, and their proprietary biomarker detection technology, Abscription®, which together in MethylMeter® provide superior sensitivity and specificity for the detection of DNA methylation in clinical samples. MethylMeter® allows quantitative analysis of DNA methylation, even with small samples containing damaged DNA, including formalin fixed paraffin embedded (FFPE) tissues.
RiboMed Biotechnologies, Inc. (http://www.ribomed.com) is a College of American Pathology (CAP) accredited and CLIA-certified molecular diagnostic clinical laboratory and Contract Research Organization. The RiboMed Clinical Services Laboratory offers DNA methylation based tests for cancer and drug response related biomarkers to physicians and for use in clinical trials, as well as development services to research institutions and Pharma. Research Use Only (RUO) kits, reagents, and technology licensing are also available. More information can be requested at info(at)ribomed(dot)com.
NuvOx was founded in 2008, after in-licensing NVX-108 for therapeutic applications, after it was demonstrated to be safe and effective as an ultrasound contrast imaging agent in more than 2200 patients. Serving as an oxygen therapeutic, previously demonstrated to be safe in humans, testing in animal models has demonstrated potential therapeutic application for sensitization to radiation treatment in many cancers, the mitigation of brain damage from stroke, heart damage from heart attack and general tissue destruction resulting from hemorrhagic shock. For additional information, please contact David Wilson at dwilson(at)nuvoxpharma(dot)com or call +1 (520) 624-6688 x1004. http://www.nuvoxpharma.com.
Disclosure Regarding Forward-Looking Statements
Except for historical information contained herein, the matters set forth in this press release, including statements regarding the Company's expectations, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with market demand for and acceptance and use of technology and tests such as the GliomaSTRAT test and NVX-108, separately or in combination, reliance upon the collaborative efforts of other parties including without limitation NuvOx, RiboMed or third parties obtaining or maintaining regulatory approvals that impact the Company's business, government regulation particularly with respect to diagnostic products and laboratory developed tests, the Company's ability to develop and commercialize technologies and products, particularly new technologies such as laboratory developed tests and genetic analysis platforms, the Company's financial position, the Company's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, litigation involving the Company, and other risks. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
SOURCE: RiboMed Biotechnologies, Inc. and NuvOx Pharma, LLC