|Rexahn Announce IND Submission for RX-3117; Luminex Receives FDA and European Clearance for xTAG® CYP2D6 Kit|
|By Staff and Wire Reports|
|Monday, 15 July 2013 19:05|
Rexahn Pharmaceuticals, Inc. (NYSE: RNN) announced Teva Pharmaceutical Industries has submitted an Investigational New Drug (IND) application to the US FDA for RX-3117, a novel oral small molecule chemotherapy agent, under a June 2009 Research and Exclusive License Option Agreement with Teva Pharmaceutical Industries Ltd. for RX-3117.
Prof. Dr. Godefridus J. (Frits) Peters, Head Laboratory Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands, commented, “RX-3117 has a novel and unique mechanism of action and a distinctly different metabolism compared to other nucleoside analogs. RX-3117's strong anti-proliferative activity against a wide variety of human cancer cell lines offers promise for its future therapeutic development and the potential of helping cancer patients.”
In August 2012, Rexahn reported the completion of an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe. The clinical trial demonstrated that RX-3117 is orally bioavailable and no adverse events were reported over the dose range tested. A further Phase I clinical trial in cancer patients is expected to be initiated in the second half of 2013.
Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer commented, “The IND filing represents an important milestone in the RX-3117 clinical development program. RX-3117, which has already demonstrated oral bioavailability in cancer patients, has the potential to treat a wide variety of solid tumors. Rexahn looks forward to advancing the clinical development of RX-3117.”
Luminex Corporation (NASDAQ: LMNX) announced it has received U.S. FDA and European clearance for a new version of xTAG CYP2D6 Kit. Additionally the company has submitted xTAG 2C19 Kit to FDA for review. Luminex is advancing its pharmacogenetic initiative for improved patient care.
"Test results that inform a physician on how a patient may react to a particular therapeutic are vital to improving patient care," said Patrick J. Balthrop, president and chief executive officer of Luminex. "Pharmacogenetics is a fast-growing field and our flexible technology provides laboratories unique options to address their needs. Attaining FDA and CE clearance for xTAG CYP2D6 Kit demonstrates Luminex's commitment to offering diagnostics that optimize patient outcomes and lower overall health-care costs."
Cytochrome P450 2D6 (CYP2D6) is a clinically important gene that encodes a phase one drug metabolizing enzyme. CYP2D6 metabolizes greater than 25% of the drugs in use today including cardiovascular drugs, anti-psychotics, anti-depressants, pain-medications, β-blockers, anti-emetics, antiarrhythmics and anti-cancer drugs. Variations in the CYP2D6 gene can result in distinct drug metabolizing phenotypes leading to sub-optimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect. An estimated 2.2 million serious ADRs occur yearly resulting in 100,000 deaths at a cost of $136 billion in the United States alone.1,2
xTAG CYP2D6 Kit is an IVD assay that analyzes a patient's CYP2D6 genotype from DNA extracted from a blood sample to aid physicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2D6 gene product. The assay is run on the flexible Luminex® 100/200™ instrument. This new version of the kit optimizes performance on the *17 allele and features an updated software algorithm that detects all 17 genotypes that the assay is cleared for, including deletion and duplication genotypes.
Luminex has also submitted xTAG CYP2C19 Kit for FDA and CE-clearance. The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat ulcers, seizures, malaria and anxiety. It is also partially responsible for metabolizing drugs such as beta-blockers and some antidepressants.
Luminex will be featuring the new xTAG CYP2D6 Kit at the American Association of Clinical Chemistry (AACC) Annual Meeting & Clinical Lab, July 30 – Aug. 1 in Houston, TX, Booth #4539. Visit the Luminex booth for more information on Luminex's pharmacogenetic portfolio.
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