Rexahn Announce IND Submission for RX-3117; Luminex Receives FDA and European Clearance for xTAG® CYP2D6 Kit Print E-mail
By Staff and Wire Reports   
Monday, 15 July 2013 19:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 15, 2013.

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.”

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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.



Also Monday:



Atossa Genetics, Inc. (NASDAQ: ATOS),
The Breast Health Company™, announced today that the Company has been added to the Russell Microcap® Index.

eHealth, Inc. (NASDAQ: EHTH),
parent company of eHealthInsurance, the Nation's first and largest private online health insurance exchange, published the third step in its six step guide to help consumers prepare for health care reform and this year's new open enrollment period, which begins October 1, 2013.

Insmed Incorporated (NASDAQ: INSM)
announced today that it is offering $60 million of its common stock in a proposed underwritten public offering.

Life Technologies Corporation (NASDAQ: LIFE)
today announces the launch of EVOS® FL Auto Imaging System with an on-stage incubator designed to enable time-lapse, high-resolution live cell imaging in a fully automated system that is priced to make high-resolution, fluorescence microscopy simple and accessible for any lab.

MAKO Surgical Corp. (Nasdaq:MAKO)
announced today that it plans to release second quarter 2013 financial results after market close on Tuesday, July 30, 2013. Maurice R. Ferré, M.D., President and Chief Executive Officer, and Fritz L. LaPorte, Senior Vice President and Chief Financial Officer of MAKO, will host a conference call to review the second quarter 2013 results starting at 4:30 pm ET on the same day.

Masimo (NASDAQ: MASI)
, inventor of breakthrough Measure-Through Motion and Low Perfusion pulse oximetry, today announced the release of EMMA™ Capnograph with waveform display, offering clinicians greater assessment of end-tidal carbon dioxide (EtCO2) and respiration rate, as well as assisting in recognition of return to spontaneous circulation, for a variety of clinical settings, including emergency medicine and transport, ORs, ICUs, patient rooms, and clinics.

Medistem, Inc. (PINKSHEETS: MEDS)
, announced today that it has filed a Form 10 registration statement with the Securities and Exchange Commission.

MiMedx Group, Inc.  (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company will slightly exceed the $13.5 million high end of its previously communicated revenue range for second quarter of 2013.

MMRGlobal, Inc. (OTCQB: MMRF)
, through its wholly owned subsidiary MyMedicalRecords, Inc. (collectively, "MMR"), today announced that it has received an Issue Notification from the United States Patent and Trademark Office for U.S. Patent No. 8,498,883 (the "883 patent") entitled, "Method for Providing a User with a Service for Accessing and Collecting Prescriptions."

MRI Interventions, Inc. (OTCQB: MRIC)
today announced the presentation of data and results indicating the benefits of its ClearPoint® Neuro Intervention System as a platform for iMRI-guided deep brain stimulation (DBS) lead placement in pediatric patients.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced a program to provide financial assistance to underinsured patients. Beginning July 22, Myriad will offer financial assistance to reduce qualified underinsured patients' out-of-pocket cost to no more than $375.

NeoGenomics, Inc. (NASDAQ: NEO)
announced today that it plans to release its second quarter 2013 financial results on Wednesday, July 31, 2013.

Organovo Holdings, Inc. (NYSE: ONVO), today rang the opening bell on the New York Stock Exchange (NYSE).  Organovo Holdings, Inc. shares began trading on the NYSE on Thursday, July 11, 2013, after qualifying as an NYSE MKT listing company.

Pazoo, Inc. (OTCQB: PZOO) features experts from the health and wellness industry as well as the pet industry. Pazoo.com offers a unique, multi-dimensional interactive web site where consumers can gain insights into health and wellness for themselves and their pets.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, received Special 510(k) clearance for an update to the Company's immunofluorescence-based Sofia® Influenza A+B FIA package insert to include analytical reactivity with an avian Influenza A (H7N9) strain, A/Anhui/1/2013, on July 5th, 2013.

Remedent, Inc. (OTCBB: REMI), an international company specializing in research, development, and manufacturing of oral care and cosmetic dentistry products, reported results for the fourth quarter and for the year ended March 31, 2013.

XTL Biopharmaceuticals, Ltd. (NASDAQ: XTLB) (TASE: XTL), a clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of pharmaceutical products for the treatment of clinical unmet needs, today announced that its ADRs began trading on NASDAQ today, July 15, 2013 under the ticker symbol "XTLB".



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