QIAGEN Announces European Launch of Therascreen IDH1/2Test for Gliomas; Results of Pluristem's Phase I/II Muscle Injury Trial to be Announced Print E-mail
By Staff and Wire Reports   
Monday, 06 January 2014 20:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 6, 2014.

QIAGEN N.V. today announced the European launch of its new therascreen® IDH1/2 RGQ Kit, enabling physicians to better diagnose and assess the prognoses of patients with gliomas, or tumors of the brain and  spinal cord. The test is based on QIAGEN's proprietary biomarkers for IDH1 and IDH2 gene mutations. The therascreen® IDH1/2 RGQ Kit has received CE marking enabling marketing in Europe and certain other markets. In addition, QIAGEN announced a new collaboration with Mayo Clinic to develop diagnostics for cholangiocarcinoma (CCA), also known as bile duct cancer, using biomarkers for the IDH1 and IDH2 mutations.

The therascreen IDH1/2 RGQ PCR Kit enables detection of 12 mutations in the IDH1 and IDH2 genes in a single test using real-time PCR. Mutations in IDH1/2 are recognized as prognostic markers for gliomas (NCCN 2013, EFNS 2010), and the therascreen IDH1/2 RGQ PCR Kit will aid clinicians in classifying the tumors and prognosticating the course of this serious disease.

"We are pleased to introduce a standardized, reliable IDH1/2 diagnostic test that improves clinical understanding and treatment of gliomas by genetically characterizing each person's disease. QIAGEN's assay for IDH1/2 mutations was designed in close collaboration with leading clinicians to rapidly provide meaningful information about their patients' gliomas," said Vincent Fert, QIAGEN's Personalized Healthcare Program Leader. "This new product strengthens QIAGEN's Personalized Healthcare portfolio, especially the assay offering for neuro-oncology, which also include CE-marked therascreen MGMT and BRAF tests. The IDH1/2 kit also adds to the growing menu of tests that run on our flexible sample-to-result QIAsymphony platform which allows an improved laboratory workflow."

QIAGEN also announced a partnership and licensing options with Mayo Clinic in Rochester, Minnesota, for use of the IDH1 and IDH2 biomarkers to diagnose and guide the treatment of cholangiocarcinoma. CCA is a rare form of cancer, originating in the bile duct that affects approximately 2,000 to 3,000 patients each year in the United States. QIAGEN and Mayo Clinic, which was also involved in the validation study of the new therascreen® IDH1/2 RGQ Kit, will collaborate on development of new IDH1/2 products for CCA.


Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR)
, today announced that the results of the company’s Phase I/II clinical trial testing the safety and efficacy of PLacental Expanded (PLX-PAD) cells for the treatment of muscle injury will be presented on January 21, 2014.

The Principal Investigator of the study will join Pluristem’s management to discuss these results as part of Pluristem’s Regenerative Medicine Day to be held on the above date at the Tel Aviv Stock Exchange, Tel Aviv Israel.

This randomized, placebo-controlled, double blinded study was conducted at the Orthopedic Clinic on the campus of the Charité University Medical School under the auspices of the Paul-Ehrlich-Institute (PEI), Germany’s health authority. The injured muscle studied was the gluteal buttock muscle that has been surgically traumatized during total hip replacement surgery.

The study was comprised of 3 treatment groups, two PLX-PAD groups of different doses and one placebo group. The primary endpoints of the study include safety and the maximal contraction force of the gluteal muscle at six months post-surgery. The secondary efficacy endpoints include an analysis of the macrostructure and microstructure of the gluteal muscle using magnetic resonance imaging (MRI) and biopsy.

“We look forward to receiving the results from this important orthopedic study. Data from this clinical trial will give us information regarding other potential surgical orthopedic injuries and non-surgical sports related injuries for which our PLX-PAD cells may be beneficial,” stated Zami Aberman, Chairman and CEO of Pluristem. “This Phase I/II study marked the first time PLX-PAD cells were used to address surgically induced muscle injury.”

Also Monday:

Actavis plc (NYSE: ACT)
, a leading global specialty pharmaceutical company, today announced that it will host an Investor Meeting on January 31, 2014 in New York.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, today announced corporate presentations at the 7th Annual OneMedForum SF 2014, Biotech Showcase 2014 and the Southern California Investment Forum in San Francisco during the week of January 13, 2014.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, and Well Bridge Health, Inc. ("Wellbridge Health"), a care management solutions company aimed at reducing unnecessary hospital re-admissions and emergency room visits resulting from congestive heart failure ("CHF"), announced the formation of a partnership to commercialize a novel approach to the management and remote monitoring of CHF patients.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, a DNA-based diagnostics company, today announced that its board of directors appointed John Pappajohn as its new Chairman, effective January 6, 2014.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
today announced that it has executed a collaboration agreement and exclusive license option with Janssen Biotech, Inc. (Janssen).

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX)
, a specialty pharmaceutical company focused on developing safe and effective, approved medicines targeting orphan neuromuscular and neurological diseases, today announced the successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) about Firdapse™ tablets (Amifampridine), its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).

Cerner Corporation (Nasdaq:CERN)
announced today it will release its fourth quarter 2013 earnings results after the market closes February 4.

Coastal Contacts Inc. (Nasdaq:COA) (TSX:COA)
, the leading manufacturer and digital retailer of high-quality glasses and contact lenses announced today that Company management will present at the 16th Annual ICR XChange Conference on January 13th, 2014 at 2:30pm ET.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the Company will present at the Biotech ShowcaseTM 2014 conference being held at Parc 55 Wyndham San Francisco – Union Square at 55 Cyril Magnin Street, San Francisco, Calif. Spiro Rombotis, President and Chief Executive Officer, will provide an overview of the Company and its progress in key programs at 9:30 a.m. PST on Monday, January 13, 2014.

John Arnone, Chairman and CEO of American CryoStem Corporation (OTCQB:CRYO), a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today issued a formal update in the form of a Letter to Shareholders posted to the Company's web site at www.americancryosystem.com.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today that John McDermott, President and Chief Executive Officer, is scheduled to present at the 32nd Annual JP Morgan Healthcare Conference in San Francisco, CA.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-functional lipid ingredients, announced today that it was granted a patent by the U.S. Patent and Trademark Office for a lipid preparation use method.

Epizyme, Inc. (NASDAQ: EPZM)
, a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced the achievement of the proof of concept (POC) milestone in the EPZ-5676 DOT1L inhibitor clinical program, earning a $25 million payment under the company's collaboration with Celgene Corporation.

Galectin Therapeutics (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/550,962 titled "Galactose-Pronged Polysaccharides in a Formulation for Anti-fibrotic Therapies."

Harris & Harris Group, Inc. (Nasdaq:TINY)
, an investor in transformative companies enabled by disruptive science, notes the close of Metabolon's $15 million Series E financing.

ICU Medical, Inc. (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced that Company management will be presenting at the 32nd

Jazz Pharmaceuticals plc (Nasdaq: JAZZ)
today announced that the company will be webcasting its corporate presentation at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced that Keith Leonard, president and chief executive officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

NanoString Technologies, Inc. (Nasdaq:NSTG)
today announced that its management is scheduled to participate in the JP Morgan 32nd Annual Healthcare Conference on January 15, 2014 in San Francisco.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, today announced the expansion of intellectual property protection surrounding the Company's lead product candidate, AMR-001, a chemotactic stem cell product enriched for CD34+ cells that treats injury from vascular insufficiency.

Northstar Healthcare Inc. (TSX: NHC)
today announced its estimated revenue for December 2013. On a consolidated basis, Northstar's estimated revenue for December 2013 was $5.3 million, an estimated increase of $3.4 million over Northstar's revenue of $1.9 million for December 2012.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Richard M. Hyslop, Ph.D. has agreed to join the Scientific Advisory Board of Medical Marijuana Sciences, Inc., a wholly-owned subsidiary of Nuvilex, Inc.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ramesh Kumar, Ph.D., President and CEO, will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. The presentation will take place on Thursday, January 16th at 1:30 p.m. PT.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
today announced that management will present a company overview at the J.P. Morgan 2014 Healthcare Conference in San Francisco.

Portage Biotech Inc. (OTCQB: PTGEF, CNSX: PBT.U)
, is pleased to announce that it has acquired approximately 54% equity in Biohaven Pharmaceutical Holding Company Limited ("Biohaven"), a private corporation formed under the laws of the British Virgin Islands, for $3.5 million, payable as $1.75 million upfront and the balance in three installments over the next eleven months.

Premier, Inc. (Nasdaq:PINC)
, a leading healthcare improvement company, today announced that its President and CEO Susan DeVore will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13, 2014, at 2:30 p.m. PT.

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, announced today that it intends to offer shares of its common stock in an underwritten public offering.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE: RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today reported preliminary positive results from a Phase I study with RHB-104, a proprietary combination antibiotic oral capsule formulation for the treatment of Crohn's disease, currently undergoing a Phase III study in the U.S., with additional clinical sites planned in Canada and Israel (the MAP US study).

The Spectranetics Corporation (Nasdaq:SPNC)
today announced that its management will be presenting at the JP Morgan 32nd Annual Healthcare Conference on January 15th, 2014 in San Francisco.

StemCells, Inc. (Nasdaq:STEM)
, a leading stem cell company developing novel cell-based therapeutics for disorders of the central nervous system, posted today the following Letter to Shareholders from its President and CEO, Martin McGlynn.

Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
will present at the 32nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2014.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced a reorganization of its leadership team.

Vitacost.com, Inc. (Nasdaq:VITC)
, a leading online retailer of more than 45,000 health and wellness products, today announced the launch of "Join the Resolution," a campaign offering health and wellness tips, special promotions on weight-loss, fitness and health food products, with contests and prizes to incentivize customers to achieve their personal goals in 2014.

, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that Mark Foley, President and Chief Executive Officer, is scheduled to present at the 32nd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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