QIAGEN Launches QuantiFERON-TB Gold In-Tube in China; Cortice Announces Enrollment of a Phase 2 Trial Evaluating TPI 287 Plus Avastin(R) Print E-mail
By Staff and Wire Reports   
Thursday, 20 March 2014 20:19
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 20, 2014.

QIAGEN N.V. (NASDAQ: QGEN)
announced the commercial launch in China of its QuantiFERON®-TB Gold In-Tube (QuantiFERON-TB), the pioneering blood test which accurately identifies people infected with Mycobacterium  tuberculosis, the bacterium that causes tuberculosis (TB). QuantiFERON-TB has become the test of choice around the world and is displacing the century-old tuberculin skin test (TST) in screening for TB infection. QIAGEN already sells QuantiFERON-TB in many markets, including the U.S. and Europe, and gained approval earlier this year from the China Food and Drug Administration (CFDA). QIAGEN announced the QuantiFERON-TB launch to coincide with World TB Day 2014, Monday March 24.

China has an estimated 1 million reported new cases of active TB each year, more than any country except India, according to the World Health Organization (WHO). Based on the previous survey, an estimated 550 million people in China, 41% of the population, are infected with the TB bacterium. Globally, WHO estimates one-third of the world's population has latent TB infection. Left untreated 5 to 10% of these people will develop active disease during their lifetimes, often when they experience weakened immunity due to other health issues. With the accelerating urbanization in China, the large population with latent TB infection will potentially increase the incidence of TB disease and transmission of the infection. The incidence of multidrug-resistant TB (MDR-TB) and extreme drug resistance TB (XDR-TB), as well as increased co-morbidities such as human immunodeficiency virus (HIV), diabetes and rheumatoid arthritis, make TB control more challenging. In 2012, WHO recommended that an interferon-gamma (IFN-) release assay (IGRA) could be part of clinical evaluation for investigating contacts of persons with infectious tuberculosis in low-and middle-income countries.

QIAGEN's QuantiFERON-TB is the industry-leading IGRA, a modern breakthrough blood test that is faster, more accurate and cost-effective than older methods. QuantiFERON-TB, which measures the body's cell-mediated immune response to a cocktail of TB-specific antigens, is one of the most studied IGRA and commonly used TB-screening assay in industry and clinical research. Compared with the tuberculin skin test (TST or Mantoux), QuantiFERON-TB is a more precise, easier-to-handle modern alternative. It can reduce false-positive readings caused by the Bacille Calmette-Guérin (BCG) vaccination, which all newborns in countries like China receive as a matter of policy. The TST is notoriously inaccurate in BCG-vaccinated persons because of cross-reacting antigens that commonly cause false positive results.

"We are pleased to announce the launch of QuantiFERON-TB in China, where QIAGEN has a major presence, to support TB control efforts. Use of QuantiFERON-TB to screen vulnerable populations is growing rapidly in the United States, Europe and other markets, and we are focusing on this important product as one of QIAGEN's global growth drivers," said Peer Schatz, QIAGEN's Chief Executive Officer. "The superiority of QIAGEN's QuantiFERON technology to deliver more reliable results than the 120-year-old tuberculin skin test already is well accepted among physicians in China, paving the way for the entry of QuantiFERON-TB into this important market."

QIAGEN advocates for the ethical usage of QuantiFERON-TB and will target its screening efforts to vulnerable subpopulations including immuno-compromised patients such as those with HIV or diabetes, as well as people with weaker immune systems such as children, the elderly, malnourished, heavy smokers and drug abusers, who have a much higher chance of progressing from latent infection to active TB. In addition, healthcare workers and groups living in congregate settings are more likely to get active TB and pass it on afterwards.

QIAGEN is committed to working with experts to encourage research and raise awareness of the disease. Around World TB Day 2014, the company has participated in activities worldwide, including Germany, France, the UK, North America, Philippines, Malaysia, Pakistan and other countries to support the research and development of TB control.


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Cortice Biosciences announced today that enrollment has begun in the first stage of a Phase 2 open-label trial designed to evaluate the safety and efficacy of the Company's lead drug candidate, TPI 287, in combination with standard-of-care Avastin® (bevacizumab) for treatment of patients with recurrent glioblastoma (GBM) that has progressed following Avastin treatment alone (clinicaltrials.gov/NCT02047214). TPI 287 is an abeotaxane, a novel taxoid derivative that works similarly to taxane chemotherapeutics, such as Taxol®, Abraxane®, and Taxotere®, but with the distinct advantages of being able to readily cross the blood-brain barrier and evade common drug resistance mechanisms.    

The first stage of this trial is designed to determine the maximum tolerated dose (MTD) of TPI 287 administered every three weeks when used in combination with Avastin administered at 10 mg/m2 every two weeks. All patients will have GBM that that has progressed while on or following treatment with Avastin. Once the MTD for TPI 287 is established in this setting, Cortice plans to expand to the second stage of the trial to evaluate additional patients with TPI 287 plus Avastin. Safety is the primary endpoint of the study. Key secondary endpoints, including overall response rate and progression-free survival, will be assessed per RANO criteria.

Prior experience with TPI 287 in recurrent GBM patients indicates that the drug may have meaningful impact on treating infiltrative disease, which often evades Avastin therapy. This suggests that TPI 287 and Avastin may be synergistic as treatment for recurrent GBM. Also designed to investigate this potential synergy, Cortice is conducting a separate clinical trial to evaluate TPI 287 in combination with Avastin for treatment of recurrent GBM naïve to prior Avastin treatment (clinicaltrials.gov/NCT01933815). 

"We are pleased to be part of this important clinical study evaluating TPI 287 in recurrent GBM, a disease with very few effective treatment options," said Dr. Burt Nabors, Director of the Division of Neuro-Oncology at the University of Alabama at Birmingham.  "Results from this trial, as well as Cortice's other Phase 2 trial evaluating TPI 287 in patients naïve to bevacizumab, could be informative and instrumental in bringing a new therapy to our patients." 



Also Thursday:


Abiomed, Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, today announced the completion of the 30th patient enrolled in RECOVER RIGHT, an Investigational Device Exemption (IDE) study of Impella® RP (Right Peripheral).

Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing the next generation of cancer immunotherapies, hosted a joint conference call with Aratana Therapeutics (Nasdaq:PETX) today at 8:00 am ET to discuss the recently announced global licensing agreement for Advaxis's ADXS-cHER2 for the treatment of osteosarcoma in dogs and three additional cancer immunotherapy products for the treatment of three other types of cancer.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced a recent court action in its legal case against biolitec AG.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced the appointment of Neil C. Morton as Vice President of Business Development.

BG Medicine, Inc. (Nasdaq:BGMD)
, the developer of the BGM Galectin-3® Test, today reported financial results for the three months ended and year ended December 31, 2013.

BG Medicine, Inc. (Nasdaq:BGMD)
today announced that on March 18, 2014, the United States Patent and Trademark Office issued patent 8,672,857, titled "Galectin-3 and Cardiac Resynchronization Therapy," to the Company.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., has named Richard C. Christopher as Chief Financial Officer, effective immediately. Mr. Christopher replaces Richard J. Pulsifer.

CannaVest Corp. (OTCBB:CANV),
a leading industrial hemp company, is continuing its plans to be in the forefront of establishing a domestic industrial hemp cultivation and production infrastructure. US Hemp Oil, LLC (USHO), its wholly-owned subsidiary, acted as a Premium Exhibitor at the National Farmers Union Convention held in Santa Fe, New Mexico March 8–11, 2014. 

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, announced today that Kamineni Hospitals based in Hyderabad, India, have introduced CGI's FHACT™ diagnostic test for the detection and management of cervical cancer.

Cara Therapeutics, Inc. (Nasdaq:CARA),
a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, announced today that the Company will host a conference call and live audio webcast on Thursday, March 27, 2014, at 4:30 p.m. ET to report fourth quarter and full year 2013 financial results and provide a corporate update.

CAS Medical Systems, Inc. (Nasdaq:CASM),
a leader in medical devices for non-invasive patient monitoring, today announced that the worldwide cumulative net shipment total of FORE-SIGHT Cerebral Oximeters reached 1,000 as of last week.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced that Krisztina Zsebo, Ph.D., President and Chief Executive Officer, will present a corporate overview at the Future Leaders in the Biotech Industry conference, being held at the Millennium Hotel in New York city on Friday, March 28, 2014.

Cempra, Inc. (Nasdaq:CEMP)
today announced that Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra, will present at The 21st Annual Future Leaders in the Biotech Industry Conference at 11:30 a.m. EDT, Friday, March 28, at the Millennium Broadway Hotel & Conference Center in New York City and at the Needham & Co. 12th Annual Healthcare Conference at 12:50 p.m. EDT, Wednesday, April 9, at The Westin New York Grand Central in New York City.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, is unveiling two new systems at the 72nd American Academy of Dermatology conference in Denver, Colorado, held from March 21-25, 2014.

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, announced today that it has completed its response to questions from the FDA regarding the Company's Ablatherm-HIFU Pre-Market Approval application, closing this step within the U.S. Food and Drug Administration review process.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced a new partnership with Mainstreet Property Group, the country's most-innovative developer of transitional care centers, to operate five new NextGeneration® Medical Resorts.

FITT Highway Products, Inc. (OTCQB:FHWY)
announces it is liquidating all inventory for the Energy Shot business due to the unavailability of financing for the retail rollout and proper market support.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer of Five Prime, will present at the 21st Annual Future Leaders in the Biotech Industry conference on Friday, March 28, at 8:30 a.m. Eastern Time.

Galena Biopharma (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark W. Schwartz, Ph.D., Executive Vice President and Chief Operating Officer will participate in the following events next week in New York, NY:  Thursday, March 27th - Panel presentation and corporate update at the 4th Annual "Cancer Immunotherapy: A Long- Awaited Reality" Conference at the New York Academy of Medicine; Friday, March 28th - Corporate presentation at the 21st Annual Future Leaders in the Biotech Industry Conference at the Millennium Broadway Hotel & Conference Center.

Hemp, Inc.'s (OTC:HEMP)
wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc. (IHMMCC), is pleased to announce that it has signed a consultant agreement with Global Links Corp. (OTC:GLCO), a holding company committed to exploring business opportunities in emerging industries, currently, the industrial hemp and medical marijuana industries.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the leader in operative surgical robotics, will hold its quarterly conference call to discuss First Quarter 2014 results, Tuesday, April 22nd, at 4:30 p.m. Eastern Time.

IOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced that Francois Lebel, M.D., Senior Vice President, Clinical Development and Medical Operations, will present at the 21st Annual Future Leaders in the Biotech Industry Conference on Friday, March 28th, 2014 at 3:00 p.m. ET at the Millennium Broadway Hotel in New York City.

MacroGenics, Inc. (Nasdaq:MGNX)
, a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today provided a corporate progress update and reported financial results for the year ended December 31, 2013.

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public it has signed a memorandum of understanding (MOU) to develop a joint venture with LiveWire Ergogenics, Inc. (OTCQB:LVVV) under the name of HempWire, LLC.

MRI Interventions, Inc. (OTCQB:MRIC)
, a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today its financial results for the fourth quarter and year ended December 31, 2013.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today noted that the Society of Gynecologic Oncology (SGO) has issued new clinical practice statements surrounding hereditary cancer testing for patients with ovarian and endometrial cancer.

Nature's Sunshine Products, Inc. (Nasdaq:NATR)
, a leading natural health and wellness company engaged in the manufacture and direct sale of premium-quality nutritional and personal care products, today announced the start of an advisory relationship between the Company and Dr. Luis N. Pacheco.

NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY)
, a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced that it has priced an underwritten public offering of an aggregate of 5,600,000 shares of its Common Stock, and 18-month warrants to purchase up to an aggregate of 1,400,000 shares of Common Stock at a combined price to the public of $1.20 for aggregate gross proceeds of $6,720,000.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has contracted with Austrianova Singapore (Austrianova), a subsidiary of SG Austria in which Nuvilex is a partial owner, to perform the cGMP (Current Good Manufacturing Practices)-compliant encapsulation of live cells to be used for Nuvilex's clinical trials in patients with advanced, inoperable pancreatic cancer and associated conditions and other types of cancer.

Premier, Inc. (Nasdaq:PINC)
has been named a 2014 World's Most Ethical Company® by the Ethisphere Institute for the seventh year in a row.

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that its President and Chief Executive Officer, Faheem Hasnain, will be presenting at the BioCentury Future Leaders in the Biotech Industry Conference at the Millennium Hotel in New York City.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced its consolidated financial results and business progress for the fourth quarter and full year ended December 31, 2013.



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