|QIAGEN Launches QuantiFERON-TB Gold In-Tube in China; Cortice Announces Enrollment of a Phase 2 Trial Evaluating TPI 287 Plus Avastin(R)|
|By Staff and Wire Reports|
|Thursday, 20 March 2014 20:19|
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.
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."
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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.
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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.
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