|Novogen Files Suite of Patents for Anti-Tropomyosin Drug Technology; BioLineRx Announces Positive Phase 2a Trial Results for IBD Treatment|
|By Staff and Wire Reports|
|Tuesday, 26 November 2013 19:15|
Novogen Limited (ASX: NRT; Nasdaq: NVGN) announced the filing of a family of provisional patents in the US covering anti-tropomyosin (ATM) drug technology.
ATM drugs represent an entirely novel approach to anti-cancer therapy, blocking the ability of cancer cells to divide and doing so in a highly cancer-specific way. Based on their action, ATMs belong to a class of anti-cancer drug known as anti-mitotics. Current anti-mitotic drugs are taxanes and vinca alkaloids and remain among the most widely prescribed anti-cancer drugs after 40 years of use.
"Filing these patents represents a critical step for the Company in protecting such a potentially valuable piece of intellectual property," said Graham Kelly, PhD, Novogen CEO. "Taxanes continue to dominate anti-cancer therapy even though they recently came off-patent. We believe that ATM drugs have the ability to replace taxanes and to become the next generation of anti-mitotic drugs."
Tropomyosin is a protein found in actin filaments, a key component of the cytoskeleton of a cell. Actin filaments provide a cell with the ability to contract. One of the ways that contraction serves a cell is during cell division when separation of the two daughter cells occurs by the formation of a ring known as the contraction ring. When that ring tightens, the two cells effectively separate.
ATM drugs target a particular isoform of tropomyosin known as Tm5NM1 on which cancer cells are highly dependent. Targeting this particular tropomyosin isoform prevents formation of the contraction ring and hence the ability of the cancer cells to divide.
"The current generation of anti-mitotic drugs, despite their widespread use, comes with two key negatives," Dr. Kelly added. "The first of those is a serious side-effect profile. The second is that many types of cancer are inherently insensitive to them. ATM drugs to date are showing an apparent lack of serious toxicity as well as an ability to kill cancer cells that are insensitive to taxanes."
BioLineRx (NASDAQ: BLRX) (TASE:BLRX), a biopharmaceutical development company, announced additional Phase 2a results showing significant improvement of disease measurements in biopsies taken from inflammatory bowel disease (IBD) patients treated with BL-7040, an orally available drug for treating IBD. The histological and biochemical analyses of inflammation indicators reinforce the initial positive results of the study, reported in April 2013, which showed that BL-7040 is safe and effective in treating ulcerative colitis, a form of IBD.
In order to perform the histological and biochemical analyses, biopsies were taken from trial participants before and after treatment. Biopsies from each time point were collected and randomly assigned to either a histological evaluation or to an assessment for levels of cytokines, considered as pro-inflammatory bio-markers. All analyses were performed in a blinded manner.
The histological results show that neutrophil levels were significantly reduced (p=0.002) in patients treated with BL-7040. Neutrophils are the major cellular participant in acute inﬂammation, and their presence in the colon mucosa is believed to play a key role in causing tissue damage and clinical symptoms in IBD patients. Neutrophil levels are known to decrease when a patient's clinical condition improves. In this respect, all patients whose neutrophil levels were reduced also showed a clinical improvement as assessed by their Mayo score, the gold standard for assessing ulcerative colitis therapy.
An additional measure of disease severity is the level of the pro-inflammatory cytokine, interleukin 6 (IL-6). IL-6 is the predominant cytokine found in inflamed areas in ulcerative colitis patients, and its concentration correlates with the Mayo endoscopic score for disease severity. IL-6 levels were also significantly reduced (p=0.046) in patients treated with BL-7040, and most patients with reduced cytokine levels showed clinical improvement.
"These positive results are an extension of the initial positive results of the Phase 2a trial for BL-7040, which showed that this promising drug is both safe and effective in treating ulcerative colitis. In fact, the clinical improvement in this trial was achieved after a relatively short treatment period, which leads us to believe that BL-7040 would have an even stronger beneficial effect after longer treatment duration," said Dr. Kinneret Savitsky, CEO of BioLineRx. "The new results, which show that BL-7040 significantly reduces inflammatory factors, such as neutrophils and cytokines, support BL-7040's mechanism of action – the ability to suppress the specific processes underlying the disease. Crohn's disease and ulcerative colitis, both forms of IBD, are prevalent conditions that affect the quality of life of millions of people across the globe. It is estimated that as many as 1.4 million persons in the United States suffer from these diseases. In addition to discomfort, which can be quite extreme, IBD can cause significant complications, including anemia, abscesses and more. Current treatments are far from satisfactory, and many people stand to benefit from a new and effective treatment for this condition. We believe that the positive results seen throughout the phase 2a study, as well its oral availability, make BL-7040 an attractive potential future treatment option."
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer, will present at the 25th Annual Piper Jaffray Healthcare Conference, December 4, 2013 at 8:00 a.m. EST.
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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 that the Company's President and CEO, Gerald Commissiong, will present at the LD Micro Sixth Annual Conference in Los Angeles, California.
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athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, has been named the Gold Level winner for the Greater Boston region at the Team Massachusetts Economic Impact Awards, awarded annually by MassEcon.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today that the company's President and CEO, Ted Schroeder, will present the company's corporate overview on Wednesday, December 4, 2013, at 11:30am Eastern Time (8:30am Pacific Time) during the 25th Annual Piper Jaffray Healthcare Conference at New York Palace Hotel in New York City.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that Kenneth I. Moch, President and CEO of Chimerix, will present at the 25th Annual Piper Jaffray Healthcare Conference on Wednesday, December 4, 2013 at 9:00 am ET at the New York Palace Hotel in New York City.
Covisint Corporation (Nasdaq:COVS), provider of a leading cloud engagement platform, today will host a webinar conducted by eHI that outlines a path to securely sharing healthcare data in the cloud.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, today announced enhancements to its sales and marketing organization.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products, today announced that it participated in the MEDICA 2013 International Trade Fair in Dusseldorf, Germany from November 20 through 23, 2013.
Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that the New Drug Application (NDA) for its investigational drug, Dalvance™ (dalbavancin hydrochloride) for injection, has been accepted for priority review by the U.S. Food and Drug Administration (FDA) with an action date of May 26, 2014.
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that Ron Ellis, Endocyte's president and CEO, will present at the Piper Jaffray 25th Annual Health Care Conference on Tuesday, Dec. 3, at 9 a.m. EST.
Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the selection of SynteractHCR, Inc. to serve as its primary contract research organization ("CRO") for its upcoming Phase 3 clinical trial of EVK-001.
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 J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the 25th Annual Piper Jaffray Healthcare Conference.
Gentium S.p.A. (Nasdaq:GENT), announced that an oral presentation and a poster on Defibrotide will be presented at the 55th Annual Meeting and Exposition of the American Society of Hematology to be held at the Ernst N. Morial Convention Center in New Orleans, LA, December 7-10, 2013.
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Hyperion Therapeutics (Nasdaq:HPTX) announced today that the company is scheduled to present at the 25th Annual Piper Jaffray Healthcare Conference on Wednesday, December 4 at 2:00 p.m. ET.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, will showcase their new universal viewer solution at Radiological Society of North America (RSNA) Annual Meeting on December 1-6, in Chicago, Ill.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate at the 25th Annual Piper Jaffray Healthcare Conference being held on December 3-4 in New York City.
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Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced the results of two Phase 2 studies evaluating MM-121 in the treatment of women with ER/PR+, HER2 negative breast cancer.
Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that Stanley C. Erck, President and Chief Executive Officer, will present at the 25th Annual Piper Jaffray Healthcare Conference on December 3, 2013 at 1:30pm ET in New York City at the New York Palace Hotel.
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Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that Remi Barbier, Chairman, President & CEO, will present at the Piper Jaffray 25th Annual Healthcare Conference in New York.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today provided information on its pending merger with Turtle Beach and reported it has filed with the SEC its Annual Report on Form 10-K for the fiscal year ended September 30, 2013.
Healthcare improvement company Premier, Inc. (Nasdaq:PINC), has been designated an early leader in population health management (PHM) by KLAS, an independent healthcare research firm.
Repligen Corporation (Nasdaq:RGEN) today announced that Walter C. Herlihy, Ph.D., President and Chief Executive Officer, will present an overview of the Company at the 25th Annual Piper Jaffray Healthcare Conference on Tuesday, December 3 at 9:50 a.m. EST.
Receptos, Inc. (Nasdaq:RCPT) announced today that Christian Waage has been appointed Senior Vice President and General Counsel of the Company.
Synergetics USA, Inc. (NASDAQ: SURG) announced today that it will host a conference call on Monday, December 9, 2013 at 4:00 p.m. Central Time (5:00 p.m. Eastern) to review the Company's results for the fiscal first quarter ended October 31, 2013.
TG Therapeutics, Inc. (Nasdaq:TGTX), today announced that Michael Weiss, the Company's Interim Chief Executive Officer, will be presenting at the 2013 Deutsche Bank BioFEST Conference being held at the Four Seasons Hotel in Boston.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 25th Annual Piper Jaffray Health Care Conference in New York City on Wednesday, December 4th at 12:00pm (EST).
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced that effective today, Howard Zauberman, currently serving as Interim Chief Executive Officer, has been promoted to Chief Executive Officer and President.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today John Varian, the company's Chief Executive Officer, is scheduled to present at the 25th Annual Piper Jaffray Healthcare Conference on December 4, 2013, at 2:00 p.m. EST, at The New York Palace Hotel.