|NovaBay Strengthens Global Aganocide(R) Patent Estate; Chelsea Therapeutics Reports Top-Line Results of CH-4051|
|By Staff and Wire Reports|
|Thursday, 31 May 2012 19:29|
NovaBay Pharmaceuticals, Inc. (NYSE:NBY), a clinical-stage biotechnology company developing first-in-class "non-antibiotic anti-infective" products for the treatment and prevention of topical infections, announced three new composition of matter patent issuances in Australia, New Zealand and Mexico and four Notices of Allowance in Canada, Japan, South Africa and Mexico on its proprietary Aganocide compounds which includes its lead compound, NVC-422.
NVC-422 is a broad-spectrum anti-bacterial, anti-viral compound with a novel mechanism of action to address the unmet medical needs in several large markets. Different topical formulations of NVC-422 are in mid-to-late-stage clinical development in ophthalmology, dermatology and urology. These newly issued patents will give composition-of-matter exclusivity for NVC-422 until August 2024 in Australia, New Zealand and Mexico. In addition, the Canadian and Japanese patent offices have given Notices of Allowance for the corresponding patent applications in those countries. NVC-422 is already covered in the United States by U.S. Patent Nos. 7,462,361 and 7,893,109 providing protection to 2026 in the U.S.
Ron Najafi, Chief Executive Officer of NovaBay Pharmaceuticals, states, "These seven new patents add to a portfolio of composition of matter patents already granted in the US. They not only validate the innovative nature of our science but also enable us to develop what we believe will be a powerful tool in the fight against highly drug-resistant infections. NVC-422 is now protected by its patents in the U.S. until 2026 and 2024 elsewhere and can address major segments of the $100 billion global market for anti-infectives."
In addition to NVC-422, these patents cover additional Aganocide compounds. These compounds have unique physicochemical properties and form the basis for a pipeline of non-antibiotic anti-infective compounds to treat topical infections.
Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP) announced a preliminary analysis of its dose-ranging exploratory Phase II trial of CH-4051, a non-metabolized antifolate, in patients with rheumatoid arthritis (RA) who experience an inadequate response to methotrexate (MTX) treatment indicates that CH-4051 did not demonstrate superior efficacy to methotrexate in the dose range evaluated.
"Results of this study provide evidence of the clinical activity of CH-4051, in a dose dependent manner, across multiple RA assessment criteria," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "However, the outcome of the trial was confounded by the unexpectedly robust response reported by patients treated with methotrexate. While we believe that higher doses of CH-4051 could provide enhanced therapeutic benefit in RA and that CH-4051 could be developed for other anti-inflammatory and autoimmune indications, we believe our current resources would be better allocated toward the planned completion of our Northera" (droxidopa) development program in neurogenic orthostatic hypotension. Consequently, we have no immediate plans to continue development of CH-4051."
Using a modified intent-to-treat (ITT) population of 244 patients with a post-baseline efficacy assessment, the primary efficacy analyses utilized the hybrid American College of Rheumatology score (hACR) followed by the traditional ACR 20 (20% improvement in ACR criteria) to compare responses among patients treated with 0.3 mg (n=48), 1.0 mg (n=48) or 3.0 mg (n=49) of CH-4051 daily, 3.0 mg of CH-4051 daily in combination with a folate supplement (n=49) or 20.0 mg MTX weekly (n=50) with a folate supplement for 12 weeks following a two-week MTX-washout.
At the end of the 12-week period, patients treated with MTX showed greater improvement in both mean hACR (38.4) and ACR20 response rate (56.0%) compared to patients treated with 0.3mg CH-4051 (hACR: 15.0, ACR20: 41.7%), 1.0 mg CH-4051 (hACR: 17.9, ACR20: 45.8%), 3.0mg CH-4051 (hACR: 25.2, ACR20: 34.7%) or 3.0mg CH-4051 with folate supplement (hACR: 25.5, ACR20: 45.8%).
CH-4051 was found to be safe and well tolerated in the study, with no dose-limiting toxicities or clear differences in the overall adverse event rate between the MTX (52.9%) and 0.3mg, 1.0mg and 3.0mg CH-4051 (38.0%, 42.9% and 30.0%) and 3.0mg CH-4051 plus folate (49.0%) treatment groups.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) will present research at the 4th Collaborative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) that examines the impact of walking impairment on different aspects of the lives of people with multiple sclerosis (MS), as well as the use of AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg in the United States.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that an article published in the May 2012 issue of Plos One, outlines a novel mechanism of action of the Company's oral anti-cancer compound, perifosine, which could provide a rationale for a novel approach to the treatment of Malignant Pleural Mesothelioma (MMe), an aggressive type of cancer associated with exposure to asbestos.
Affymetrix, Inc. (NASDAQ:AFFX) and Leica Microsystems are pleased to announce a world-wide collaboration that automates Affymetrix’ QuantiGene® ViewRNA ISH Tissue Assay on the Leica BOND RX staining platform for research applications*.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer, will present at the 2012 Jefferies Global Healthcare Conference on Thursday June 7, 2012 at 3:00 pm Eastern Time.
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that an abstract analyzing a subset of efficacy results from its Phase 3 trial of APF530 has been published in conjunction with the American Society of Clinical Oncology’s (ASCO) 2012 Annual Meeting.
The U.S. Food and Drug Administration (FDA) has approved revised product labeling for the Boston Scientific Corporation (NYSE: BSX) INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that results from its PIX301 phase 3 clinical trial of Pixuvri® (pixantrone) have been published online in The Lancet Oncology.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc., will present at the Jefferies 2012 Global Healthcare Conference in New York City on Wednesday, June 6, 2012 at 8:30 a.m. ET.
Covidien (NYSE: COV), a leading global provider of healthcare products, will present at the Goldman Sachs 33rd Global Healthcare Conference in Rancho Palos Verdes, CA, on Thursday, June 7, 2012.
Exelixis, Inc. (NASDAQ: EXEL) announced today that Michael M. Morrissey, Ph.D., the company’s president and chief executive officer, will present at the Goldman Sachs 33rd Annual Global Healthcare Conference at 12:20 p.m. EDT / 9:20 a.m. PDT on Wednesday, June 6, 2012, in Rancho Palos Verdes, California.
GenSpera, Inc. (OTCBB:GNSZ) announced the appointment of Peter E. Grebow, Ph.D. to its Board of Directors. Dr. Grebow will be the company’s third independent director and will serve on the company’s (i) Audit Committee, (ii) Nominating and Corporate Governance Committee, and (iii) Leadership Development and Compensation Committee, of which he will chair the Nomination and Corporate Governance Committee.
Illumina (NASDAQ:ILMN) today introduced the Nextera XT DNA Sample Preparation Kit, the easiest way for researchers to prepare and sequence small genomes, PCR amplicons, and plasmids.
La Jolla Pharmaceutical Company (OTCQB: LJPC) (PINKSHEETS: LJPC) (the "Company" and "La Jolla") announced today that the United States Patent and Trademark Office (USPTO) has issued patent number 8,187,642 covering compositions of modified pectins.
Life Technologies Corporation (NASDAQ: LIFE) today announced the 5500xl W Genetic Analyzer has radically simplified the next generation sequencing workflow, as well as significantly improved the economics of sequencing.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today announced that it has entered into an amended services agreement with E-Mail Frequency (www.emailfrequency.com) to offer the Company's MyMedicalRecordsPersonal Health Record (PHR) products and services exclusively to a consortium of wholesale affinity and employee benefit Telemedicine Providers starting this July.
MultiCorp International, Inc./XTend Medical Corporation (PINKSHEETS: XMDC), has agreed to acquire WEUS 810AM radio station located in Orlando, Fl.
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NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that it will exhibit and participate in the American Diabetes Association (ADA) 72nd Scientific Sessions.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has completed patient enrollment in its pivotal Phase III CRUISE-1 clinical study, designed to provide iron-delivery to hemodialysis-dependent CKD patients.
Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, today announced that data from studies demonstrating the clinical utility of two of the Company's miRview® products to identify and classify tumors will be presented at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting taking place at the McCormick Place Convention Center in Chicago from June 1-5, 2012.
RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) today announced that it has received clearance for its investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA) to initiate clinical trials with RXI-109, a self-delivering RNAi compound that selectively targets Connective Tissue Growth Factor (CTGF).
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company’s business strategy will be given at the Jefferies 2012 Global Healthcare Conference being held at The Grand Hyatt Hotel in New York City.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced key presentations of clinical data, including five ZEVALIN-related poster presentations, as well as a poster presentation and one e-abstract publication of clinical data for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, from June 1-5, 2012.
Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced that the Company will present at the Jefferies 2012 Global Healthcare Conference on June 7, 2012, in New York City.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that Jeff Black, Senior Vice President and Chief Financial Officer, will present at the upcoming Ardour Capital Energy Technology Conference.
Shareholder Rights Law Firm Johnson & Weaver, LLP announces that it is investigating whether certain officers and directors of ViroPharma, Inc. (“ViroPharma” or “the Company”) (NASDAQ:VPHM), may have engaged in fraudulent conduct that breached their fiduciary duties to shareholders and violated United States securities laws.
WuXi PharmaTech (NYSE: WX) today announced that its toxicology facility in Suzhou had received a statement of Good Laboratory Practice (GLP) from the Belgium Scientific Institute of Public Health after successfully passing two GLP inspections conducted by the Belgium GLP Monitorate.