|New Analysis of Phase III Shows Gout Patients Responded to KRYSTEXXA®; Celgene Advances ABRAXANE® Development in Cancers|
|By Staff and Wire Reports|
|Wednesday, 06 June 2012 18:57|
Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced new data presented in an oral session at the European League Against Rheumatism (EULAR) 2012 congress showed that patients with refractory chronic gout (RCG) who also suffer from chronic kidney disease (CKD) responded to treatment with KRYSTEXXA® (pegloticase) regardless of baseline CKD stage. CKD stage is assigned based upon level of kidney function as measured by glomerular filtration rate (GFR), with higher stages having lower GFR levels. Six additional abstracts, including a study measuring the impact of gout pain on quality of life in Western Europe, were accepted for presentation or publication at EULAR, June 6-9, 2012.
Uric acid, which is high in patients with gout, is processed and excreted primarily by the kidney. Impairment of kidney function can alter the uric acid lowering effect of conventional gout treatments and decrease the threshold for a patient to experience treatment-related toxicity. Some treatments for gout require a dose reduction to avoid toxicity, yet elevated uric acid has been associated with worsening kidney function.
"There are currently limited treatment options available for gout patients with CKD so these data are encouraging because they showed that KRYSTEXXA is effective regardless of CKD stage, or severity of disease, and treatment with KRYSTEXXA does not impact estimated GFR levels, an indicator of kidney function," said Robert A. Yood, M.D., Principal Investigator, Chief of Rheumatology at Reliant Medical Group, and Clinical Professor of Medicine at the University of Massachusetts Medical School.
This post-hoc analysis evaluated more than 200 patients with CKD stages one through four (n=34, 74, 80, 23, respectively) who were randomized to receive treatment with KRYSTEXXA 8 mg every other week, 8 mg every four weeks or placebo. Baseline CKD stage was similar across treatment arms, and there was no significant difference in rates of response to KRYSTEXXA by CKD stage (p<0.311). Additionally, treatment with KRYSTEXXA did not impact estimated GFR levels in patients with or without CKD. Similar results were seen in a 24-month open-label extension study.
In another study presented as a poster at EULAR, 35 percent of patients diagnosed with gout in Western Europe reported experiencing pain in the last 30 days (versus 20 percent in the control group of those who did not report gout; p<0.05). Of those patients, 23 percent reported severe daily pain (versus 13.5 percent in control group; p<0.05), which impacted quality of life as assessed by the SF-12 health outcome measurement tool. Based on study data, it is estimated that one in five gout patients in Western Europe experiences moderate to severe daily pain, one of the symptoms of gout.
"Currently there are no approved treatments for RCG in the European Union, so there remains an unmet need in Europe for treatment options for this often debilitating form of gout. Savient remains committed to working with European regulatory authorities to bring KRYSTEXXA to market as soon as possible," said Kenneth Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient Pharmaceuticals, Inc.
Savient is seeking approval for KRYSTEXXA in Europe and filed its Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in May 2011.
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) announced a series of milestones related to the development of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic pancreatic cancer, advanced non-small cell lung cancer, metastatic breast cancer and metastatic melanoma.
The company completed enrollment in the largest phase III study of metastatic pancreatic cancer to date (NCI clinical trial reference number NCT00844649). In this global study, 861 patients were randomized to receive either nab-paclitaxel plus gemcitabine or gemcitabine alone. Results from the study with a primary endpoint of overall survival are expected during the second half of 2012. The design of the study is based on the promising results of a phase I/II study in 67 patients published in the Journal of Clinical Oncology in December 2011 (Von Hoff et al, 2011 JCO).
In advanced non-small cell lung cancer, additional regulatory submissions were filed in Japan, Australia and New Zealand, which were based on the positive randomized phase III study reported online in the Journal of Clinical Oncology (Socinski et al, 2012 JCO (epub)). In the United States, the Food and Drug Administration (FDA) has set a PDUFA date of Oct. 12, 2012.
Amarantus BioSciences, Inc. (OTCBB: AMBS), a biotechnology company developing drug and diagnostic products for the treatment of Parkinson's disease and other nervous system disorders including Traumatic Brain Injury, today announced that it has been selected to participate in the National Investment Banking Association's 122nd Conference in New York City at Le Park Meridien Hotel June 7-8, 2012.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that it will voluntarily transfer its stock exchange listing from the NYSE Amex Exchange to the NASDAQ Stock Market LLC.
Arrowhead Research Corporation (NASDAQ: ARWR), a targeted therapeutics company, today announced that its hepatitis B virus (HBV) program has completed all internal preclinical requirements and has named a clinical candidate.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that additional safety and efficacy results from its BCX4208 gout program will be presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Berlin, Germany on June 7 & 8, 2012.
Chembio Diagnostics, Inc. (OTCQB: CEMI) (PINKSHEETS: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, announced today that its common stock will commence trading on the NASDAQ Capital Market® on Thursday, June 7, 2012, under the ticker symbol "CEMI."
China Cord Blood Corporation (NYSE: CO) ("the Company") today announced its plan to release financial results for the fourth quarter and full year of fiscal year 2012 on Monday, June 11, 2012, after market close in the US.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it will support the Brazilian Stroke Network (BSN), a non-governmental organization, through an unrestricted educational grant designed to assist the BSN in its efforts to increase education and awareness about stroke treatment and prevention in Brazil.
Depomed, Inc. (NASDAQ: DEPO) today announced the issuance of a new patent expanding the patent estate around the company's Gralise® (gabapentin), Depomed's once-daily gabapentin product approved for the management of postherpetic neuralgia.
Enzo Biochem, Inc. (NYSE: ENZ), will hold a conference call to discuss fiscal 2012 third quarter results on Tuesday, June 12, 2012, at 8:30 AM E.T.
Express Scripts, Inc. (Nasdaq: ESRX) announced that it will present at the William Blair Growth Stock Conference on June 12, 2012 at 11:30 a.m. Central (12:30 p.m. Eastern) at the Four Seasons Hotel in Chicago, Illinois.
Galena Biopharma (Nasdaq: GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today announced that President & CEO Mark J. Ahn, PhD, will present at RetailInvestorConferences.com.
Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today a podium presentation on the technology and clinical results from the on-going Phase II clinical trial of the AE37 breast cancer vaccine being developed by Generex wholly-owned subsidiary Antigen Express, Inc.
Gilead Sciences, Inc. (Nasdaq: GILD) announced today the appointments of Lord Paul Boateng, LLB, member of the United Kingdom House of Lords, and Hannah Kettler, PhD, senior health program officer and economist at the Bill & Melinda Gates Foundation, to the Gilead Health Policy Advisory Board.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that its corporate presentation will be webcast from the 32nd Annual William Blair & Company Growth Stock Conference in Chicago.
HASCO Medical, Inc. (OTCBB: HASC), www.HascoMed.com, a Company that conducts sales of handicap accessible vans, parts, service and rental operation in sixteen locations from Maine to Florida and sales of medical equipment and supplies in Alabama, Florida and Mississippi, announced today after releasing its financial results for the first quarter of 2012, during the allotted period in which officers and directors are free to trade, that all the officers and directors purchased shares of the Company's common stock.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, announced today that it is expanding its leading position in adherence packaging with the acquisition of AARDEX Group SA. AARDEX Group is the leader and pioneer in the design and use of electronic medication event monitoring systems and applications designed to measure, analyze, and manage patient adherence in clinical drug trials.
mPhase Technologies, Inc. (OTCBB: XDSL) said negotiations with two creditors have led to a standstill agreement and restructuring of approximately $1,500,000.00 Dollars in Toxic Convertible Debentures.
Monsanto Company (NYSE: MON) announced today that its Board of Directors has approved a new three-year share repurchase program and declared a quarterly dividend.
Bob Lorsch, Chairman and CEO of MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), today stated that AARP's launch of a Personal Health Record (PHR) is the most important measure of credibility to date for the PHR industry.
Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Lymphoseek and AZD4694 programs were accepted for presentation at the Society of Nuclear Medicine Annual Meeting from June 9-13 in Miami, Florida.
Ohr Pharmaceutical Inc. (OTCBB: OHRP) today announced the addition of two prominent ophthalmologists to its Scientific Advisory Board ("SAB") comprised of leading retinal ophthalmology experts to assist in advancing the Squalamine eye drop program into clinical efficacy trials.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, and Sharecare® an interactive health and wellness social platform providing people with access to expert-developed answers, information and programs to live their healthiest life, announce their partnership for WeightMate™, a comprehensive weight management program developed for participants in the Light Study.
Pall Corporation (NYSE:PLL) today reported financial results for the third quarter of fiscal year 2012 which ended on April 30, 2012.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced it has been issued US patent No. 8,192,408 titled “Ocular Trocar Assembly” for a new inserter developed to facilitate administration of micro-drug delivery devices.
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, today announced that Rob Chioini, CEO, and Ajay Gupta, M.D., CSO (Chief Scientific Officer) will co-present at RetailInvestorConferences.com.
Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, today announced the appointment of Roy N. Davis (age 65) to its Board of Directors.
Rosetta Genomics(NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, today announced that the NASDAQ Listing Qualifications Staff has determined that the Company is in compliance with the $2.5 million stockholders' equity requirement for continued listing on The NASDAQ Capital Market® as set forth in NASDAQ Listing Rule 5550(b)(1).
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) announces it has installed the VMS™ heart analysis system in six leading medical centres in the United States and Canada to enable the multi-centre clinical trial to assess the VentriPoint Medical System (VMS™) in patients with Pulmonary Arterial Hypertension (PAH).
Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that Thomas Braun, the Company's President & CEO, has been invited to speak at the International Society of Radiographers & Radiological Technologists (ISRRT) World Congress and the Canadian Association of Medical Radiation Technologists (CAMRT's) Annual General Conference on June 9, 2012 at 10:30 am.
Walgreens (NYSE: WAG) (NASDAQ: WAG) has named Alan E. London, M.D., Chief Medical Officer of Take Care Health Systems Consumer Solutions Group.