|Arrowhead Receives Regulatory Approval to Begin Phase 2a Trial of ARC-520; Dendreon to Make PROVENGE® Commercially Available in Europe|
|By Staff and Wire Reports|
|Monday, 03 March 2014 20:46|
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, announced it received regulatory approval to begin a Phase 2a clinical trial of ARC-520, its RNAi-based drug candidate for the treatment of chronic hepatitis B virus (HBV) infection. The Hong Kong Department of Health issued a Certificate for Clinical Trial, allowing the Company to proceed with its planned single-dose study of ARC-520 in two cohorts at two dose levels to be conducted at Queen Mary Hospital and Prince of Wales Hospital in Hong Kong. A site initiation was completed and patient screening will initiate shortly. The Company expects top line study results to be available in the third quarter of 2014.
The Phase 2a study is a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to determine the depth and duration of hepatitis B surface antigen (HBsAg) reduction after a single intravenous dose of ARC-520 in combination with entecavir in patients with chronic HBV infection. Single doses of ARC-520 will be evaluated at up to two ascending doses of 1.0 mg/kg and 2.0 mg/kg. At each of the two dose levels to be evaluated, a cohort of 8 patients will be enrolled with 6 being dosed with ARC-520 and 2 being dosed with placebo. This study will be conducted in adult male and female patients aged 16 to 65 years, with immune active chronic HBV infection, HBV e antigen (HBeAg) negativity, and ongoing entecavir therapy.
The primary objective of the study is to evaluate the depth and duration of HBsAg decline in response to a single dose of ARC-520 in combination with entecavir. Secondary objectives include evaluation of safety and tolerability and pharmacokinetic (PK) measures. Additional exploratory pharmacodynamics (PD) objectives include evaluation of the effect of ARC-520 on HBV DNA serum titers and antibodies to HBsAg (anti-HBs).
Dendreon Corporation (NASDAQ: DNDN) announced that it plans to make PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) available in Europe, beginning with Germany and the United Kingdom.
Dendreon will make PROVENGE commercially available to patients within the approved label through Centers of Excellence using its Contract Manufacturing Organization, PharmaCell. Centers of Excellence are institutions where a high volume of prostate cancer patients are treated by leading prostate cancer experts. These centers will be located in larger cities, which will allow for convenient patient access. In some cases, a Center of Excellence may be a co-op group of institutions. Following the implementation of automation, which will enable Dendreon to manufacture more cost effectively, the Company will explore opportunities to make PROVENGE more broadly available in Europe and other world markets.
“Bringing PROVENGE commercially to Europe marks a major milestone for Dendreon,” said John H. Johnson, chairman, president and chief executive officer of Dendreon. “Both urology and oncology key opinion leaders in Europe have expressed a desire to have PROVENGE available to their patients and it is evident that there is pre-market demand as the first – and only – personalized immunotherapy approved for the treatment of mCRPC. We are pleased to be able to make PROVENGE available to oncologists and urologists and their prostate cancer patients in this important market.”
“As the first personalized immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE provides a new therapeutic option for advanced prostate cancer patients with a different mechanism of action than existing therapies,” said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. “We have a commercially-favorable label in Europe, including PSA quartile analysis and positive correlation between immune response and overall survival. These data will allow for early positioning and strong messaging for our reimbursement dossiers.”
PROVENGE is approved in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. Dendreon received marketing authorization for PROVENGE from the European Commission in September 2013, which provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced that ADXS-cHER2, its proprietary immunotherapy designed to treat women with breast cancer, was featured on CNN in a segment focused on its success in treating dogs with osteosarcoma (bone cancer).
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today outlined its research collaboration strategy for MANF, the Company's flagship therapeutic protein candidate.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced the appointment of Jay A. Barth, MD as Chief Medical Officer, effective today.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the full-year ended December 31, 2013.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today that Joseph M. DeVivo, President and Chief Executive Officer, is scheduled to address the Barclays Global Healthcare Conference on Tuesday, March 11, 2014, at 4:15 p.m. ET.
Baxano Surgical, Inc. (Nasdaq:BAXS) announced today that it plans to release fourth quarter 2013 financial and operating results after market close on Thursday, March 6, 2014.
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced the online publication in the journal Nature of extensive laboratory and nonclinical characterizations of BCX4430, including efficacy results in animal models of infection with Marburg virus and Ebola virus, two highly virulent pathogens responsible for viral hemorrhagic fever diseases.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the fourth quarter and year ended December 31, 2013 and outlined the Company's major clinical development goals for 2014.
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 it has appointed Dr. Peter K. Honig and Dr. Patrick Y. Yang to its Board of Directors.
Cesca Therapeutics Inc. (Nasdaq:KOOL), formerly known as ThermoGenesis Corp., today announced that Dr. Mahendra Rao has been appointed to the Company's board of directors effective April 1, 2014.
ChemoCentryx, Inc. (Nasdaq:CCXI) announced today that the Company's fourth quarter and year-end 2013 financial results will be released after market close on Thursday, March 13, 2014.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the initiation of a Phase 2 clinical trial of its lead drug candidate, emricasan, in patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH).
Cryo-Cell International, Inc. (OTCQB:CCEL), the world's first private cord blood bank to separate and store stem cells in 1992, today announced results for its fiscal year 2013.
Diversicare Healthcare Services, Inc. (Nasdaq:DVCR) today announced the Company has assumed operations of a 135-bed skilled nursing center in Huntsville, Alabama, effective March 1, 2014.
ExlService Holdings, Inc. (Nasdaq:EXLS), a leading provider of outsourcing and transformation services, today announced its financial results for the fourth quarter of 2013 and the year ended December 31, 2013.
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 the launch of Galena Patient Services (GPS), a full-service support program designed to enhance patient access to commercial products offered by the Company.
Hemp, Inc. (OTC:HEMP), through its wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc. (IHMMCC), announced today that its Board of Directors has appointed Dannion Brinkley to serve as Hemp Ambassador to Dewmar International BMC, Inc. (OTCBB:DEWM).
ICU Medical, Inc., (Nasdaq:ICUI), a leader in innovative medical devices used in infusion therapy, oncology and critical care applications, announced today that Scott Lamb, the Company's Chief Financial Officer, will be presenting at the 26th Annual ROTH Conference to be held on March 9-12, 2014 at the Ritz-Carlton Hotel in Laguna Niguel, CA.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that it will present at the following conference next month: At 1:30 PM ET on Tuesday, March 11, 2014, Mr. Jack Henneman, Chief Financial Officer of Integra LifeSciences, will present at the Barclays 2014 Global Healthcare Conference in Miami, FL.
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT), a Canadian drug delivery company focusing on oral drug delivery, today announced, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage drugs, that they submitted a response to the Complete Response Letter ("CRL") of the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") for their VersaFilm™ Oral Film Product for the treatment of acute migraines.
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 announced that Jon Wigginton, M.D., Senior Vice President, Clinical Development and Jim Karrels, Vice President and Chief Financial Officer, of MacroGenics, are scheduled to present at the 26th Annual ROTH Conference on Monday, March 10, at 10:30 a.m. Pacific (1:30 p.m. Eastern Time).
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 estimates sales for the full year 2014 in a range of $488.0 to $498.0 million.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has published data from the PROCEDE 500 study in the journal Current Medical Research and Opinion, demonstrating that 65 percent of physicians changed their original treatment plans for men with prostate cancer based on results from the Prolaris test.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that it will host an Investor Day on Thursday, March 20, 2014, beginning at 8:00am Eastern Time, in New York City.
Ohr Pharmaceutical (Nasdaq:OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, and leading global cancer research center Cold Spring Harbor Laboratory (CSHL) today announced the establishment of DepYmed Inc., a new joint venture to develop trodusquemine and related analogs.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today the promotion of Tara Nickerson, PhD, MBA, to Chief Business Officer.
RadNet, Inc. (Nasdaq:RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and/or operated outpatient imaging centers, today reported financial results for its fourth quarter and full year ended December 31, 2013.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage drugs, today announced, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT), a Canadian drug delivery company focusing on oral drug delivery, that they submitted a response to the Complete Response Letter ("CRL") of the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") for RHB-103, an oral thin-film rizatriptan for the treatment of acute migraines.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) expects to announce its Q4 2013 and full year 2013 financial results after market closes on Thursday, March 13, 2014.
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a development stage specialty pharmaceutical company, today announced that it recently held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of TNX-201 (single isomer isometheptene, or IMH) for the relief of episodic tension-type headache (ETTH).