|Arena Pharma Reports Closing of Phase 1b Clinical Trial for APD811; Cepheid Reports Xpert MTB/RIF Categorized 'Moderate Complexity' by FDA|
|By Staff and Wire Reports|
|Wednesday, 28 August 2013 19:35|
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced the completion of a Phase 1b clinical trial for APD811, an investigational oral prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). The company plans to initiate a Phase 2 clinical trial for APD811 in the first quarter of 2014.
"Arena's internal GPCR-focused efforts led to the discovery of this novel drug candidate," said William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "We believe APD811 is a promising new chemical entity that could improve current patient care by providing an oral option for IP-targeted therapy. Based on the encouraging Phase 1 results, we look forward to initiating the Phase 2 program early next year."
This randomized, double-blind and placebo-controlled Phase 1b clinical trial evaluated the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD811. Arena previously evaluated single-ascending doses of APD811 in a Phase 1a clinical trial.
In the Phase 1b clinical trial, 40 healthy volunteers received APD811 and 15 received placebo, and the safety profile of APD811 was characteristic of IP receptor agonists. No serious adverse events were observed, and the most frequent treatment-emergent adverse events were headache, nausea and jaw pain. The results of the Phase 1 program led to the decision to proceed with Phase 2 development of APD811, which will include further exploration of dosing regimens in PAH patients.
Cepheid (NASDAQ: CPHD) announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert^® MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene.
The test runs on Cepheid's GeneXpert® Systems and is the first and only molecular TB (tuberculosis) test to be categorized as Moderately Complex.
ActiveCare, Inc. (OTCBB:ACAR), the service leader in disease and diabetes management today reported revenues for the third quarter and nine months ended June 30, 2013.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) today announced that its request to transfer its listing to the NASDAQ Capital Market® from the NASDAQ Global Market® has been approved by the NASDAQ Listing Qualifications Staff.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has notified the Company that it is extending the Prescription Drug User Fee Act ("PDUFA") goal date for the Company's supplemental biologics license application ("sBLA") for XIAFLEX®(collagenase clostridium histolyticum) for the treatment of Peyronie's disease ("PD") from September 6, 2013 to December 6, 2013.
Sheldon T. Anderson has been elected to the Board of Directors of Bioheart, Inc. (OTCQB: BHRT), a biotech company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage as well as severe peripheral vascular disease.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that its abstract entitled "BL-7010: Non-Absorbable Polymeric Sequestering Agent for Celiac Disease" was accepted for an oral presentation at the 15th International Celiac Disease Symposium, which will take place September 22-25, 2013 in Chicago.
BioTime, Inc. (NYSE MKT: BTX) today announced that it has received approval from The Spanish Agency of Medicines and Medical Devices (AEMPS) to begin human clinical trials of Renevia™, a unique biomaterial used as a delivery matrix for autologous adipose derived cells to treat the loss of subcutaneous adipose tissue (lipoatrophies) arising from trauma, surgical resection, and congenital defects and disease.
Can-Fite BioPharma (TASE: CFBI) (PINKSHEETS: CANFY), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it will initiate a its Phase 2 study in the U.S., Europe and Israel for its anti-cancer drug CF102 in the treatment of primary liver cancer (hepatocellular carcinoma, or HCC).
The Board of Directors of Eli Lilly and Company (NYSE: LLY) has elected Marschall S. Runge, M.D., Ph.D., as a new member, effective September 1, 2013.
Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced its participation in upcoming September conferences.
Given Imaging (Nasdaq:GIVN) today announced that Homi Shamir, President and CEO, will present at the Morgan Stanley Global Healthcare Conference taking place in New York City September 9 – 11, 2013.
IsoRay, Inc. (NYSE MKT: ISR), specializing in the development, manufacture, and sale of isotope-based medical products and devices for the treatment of cancer and other malignant diseases primarily in the United States, today announced the pricing of an underwritten offering of units of its common shares, convertible preferred shares and short-term "greenshoe" warrants.
LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME) announced that its VELscope® Vx Enhanced Oral Detection device has received the Pride Institute's "Best of Class" Technology Award for 2013.
LeMaitre Vascular, Inc. (Nasdaq:LMAT), a provider of peripheral vascular devices and implants, announced today that it acquired the assets of InaVein, LLC for $2.5mm, or 1.1X InaVein's 2012 sales, and potential earn-out payments in 2014 and 2015 based on the performance of the acquired business and regulatory approval in China. InaVein owned and marketed the TRIVEX® System, a business that carried a 60-70% gross margin.
Magellan Pharmacy Solutions, a division of Magellan Health Services (NASDAQ: MGLN), will host its 10th annual Oncology Summit – What You Don’t Know Can Hurt You – on September 18 and 19 in Baltimore, Maryland.
As Nuvilex, Inc. (OTCQB: NVLX) continues to methodically build its brand as a biotechnology firm ahead of its future Phase III clinical trials for the treatment of advanced, inoperable pancreatic cancer, it looks on while one more big pharmaceutical company produces inferior data to its own.
Perrigo Company (NYSE, TASE: PRGO) and Elan Corporation, plc. (NYSE: ELN) today announced that Perrigo Company Limited ("New Perrigo") has filed with the U.S. Securities and Exchange Commission (SEC) a registration statement on Form S-4 in connection with Perrigo's proposed acquisition of Elan, which included a joint proxy statement of Elan and Perrigo (the "Form S-4").
PURE Bioscience (OTCQB: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced the strengthening of its sales and marketing leadership team.
Rexahn Pharmaceuticals (NYSE MKT: RNN) announced today that Teva Pharmaceutical Industries has decided, for strategic reasons, not to exercise its option to license RX-3117 from Rexahn.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 2013 Stifel Nicolaus Healthcare Conference in Boston on Wednesday, September 11 at 9:10am (EDT).
Walgreens (NYSE: WAG) (Nasdaq: WAG) and Orlando Health, a comprehensive not-for-profit health care organization based in Orlando, Fla., today announced a clinical collaboration that will provide coordinated and expanded health care services, while improving patient access to high-quality, convenient and affordable care throughout Central Florida.