|Omeros Announces Phase 3 Results on OMS103HP; Cepheid Wins FDA Clearance for Xpert CT/NG|
|By Staff and Wire Reports|
|Thursday, 27 December 2012 19:37|
Omeros Corporation (NASDAQ: OMER) reported results from its first pivotal Phase 3 clinical trial evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery. In this multicenter, double-blind, Phase 3 clinical trial comparing OMS103HP to vehicle control in 344 subjects, the pre-specified primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) – a patient-reported measure that is comprised of questions about knee swelling, clicking, catching and stiffness. In addition, pain measured in the early postoperative period was a pre-specified secondary endpoint. Although the Symptoms Subscale of the KOOS did not reach statistical significance, OMS103HP achieved statistically significant (p=0.0003) reduction of postoperative pain. The pain reduction data were similar in magnitude to those in the Phase 2 clinical trial. OMS103HP also demonstrated improvement across a series of pain-related assessments including postoperative narcotic usage (with more than twice as many OMS103HP-treated subjects taking no postoperative narcotics), incidence of inflammatory adverse events, tourniquet use, and crutch use as well as time to discontinuation of crutches and return to work, a number of which also achieved statistical significance. In this study, as in the earlier clinical trials, OMS103HP was well tolerated. Given the strength and consistency of the data in this Phase 3 clinical trial, Omeros' second OMS103HP Phase 3 trial remains on track and will begin in the first half of 2013.
"The data from this Phase 3 trial are compelling and demonstrate the benefits of preemptive and multimodal treatment during surgery," stated William E. Garrett, Jr., M.D., Ph.D, professor of orthopaedic surgery and team physician at Duke University. "Early postoperative pain is predominantly inflammatory pain, and control of postoperative pain and inflammation is critical to functional recovery in arthroscopy patients. While OMS103HP demonstrated positive KOOS data in the Phase 2 trial, the absence of similar data in this trial does not detract from the drug's therapeutic value in light of its reduction of inflammatory pain. Arthroscopy patients with significant early postoperative pain and inflammation generally face a slower and more difficult recovery."
OMS103HP, added to standard irrigation solution used during arthroscopy, is Omeros' proprietary PharmacoSurgery™ product designed to provide a multimodal approach to reduce pain and inflammation following arthroscopic surgery. Inhibiting inflammation and resultant postoperative pain is critical to the management of arthroscopy patients. Comprised of only anti-inflammatory active ingredients without any anesthetic agents, such as lidocaine or bupivacaine, and delivered directly to the joint in the arthroscopic irrigation solution, use of OMS103HP avoids the frequently reported damage to cartilage cells due to intraarticular delivery of local anesthetics as well as the detrimental effects of systemically delivered analgesics.
Results from this first Phase 3 arthroscopic meniscectomy clinical trial are expected to be presented at an upcoming major orthopedic sports medicine meeting. Omeros also plans to publish the results in a leading peer-reviewed arthroscopy journal.
Cepheid (NASDAQ: CPHD) announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® CT/NG. Running on Cepheid's GeneXpert® Systems, Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). For the first time, same-day patient consultation and treatment is possible for the two most common sexually transmitted bacterial infections in the United States.
"We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG — a test we designed from the ground up to provide accuracy, ease of use, and results availability," said John Bishop, Cepheid's Chief Executive Officer. "We expect this innovative diagnostic test to deliver new levels of confidence to clinicians, in addition to enabling same-day decisions about treating their patients — the critical first step in effectively managing these epidemics."
"An on-demand test capable of delivering accurate results while patients are still present in the clinic provides a much-needed advantage in our efforts to control infectious diseases such as chlamydia and gonorrhea. Delays in treatment can lead to complications in about 1 in 25 infected women awaiting test results," said Dr. Edward Hook, MD, Professor of Medicine and Epidemiology at the University of Alabama, Birmingham, and Director of the STD Control Program for the Jefferson County Department of Health. "In addition, the availability of results in less than 90 minutes is especially important for patients presenting to Emergency Departments and in managing patients who may not return for treatment."
Based on Cepheid's unique experience with the biothreat detection program, where more than 11 million tests have been performed, the Company has learned that the best way to minimize gonorrhea false positive results is to include more than one genetic target.
"Xpert CT/NG incorporates several novel design features. First, our research team used in silico approaches to uncover multiple genomic targets for improving the accuracy of both CT and NG detection. Second, we included a first-in-class sample adequacy control that we believe overcomes limitations of first-generation technologies and adds significantly to the interpretation of diagnostic results generated by the GeneXpert System," said David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert CT/NG is clearly the most sophisticated test in its class, yet it can be performed on-demand by virtually any laboratory in order to maximize the medical impact of the results."
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis centered around its patented anti-apoptosis therapeutic protein MANF, today announced that President & CEO Gerald Commissiong will make a corporate presentation at Biotech Showcase 2013 on Wednesday January 9, 2013 at 9:00am PST at the Parc 55 Wyndham Hotel in San Francisco, CA.
Amarantus Biosciences, Inc. (OTC:AMBS), a development-stage biotechnology company, focuses on the discovery and development of therapeutic proteins and biologics for the treatment of Parkinson's disease, traumatic brain injury (TBI), and other human diseases in the United States.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease (PD).
AVEO Oncology (NASDAQ: AVEO) today announced that Tuan Ha-Ngoc, president and chief executive officer, is scheduled to present at the 31st Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2013 at 11:00 a.m. (PT) in San Francisco.
BASi (Bioanalytical Systems, Inc.) (NASDAQ:BASI) today announced the launch of Culex® NxT, the latest generation of the Company’s proprietary in vivo automated sampling system.
China Cord Blood Corporation (NYSE: CO) ("CCBC" or the "Company"), the first and largest cord blood banking operator in China, today announced that the Company will participate in the 31st Annual J.P. Morgan Healthcare Conference to be held January 7-10, 2013 at the Westin St. Francis Hotel in San Francisco.
Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today announced that Patrick T. Mooney, M.D., Chairman & CEO of Echo Therapeutics, will present at the Biotech Showcase 2013 Conference.
Global pharmaceutical chemistry services leader, Cambridge Major Laboratories, Inc. (“CML”) announced today that it has taken on a new private equity partner, American Capital, Ltd. (Nasdaq: ACAS) (“American Capital”).
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that President and CEO Bruce Barclay is scheduled to present at the 31st Annual J.P. Morgan Healthcare Conference.
Health Discovery Corporation (OTCBB: HDVY) announced today that on December 18, 2012, the Board of Directors appointed Dr. John Norris as its new CEO.
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it closed a private placement on December 21, 2012 for a gross proceeds of $2.0 million.
LiveWire Ergogenics, Inc. (OTCBB: LVVV) (OTCQB: LVVV) has expanded the retail markets for its LiveWire Energy™ chews in the northeastern United States with food wholesaler and distributer Garber Bros., Inc. and with food broker, Progressive Food Products, Inc., both of Stoughton, MA.
MGC Diagnostics Corporation (NASDAQ: MGCD), a global medical technology company, today announced that Gregg Lehman, chief executive officer and Rob Wolf, chief financial officer will present at the Sidoti & Company Annual New York Micro Cap Conference on Monday, January 7, 2013 at 1:30pm ET.
Omeros Corporation (NASDAQ: OMER) today reported results from its first pivotal Phase 3 clinical trial evaluating OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery.
PAREXEL International Corporation (Nasdaq: PRXL) announced today that on December 21, 2012, the Company acquired all of the outstanding equity securities of Liquent, Inc., a leading global provider of Regulatory Information Management (RIM) solutions.
Rapid Fire Marketing (PINKSHEETS: RFMK) announced today that Rapid Fire Marketing is now attained the status of "OTC Pink Current Information" at OTCMarkets.com. Reporting companies that submit filings to regulators with powers of review and that make the filings publicly available or non-reporting companies that make current information publicly available on the OTC Disclosure and News Service pursuant to OTC Markets Guidelines for Providing Adequate Current Information are designated as OTC Pink Current Information.
Retrophin (OTCQB: RTRX), a biotechnology company focused on discovering and developing treatments for rare and life-threatening diseases, today announced that Martin Shkreli, Founder & Chief Executive Officer, will be presenting at Biotech Showcase™ 2013, which is being held January 7-9, 2013 in San Francisco, CA.
TNI BioTech, Inc. (PINKSHEETS: TNIB), a biotech company combating fatal diseases through the activation and mobilization of the body's immune system using patented immunotherapy, is pleased to announce that Umbrella Research has initiated coverage on TNI Biotech, Inc.
TRIMEDYNE, INC. ("Trimedyne") (OTCBB: TMED) today announced Professor Anthony J. Costello, M.D., Head of the Department of Urology of the Royal Melbourne Hospital of the University of Melbourne (Australia), will serve as Lead Investigator in Asia and Southeast Asia, subject to their receiving funding, of the three (3), 300 patient, randomized, controlled clinical trials of Urodyne, Inc. ("Urodyne") in the treatment of Benign Prostatic Hyperplasia or BPH (commonly called an enlarged prostate) and the treatment of Urinary Incontinence and Fecal Incontinence and, subject to their receiving funding, the two (2), 300 patient randomized, controlled clinical trials of Hyperdyne, Inc. ("Hyperdyne") in the treatment of Uncontrolled Hypertension (high blood pressure not controllable by drugs) in Endoscopic and Percutaneous (balloon angioplasty-like) Procedures.