2014 Marked by Continued Success in International Orthopedics Markets and Conditional Clearance for First U.S. Clinical Trial to Begin in 2015
East Providence, RI (December 10, 2014) – IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has been issued two new patents related to its internal bone fixation system. IlluminOss now owns 25 issued U.S. patents and its complete intellectual property portfolio includes over 55 issued patents in 17 countries around the world - with many more patent applications Hollister Outlet currently pending related to its revolutionary IlluminOss System for minimally invasive fixation and treatment of broken bones.
IlluminOss Medical Caps off Flagship Year with Addition of New Patents to Bone Fixation Portfolio
Afferent Clinical Data Demonstrating AF-219 Treatment Reduces Cough Frequency by 75% in Chronic Cough is Published in The Lancet
SAN MATEO, Calif.--(BUSINESS WIRE)-- Afferent Pharmaceuticals today announced publication of results from a Phase 2 clinical trial demonstrating that the company’s novel drug candidate, AF-219, reduced daytime cough frequency by 75% compared to placebo in patients with treatment-refractory chronic cough. These data are featured in an article titled, "P2X3 Receptor Antagonist (AF-219) in Refractory Chronic Cough: A Randomised, Double-Blind, Placebo-Controlled Phase 2 Study," which is appearing online in The Lancet. These results support Afferent’s current development strategy to initiate a Phase 2b clinical trial early in 2015. AF-219 is a selective, non-narcotic and orally administered agent that targets the mechanism by which certain nerve fibers become hyper-sensitized and lead to chronic and debilitating symptoms such as cough.
Milestone Announces Positive Phase 1 Data for MSP-2017; Supports Advancement into Phase 2 in PSVT Patients
Montreal, QC, November 24, 2014 – Milestone Pharmaceuticals, Inc. today announced data from a Phase 1 clinical trial conducted in Melbourne, Australia of MSP-2017, a novel calcium channel antagonist for the potential treatment of paroxysmal supraventricular tachycardia (PSVT). The results demonstrated that an intra-nasal formulation of MSP-2017 was well tolerated at single doses up to and including 140 mg with an excellent safety profile, desirable PK properties including rapid onset, and validating proof of concept by PR interval prolongation as measured by ECG. Milestone expects to initiate a Phase 2 clinical trial of MSP-2017 in patients with PSVT during the first half of 2015.
IlluminOss Medical Announces Conditional FDA Approval for Clinical Trials of Groundbreaking Photodynamic Bone Stabilization System in the U.S.
Currently Recruiting Clinical Sites for Trial that May Offer Significant Advantages to Surgeons Treating Impending and Pathologic Fractures
East Providence, RI (November 18, 2014) – IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received conditional approval from the FDA to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma. IlluminOss expects to begin enrolling clinical sites and initiate the trial shortly.
Chimerix's Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa by International Consortium
DURHAM, N.C., Nov. 13, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the University of Oxford are in the process of finalizing a definitive agreement for supplying brincidofovir for the planned clinical trial.
Ultragenyx Granted EU Orphan Drug Designation for KRN23 for the Treatment of X-Linked Hypophosphatemia
Novato, CA, Oct. 30, 2014 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the European Commission has granted orphan medicinal product designation for recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (KRN23 or UX023) for the treatment of X-linked hypophosphatemia (XLH). XLH is an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures, and muscle weakness.
Chimerix hammers out an emergency PhII Ebola study for antiviral
October 28, 2014 -- Chimerix has outlined plans for a small Phase II study of its powerful antiviral brincidofovir as a counterpunch to Ebola.
In recent weeks the biotech ($CMRX) has added details on its study design listed on clinicaltrials.gov. The trial calls for 50 patients aged 2 months to 75 years old who test positive for the lethal Ebola virus. While the online site notes that no recruiting is being done yet, Chimerix lists a company contact for the study along with plans to start off Ebola patients with a 200-mg dose of brincidofovir (CMX001), to be followed up with four 100-mg doses over the next two weeks. The study is slated to wrap up a little more than a year from now.
Ultragenyx Granted Orphan Drug Designation for Triheptanoin for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome
NOVATO, CA – October 27, 2014 – Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS, also known as De Vivo disease, is a rare and potentially severely debilitating disease characterized by seizures, developmental delay, and movement disorder. Ultragenyx is conducting a Phase 2 study of triheptanoin in patients with Glut1 DS.
CardioDx Announces Results of Study Demonstrating the Benefits of the Corus CAD Gene Expression Test Use in an African American Patient Population
- Patients with Low Corus CAD Scores Had a 95% Decreased Rate of Referral for Advanced Cardiac Testing Versus Patients with Elevated Corus CAD Scores -
REDWOOD CITY, Calif. – [October 20, 2014] - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the presentation of the study, “The Use of a Gene Expression Score Showed Clinical Utility in Evaluating African Americans Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease in a Primary Care Practice,” at the 36th Annual North American Meeting of the Society for Medical Decision Making, taking place from Oct. 18-22 in Miami.
LabCorp Announces Agreement to Acquire LipoScience
NMR LipoProfile test expands LabCorp’s offering of personalized diagnostic tests
BURLINGTON, N.C.--(BUSINESS WIRE)--Sep. 25, 2014-- Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) and LipoScience, Inc. (NASDAQ:LPDX), a provider of specialized cardiovascular diagnostic laboratory tests based on nuclear magnetic resonance (NMR) technology, today announced that they entered into a definitive merger agreement under which LabCorp would acquire LipoScience for a purchase price of $5.25 per share in cash, or a transaction value of $85.3 million which represents a total enterprise value of approximately $63 million. The Board of Directors of LipoScience has unanimously approved the agreement and recommended approval of the transaction by LipoScience’s stockholders.
“We are very pleased that LipoScience, a premier laboratory focused on personalized diagnostics for cardiovascular and metabolic disorders, is joining the LabCorp family,” said David P. King, Chairman and Chief Executive Officer of LabCorp. “LipoScience’s NMR LipoProfile test will enhance our innovative clinical decision support programs, advancing the Fifth Pillar of our strategy as we provide ever-broader, differentiated knowledge services to physicians and patients. Furthermore, LipoScience’s novel application of NMR technology furthers the Fourth Pillar of our strategy by continuing our leadership in scientific innovation. In addition to LipoScience’s strategic fit, the transaction is expected to be accretive to LabCorp’s earnings in year one, and to earn its cost of capital by year three.”
