Medtronic Announces First Patient Enrollment in the WRAP Infection Clinical Trial
MINNEAPOLIS – Jan. 7, 2015 – Medtronic, Inc. (NYSE: MDT) today announced the first patient enrollment in the WRAP Infection Clinical Trial, which will evaluate the effectiveness of the TYRX™ Absorbable Antibacterial Envelope in reducing major infections in patients with cardiac implantable electronic devices (CIEDs) at risk for infection. The global clinical trial also will assess healthcare costs related to treatment of major infections in CIED patients. The first patient implant was performed by Edward J. Schloss, M.D., director of electrophysiology at The Christ Hospital in Cincinnati.
New Clinical Trial Will Evaluate Antibacterial Envelope in Cardiac Implantable Electronic Device Patients at Risk for Major Infections
Athersys Finishes Enrollment of Phase 2 Study of MultiStem(R) Cell Therapy for Ischemic Stroke Top-Line Data Readout Expected Around the End of the First Quarter, 2015
Top-Line Data Readout Expected Around the End of the First Quarter, 2015
CLEVELAND, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys' MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015.
Mirati Therapeutics Doses First Patient in Expansion Cohorts of Phase 1b Trial of MGCD265 in Genetically Selected Patients
Study Seeks to Confirm a High Response Rate among Cancer Patients with MET and Axl Genetic Alterations
SAN DIEGO, Dec. 23, 2014 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that the first patient with Non-Small Cell Lung Cancer (NSCLC) has been dosed in a Phase 1b clinical trial of MGCD265 in selected patients exhibiting genetic alterations of MET or Axl. In this segment of the study, one of the expansion cohorts will enroll patients with NSCLC and another will enroll patients with other solid tumors. Both cohorts will enroll only those patients that have specific MET driver mutations including MET gene point mutations, gene amplification, and MET or Axl gene rearrangements.
CardioDx Raises $35 Million in Equity Financing
- Funding Slated for Further Commercial Deployment of the Corus® CAD Blood Test and Continued Development of Next Generation Products -
REDWOOD CITY, CA – December 18, 2014 - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the close of $35 million in total equity financing. Alberta Investment Management Corporation (AIMCo) participated in this round together with the company's existing investors.
Chimerix and ContraVir Pharmaceuticals Establish Strategic Collaboration for Antiviral Drug Candidate CMX157
DURHAM, N.C. and EDISON, N.J., Dec. 18, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, and ContraVir Pharmaceuticals, Inc. (OTCBB:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the companies have entered into a strategic collaboration for the further clinical development and commercialization of CMX157. CMX157 is a highly potent analog of the successful antiviral drug tenofovir DF (Viread®).
Under the agreement, ContraVir licenses CMX157 from Chimerix in exchange for an upfront payment consisting of 120,000 shares of ContraVir preferred stock with a stated value of $1.2 million. In addition, Chimerix is eligible to receive up to approximately $20 million in clinical, regulatory and initial commercial milestones in the United States and Europe, as well as royalties and additional milestones based on commercial sales in those territories.
Ultragenyx Announces Initiation of Phase 3 Study of Recombinant Human Beta-Glucuronidase in Mucopolysaccharidosis Type 7
Agreement Reached With Both FDA and EMA on Pivotal Trial Design
NOVATO, Calif., Dec. 15, 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 the dosing of the first patient in the pivotal Phase 3 study of recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of Mucopolysaccharidosis 7 (MPS 7, Sly syndrome).
"We are pleased to have reached alignment with both the FDA and EMA on our single pivotal study design for this devastating disease," commented Sunil Agarwal, M.D., Chief Medical Officer of Ultragenyx. "This is an important step forward for these patients who have no approved treatment options. It is also an important milestone for Ultragenyx as it is the start of our first Phase 3 program."
The Phase 3 global, randomized, placebo-controlled, blind-start clinical study will assess the efficacy and safety of rhGUS in 12 patients between 5 and 35 years of age. Patients will be randomized to one of four groups. One cohort begins rhGUS therapy immediately, while the other three start on placebo and cross over to rhGUS at different predefined time points in a blinded manner. This novel trial design generates treatment data from all 12 patients, improving the statistical power of the study relative to a traditional parallel-group design. Based on data from the Phase 1/2 study, patients will be dosed with 4 mg/kg of rhGUS every other week for up to a total of 48 weeks, and all groups will receive a minimum of 24 weeks of treatment with rhGUS.
IlluminOss Medical Caps off Flagship Year with Addition of New Patents to Bone Fixation Portfolio
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.
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.
