Lisa Dreyer - Page 29 - Pappas Capital

Chimerix Announces Top Line Data From CMX001 Phase 2 Adenovirus Study and Late-Breaker Presentation at ICAAC

-Encouraging results from the first proof-of-concept study for adenovirus infection support continued clinical development of CMX001 as a first-in-class broad-spectrum antiviral for prevention of double-stranded DNA viral infections

-Data accepted for oral late-breaker presentation at the ICAAC Annual Meeting on September 10th

DURHAM, N.C., Aug. 14, 2013 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced top line data from the exploratory Phase 2 study of CMX001 as preemptive therapy for adenovirus (AdV) infection, the first interventional trial in AdV infection. In this trial in allogeneic hematopoietic cell transplant (HCT) recipients, the 100 mg dose given twice weekly (BIW) demonstrated decreased levels of AdV viremia and showed a potential benefit in reducing both progression to AdV disease and all-cause mortality, compared to subjects who received placebo or CMX001 given once weekly (QW). Planned intent-to-treat analyses as well as exploratory analyses in specific patient groups were consistent in trends favoring the CMX001 BIW regimen over placebo, although statistical significance was not established in this exploratory study.

Chimerix - 08/14/2013

Ultragenyx Receives Approval of Clinical Trial Application (CTA) for a Phase 1/2 Trial TestingUX003 in Mucopolysaccharidosis Type 7 (MPS 7)

Ultragenyx Receives Approval of Clinical Trial Application (CTA)
for a Phase 1/2 Trial TestingUX003 in Mucopolysaccharidosis Type 7 (MPS 7)

NOVATO, CA – August 14, 2013 - Ultragenyx Pharmaceutical Inc., a biotechnology company, received Clinical Trial Application (CTA) approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. to conduct a Phase 1/2 clinical trial of UX003, recombinant human β-glucuronidase, in MPS 7, a rare autosomal recessive lysosomal storage disorder characterized by a deficiency of the enzyme β-glucuronidase. MPS 7 is a severe multi-system disease resulting in cellular and organ dysfunction. There is no approved drug therapy.

Ultragenyx Pharmaceutical - 08/14/2013

TYRX Announces First U.S. Implantation of AIGISRx® R Fully Bioresorbable Antibacterial Envelope

Procedure Performed at Vanderbilt Heart and Vascular Institute

Monmouth Junction, NJ. (August 7, 2013): TYRX, Inc. announced today that the first implantation of its new AIGISRx R Fully Resorbable Antibacterial Envelope has taken place at the Vanderbilt Heart and Vascular Institute in Nashville, TN by Dr. Christopher R. Ellis. The AIGISRx R Antibacterial Envelope received U.S Food and Drug Administration (FDA) clearance on May 20, 2013.

TYRX - 08/12/2013

Ultragenyx Initiates New Development Program Studying Triheptanoin (UX007) for the Treatment of Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)

Phase 2 Trial Initiation Planned for Year End

NOVATO, Calif., Aug 05, 2013 (GLOBE NEWSWIRE via COMTEX) -- Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced its plan to develop triheptanoin (UX007) for the treatment of seizures in glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS is a rare and severely debilitating disease caused by mutations in the SLC2A1 gene, which encodes for a protein called glucose transporter type-1 (Glut1). The disease is characterized by seizures, developmental delay and movement disorders. The Glut1 protein transports glucose from blood into the brain. Because glucose is the primary source of energy for the brain, this defect in the Glut1 transporter results in a chronic state of brain energy deficiency. The company is planning to initiate a Phase 2 trial studying triheptanoin in Glut1 DS by the end of 2013.

Ultragenyx Pharmaceutical - 08/05/2013

LipoScience Research Sheds Light On Novel Markers Via Nuclear Magnetic Resonance (NMR) Spectroscopy

Posters Presented at American Association of Clinical Chemistry (AACC) Meeting Highlight Utility of NMR Technology in Inflammatory Disease Risk Assessment and Diagnosis of Diabetes

RALEIGH, N.C., JULY 31, 2013 — /PRNewswire/ -- Researchers from LipoScience, Inc. (NASDAQ: LPDX), a diagnostic company pioneering a new field of personalized NMR diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, are presenting two posters today that highlight the utility of the company's proprietary nuclear magnetic resonance (NMR) technology in measuring novel markers of systemic inflammation, as well as in diagnosing diabetes through measurement of blood glucose. The posters, which will be presented during the Technology/Design Development session at the American Association of Clinical Chemistry (AACC) annual meeting in Houston, Tex., will be on display today from 9:30 a.m. to 5:00 p.m.

LipoScience - 07/31/2013

TESARO Initiates Phase 3 Trial of Niraparib for Treatment of Patients with Ovarian Cancer

First Patients Enrolled in the NOVA Study

WALTHAM, Mass., July 23, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has initiated patient enrollment in a Phase 3 trial of niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), for the treatment of ovarian cancer. This trial, referred to as NOVA, will evaluate a single daily 300 milligram dose of niraparib in 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer compared to placebo.

TESARO - 07/23/2013

TYRX Receives FDA Clearance for AIGISRx® Neuro Antibacterial Envelope

Expands Access to Proven Antibacterial Technology to Neurosurgery

Monmouth Junction, NJ. (July 23, 2013): TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the AIGISRx Antibacterial Envelope for use with vagus nerve stimulators, which are currently used to treat seizure disorders and depression. This approval extends TYRX’s leadership in the
commercialization of implantable medical devices designed to help reduce surgical-site infections (SSIs) associated with implantable devices into the field of neurosurgery.

TYRX - 07/23/2013

Stem cell therapy for transplants developed by Athersys Inc. may end need for long-term immunosuppressive drugs

CLEVELAND, Ohio (July 23, 2013) -- One of the biggest problems facing anyone who receives an organ transplant is rejection. When the immune system, which is designed to keep us healthy, reacts to a donated organ as if it were a foreign invader and attacks, doctors have to prescribe powerful drugs to keep it in check.

Those drugs, called immunosuppressants, are a necessary evil for most transplant recipients for as long as they live. They prevent rejection, but can lead to infection, gastrointestinal disease, pancreatitis, cancer and kidney failure.

Athersys - 07/23/2013

Chimerix CEO: Public market is critical to financing biotech R&D

July 15, 2013
Chimerix (Nasdaq: CMRX) CEO Ken Moch is speaking out about the role of the public market in financing research and development.

Moch, whose company hit the public market earlier this year, recently spoke at a hearing held by the House Financial Services’ Subcommittee on Capital Markets and Government Sponsored Enterprises.

Chimerix - 07/15/2013

Ultragenyx Gains Worldwide Rights for Triheptanoin (UX007)

Option Exercised for Ex-North American Territories

Novato, CA –July 11, 2013--Ultragenyx announced that it has expanded its exclusive license from Baylor Research Institute (BRI)in Dallas, Texas,to develop and commercialize triheptanoin outside of North America. The global license includes rights to patents, patent applications and other intellectual property related to the composition and formulation of UX007 as well as its use in treating a number of diseases including fatty acid oxidation disorders (FAOD), the lead indication being developed by the company.

Ultragenyx Pharmaceutical - 07/11/2013